Design and Rationale for ADAPT+: Optimizing an Intervention to Promote Healthy Behaviors in Rural, Latino Youth with Obesity and their Parents, using Mindfulness Strategies.

Abstract

Latino youth living in rural areas represent an ethnic and geographical minority population at increased risk for obesity and obesity-related complications. We previously modified our child obesity intervention to be a multi-family behavioral intervention, Adaptando Dieta y Acción Para Todos (ADAPT), to better meet the needs of our target population, rural Latino youth with obesity (8–12 years old) and their parents. Recognizing the role of parent stress on obesity, the main goal of this study is to 1) further refine and optimize the original ADAPT multi-family behavioral obesity intervention protocol to include mindfulness parent stress reduction strategies (now called ADAPT+) and then 2) assess the feasibility of ADAPT+ implementation via a small randomized control trial (RCT) with rural Latino families. Two aims guide the study. For Aim 1 we conduct a series of focus groups with stakeholders and parents, and then conduct a one-arm trial with both parents and their children to obtain feedback for further refining each of our eight integrated ADAPT+ sessions. Aim 2 tests the acceptability and feasibility of our intervention with multi-family groups of Latinos in two rural communities over time (pre-intervention, post-intervention, 3-month follow-up) in a randomized pilot trial (ADAPT+ vs. Enhanced Usual Care [EUC] comparison). This study is intended to set the groundwork for a larger clinical trial to test ADAPT+’s efficacy to improve rural Latino families’ eating and physical activity behaviors.

1. Introduction.

Rates of obesity among Latino youth are increasing exponentially [1–4]. It is estimated that unless this trend is reversed, 90% of US-born children of Mexican immigrants will be of overweight or obese status by 2030 [5], particularly those living in rural communities [6–9]. Lack of access to affordable, healthy foods; few community resources; acculturation-related dietary changes (e.g., eating more processed and fast foods) [10]; and poverty are key contributing factors to obesity [7–9]. With this rise in obesity, Latino youth are at increased risk for metabolic syndrome, type 2 diabetes, cardiovascular disease, and cancer [11–14].

Most lifestyle interventions depend on education and cognitive-behavioral strategies to improve diet and physical activity, with parent-focused interventions showing the most consistent success for youth [15, 16]. These interventions often produce only modest and short-term results [17], frequently lack consideration of psychological factors impacting uptake of behavior changes, and are rarely culturally tailored. Importantly, pre-adolescence (ages 8–12) is a developmentally critical age for developing health-behavior skills that need further study in the Latino population [17]. Based on our earlier pilot study with Latinos living in rural communities, we developed an 8-session, culturally sensitive multi-family behavioral obesity intervention targeting families with pre-adolescents, Adaptando Dieta y Acción Para Todos (ADAPT), to increase healthy eating and physical activity lifestyle behaviors in both parents and their children [18]. This initial pilot study was conducted through a collaboration with a Federally Qualified Health Center clinic [see 18 for details]. We found that our ADAPT intervention was acceptable and feasible in promoting healthier eating and physical activity behaviors. However, stress, which was identified as a top concern by these rural, migrant Latino study participants was not targeted in ADAPT. In the present study, we partner with a community-based organization, the Hispanic Services Council, to investigate the expansion of ADAPT to target both obesity and parental stress, a critical contributor to childhood obesity [19–21].

The incidence of Latino youth obesity increases substantially with the number of caregiver stressors [19]. Mindfulness techniques for stress reduction are associated with improved parent well-being [22], as well as increased receptiveness and adherence to eating and physical activity behavior intentions [22, 23]. Several mindfulness-based programs have been successfully delivered to low-income, minority, public school students [24], providing evidence of the feasibility of using mindfulness approaches with underserved populations. Notably, few of these studies target Latino families [24–26]. Even fewer studies have investigated the cultural feasibility of introducing mindfulness techniques to low income, rural Latino groups. Our rationale is that incorporating a mindfulness-based approach to reduce parent stress will potentially increase intervention skills uptake among Latino families to improve eating and physical activity behaviors of youth.

