Skip to main content
NCBI home page
NIHPA Author Manuscripts logoLink to NIHPA Author Manuscripts
. Author manuscript; available in PMC: 2022 Sep 1.
Published in final edited form as: Pediatrics. 2021 Aug 19;148(3):e2021050261. doi: 10.1542/peds.2021-050261

Weight Loss Interventions for Adolescents with Intellectual Disabilities: A RCT

Lauren T Ptomey a, Richard A Washburn a, Jeannine R Goetz b, Debra K Sullivan b, Cheryl A Gibson a, Matthew S Mayo c, Ron Krebill c, Anna M Gorczyca a, Robert N Montgomery c, Jeffery J Honas a, Brian C Helsel a, Joseph E Donnelly a
PMCID: PMC8477713  NIHMSID: NIHMS1742082  PMID: 34413247

Abstract

Objectives:

This randomized trial compared the effectiveness of 2 diets [enhanced Stop Light diet (eSLD) vs. conventional meal plan diet (CD)], and 2 delivery strategies [face-to-face (FTF) vs. remote delivery (RD)], for weight loss across 6 months in adolescents with intellectual and developmental disabilities (IDD) with overweight and obesity.

Methods:

Participants were randomized to one of 3 arms: FTF/CD, RD/CD, or RD/eSLD, and asked to attend one-on-one sessions with a health educator every 2 weeks to aid in maintaining compliance with recommendations for a reduced energy diet and increased physical activity. The CD followed the US dietary guidelines. The eSLD utilized the Stop Light guide and was enhanced with portion-controlled meals. The FTF arm was delivered during in-person home-visits. The RD arms were delivered using video conferencing.

Results:

110 adolescents with IDD (age ~16 yrs., 53% female, BMI 33 kg/m2) were randomized to the FTF/CD (n=36), RD/CD (n=39) or RD/eSLD (n=35) groups. Body weight at 6 months was obtained from 97%, 100%, and 86% of participants in the FTF/CD, RD/CD, and RD/eSLD arms, respectively. The eSLD elicited significantly greater weight loss than the CD: RD/eSLD (−5.0±5.9 kg; −6.4%) vs. RD/CD (−1.8±4.0 kg;−2.4%) (p=.01). However, weight loss did not differ by delivery strategy: FTF/CD (−0.3±5.0 kg; −0.2%) vs. RD/CD (−1.8±4.0 kg; −2.4%) (p=0.20).

Conclusion:

The eSLD elicited significantly greater 6-month weight loss compared with a CD when both interventions were delivered remotely. Minimal 6-month weight loss, which did not differ significantly between FTF and remote delivery, was observed using a CD.

Article Summary:

This randomized trial compared the effectiveness of 2 diets and 2 delivery strategies, for weight loss in adolescents with intellectual and developmental disabilities.

INTRODUCTION

Approximately 1–3% of the US population is diagnosed with an intellectual or developmental disability (IDD) defined as a disability originating before the age of 10, characterized by significant limitations in both intellectual functioning (IQ < 75) and in 2 or more adaptive behaviors1. The prevalence of obesity (BMI ≥ the 95th%ile) is higher in adolescents with IDD (22% – 60%)2–4 compared with typically developing peers (20.6%)5. However, evidence-based strategies for weight management specific to adolescents with IDD are currently unavailable.

The limited number of small sample (n ≤ 20), short-term (≤ 20 weeks) trials (total n= 11 trials, n =2 randomized) that have evaluated the impact of lifestyle interventions on body weight in youth with IDD have shown minimal 6-month weight loss, i.e , < 3 kg2, 6. The majority of these trials included increased physical activity without an energy reduced diet, and thus do not comply with current guidelines for the management of overweight and obesity7. The limited available evidence and the generally small magnitude of reported weight loss suggests that additional innovative strategies for weight management for adolescents with IDD need to be developed and evaluated.

Previous work by our group has suggested the potential of an enhanced version of the Stop Light Diet (eSLD) when delivered remotely and using technology for self-monitoring diet and physical activity to elicit clinically relevant weight loss in adolescents with IDD. The Stop Light Diet, originally developed by Epstein and Squires for use in children8, categorizes foods by energy content: green (low energy-consume freely), yellow (moderate energy-consume in moderation), and red (high energy-consume sparingly). In addition to using the Stop Light system for making appropriate food choices, the eSLD encourages the consumption of high volume, low energy portion-controlled entrées and shakes, and fruits and vegetables. The eSLD is easy to understand, simplifies meal planning and food shopping/meal preparation, and does not require the ability to read and comprehend educational materials, nutrition labels, etc. that are required in weight management programs designed for typically developed individuals. Remote delivery offeres potential benefits for the delivery of weight management to adolescents with IDD. The group based on-site face-to-face format (FTF) that is traditionally used for the delivery of weight management programs in typically developing individuals may be problematic for individuals with IDD who frequently have dificulty maintaining focus in a group setting and require individualized instruction and support that is impractical in a group format. The costs and time associated with travel to attend on-site programs may also present barrier to participation for adolescents with IDD who are dependent on parents or care providers for transportation. Additionally, in many areas (e.g.. rural or inner-city), access to on-site programs is limited.

