Abstract
Objective:
To assess whether a novel parent stress with nutrition vs. nutrition alone intervention decreases early childhood obesity risk.
Methods:
A prospective, parallel, 12-week randomized controlled trial with parents who were overweight (114 dyads BMI: 34.7±6.6) and their young children (2–5 years old) was conducted between November 2018-July 2022. Parenting mindfully for health (PMH+N) was compared to the Control (CTL+N) weekly group intervention, each with nutrition and physical activity (N) psychoeducation. Changes in child BMI and parent stress were co-primary, while observed parenting in an established laboratory-based parent-child Toy-Wait Task (TWT) and child food intake were secondary outcomes.
Results:
Child BMI Z-score significantly increased by 0.41 ([0.13, 0.69], p<0.005) in the CTL+N, but PMH+N remained unchanged (0.20 [−0.49, 0.09], p>0.17) over the 3-month follow-up, and parent stress decreased (3.17 [−5.19, −1.15] points, p<0.003) only in the PMH+N arm. Significant time main effects indicated increased TWT positive parenting (2.82 [1.24, 4.4], p<0.001) and reduced unhealthy child food intake (−1.78 [−3.02, −0.54]), driven by the PMH+N arm (p’s<0.02). Parent stress interacted with PMH+N vs CTL+N intervention to predict lower TWT positive parenting and child healthy food intake in the CTL+N arm (−1.74 [−3.26, −0.22] and −3.41 [−7.25, 0.42], respectively).
Conclusions:
Targeting parent stress with healthy nutrition is effective in preventing short term early childhood obesity risk and in improving positive parenting and child healthy food intake. Further assessment of long-term effects of the PMH+N intervention on early childhood risk is warranted. (Clinical Trials Registration: NCT03950453)
Video Abstract
Article Summary:
A parent stress plus healthy nutrition intervention reduced early childhood obesity risk and parent stress, and improved positive parenting and child food intake.
Introduction
Early childhood obesity is a serious public health problem in the United States with 12.7% of children ages 2–5 years old meeting criteria.1 Childhood obesity predisposes to adult obesity2,3 and increases risk for chronic weight-related diseases.4 Obesity is particularly common in those with low to mid income,5 in ethnic minority children,6 and in those with parents who have obesity.7,8 One potential pathway to obesity in children is parent stress.
Parent stress and adversity is associated with high consumption of fast foods, overeating, decreased physical activity, and increased weight in both parents and children.9–12 High levels of adult and parent stress and trauma alter peripheral stress responses and reward/motivation brain circuits that are critical for parenting and for healthy decision-making about family food choices.13,14 Parent stress also alters child stress responses15,16 and increases child negative behaviors17,18 including overeating and weight gain.13,19 Higher stress in parents is associated with greater negative affect and punitive behaviors, as well as lower parent positive affect and behaviors such as warmth, listening and behavioral involvement, that are all associated with obesity risk in children.12,20–22 Despite the evidence of the effects of parental stress and trauma on parenting, food choices, and childhood obesity risk, targeted interventions that reduce parent stress and improve parents’ family food choices to address early childhood obesity risk are rare.
We previously developed a novel manualized 8-week mindfulness-based parent stress intervention to reduce parent stress and improve positive parenting to prevent childhood obesity risk in 2–5 year old children for parents who are overweight.22 The Parenting Mindfully for Health (PMH+N) intervention included components of mindfulness and behavioral self-regulation to reduce parent stress;23–28 and healthy nutrition and physical activity (N) psychoeducation based on US child dietary and physical activity guidelines,29,30 while the control (CTL+N) intervention involved parents watching nature videos and also provided the N psychoeducation component.22 Both PMH+N and CTL+N arms were provided in a weekly group setting, and found to be feasible and acceptable in the pilot sample. Findings also showed only the PMH+N arm improved positive parenting behaviors in a mildly challenging parent-child interaction task called the Toy-Wait Task (TWT)23,31 and minimal change in child BMI percentiles.22
Building on this initial development work, the current proof-of-concept 12-week randomized controlled trial (RCT) assessed the efficacy of the PMH+N versus CTL+N intervention for reducing early childhood obesity risk short term. The primary pre-specified child outcome was child BMI assessed as change from baseline (pre-intervention) to week 12 (post-intervention) and to a short-term 3-month follow up. The primary prespecified parent outcome was change in parent stress from pre- to post- intervention. Observed parenting behaviors using the previously validated TWT22,23,31,32 and parent report of child healthy and unhealthy food intake assessed at pre- and post-intervention were secondary outcomes. Based on our prior work,22 we hypothesized that the CTL+N arm only will show increases in child BMI Z-score from pre-intervention baseline to the 3-month follow up, and that the PMH+N arm will show reductions in parent stress. Based on our preliminary work,22 we also expected the PMH+N vs CTL+N intervention to moderate parent stress-related improvements in positive parenting and changes in child food intake, and high acceptability as measured by parent attendance and satisfaction ratings in both the PMH+N and CTL+N arms. Finally, a non-randomized Assessment (Asmt Only) group was also enrolled to separately assess the non-specific effects of study procedures.