1.1. Primary Aims

Our scientific premise reflects the urgency of addressing the obesity epidemic among Latino youth living in rural communities, a “double health disparity” group at significant risk. The goal is to increase healthy lifestyle behaviors consistent with the needs of Latinos living in rural communities by developing an obesity intervention applicable to rural underserved Latino children and their parents. We combine a standard family-based behavioral approach, the “gold standard” for pediatric obesity treatment [16, 27–29], with a mindfulness approach focusing on stress reduction (now ADAPT+). Two main aims guide the study protocol. Aim 1 is to refine and optimize ADAPT+ by obtaining information from focus groups of facilitators/Promotoras (acculturated community members who retain credibility with the target population; Aim 1A), and Latino migrant parents of pre-adolescents (Aim 1B) and conducting a one-arm group assessment and optimization of the ADAPT+ program (Aim 1C). Aim 2 tests the acceptability and feasibility of the refined ADAPT+ intervention in a pilot randomized controlled trial (RCT). Feasibility and acceptability data and manual optimization from the present study will inform a multisite R01.

2. Overview of design and methods

2.1. Community Partner Study Site

We are partnering with a well-established community-based organization, the Hispanic Services Council (HSC), to implement our project. HSC’s primary mission is to increase the access and opportunities of low-income, non-English dominant speaking Latinos. HSC prioritizes promoting healthier diets and lifestyles of the Latino families they serve. HSC-trained Promotoras are central to the delivery of HSC dietary and lifestyle programs, bringing programs and services directly to individuals where they live, work, play and pray. In the past two years, HSC Promotoras have delivered programs reaching over 5,900 families. To increase the feasibility of our study and ensure disseminability and sustainability of our program in the community, ADAPT+ will be integrated into the HSC curriculum offerings. All ADAPT+ training, assessments and intervention sessions take place in HSC space used for their programs.

2.2. Participants

2.2.1. Eligibility Criteria

We will implement ADAPT+ with migrant Latinos living below the poverty line in two primarily rural communities (meeting the USDA definition of rural) [30]. Promotoras trained by both our study staff and our study site partner, HSC, will identify families living in our target community that meet our eligibility criteria: (1) Latino families with a child between the ages of 8 and 12; (2) the child has a body mass index percentile (BMI %ile) of 85 or higher; and (3) the target parent is at least 18 years old, is the main meal preparer, speaks and reads Spanish at a minimum of a 4^th grade reading level (i.e., able to follow basic instructions in Spanish), and is able to perform simple physical exercises. The parent is ineligible if he/she is non-ambulatory, is pregnant, or has a medical condition that may be negatively impacted by physical activity.

Potential participants will be identified by HSC Promotoras for all aspects of the current project from ongoing HSC educational and nutrition programs, posted flyers throughout the community (e.g., local stores, churches), and through community social networks (including the HSC Facebook page). Study staff will work with the Promotoras to follow-up with interested parents, explain the study, and screen families for eligibility. Aim 1C and Aim 2 will have 12 different sets of eligible parent-child dyads, with an expectation that 8–10 dyads will complete each study aim. For Aim 2, groups of families will be recruited from two rural Latino communities to participate at each of the two sites.

2.3. Aim 1: Refinement of ADAPT+ and Study Design

Aim 1 will be conducted during the first year and will consist of two sets of focus groups and a one arm assessment of our intervention to assess acceptability and cultural relevance of ADAPT+, particularly related to the addition of the mindfulness parent stress reduction component (see proposed ADAPT+ session content in Table 1). We follow recommended procedures for adapting interventions with established efficacy [31, 32] to better fit our target population [33].

Table 1.

ADAPT+: Brief Content of the Sessions Targeting Parents.