We completed a 2-month pilot trial in adolescents with IDD who were overweight or obese to compare the effectiveness of the eSLD and conventional diet (CD) and to determine the feasibility of intervention delivery using individual meetings with the adolescent and a parent conducted via video chat (FaceTime™) on a tablet computer (iPad®) and using technology for remote self-monitoring of diet (LoseIt! ®) and physical activity (Fitbit®)9. Twenty participants (45% female, age ~15 years) were randomized (eSLD, n=10 ; CD, n=10) and completed the intervention. Participants and parents met weekly (~30 min) with a registered dietitian nutritionist to receive nutrition education and feedback relative to their self-monitoring data on diet and physical activity. Although not statistically significant, weight loss was greater in the eSLD (− 4.9%) compared with the CD (− 3.3%, p=0.13). Participants were able to use the tablet computer to track their dietary intake and physical activity on ~ 83% and 60% of possible study days, respectively. Adolescents and parents attended 80.0% of the scheduled weekly video chat meetings. Based on the encouraging results from our 2-month pilot trial we conducted a adequately powered randomized trial to evaluate two important components of a weight management intervention which have not previously been evaluated in adolescents with IDD and with overweight and obesity; strategies for reducing energy intake (eSLD vs. CD) and intervention delivery (remote (RD) vs. FTF). Intervention arms included FTF delivery with a conventional meal plan diet (FTF/CD), remote delivery with a conventional meal plan diet (RD/CD) and remote delivery with an eSLD (RD/eSLD). Results for our primary aims, a comparison of diets (RD/CD vs. RD/eSLD) and delivery strategies (FTF/CD vs RD/CD) for weight loss across 6 months are presented, herein.

METHODS

Overview

A detailed description of the rationale, design and methods for this trial have been published previously10. We randomized 110 adolescents with mild to moderate IDD with overweight and obesity to one of 3 intervention arms for a 6-month weight loss trial, followed by 12 months of weight maintenance to compare strategies for reducing energy intake and intervention delivery. This trial which was approved by the University’s Institutional Review Board and registered on clinicaltrails.gov (NCT02561754) was conducted in the local metropolitan area from November 2015 to May 2020.

Participant Eligibility

Participants satisfying the following criteria were eligible for this trial. Inclusion: Age 13–21years with mild to moderate IDD (IQ 40–74), as verified by a primary care physician, body mass index (BMI) ≥ 85th percentile on CDC growth charts (≤19 years of age) or ≥ 25 kg/m2 (<19 years of age), or waist circumference to height ratio > 0.5 which indicates excess central adiposity in children and adolescents11–14 and is commonly observed in youth with Down Syndrome15, sufficient functional ability to understand directions, communicate through spoken language, living at home with a parent or guardian, and internet access in the home. Exclusion: Type 1 diabetes, or Type 2 diabetes treated with insulin, Prader-Willi Syndrome, participation in a weight management program involving diet and physical activity in the past 6 months, eating disorders, serious food allergies, consuming special diets, or the inability to participate in moderate to vigorous physical activity. To enhance the generalizability of our findings, individuals who used medications for prevalent conditions associated with obesity or other medications commonly prescribed for individuals with IDD were allowed to participate. Clearance from a primary care physician was required for all participants.

Recruitment/Randomization

Participants were recruited through local community programs serving adolescents with IDD and using print and web advertisements in the target area. Participants were randomized to intervention arms after providing signed informed parental consent/adolescents assent and written physician clearance. Randomization was stratified by BMI (25.0–29.9 kg/m2 vs. ≥30 kg/m2) for participants over age 19 and BMI percentile (<95th percentile vs ≥ 95th percentile) for participants age 19 and younger.

Orientation

Health educators conducted 2 home visits with each adolescent and a parent prior to initiating the intervention. These sessions included detailed descriptions of the dietary and physical activity components of the intervention, and the respective delivery and self-monitoring formats. Participants were oriented to the use of the iPad® (Apple Inc, Cupertino, CA), provided by the trial. The iPads® for the RD arms were pre-loaded with the Lose It! (Fitnow, Boston MA), Fitbit® (Google, LLC, Mountain View, CA), and wireless scale apps (Withings Inc., Cambridge, MA) which were used for self-monitoring diet, physical activity and body weight, respectively. Participants in the RD arms were oriented to the use of these apps and to FaceTime™ that was used for intervention delivery. Participants in the FTF arm were provided pedometers to self-monitor physical activity (Omron HJ-320, Lake Forest, IL) and were shown how to self-monitor diet and body weight using paper records designed specifically for individuals with IDD.

Role of the Parent

Adolescents were required to designate one parent to serve as the primary family contact. The parent was asked to attend all behavioral sessions to familiarize themselves with both the diet and physical activity recommendations and the behavioral strategies incorporated in the intervention. The parent was asked to provide support and encouragement, while providing assistance in following the prescribed diet, promoting physical activity, and self-monitoring of diet and physical activity, if necessary. For example, parents were asked to assist with meal planning, grocery shopping, preparation of meals following the diet recommendations, encouraging physical activity, and assisting participants in self-monitoring their diet, physical activity and body weight.

Intervention Components

Diet

Energy Intake.

Energy intake for weight loss was prescribed at 500–700 kcal/d below total daily energy expenditure estimated using the Dietary Reference Intake total energy intake equation for overweight boys/girls16.

Enhanced Stop Light Diet (eSLD).

The SLD was enhanced by encouraging the consumption of high volume, low energy portion-controlled entrées and shakes (HRM Weight Management Services Corp, Boston, MA) and fruits and vegetables. Participants were encouraged to consume a minimum of 2 entrées (200–270 kcal each), 2 shakes (~100 kcal each) 5 one-cup servings of fruits and vegetables each day, and lower energy foods (green/yellow) from a chart/pictures of foods that were color-coded based on the SLD system. The recommended entrées and shakes, which were provided by the trial, were shipped to the participant’s homes every other week. The entrées and shakes provided ~700 kcals/day or ~50% of a participants recommended energy intake (based on a 1400 kcal/day diet).

Conventional meal plan diet (CD).

Participants randomized to the CD arms were asked to follow a nutritionally balanced, reduced energy diet which followed the recommendations found on the USDA website ChooseMyPlate.gov17 and the Dietary Guidelines for Americans18. Participants were provided with examples of meal plans consisting of suggested servings of grains, proteins, fruits and vegetables, dairy, and fats based on their energy needs and were counseled on appropriate portion sizes required to achieve the prescribed level of energy reduction. The consumption of a minimum of 5 one-cup servings of fruits and vegetables per day was also encouraged. To assist in offsetting any additional costs associated with complying with dietary recommendations, participants in the CD arms received $2.00/day.