Methods (Detailed Procedures in Supplementary Materials)
Participants:
Parent (or primary caregiver) and preschooler dyads were recruited from the greater New Haven, CT area from November 2018 through January 2022 via online advertising, social media, and study flyers in local community areas. Inclusion criteria were parents (1) with a child in the 2–5 age group, (2) with a BMI ≥ 25 kg/m2, and (3) who were able to read or write and (4) those completing intakes and both pre- and post- intervention TWT. Written parent informed consent and verbal child assent (presented by study staff and parent) was obtained at study enrollment and the protocol was approved by the Yale IRB (Yale HIC#: 2000023271) and registered in clinicaltrials.gov (NCT03950453) (see Figure 1).
Figure 1. Study CONSORT:

Of the 343 parent-child dyads that provided consent, 134 completed both baseline and post- observed parenting TWT assessments and were randomized to PMH+N and CTL+N arms and 114 started the study (PMH+N=55, CTL+N=59). In addition, a non-randomized assessment (Asmt. Only) group completing both TWT assessments was also studied to assess non-specific aspects of study participation and procedures (Asmt. only=63). Note: Ineligible/ protocol violation category included those who became ineligible due to meeting an exclusion criteria after intake and randomization or revealed an acute emergent illness for parent or child that precluded study participation.
Randomization to Treatment and Procedures
After the intake phase, parents were randomized in a parallel group study design with a 1:1 allocation ratio to either PMH+N or CTL+N using a minimization covariate balanced randomization procedure,33,34 implemented by study biostatistician (NF). This involved counterbalancing across parental: age, race (Non-Hispanic White or not), BMI, sex, and years of education, and on child: age (in months) and sex. Due to the COVID-19 pandemic shut down starting on March 16th, 2020, weekly group sessions for both arms were offered remotely via zoom (April – September 2020), with the continued option through the end of the study that offered flexible weekly attendance via remote or in-person. The non-randomized Asmt Only group was enrolled separately during the same period and participated in the same study assessments at the same schedule as the randomized groups, but without any weekly group intervention participation.
Assessments
Demographics and health screen.
Demographic data on parent and child, including age, race, and parent education level, was assessed with parent-report forms (Table 1). Per NIH (funder) guidelines the following race options were provided for self-reported endorsement: White, Black/African American, American Indian or Alaska Native, Asian, Native Hawaiian or Pacific Island, or Other with specification for ethnicity (Hispanic/non-Hispanic).
Table 1.
Demographics.