Session	Content
Session 1 Overview & Get Ready for Success	Purpose of ADAPT+. Effects of stress on health. Challenges of living in rural area & acculturation. Introduction to mindfulness techniques.
Session 2 Mindful Meal Prep	Reading labels & culturally tailored portion sizes. Using mindfulness to control eating during social large gatherings.
Session 3 Mindfulness and Making Healthy Lifestyle Choices + Get Moving!	Effects of sedentary lifestyles. Being healthy, physical activity & mindfulness. Screen-free activities.
Session 4 Parenting in the moment & Increasing Healthy Lifestyles	Parental styles, modeling & mindfulness. Time management and sleep hygiene. Being present and in the moment.
Session 5 Awareness of our Thinking + Healthy Eating	Overcoming Barriers. Stress, stress reactivity & mindfulness. Culturally tailored ways to increase fruit/veg intake.
Session 6 Mindful Eating + Observing vs. Judging	Making favorite dishes healthier. Food accessibility. Using mindfulness to examine hunger cues.
Session 7 Reacting vs. Responding + High Risk Eating/Be Prepared!	Making wise healthy behavior choices. Reducing stress, reacting vs responding & mindfulness. Solutions and strategies for high-risk eating.
Session 8 Practice not Perfection + Progress & Dealing with Setbacks	Practice not Perfection & mindful communication. Coping with setbacks to lifestyle, PA & mindfulness goals. Promoting healthy lifestyle, PA & mindfulness in the long-term.

2.4.1. Aim 1A: In-depth Focus Groups with Promotoras

Our bilingual research assistant (RA) and our mindfulness consultant will obtain feedback about the proposed ADAPT+ program from three Promotoras from each of our two target rural communities. Each component of the program will be reviewed, and feedback on each of our proposed sessions will be elicited.

2.4.2. Aim 1B: Focus Groups with Latino Parents

Two iterative single-session focus groups with Latino parents of children (8–12 years) with obesity will be conducted in each of our two target rural communities (4–6 parents in each group). Feedback from this first focus group will be used to refine the ADAPT+ intervention manual (see Table 1 for session content to be discussed in the focus groups). The revised ADAPT+ manual then will be reviewed by the second focus group. All focus group sessions and interviews will be audiotaped for later coding.

Focus groups will be conducted by Promotoras from the same community as participants, as well as bilingual RAs to maintain focus group fidelity (e.g., detailed notetaking for subsequent assessment of adherence to protocol). Similar to previous focus group research [34–37], Promotoras will be trained to elicit feedback from participants using structured interviews and prompts for each of our eight ADAPT+ intervention sessions, including session goals and activities, as well as their relevance to participants’ daily lives.

Psychoeducation and interactive exercises targeting eating behaviors are planned to occur throughout the entire 8-week program. Table 1 provides examples of content to be covered in the parent sessions, with several sessions focusing on diet and preparing easy, practical meals, especially related to healthy adaptations of cultural common foods [38–40]. We are particularly interested in the acceptability (e.g., cultural and individual) of the mindfulness parent stress reduction components, and how best to integrate them into the original manualized ADAPT program.

2.4.3. Aim 1C: One-Arm Intervention Assessment

In Aim 1C, we consider both the acceptability of the content of ADAPT+, as well as the feasibility of delivering the program in Spanish via Promotoras. We will conduct a one-arm assessment of ADAPT+ with 8–10 primary meal preparers who meet our eligibility criteria and their children. Parents and children will participate in primarily separate, but parallel programs. Two of our trained Promotoras will conduct the revised ADAPT+ sessions in Spanish with parents over eight weeks. A bilingual RA with child development training will conduct the child group over eight sessions in English. Child sessions will include the same topics as in the parent sessions, delivered in child-friendly language and will incorporate more activities and opportunities for physical activity. Consistent with the original ADAPT program piloting, parents and children will come together for about 20 minutes of each of the eight sessions. After each ADAPT+ session, both parents and children will be asked to complete a brief survey assessing their impressions of that session. To assess the feasibility of the pilot study data collection, all participants also will complete the proposed set of questionnaires and anthropometric assessments. This information will be used to finalize and optimize a culturally acceptable ADAPT+ program and ensure the feasibility of quality data collection in Aim 2.