Physical Activity

Participants in each intervention arm were asked to reach a target of 60 min./day of moderate-to-vigorous intensity physical activity (3–6 METs) at least 5 days/wk. (total 300 min/wk.) as recommended by the US Department of Health and Human Services19. The recommendation progressed from 15 min/day-3 days/wk. at week one (or current activity level if higher) to 60 min/day-5 days/wk. at week 12 and remained at that level through 6 months. Participants were also asked to increase their daily steps by 10% each week from their current level until reaching a goal of 10,000 steps/day.

Behavioral Education Sessions

Participants and parents in all intervention arms were asked to attend ~30–45 min. sessions with a health educator twice each month. Behavioral session content and duration were identical in all 3 intervention arms and included strategies to improve weight loss, e.g., social support, self-monitoring, planning, environmental control, self-efficacy, etc. In addition to the lesson, health educators reviewed self-monitoring data for diet, physical activity and weight, answered questions, problem-solved, and provided support. Due to COVID-19 restrictions on FTF contacts, one participant completed 2 behavioral sessions and one participant completed 1 behavioral session by telephone. The duration and content of the telephone sessions was identical to the originally scheduled FTF sessions.

Self-Monitoring

RD arms.

Participants were asked to record all food and beverages consumed using the Lose it! app on the iPad®. This data was accessible to health educators to inform participant counseling during behavioral sessions. Self-monitoring of physical activity was completed using a Fitbit® Charge HR wireless activity tracker (size 35.5 × 28 mm) worn on the wrist and data was available to health educators for use in participant counseling. To provide feedback regarding weight change, participants in the RD arms self-weighed during the FaceTime™ health education session using a calibrated wireless digital scale (Model: WS-30, Withings Inc. Cambridge, MA).

FTF arm.

Participants were asked to record the number of servings of each food group consumed using a paper form containing pictorial representations of each food category as well as the minutes of physical activity and the number of pedometer steps each day. These records were collected by health educators and were used to provide participant feedback and counseling. Body weight was monitored using a calibrated digital scale (Model #PS6600, Belfour, Saukville, WI) during each behavioral session. FTF participants who completed behavioral sessions by telephone, i.e. COVID protocol, verbally provided self-monitoring data to the health educator; however, body weight typically, obtained during FTF sessions, was unavailable for sessions conducted by telephone.

Intervention fidelity

Health educators were randomly assigned to participants in each of the 3 intervention arms to diminish the potential for health educator bias. All health educator/participant sessions were recorded and intervention fidelity was assessed by comparing recordings with a check list of content to be delivered. On average, behavioral education sessions delivered 96% of the scheduled content. Eighty percent or more of scheduled content was delivered in all behavioral sessions.

Incentives

All participants were allowed to keep their iPad®. As an additional incentive, participants received $2 for each week they completed self-monitoring for diet and physical activity on at least 5 of 7 days/wk. All participants and parents received gift cards ($15 participants, $10 parents) for completing outcome assessments at baseline and 6 months.

Outcome Assessments

Weight, height, and waist circumference were assessed during home visits at baseline and 6 months by trained staff blinded to condition. Weight was measured, in duplicate, to the nearest 0.1 kg using a calibrated digital scale (Model #PS6600, Belfour, Saukville, WI) with participants wearing shorts and a t-shirt. Standing height was measured in duplicate with a portable stadiometer (Model #IP0955, Invicta Plastics Limited, Leicester, UK). Waist circumference was measured using the procedures described by Lohman et al20. Three measurements were obtained with the outcome recorded as the average of the closest 2 measures. The percentage of behavioral sessions attended was calculated from attendance data collected by the health educator. The percentage of days for which participants provided data for self-monitoring of diet and physical activity was collected from health educator records.

Statistical Power and Analysis Plan

We realize there is controversy regarding the most informative measure for assessing change in adiposity in longitudinal trials in adolescents who increasing in height over time, e.g., change in weight, BMI, BMI Z-score, or the percent of participants at or above the 95th percentile21–23. Our study population ranged in age from 13 to 21 years, and thus included 15 participants over age 19 (17%) for which the BMI percentile and associated outcomes, i.e. BMI Z-score, percent at or above the 95th percentile calculations are unavailable. Thus, we selected change in body weight (kg) as our primary outcome. Secondarily we evaluated changes in BMI between intervention arms which accounts for any increases in height over the intervention period22.

Based on the data from our preliminary trial we expected significantly greater weight loss for RD/CD (− 4.0 kg) compared to FTF/CD (− 1.5 kg) and significantly greater weight loss for RD/eSLD (−6.5 kg) compared to RD/CD (− 4.0 kg) at 6 months with a common standard deviation of 3.6 kg9. With these weight loss assumptions, 35 participants in each of the 3 intervention arms at 6 mos. would provide over 99% power for an overall ANOVA comparing the three groups for a global difference. However, we were interested in two pair-wise comparisons (RD/CD vs. FTF/CD; RD/eSLD vs. RD/CD) and chose our sample size to ensure sufficient power for those comparisons. Thus, this design results in 80% power to detect the hypothesized differences with a type 1 error rate of 0.025 for each of the 2 pair-wise comparisons of interest from the overall ANOVA. This Bonferroni adjustment is very conservative adjustment to the type one error rate to ensure our overall type I error rate is less than or equal to 5%.

Sample characteristics and outcomes were summarized using means and standard deviations for continuous variables and frequencies and percentages for categorical variables. Separate two sample t-tests were used to compare weight loss (0–6 mos.) between RD/CD and RD/eSLD (diet effect) and RD/CD and FTF/CD (delivery strategy effect). Analysis of the primary outcome, weight change (kg) from baseline to 6 months, was based on intent-to-treat principles with multiple imputation, followed by a completer’s only analysis. SAS Proc MI was used to create 5 imputed data sets for weight change across 6 months by modeling missing data as a function of baseline weight, intervention arm and age. All other analyses were performed on completers only per the study design. Between arm differences in percent weight change, changes in BMI, percent change in BMI, and waist circumference were evaluated using two-sample t-tests. Separate linear regressions were used to evaluate the independent effects of age, sex, race, behavioral session attendance, self-monitoring and Down syndrome diagnosis on weight change after controlling for intervention arm. All analyses were conducted using SAS 9.4 (Cary, NC).