| Total N = 114 | CTL+N N = 59 | PMH+N N = 55 | ||
|---|---|---|---|---|
| Parent | Female | 109 [95.6] | 56 [94.9] | 53 [96.4] |
| Age (years) | 34.6 ± 5.8 | 34.8 ± 6.8 | 34.4 ± 4.6 | |
| 21–53 | 21–53 | 23–46 | ||
| BMI$ | 34.8 ± 6.2 | 34.2 ± 5.0 | 35.4 ± 7.2 | |
| 26.5–54.3 | 26.5 – 53.7 | 27.1 – 54.3 | ||
| White | 73 [64.0] | 39 [66.1] | 34 [61.8] | |
| Black | 27 [23.7] | 13 [22.0] | 14 [25.5] | |
| Other | 14 [12.3] | 7 [11.9] | 7 [12.7] | |
| Hispanic | 27 [23.7] | 13 [22.0] | 14 [25.5] | |
| Education | 15.6 ± 2.1 | 15.6 ± 2.0 | 15.7 ± 2.2 | |
| 12–22 | 12–20 | 12–22 | ||
| Above Poverty | 92 [80.7] | 48 [81.4] | 44 [80.0] | |
| At or Below Poverty | 22 [19.3] | 11 [18.6] | 11 [20.0] | |
| Partnered | 77 [67.5] | 40 [67.8] | 37 [67.3] | |
| Child | Female | 60 [52.6] | 30 [50.8] | 30 [54.5] |
| Age (Months) | 43.5 ± 13.5 | 45.1 ± 13.0 | 41.9 ± 13.9 | |
| 22–70 | 23–70 | 22–69 | ||
| White | 67 [58.8] | 34 [57.6] | 33 [60.0] | |
| Black | 28 [24.6] | 13 [22.0] | 15 [27.3] | |
| Other | 19 [16.7] | 12 [20.3] | 7 [12.7] | |
| Hispanic | 32 [28.1] | 15 [25.4] | 17 [30.9] | |
| BMI Percentile | 62.3 ± 30.0 | 60.7 ± 28.8 | 64.0 ± 31.4 | |
| 0.1–99.9 | 0.1–99.9 | 0.1–99.9 | ||
| BMI Overweight/Obesity* | 35 [30.7] | 13 [22.0] | 22 [40.0] |
CTL+N = 48, PMH+N N = 46.
No significant differences between groups, except Child BMI Overweight/Obesity (p<0.044). Race and ethnicity were self-identified in separate questions. Race options included White, Black/African American, American Indian or Alaska Native, Asian, Native Hawaiian or Pacific Island, or Other with specification for ethnicity (Hispanic/non-Hispanic) based on NIH (funder) guidelines. The latter 4 groups were condensed into “Other” due to low endorsement (endorsements for parents: 1 American Indian or Alaska Native, 3 Asian, 3 Multiple Races, and 7 no racial identity chosen; endorsements for children: 2 Asian, 12 Multiple Races, and 5 no racial identity chosen).
Primary Outcomes:
Child BMI
was the primary child outcome measured at baseline, post intervention, and 3-month follow-up after the intervention conclusion as both a Z-score and percentiles.
Parent stress
was the primary parent outcome measured by the well-established and validated Perceived Stress Scale (PSS) self report survey35 at baseline and post intervention.
Secondary Outcomes:
Observed parenting behavior in the TWT parent-child interaction task:
The TWT is an established 5-minute parent-child interaction task that assesses observed videotaped parenting and child behaviors and has been successfully repeated in prospective longitudinal studies with minimal practice effects.22,23,31,32 The videotaped were blindly coded by trained raters using a previously validated standardized observed parenting behavior manual22,23,31,32 Summed and computed observed parenting scores for (1) Total Positive (2) Total Negative, and (3) Total Sum (Positively Valanced) were calculated for the pre- and post- intervention TWT sessions.
Child Food Consumption:
Parent reports of their child’s recent typical food intake patterns (i.e., quantities and servings of fruits, vegetables, sweets, processed foods, etc.) were assessed using an adapted preschool version of the Block Kid’s Food Frequency Questionnaire.36 Healthy and Unhealthy Food scores were then tabulated as secondary outcome measures.
Attendance and Satisfaction.
Parents attended weekly PMH+N or CTL+N sessions, with attendance reflecting total percentage of sessions attended. Parents also reported their satisfaction and how positive the experience was for each weekly session.
PMH+N and CTL+N Weekly Intervention for 12 Weeks over 9 Group Cycles
The 12-week intervention for both PMH+N and CTL+N arms was conducted weekly in a group setting for 2 hours each and was comprised of up to 3–12 parents and 1–2 group leaders.
PMH+N Arm:
The PMH+N intervention was further adapted from the previously developed manualized intervention for 12 weeks.22 Each session also included the same nutrition and physical activity psychoeducation content as the CTL+N arm that was integrated and taught in the context of PMH+N mindfulness and behavioral self-regulation skills.
CTL+N Arm:
The structure and format of the CTL+N sessions included passive watching of relaxing nature and home improvement videos for the first hour followed by nutrition and physical activity psychoeducation.
Statistical Analysis:
All data were analyzed in R version 4.3.0.37 Sample size and power analysis determinations were based on our previous work.22 Baseline differences between PMH+N and CTL+N arms in demographic and target variables of interest were assessed.