Bilingual RAs will attend each session for both the parent and child groups and will provide impressions and maintain detailed notes. Sessions will be audiotaped for subsequent coding and fidelity checks. General implementation fidelity checks of the session content and specific fidelity checks of the mindfulness components will be conducted to ensure that ADAPT+ can be delivered as intended by Promotoras. Content will be revised, as needed, to increase the accuracy of program delivery by the Promotoras.

2.5. Aim 2: Pilot Randomized Trial Testing the Feasibility of ADAPT+ vs. EUC

2.5.1. Aim 2 Study Design

Following optimization of ADAPT+ through Aims 1A-C, we will test the feasibility and acceptability of ADAPT+ in a small quasi-RCT. Participants will either receive ADAPT+ or a single session control condition that provides psychoeducation about the role of diet and exercise in childhood obesity (Enhanced Usual Care; EUC). This EUC was successfully used as a control condition in a recent RCT [41–43] and is described more fully below.

Because this is a small feasibility exploratory study, true randomization cannot be applied. Table 2 shows a hypothetical quasi-randomization schedule. The ordering of which site offers ADAPT+ first will be randomly selected for cycle 1 of the pilot RCT, with one site offering ADAPT+ and the second site offering EUC. Cycle 2 will counterbalance cycle 1, with the site that offered EUC in cycle 1 now offering ADAPT+ in cycle 2. ADAPT+ will be randomly assigned to a site for cycle 3, with the second site offering EUC. This quasi-cluster randomization approach minimizes site and time effects, as well as threats to internal validity associated with assigning each site to one condition.

Table 2.

Hypothetical Counterbalance Design.

	Rural Site 1	Rural Site 2
Cycle 1	ADAPT+ Cohort 1	EUC Cohort 1
Cycle 2	EUC Cohort 2	ADAPT+ Cohort 2
Cycle 3	ADAPT+ Cohort 3	EUC Cohort 3

Based on this design, there will be cohorts of 8–10 child/parent pairs at each site (two sites) across three intervention cycles. Estimating that all cohorts have 8–10 pairs, we will have a total sample size of 48–60 pairs (i.e., 48–60 parents and 48–60 youth). This sample is sufficient to explore sensitivity of included measures to detect moderate change (see power analysis below).

2.5.2. Aim 2 Retention

Proven retention and incentive strategies [44–46] will be used to encourage program attendance and completion of the end-of-intervention and post-intervention assessment. A graduated incentive structure involving gift cards, small door prizes at each session, and awarding a Certificate of Completion to those attending the final ADAPT+ session will be implemented. Childcare also will be provided for siblings at all sessions and assessments. In addition, we will ask for addresses and phone numbers of those who will know how to contact participating families and use reminder texts for all sessions/assessment appointments (texts were preferred by parents in earlier piloting). These strategies have worked well in studies conducted with Latino families in Florida with 85%−90% retention across an 18-month project [47]. Structured phone interviews will be attempted with those who drop out early to determine withdrawal reasons and reactions to the overall treatment protocol.

2.5.2. Aim 2 Feasibility Assessments

At baseline assessment, a bilingual RA will obtain signed consents/assents. All participants (ADAPT+ and EUC) will complete assessments at baseline, end-of-intervention (i.e., eight weeks), and then at three months post-intervention. Post-intervention phone check-ins will be scheduled to keep in contact with and to increase engagement and retention of all participating families through the 3-month follow-up assessment. Because of the migratory nature of the target population, we plan to conduct the study during the Fall and Winter/Spring when migrant families are in Central Florida. Each of the three assessments will include: anthropometric measurements by study staff (BMI assessed using a weight scale and stadiometer); parent and child self-report surveys (e.g., acculturation, dietary behaviors, perceived stress; all described below); and allocation of a fitness tracker to capture one week of physical activity data at baseline and post- 8-week intervention. In addition, participants in both arms (EUC and ADAPT+) will complete an exit satisfaction survey at the end-of-intervention assessment (i.e., eight weeks) and a qualitative program impression interview at 1-month post-intervention via phone using a semi-structured interview guide.