RESULTS

Participants

Adolescents with IDD (n=110) were randomized to the FTF/CD (n=36), RD/CD (n=39) or RD/eSLD (n=35) arms. Body weight was obtained from 35 (97%), 39 (100%), and 30 (86%) participants following weight loss for the FTF/CD, RD/CD, and RD/eSLD groups respectively (Figure 1). Due to COVID-19 restrictions we were unable to obtain 6-month data for waist circumference and height on five participants. Baseline participant characteristics are presented in Table 1. Participants were ~16 years of age, ~53% female, and ~81% non-Hispanic white. Additionally, ~48% were diagnosed with Down Syndrome and ~28% were diagnosed with Autism Spectrum Disorder. No serious adverse events occurred during the intervention.

Figure 1.

Figure 1.

Open in a new tab

Consort Diagram. FTF/CD=Face-to-face delivery/Conventional Diet, RD/CD = Remote delivery/Conventional Diet, RD/eSLD= Remote Delivery/Enhanced Stop Light Diet

Table 1.

Baseline characteristics of adolescents with intellectual and developmental disabilities by intervention arm

FTF/CD1
(n=36)		 RD/CD2
(n=39)		 RD/eSLD3
(n=35)
M (SD) / % (n) M (SD)/ % (n) M (SD) / % (n)
Age (yrs.) 16.3 (2.7) 15.6 (1.7) 16.7 (2.5)
Sex
 Male 56% (20) 39% (15) 49% (17)
 Female 44% (16) 62% (24) 51% (18)
Race
 White 83% (30) 97% (38) 83% (29)
 Black 8% (3) 0% (0) 11% (4)
 Two or More Races 8% (3) 3% (1) 6% (2)
Ethnicity
 Not Hispanic/Latino 94% (34) 95% (37) 89% (31)
 Hispanic/ Latino 6% (2) 5% (2) 11% (4)
Diagnosis
 Autism Spectrum Disorder 42% (15) 36% (14) 37% (13)
 Down Syndrome 47% (17) 54% (21) 43% (15)
 Other 11% (4) 10% (4) 20% (7)
Weight (kg) 88.4 (29.5) 74.9 (16.5) 83.6 (26.4)
BMI (kg/m2) 34.1 (8.3) 31.3 (5.8) 32.7 (7.1)
BMI Percentile a 96% (6%) 95% (6%) 96% (4%)
BMI Classification
 Healthy weight with a waist circumference to height ratio > 0.5b 1 (3%) 3 (8%) 1 (3%)
 Overweightc 9 (25%) 9 (23%) 9 (26%)
 Obesed 26 (72%) 27 (69%) 25 (71%)
Waist Circumference(cm) 98.3 (17.1) 90.5 (11.3) 94.4 (15.3)
Open in a new tab
1

FTF/CD=Face-to-face Delivery/ Conventional Diet

2

RD/CD= Remote Delivery/ Conventional Diet

3

RD/eSLD= Remote Delivery/ Enhanced Stop Light Diet

a

Calculated for participants age ≤ 19 years (FTF/CD=30, RD/CD=38, RD/eSLD= 27)

b

BMI percentile: <85 % (age ≤ 19 years) or BMI: <25 kg/m2 (age >19 years)

c

BMI percentile: 85–94 % (age ≤ 19 years) or BMI: 25–29.9 kg/m2 (age >19 years)

d

BMI percentile: ≥95% (age ≤ 19 years) or BMI: ≥30 kg/m2 (age >19 years)

Effect of diet (RD/CD vs. RD/eSLD) (Table 2)

Table 2.

Change in weight, BMI and waist circumference across 6 months in adolescents with intellectual and developmental disabilities.

FTF/CD1 RD/CD2 RD/eSLD3 Delivery
p-value		 Diet
p-value
n M (SD) n M (SD) n M (SD)
Weight Δ (kg) 35 −0.3 (5.0) 39 −1.8 (4.0) 30 −5.0 (5.9) 0.16 0.02
Weight Δ (%) 35 −0.2 (5.4) 39 −2.4 (5.1) 30 −6.4 (7.9) 0.07 0.02
BMIΔ (kg/m2) 34 −0.4 (1.6) 36 −0.9 (1.6) 29 −2.2 (2.5) 0.24 0.02
BMI Δ (%) 34 −1.0 (4.9) 35 −3.0 (5.1) 29 −6.9 (8.1) 0.10 0.02
Waist CircumferenceΔ (cm) 34 −1.1 (4.2) 31 −2.4 (4.4) 27 −4.2 (6.1) 0.23 0.23
Open in a new tab

Note: p-values based on analysis of completers only, i.e. participants with data at baseline and 6 months.

1

FTF/CD=Face to Face Delivery/ Conventional Diet

2

RD/CD= Remote Delivery/ Conventional Diet

3

RD/eSLD= Remote Delivery/ Enhanced Stop Light Diet

Weight loss at 6 months was significantly greater in the RD/eSLD (−5.0 ± 5.9 kg; − 6.4%) compared with the RD/CD arm (−1.8 ± 4.0 kg, −2.4%) (p=.01 imputation, p=0.02 completers only) (Table 2, Figure 2). Similar to the results for body weight, reductions in BMI were significantly greater in the RD/eSLD (−2.2 ± 2.5 kg/m2; 6.9%) compared with the RD/CD arm (−0.9 ± 1.6 kg/m2; 3.0%) (p=0.02) (Table 2, Figure 3). However, there were no significant differences for change in waist circumference (p =0.23) between the RD/eSLD and RD/CD arms. The proportion of participants with ≥ 5% weight loss was higher in the RD/eSLD (53%) than in the RD/CD arm (28%), and the proportion of participants with ≥3% of weight gain was higher in the RD/CD (10%) than in the RD/eSLD arms (3%) (Table 3, Figure 2). There were no significant differences between the RD/CD and RD/eSLD arms for the percentage of behavioral sessions attended as assessed from health educator records (RD/CD=83%, RD/eSLD=79%, p = 0.56), or for the percentage of days of self-monitoring of diet (RD/CD = 76%, RD/eSLD = 76%, p = 0.93) or physical activity (RD/CD =71%, RD/eSLD = 73%, p = 0.69) assessed as the percentage of days participants recorded data for diet and physical activity.