Linear mixed effects (LME) models with a random intercept, and within group cycle nesting as appropriate, tested the randomized intervention arms (Between Subjects: PMH+N v. CTL+N) by Time (Within Subjects) on primary and secondary outcomes. Proportion of group sessions attended, and ages of caregiver and child were included as covariates. Notably, in-person or remote participation in weekly groups was not found to be a significant predictor of any outcome and was therefore not included as a covariate in the final analyses. The moderating effects of parent PSS change (Post Intervention minus Baseline) on child outcomes were also assessed. Post-hoc exploratory mediation tested if change in PSS scores mediated the intervention effects on BMI Z scores. Finally, as the Asmt only group was not as part of the RCT and had no a priori hypotheses, they could not be included in the overall RCT analyses. However, separate baseline to 3-month follow up change assessment of child BMI and changes from baseline to post-intervention for other outcomes are presented in the Supplemental Results.
Results
Sample Demographics
Parents/primary caregivers were predominantly female (96%) with a mean parent BMI of 34.8 ± 6.2 kg/m2 while children were distributed evenly between male and female (53% female). There were no significant differences between PMH+N and CTL+N on demographics (see Table 1) or baseline values of outcome measures (see Supplemental Table 1).
Attendance and Satisfaction and Follow-up Rates:
Weekly attendance was high for both PMH+N and CTL+N arms over the 12-week period (M: 82% ± SD: 24%). There were also high rates of retention at the 3-month follow up across both groups (88.6%), with no differences between RCT arms, and similar retention for assessment sessions the Asmt only group (see Figure 1 CONSORT). See Supplemental Results for information by group on attendance and satisfaction.
Primary Outcomes
Child BMI Z-score.
A significant intervention arm X time interaction was observed for child BMI Z-score (p<0.010). Child BMI z-score in the CTL+N arm increased significantly (3 month v. Baseline: 0.41 [0.13, 0.69] p<0.005), with no significant change for the PMH+N arm (3 month v. Baseline: −0.2 [−0.49, 0.09] p>0.17) (Figure 2a). Notably, significant increases in the number of children meeting CDC cut-off38 for overweight/obesity increased from 22% at baseline to 39.6% at 3 month follow-up for CTL+N (OR: 6.04 [1.06, 34.4], p<0.04), but only from 40% to 41.7% (p>0.80) in the PMH+N arm (Figure 2b).
Figure 2. Primary Outcome Changes.

Panel A: Significant increases in child BMI Z-Score from Baseline to 3-month follow-up in CTL+N (p<0.005), but not PMH+N (p’s>0.17). No significant between group differences. Panel B: Percent change in number of children meeting the CDC BMI percentile cut-off of ≥ 85 for overweight/obesity significantly increased 17.6% in the CTL+N arm (22% to 39.6%, OR: 6.04, p<0.04), but only 1.7% in the PMH+N arm (40% to 41.7%, p>0.81). Panel C: PMH+N saw a significant decrease in parent PSS scores between Baseline and Post Intervention (p<0.003), but no significant change was observed for the CTL+N arm (p>0.79). No significant between group differences. Graphs represent means ± standard error. *p<0.05, **p<0.01.
Parent Stress (PSS scores):
A significant intervention arm X time interaction was observed for parent PSS scores (p<0.016). This resulted from significant reductions in PSS from baseline to post-intervention (−3.17 [−5.19, −1.15], p<0.003) for PMH+N but not CTL+N (0.27 [−1.65, 2.19], p>0.78 (Figure 2c).
Secondary Outcomes
Observed Parenting Behaviors (TWT) Baseline vs Post Intervention Changes:
Parent and Child Affect and Behavior.
Only significant main effects of time and no intervention interaction effects (p’s>0.24) were observed. Positive observed affect and behavior scores improved from baseline to post intervention (Total Positive Sum: b: 1.73 [0.44, 3.03], p<0.010; Total Sum Positive Valanced: b: 2.82 [1.24, 4.4], p<0.001). Negative observed parenting scores decreased from baseline to post intervention (Total Negative Sum: relative ratio: 0.38 [0.29, 0.49], p<0.001).