2.5.3. Intervention Procedures

A program overview will be provided during the assessment evening. ADAPT+ and EUC sessions will be scheduled to begin within one week of the assessments. Bilingual RAs will conduct all assessments and provide instructions on how to use the generic fitness trackers (to assess steps/physical activity of both parents and children) and complete the dietary information log. Participants will wear fitness trackers for at least three days in a row and will bring the fitness tracker data and dietary information logs to the first ADAPT+ or EUC session. Study staff will use the information to complete the dietary recall measures (ASA24; described below) with both the parents and children.

Promotoras will be trained by our staff to lead ADAPT+ sessions. Each of the eight sessions includes a mindfulness parent stress reduction component that is integrated into the behaviorally focused ADAPT+ sessions (see initial session content of ADAPT+ in Table 1). The separate children and parent sessions will be 1 to 1.5-hour group meetings, followed by about 20 minutes of parent/child joint goal setting session. Each session begins with a review of the previous week, monitoring of goal progress. Family-based behavior change activities are assigned at the end of each session so the skills are practiced and reinforced [48]. Joint goal setting sessions will include reviewing that week’s group content, discussing how to work together to meet weekly goals, identifying possible barriers, and developing strategies for success.

2.5.3. Enhanced Usual Care

EUC is designed as a one-time two-hour session and uses publicly available material in both English and Spanish from the We Can! manual [49]. The same format will be used in EUC as in ADAPT+ where parents and children first participate in separate discussion groups and then come together for a joint session led by our bilingual RA and Promotoras. To maintain scientific control for attention threats related to number of contacts with participants, EUC families also will be mailed publicly available brochures and web-based information about a range of behaviors and receive phone check-ins over the course of 8-weeks to correspond with the timing and number of ADAPT+ intervention sessions.

2.7. Changes to the Protocol due to COVID-19

The challenges of moving forward with our research plans in the face of COVID-19 has required us to consider all alternatives and we raise them here because our research protocol may be modified to meet these unforeseen challenges. Focus group protocols will include questions asking participants about the impact of COVID-19 on their lives.

In the initial protocol design, we proposed that all focus groups and family contacts would be conducted face-to-face. We initially prepared to transition to virtual training due to COVID-19, but ultimately concluded that this is not feasible. We therefore are proceeding with our project as originally designed but ensuring that the meeting spaces will accommodate safe distancing of 6 feet, rigorous sanitation before and after each session, and required mask wearing of participants, Promotoras and research staff. We are training the Promotoras to facilitate focus groups (Aim 1B) and conduct the one-arm intervention assessment (Aim 1C) via in-person training, but also use video conferencing so that others on our team can view the training and take detailed notes about the sessions. We plan to use face-to-face training for Aim 2.

3. Benchmarks for Establishing Feasibility and Acceptability

3.1. Acceptability and Feasibility

A list of benchmarks of acceptability and feasibility related to ADAPT+ are listed in Table 3 for Aims 1 and 2 [50–52]. Qualitative data will be used to evaluate program satisfaction, intervention acceptability, and to identify any additional barriers related to the population’s minority status. The quantitative data will establish intervention and data collection method feasibility, with an exit survey in Aim 1C and Aim 2 used to evaluate overall program acceptability and satisfaction. The number of sessions attended, and the number of assessments completed by parent-child dyads will be recorded as indicators of adherence feasibility and acceptability.

Table 3.

Benchmarks for Acceptability and Feasibility of ADAPT+.