Figure 2.

Figure 2.

Open in a new tab

Individual variations of percent change in weight in adolescents with intellectual and developmental disabilities across 6 months. FTF/CD=Face-to-face delivery/Conventional Diet, RD/CD = Remote delivery/Conventional Diet, RD/eSLD= Remote Delivery/Enhanced Stop Light Diet.

Figure 3.

Figure 3.

Open in a new tab

Individual variations of percent change in BMI in adolescents with intellectual and developmental disabilities across 6 months. FTF/CD=Face-to-face delivery/Conventional Diet, RD/CD = Remote delivery/Conventional Diet, RD/eSLD= Remote Delivery/Enhanced Stop Light Diet.

Table 3.

Distribution of weight change in adolescents with intellectual and developmental disabilities across 6 months

FTF/CD1 RD/CD2 RD/eSLD3
n % n % n %
Weight loss
0 – <3% 11 31% 13 33% 2 7%
3 – <5% 4 11% 5 13% 5 17%
5 – <10% 3 9% 7 18% 7 23%
≥ 10% 1 3% 4 10% 9 30%
Weight gain
0 – <3% 9 26% 6 15% 6 20%
≥3 % 7 20% 4 10% 1 3%
Open in a new tab
1

FTF/CD=Face to Face Delivery/ Conventional Diet

2

RD/CD= Remote Delivery/ Conventional Diet

3

RD/eSLD= Remote Delivery/ Enhanced Stop Light Diet

Effect of delivery strategy (FTF/CD vs. RD/CD) (Table 2)

Weight loss at 6 months did not differ significantly between the FTF/CD (−0.3 ± 5.0 kg; −0.2%) or RD/CD arms (−1.8 ± 4.0 kg; −2.4%) (p=0.20 imputation, p=0.16 completers only) (Table 2, Figure 2). There were no significant differences between the FTF/CD and RD/CD arms for change in BMI (p=0.24), percent change in BMI (p=0.10) or waist circumference (p= 0.23) (Table 2, Figure 3). The proportion of participants with ≥ 5% weight loss was higher in the RD/CD (28%) than in the FTF/CD arm (12%), while the proportion of participants who had ≥ 3% weight gain was higher in the FTF/CD (20%) than in the RD/CD arms (10%) (Table 3, Figure 2). There were no significant differences between the FTF/CD and RD/CD arms for the percentage of behavioral sessions attended (FTF/CD=86%, RD/CD=83%, p = 0.40), or for the percentage of days of self-monitoring of diet (FTF/CD = 81%, RD/CD = 76%, p= 0.45) or physical activity (FTF/CD =76%, RD/CD = 71%, p = 0.41).

Factors associated with 6-month weight change

There was a weak negative association between participant age and weight change across 6 months ((r=−0.23, p <.01). None of the other factors evaluated including sex (r= −0.09, p=0.35), race (r=−0.26, p =.15), Down syndrome diagnosis (r=0.03, p =.81), attendance at behavioral sessions (r=−0.12, p =0.24), and self-monitoring of diet (r= −0.14, p =0.16), and physical activity (r=−0.11, p =0.27) were associated with 6-month weight loss.

DISCUSSION

This trial was designed to evaluate strategies for reducing energy intake and the delivery of a multicomponent weight management intervention (diet, physical activity, behavioral change strategies) in a sample of adolescents with mild to moderate IDD with overweight or obesity. Results indicated significantly greater 6-month weight loss using an eSLD (−6.4%, 53% ≥ 5%) compared with a CD (−2.4%, 28% ≥ 5%) when both interventions were delivered remotely using FaceTime™, and no significant differences in mean weight loss between FTF (−0.2%) and remote delivery (−2.4%) when using a CD.

We are unaware of other weight loss trials that have compared an eSLD with a CD, or FTF with remote delivery in adolescents with IDD. However, these results for 6-month weight loss are consistent with those from our previous trial in 149 adults with mild to moderate IDD randomized to a multicomponent intervention using an eSLD or CD, with both intervention arms delivered during monthly FTF home visits24. Weight loss was significantly greater in the eSDL (−7.0%, ~63% ≥ 5%) compared with the CD (−3.8%, ~40% ≥ 5%, p<0.001). The magnitude of weight loss using the eSLD in adults with IDD (−7.0%) was similar to that observed in the current trial in adolescents with IDD (−6.4%). Together, these results suggest that the eSLD provides a viable strategy for 6-month weight loss in individuals with IDD.

The minimal 6-month weight loss observed in the current trial using the CD delivered both FTF (−0.2%) and remotely (−2.4%) are consistent with the results from our trial in adults with IDD24, previously described, and in other weight loss trials in adolescents6, 25 and adults with IDD26. For example, Curtin et al6 reported results from a small randomized pilot trial which compared weight loss in adolescents and young adults with Down syndrome (13–26 yrs.) who were prescribed a conventional reduced energy diet, increased physical activity and were randomized to a 16-session nutrition and physical activity program with (n=11) or without (n=10) a parent-supported behavioral intervention, delivered FTF. Weight loss achieved using the CD was minimal in the parent supported arm (−3.4%) while weight was essentially unchanged in the non-parent support arm (+0.6%). Results from 2 trials using the same protocol, i.e., a conventional reduced energy diet in conjunction with increased physical activity and individually delivered FTF behavioral counseling sessions, have also shown modest weight loss (−3.3 and −4.4%) in adults with IDD whose BMI was ≥ 30 kg/m2 at baseline26, 27. Thus, the available evidences suggest that a conventional energy reduced diet produces minimal mean 6-month weight loss in adolescents with IDD when delivered FTF in the context of a multicomponent weight management intervention.