To better understand the main effect of time, exploratory analyses assessed baseline to post intervention within each arm. The Total Positive Sum and Total Sum (positively valanced) parenting score increased significantly from baseline to post intervention for the PMH+N group (Total Positive Sum b: 2.4 [0.49, 4.31], p<0.015; Total Sum Positively Valanced b: 3.75 [1.34, 6.15], p<0.003), but not for the CTL+N group (p’s>0.070). Thus, though there was not a significant intervention X time interaction, it appears that positive parenting improved for the PMH+N group and not for the CTL+N group. Both PMH+N and CTL+N arms showed a significant decrease in Total Negative Affect/Behavior from baseline to post intervention (PMH+N: b: 0.36 [0.25, 0.51], p<0.001; CTL+N: b: 0.40 [0.26, 0.60], p<0.001) (Figure 3a–3c).
Figure 3. Observed Parenting of Child Affect and Behavior and Unhealthy Foods.

A Time main effect indicated significant improvements from baseline to Post-Intervention in TWT Total Positive Affect & Behavior (p<0.009; Panel A) and in Total Affect & Behavior Sum (Positively Valanced) (p<0.001; Panel B). Exploratory analyses assessed change within each arm and showed PMH+N specifically exhibiting significant improvement for Total Positive Affect and Behavior (p<0.015) and for Total Affect and Behavior Sum (p<0.003) that was not observed in the CTL+N arm (p>0.23 and p>0.07). Panel C. A main effect of time indicated Total Negative Sum decreased over time (p<0.001). Exploratory analyses indicated that both PMH+N (p<0.001) and CTL+N (p<0.001) exhibited a decrease over time. Panel D. A main effect of Time emerged on Weekly Unhealthy Food Servings, with a decrease in these servings over time (p<0.006). Exploratory analyses indicated that PMH+N specifically exhibited a decrease (p<0.016), whereas CTL+N did not (p>0.14). Graphs represent means ± standard error. *p<0.05, **p<0.01, ***p<0.001.
Child Food Consumption.
Across both arms, unhealthy food intake frequency decreased significantly from baseline to post intervention (Time: b: −1.78 [−3.02, −0.54], p<0.006). There were no significant effects of intervention arm or intervention X time on unhealthy food frequency (p’s>0.43). See Figure 3d. Exploratory analyses within each arm separately revealed a significant decrease from baseline to post intervention in unhealthy food intake frequency for the PMH+N arm (b: −2.27 [−4.08, −0.45], p<0.016) but not the CTL+N arm (p>0.14). There were no significant effects of Intervention arm, time, or their interaction on number of healthy food servings (p’s > 0.38).
Changes in the Non-Randomized Assessment Only (Asmt only) Group:
The Asmt only group showed no significant within group changes in child BMI Z-score, BMI percentile, parent PSS scores, or child food intake. However, they showed significant improvement in positive TWT scales (see Supplemental Results).
Change in Parent Stress PSS scores Predicts Intervention Effects on Secondary Outcomes (Moderator Analyses)
Parent and Child Affect and Behavior.
Parent PSS change scores significantly interacted with intervention arm to predict change in positive parenting behavior scores at the post intervention TWT assessment (Total Positive Sum p<0.017; Total Sum Positively Valanced p<0.026). An increase in parent PSS scores from baseline to post intervention (worsening of parent stress) was associated with lower positive parenting scores for CTL+N (Total Positive Sum b: −1.57 [−2.97, −0.17], p<0.029 and Total Sum Positively Valanced b: −1.74 [−3.26, −0.22], p<0.26), but not for PMH+N (p’s>0.21; See Figure 4a–4b). There were no significant effects of changes in PSS by intervention arm for changes in the Total Negative Sum scores post intervention (p’s>0.16).
Figure 4: Greater Parent Stress from Baseline to Post Intervention (PSS change) Predicts Lower Positive TWT Scores and Child Weekly Healthy Food Intake at Post Intervention in CTL+N Group Only.

Panel A: In CTL+N but not the PMH+N arm, higher parent PSS scores at post intervention relative to baseline were significantly associated with lower observed total positive affect and behavior sum scores (CTL+N: p<0.017; PMH+N: p>0.21). Panel B: In CTL+N but not the PMH+N arm, higher parent PSS scores at post intervention relative to baseline was significantly associated with lower observed total sum scores positively valanced (CTL+N: p<0.026; PMH+N: p>0.34). Panel C: In CTL+N but not the PMH+N arm, higher parent PSS scores at post intervention relative to baseline was associated with lower child healthy food consumption (CTL+N: p>0.08; PMH+N: p>0.11). This contrast was significant (p<0.02). Graphs represent model estimates ± standard error. *p<0.05.