We found no significant differences in 6-month weight loss using a conventional diet delivered FTF (−0.2%) or remotely (−2.4%). The observation of no significant differences in weight loss between FTF and remotely delivered interventions is in agreement with results in samples of typically developed adults conducted by our group28, 29 and others30. For example, we demonstrated equivalent 6-month weight loss in 295 adults with obesity who were randomized to a multi-component weight loss intervention delivered FTF (−13.4%) or in a group phone format (−12.3%)28, 31. Appel et al30 compared weight loss between interventions supported remotely (phone, study specific web site, and emails) or FTF during group and individual sessions with a self-directed control condition. Six-month weight loss was clinically relevant and similar in the remote support (−6.1 kg) and the FTF groups (−5.1 kg), and minimal in controls (−1.4 kg). Thus, results from our group and others suggest that RD may be a viable weight management interventions delivered FTF with the potential for improved dissemination and reach.

Rate of attendance at behavior sessions (range 79%–86%) or self-monitoring of diet (range 76%–81%) and physical activity (71–76%) were high and did not differ significantly across intervention arms. In this trial the FTF intervention was delivered during individual home visits, thus differences in session attendance between FTF and remotely delivered arms that may occur when participants are required to travel to a site to attend behavioral sessions were not expected. Compliance with self-monitoring of diet and physical activity was completed using technology in the RD arms and paper and pencil records in the FTF arm. We are unaware comparisons of compliance with self-monitoring for diet or physical activity between technology- based and paper and pencil records in adolescents with IDD. However, the literature regarding the superiority in self-monitoring of diet and physical activity using technology versus paper records in typically developing adolescents32 and adults is mixed33, 34.

As is commonly observed in trials in both typically developed adults and adolescents, not all participants lost weight across the 6-month intervention28, 35. Natural growth in adolescents with IDD is associated with a 2% increase in BMI percentile per year36, thus weight gain in some participants was not unexpected. In this trial 34% of participants gained weight; however, weight gain and increased BMI of ≥3% were observed in only 12% and 10% of all participants, respectively. In addition to significantly greater weight loss observed in the RD/eSLD arm, weight gain in participants in the RD/eSLD arm was significantly lower compared with the RD/CD arm, with only one participant in the RD/eSLD arm gaining ≥3% of their baseline weight.

Strengths of this trial include: a randomized design with adequate power to evaluate the primary aims, an intervention tailored to the cognitive abilities of adolescents with IDD, intervention delivery by health educators trained and supervised by a member of the investigative team to ensure intervention fidelity, high compliance to the behavioral meeting and self-monitoring protocol, high participant retention, and assignment of the same health educator to participants in all 3 arms to reduce the potential for health educator bias. The major weakness in this trial was the inability to obtain data of sufficient quality and quantity to evaluate participant compliance with the dietary, i.e. energy intake, consumption of fruits and vegetables, entrées and low-calorie shakes, and physical activity recommendations. Problems with poor estimates of energy intake obtained by self-report records in typically developed adolescents and adults37–39 has been well documented. We attempted to assess dietary intake at baseline and 6 months using an image-assisted (iPad) food record procedure based on encouraging results from a previous trial from our group which suggested that this procedure may improve dietary assessment in adolescents with IDD40. Unfortunately, the quantity and quality of the food record data was poor. For example, < 50% of participants provided valid data (e.g., the average daily energy intake across 3 days was <500 kcal, participant reported forgetting what they ate, did not represent a typical day) at 6 months. These observations suggest that alternative methods of dietary assessment for adolescents with IDD need to be developed and validated. Portable accelerometers, typically worn on a belt at the waist, are widely used to assess physical activity in typically developed populations41, 42. In this trial less than 40% of participants complied with our waist worn accelerometer protocol (minimum of four 10 hr. days) due to forgetting or refusing to wear the accelerometer. Poor compliance with waist worn accelerometer protocols in adults with IDD has also been reported by our group43 and others26, 44, 45. Participants in the remotely delivered arms used a Fitbit® to self-monitor physical activity. They wore the device on ~72% of the 168 intervention days. These observations suggest that the evaluation of the validity of accelerometers or other devices, e.g. Fitbit® etc. worn at the wrist for the assessment of daily physical activity in adolescents with IDD are warranted. Finally, these results are based on a sample of adolescents with mild to moderate IDD with overweight or obesity living in the community who volunteered and were financially incentivized to participate in a weight loss trial. Additionally, portion-controlled entrées and shakes were provided to participants in the eSLD arm which may have contributed to the greater weight loss observed in this arm. Thus, our results may not generalize to adolescents with more severe IDD, over longer time frames, using other behavioral intervention strategies, or where entrée and shakes were not provided.

CONCLUSION

Our results suggest that an eSLD, delivered remotely as part of a multicomponent weight management intervention tailored to their cognitive abilities, is a viable strategy to achieve 6-month weight loss in adolescents with mild to moderate IDD and with overweight or obesity. Six-month weight loss did not differ when a CD was delivered either remotely or FTF, suggesting that RD may be a viable alternative for the delivery of weight loss interventions to adolescents with IDD with the potential for improved dissemination and reach.

What’s Known on This Subject:

The prevalence of overweight and obesity are higher in adolescents with intellectual and developmental disabilities compared with their typically developing peers. However, evidence-based strategies for weight management specific to adolescents with developmental disabilities are currently unavailable.

What This Study Adds:

This study compared two diets and two delivery systems for weight loss in adolescents with intellectual and developmental disabilities. Results demonstrated that the enhanced stop light diet, delivered remotely, is a viable strategy to achieve weight loss.

Acknowledgements:

We acknowledge HMR Weight Management Services Corp. for providing the low-calorie shakes.

Funding:

National Institutes of Child Health and Development (R01HD079642).

Role of Funder:

The funder did not participate in the work

Abbreviations:

IDD

intellectual and developmental disabilities

FTF

Face to Face

RD

Remote Delivery

eSLD

Enhanced Stop Light Diet

CD

Conventional Diet

Footnotes

Conflict of Interest: No authors declare any conflicts of interest

Clinical Trials Number: NCT02561754

Data Sharing Statement: Deidentified individual participant data (including data dictionaries) will be made available, in addition to study protocols, the statistical analysis plan, and the informed consent form. The data will be made available upon publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to the corresponding author at lptomey@kumc.edu.

REFERENCES

  • 1.Schalock RL, Borthwick-Duffy SA, Bradley VJ, et al. Intellectual disability: Definition, classification, and systems of supports. ERIC; 2010. [Google Scholar]
  • 2.Maïano C, Normand CL, Aimé A, Bégarie J. Lifestyle interventions targeting changes in body weight and composition among youth with an intellectual disability: A systematic review. Res Dev Disabil. 2014;35(8):1914–1926.. [DOI] [PubMed] [Google Scholar]
  • 3.Foley JT, Lloyd M, Vogl D, Temple VA. Obesity trends of 8–18 year old special olympians: 2005–2010. Res Dev Disabil. 2014;35(3):705–710. [DOI] [PubMed] [Google Scholar]
  • 4.Maiano C. Prevalence and risk factors of overweight and obesity among children and adolescents with intellectual disabilities. Obes Rev. 2011;12(3):189–197. [DOI] [PubMed] [Google Scholar]
  • 5.Hales CM, Fryar CD, Carroll MD, Freedman DS, Ogden CL. Trends in obesity and severe obesity prevalence in US youth and adults by sex and age, 2007–2008 to 2015–2016. JAMA. 2018;319(16):1723–1725. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 6.Curtin C, Bandini LG, Must A, et al. Parent support improves weight loss in adolescents and young adults with Down syndrome. J Pediatr. 2013;163(5):1402–1408. e1. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 7.Spear BA, Barlow SE, Ervin C, et al. Recommendations for treatment of child and adolescent overweight and obesity. Pediatrics. 2007;120(Supplement 4):S254–S288. [DOI] [PubMed] [Google Scholar]
  • 8.Epstein L, Squires S. The stoplight diet for children: An eight-week program for parents and children. Little Brown & Co; 1988. [Google Scholar]
  • 9.Ptomey LT, Sullivan DK, Lee J, Goetz JR, Gibson C, Donnelly JE. The use of technology for delivering a weight loss program for adolescents with intellectual and developmental disabilities. J Acad Nutr Diet. 2015;115(1):112–118. [DOI] [PubMed] [Google Scholar]
  • 10.Donnelly J, Ptomey L, Goetz J, et al. Weight management for adolescents with intellectual and developmental disabilities: Rationale and design for an 18 month randomized trial. Contemp Clin Trials. 2016;51:88–95. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 11.Mokha JS, Srinivasan SR, Dasmahapatra P, et al. Utility of waist-to-height ratio in assessing the status of central obesity and related cardiometabolic risk profile among normal weight and overweight/obese children: the Bogalusa Heart Study. BMC Pediatr. 2010;10:73. doi: 10.1186/1471-2431-10-73 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 12.Nambiar S, Hughes I, Davies PS. Developing waist-to-height ratio cut-offs to define overweight and obesity in children and adolescents. Public Health Nutr. October2010;13(10):1566–74. doi: 10.1017/s1368980009993053 [DOI] [PubMed] [Google Scholar]
  • 13.Nambiar S, Truby H, Abbott RA, Davies PS. Validating the waist-height ratio and developing centiles for use amongst children and adolescents. Acta Paediatr. January2009;98(1):148–52. doi: 10.1111/j.1651-2227.2008.01050.x [DOI] [PubMed] [Google Scholar]
  • 14.Garnett SP, Baur LA, Cowell CT. Waist-to-height ratio: a simple option for determining excess central adiposity in young people. Int J Obes (Lond). June2008;32(6):1028–30. doi: 10.1038/ijo.2008.51 [DOI] [PubMed] [Google Scholar]
  • 15.González-Agüero A, Ara I, Moreno LA, Vicente-Rodríguez G, Casajús JA. Fat and lean masses in youths with Down syndrome: gender differences. Res Dev Disabil. 2011;32(5):1685–1693. [DOI] [PubMed] [Google Scholar]
  • 16.Institute of Medicine. Dietary reference intakes for energy, carbohydrate, fiber, fat, fatty acids, cholesterol, protein, and amino acids (Macronutrients). 2002. [DOI] [PubMed]
  • 17.U.S. Department of Agriculture. Choose MyPlate. www.choosemyplate.gov.AccessedJanuary 21, 2021.
  • 18.Dietary Guidelines Advisory Committee. Report of the dietary guidelines advisory committee on the dietary guidelines for Americans, 2010, to the Secretary of Agriculture and the Secretary of Health and Human Services. Agricultural Research Service. 2010; [Google Scholar]
  • 19.2018 Physical Activity Guidelines Advisory Committee. 2018 Physical activity guidelines advisory committee report to the Secretary of Health and Human Services in February 2018. 2018. https://health.gov/sites/default/files/2019-09/PAG_Advisory_Committee_Report.pdf.AccessedJanuary 22, 2021.
  • 20.Lohman TG, Roche AF, Martorell R. Anthropometric standardization reference manual. Human Kinetics Books; 1988. [Google Scholar]
  • 21.Dietz WH. Time to adopt new measures of severe obesity in children and adolescents. Pediatrics. September2017; 1;140(3). [DOI] [PubMed] [Google Scholar]
  • 22.Cole TJ, Faith MS, Pietrobelli A, Heo M. What is the best measure of adiposity change in growing children: BMI, BMI%, BMI z-score or BMI centile? Eur J Clin Nutr. 2005;59(3):419–425. [DOI] [PubMed] [Google Scholar]