Child Food Consumption.
An increase in parent PSS scores from baseline to post intervention (worsening of parent stress) interacted with intervention arm to predict significantly lower healthy food consumption in the CTL+N compared to PMH+N (b: −3.41 [−7.25, 0.42] v. b: 3.30 [−0.81, 7.4], p<0.02). There were no significant effects on unhealthy foods (p>0.87).
Mediation Analyses of Changes in PSS, TWT Total Positive Parenting, and Food Intake on child BMI Z score.
A mediation analysis explored if the intervention effects on change in child BMI Z-score (3 month follow up v. baseline) was accounted for by change in parent PSS scores (post-intervention minus baseline), change in parent positive behaviors or unhealthy food intake, but these were not significant (total direct effect p’s>0.05, indirect effect’s p>0.57).
DISCUSSION
Current findings are the first to show that a novel manual-guided 12-week parent stress (PMH+N) intervention prevented short-term increases in child BMI Z-score/percentile and reduced parent stress over the 12-week intervention period in contrast to the CTL+N arm. Remarkably, the CTL+N saw a six times risk for crossing the CDC overweight threshold38 from baseline to 3 month follow-up, but minimal effects in the PMH+N arm. Notably, the non-randomized Asmt only group enrolled in parallel to the RCT to evaluate effects of study assessments at the same schedule without receiving intervention did not show any significant improvements in these outcomes. Thus, while the child BMI effects were observed over a short-term follow-up, the positive findings of the RCT lend support to further evaluation of PMH+N for potential sustained long-term effects on early childhood obesity risk reduction.
An additional novel aspect based on previous development work was to assess potential pathways of intervention efficacy using a brief parent-child task (TWT) and parent reports of child food intake. Across both arms, we saw improved positive parenting interactions, reduced negative parenting interactions, and reductions in child unhealthy eating from baseline to post intervention. The effect across arms is not entirely surprising as parenting and family food choices may vary as a function of stress-related family context factors9,39 that are likely to shift during the 12-week intervention period. However, an exploration of main effects indicated that positive parent-child interaction ratings and reductions in child unhealthy food intake were driven primarily by the PMH+N group. Growing evidence indicates that greater parent stress, parenting stress, and family chaos reduces positive parenting behaviors40 and increases unhealthy food intake in parents and their children.9 A reduction in positive parenting and increases in unhealthy food intake are both associated with increased weight gain and obesity risk in children.41 On the other hand, change in PSS scores, TWT positive parenting, and neither healthy nor unhealthy food intake showed significant mediation of PMH+N effects on child BMI outcomes. Lack of mediation effects could be due to current sample size, especially as moderated mediation models may need larger samples for adequate mediation testing.42 Also, stress is associated with multifaceted responses to environmental challenges, and while PSS is a well validated measure of subjective perceived stress, it may not capture autonomic and behavioral stress reactivity known to impact child outcomes.18 Thus, future work should assess whether PMH+N lowers childhood obesity risk via diminished parent emotional/behavioral stress reactivity.
Increases in parent stress during the intervention period predicted fewer positive parenting and less healthy child food intake only in the CTL+N and not the PMH+N. High levels of repeated and chronic stress increases negative affect, emotional reactivity, greater risk of maladaptive coping behaviors, and unhealthy family choices and decisions,43,44 thus increasing the risk of parental emotional reactivity and reducing parent coping resources.45 Our findings suggest that only the PMH+N intervention uniquely diminished the otherwise well-known link between parent stress and lower positive parent-child interactions and healthy food intake.
We found over 75% session attendance for the weekly groups and high satisfaction ratings across both arms, suggesting good feasibility and acceptability of the intervention among parents who are overweight. Nonetheless and interestingly, there was lower session attendance but higher satisfaction and positive experience ratings in PMH+N versus CTL+N. The positive outcomes of the PMH+N arm, despite the lower attendance, may suggest that a lower dose of PMH+N is effective. This is promising given that parents of young children have busy lives and an intervention to decrease stress should not be overly time consuming.