  • 23.Wei R, Ogden CL, Parsons VL, Freedman DS, Hales CM. A method for calculating BMI z-scores and percentiles above the 95th percentile of the CDC growth charts. Ann Hum Biol. 2020/August/172020;47(6):514–521. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 24.Ptomey LT, Saunders RR, Saunders M, et al. Weight management in adults with intellectual and developmental disabilities: A randomized controlled trial of two dietary approaches. J Appl Res Intellect Disabil. January2018;31Suppl 1:82–96. [DOI] [PubMed] [Google Scholar]
  • 25.Hinckson EA, Dickinson A, Water T, Sands M, Penman L. Physical activity, dietary habits and overall health in overweight and obese children and youth with intellectual disability or autism. Res Dev Disabil. April2013;34(4):1170–8. doi: 10.1016/j.ridd.2012.12.006 [DOI] [PubMed] [Google Scholar]
  • 26.Melville CA, Boyle S, Miller S, et al. An open study of the effectiveness of a multi-component weight-loss intervention for adults with intellectual disabilities and obesity. Br J Nutr. May2011;105(10):1553–62. [DOI] [PubMed] [Google Scholar]
  • 27.Harris L, Hankey C, Jones N, et al. A cluster randomised control trial of a multi-component weight management programme for adults with intellectual disabilities and obesity. Br J Nutr. 2017;118(3):229–240. [DOI] [PubMed] [Google Scholar]
  • 28.Donnelly JE, Goetz J, Gibson C, et al. Equivalent weight loss for weight management programs delivered by phone and clinic. Obesity. 2013;21(10):1951–1959. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 29.Willis EA, Szabo-Reed AN, Ptomey LT, et al. Distance learning strategies for weight management utilizing online social networks versus group phone conference call. Obes Sci Pract. 2017;3(2):134–142. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 30.Appel LJ, Clark JM, Yeh H-C, et al. Comparative effectiveness of weight-loss interventions in clinical practice. N Engl J Med. 2011;365(21):1959–1968. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 31.Lambourne K, Washburn RA, Gibson C, et al. Weight management by phone conference call: A comparison with a traditional face-to-face clinic. Rationale and design for a randomized equivalence trial. Contemp Clin Trials. September20122012;33(5):1044 – 1055 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 32.Jimoh F, Lund EK, Harvey LJ, et al. Comparing diet and exercise monitoring using smartphone app and paper diary: a two-phase intervention study. JMIR mHealth and uHealth. 2018;6(1):e17. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 33.Turner-McGrievy GM, Beets MW, Moore JB, Kaczynski AT, Barr-Anderson DJ, Tate DF. Comparison of traditional versus mobile app self-monitoring of physical activity and dietary intake among overweight adults participating in an mHealth weight loss program. J Am Med Inform. 2013;20(3):513–518. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 34.Burke LE, Conroy MB, Sereika SM, et al. The effect of electronic self-monitoring on weight loss and dietary intake: a randomized behavioral weight loss trial. Obesity. 2011;19(2):338–344. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 35.Epstein LH, Wing RR, Penner BC, Kress MJ. Effect of diet and controlled exercise on weight loss in obese children. J Pediatr. 1985;107(3):358–361. [DOI] [PubMed] [Google Scholar]
  • 36.Ptomey L, Walpitage D, Mohseni M, et al. Weight status and associated comorbidities in children and adults with Down syndrome, autism spectrum disorder and intellectual and developmental disabilities. J Intellect Disabil Res. 2020;64(9):725–737. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 37.Subar AF, Freedman LS, Tooze JA, et al. Addressing current criticism regarding the value of self-report dietary data. J Nutr. December2015;145(12):2639–45. doi: 10.3945/jn.115.219634 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 38.Schoeller DA, Thomas D, Archer E, et al. Self-report-based estimates of energy intake offer an inadequate basis for scientific conclusions. Am J Clin Nut. June2013;97(6):1413–5. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 39.Burrows T, Goldman S, Rollo M. A systematic review of the validity of dietary assessment methods in children when compared with the method of doubly labelled water. Eur J Clin Nutr. 2020;74(5):669–681. [DOI] [PubMed] [Google Scholar]
  • 40.Ptomey LT, Willis EA, Goetz JR, Lee J, Sullivan DK, Donnelly JE. Digital photography improves estimates of dietary intake in adolescents with intellectual and developmental disabilities. Disability and health journal. 2015;8(1):146–150. [DOI] [PubMed] [Google Scholar]
  • 41.Troiano RP, Berrigan D, Dodd KW, Masse LC, Tilert T, McDowell M. Physical activity in the United States measured by accelerometer. Med Sci Sports Exerc. 2008;40(1):181. [DOI] [PubMed] [Google Scholar]
  • 42.Bassett DR Jr, Rowlands AV, Trost SG. Calibration and validation of wearable monitors. Med Sci Sports Exerc. 2012;44(1 Suppl 1):S32. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 43.Ptomey L, Willis E, Lee J, et al. The feasibility of using pedometers for self-report of steps and accelerometers for measuring physical activity in adults with intellectual and developmental disabilities across an 18-month intervention. J Intellect Disabil Res. 2017;61(8):792–801. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 44.Melville CA, Oppewal A, Schäfer Elinder L, et al. Definitions, measurement and prevalence of sedentary behaviour in adults with intellectual disabilities - A systematic review. Prev Med. April2017;97:62–71. [DOI] [PubMed] [Google Scholar]
  • 45.Spanos D, Hankey CR, Melville CA. The effectiveness of a weight maintenance intervention for adults with intellectual disabilities and obesity: A single stranded study. J Appl Res Intellect Disabil. April272015. [DOI] [PubMed] [Google Scholar]

RESOURCES