It is important to acknowledge some study limitations. First, due to small numbers of parents in the different race/ethnic and socioeconomic subgroups, intervention effects in these subgroups could not be assessed. Second, the sample included over 95% women which precluded testing intervention effects in fathers, who are increasingly becoming primary caretakers, and positive parenting effects for fathers has been reported.23 Third, healthy food items in the adapted Block Food Frequency Questionnaire are limited to fruits and vegetables, excluding a comprehensive list of foods that are fiber, polyphenols and antioxidants rich, and are minimally processed. While the N psychoeducation component incorporated current US dietary and physical activity guidelines for children, it did not incorporate specific information on foods that boost natural GLP-1 either directly or indirectly. Such information could have increased healthy food choices of young families and intervention effectiveness. Complementarily, there may have been social bias by parents to report positive food improvements. Therefore, future work would also benefit from better assessment of child food intake using the non-invasive Veggie Meter,46 which provides a biomarker of skin carotenoid levels to validate the parent reports of child healthy food intake. Finally, this study was conducted during the COVID-19 pandemic and was impacted by the inclusion of participants who could complete the TWT in-person assessments, potentially creating a selection bias in the study sample.
Despite these limitations, this early phase proof-of-concept RCT showed positive effects of a novel mindfulness-based parent stress reduction on early childhood obesity risk in the short term, supporting future assessment of intervention effects over the long term. Such early childhood interventions that address parent stress have been lacking in the literature.47 A range of parent interventions focused on young child nutrition, feeding behaviors, family physical activity, and other family and community context factors have been tested, but have failed to show sustained effects on child BMI over the long term.48–50 If the short term gains in early childhood obesity risk prevention are shown to endure long term, the PMH+N intervention may be recommended and even offered in community pediatric clinics to reduce obesity risk and promote healthy childhood growth. Our effects showing high engagement, acceptability, and no differences between in-person vs. remote digital implementation. Therefore, in future work a digital version of the PMH+N intervention could promote more widespread and easy access with greater flexibility for parents with young families.
Supplementary Material
What’s Known on this Subject:
Childhood obesity is increasing at alarming rates, which has implications for child and adult health. Parent stress and obesity are known risk factors for early childhood obesity risk. However, effective ways to decrease such risk are not clear.
What This Study Adds:
The parent stress vs. control intervention reduced childhood obesity risk and parent stress along with improved positive parenting and child food intake, thereby supporting the need to assess its impact on long term childhood obesity risk in the future.
Acknowledgements:
We are grateful for the contributions of Julie Schwartz, Maria Isabel Guinle, Max Golden, Luke Harrison, Shaina Barreto, Colleen McGowan, Shiyu Wang, Elcin Sakmar, Rachel Hart, Valeria Martinez, Alexandra Jordan, Arianne Norman, Mary Kurjanowicz and Alexandra McGovern to data collection, coding and analysis.
Funding/Support:
NIH NIDDK (National Institute of Diabetes and Diseases of the Kidney) R01-DK110751 (MPIs: Sinha, Jastreboff, Silverman)
Conflict of Interest Disclosures (includes financial disclosures):
Dr. Sinha has served as a scientific consultant for Imbrium Therapeutics and Embera Neurotherapeutics and received research support from Ct Pharmaceutical Solutions, AELIS Farma and Tenacia Biotechnology, Inc. Dr. Jastreboff conducts multi-center trials with Amgen, Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Rhythm Pharmaceuticals; serves on scientific advisory boards for Amgen, AstraZeneca, Boehringer Ingelheim, Biohaven, Eli Lilly, Intellihealth, Metsera, Novo Nordisk, Pfizer, Regeneron, Scholar Rock, Structure Therapeutics, Syntis Bio, Terns Pharmaceuticals, WeightWatchers, and Zealand Pharmaceuticals; and receives institutional grant funding from the NIH/NIDDK. The other authors have no conflicts of interest relevant to this article to disclose.
Role of Funder/Sponsor (if any):
The NIH NIDDK had no role in the design and conduct of the study.
Footnotes
Clinical Trial Registration: Trial is registered in Clinicaltrials.gov. Registration #: NCT03950453, registered November 11th, 2018 and can be found on the link: https://clinicaltrials.gov/study/NCT03950453
Data Sharing Statement:
Deidentified individual participant data will not be made available.
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Data Availability Statement
Deidentified individual participant data will not be made available.