Area of Interest	Description of Outcome to be Evaluated	Assessment Tools
Acceptability	Participant Satisfaction	Exit Questionnaire administered at post-testing
	Intention to continue to use skills learned from the intervention	Exit Questionnaire and follow-up check-in interviews
	Perceived cultural appropriateness of the intervention as a whole (ADAPT+) within the community	Exit Questionnaire and feedback from Promotoras
	Perceived utility of knowledge gained about health behavior and of mindfulness and stress reduction techniques	Exit Questionnaire
Feasibility of Study Implementation	Enrollment/Recruitment rates for study	Master tracking log for eligible families
	Completed sessions	Attendance log for participating families
	Completion of weekly-goal homework	Goal completion checklist
	Screening/eligibility rates for study	Log number of call attempts for each participant and reasons for ineligibility
	Retainment/dropouts	Master tracking log for participating families
	Assessment completion	Assessment checklist

In addition to these program-focused acceptability/feasibility outcomes, we also will evaluate the acceptability and feasibility of our research methods. Specifically, we will assess the acceptability of randomization by participants to ADAPT+ vs. EUC; the fidelity of screening for eligibility criteria; the feasibility of administering questionnaires and assessing for completeness; and feasibility of scheduling participants for intervention sessions, assessment visits (pre- and end-of-intervention), and follow-up check-in phone interviews.

3.3. Training in Cultural Competence, Supervision, and Fidelity Checks

(1) Training in Cultural Competence. All staff will be trained in the delivery of culturally competent interventions, with emphasis on the importance of family preferences and cultural relevance [39, 53]. (2) Monitoring fidelity. Reliable delivery of the intervention will be promoted by incorporating, a) a clear, detailed manual; b) facilitator training; c) frequent communication between the Promotoras and the primary research team and our mindfulness consultant; and d) participation by Promotoras in weekly session reviews and supervision. (3) Quality assurance measures will be used to verify that the intervention is delivered as planned. Briefly, a) Promotoras will complete a <2 minute checklist documenting planned activities and content; b) participants will complete a brief questionnaire assessing likability of each session’s content; c) fidelity raters will observe and evaluate 20% of all group sessions using the Fidelity of Implementation Rating System checklist [54]; and d) any identified deviation from the standard protocol will result in retraining staff to meet protocol fidelity criteria.

4. Assessment Design and Outcome Measures

Our main assessment goals are measuring the acceptability and feasibility of the ADAPT+ program, and demographic and outcome variables. We will assess sensitivity to intervention effects on anthropometric, blood pressure, physical behavior outcomes, as well as stress-related indicators, for all children and parents at baseline, end-of-intervention (in Aim 1C and Aim 2) and at 3-month follow-up in Aim 2. All parent measures will be in Spanish; all child measures will be in English or administered in English.

4.1. Acculturation

At the baseline assessment of the one-arm evaluation of ADAPT+ (Aim 1C) and the small RCT (Aim 2) parents will complete an assessment of acculturation using the Stephenson Multigroup Acculturation Scale (SMAS) [55].

4.2. Anthropometric Measurements and Blood Pressure (BP)

Using standardized equipment, a bilingual RA will conduct all physical assessments using a weight scale and stadiometer and calculate BMI z-score (child-based on CDC Growth Charts), BMI (parent), waist-to-hip ratio (WHR) and resting blood pressure (BP) assessed in triplicate with the participant in a seated position. Elevated BP is defined for age, sex, and height [56]. These assessments are conducted both at baseline and at post-intervention.

4.3. Physical Activity Behaviors

Fitness trackers will assess one week of physical activity frequency (i.e., average daily steps) for both child and parent at baseline and post-intervention, and data will be extracted by participants and logged. Steps will be calculated as the average number of steps of 3/7 days.

4.4. Dietary Behaviors

Dietary intake (calories, fat, and sugar) will be assessed at baseline and at post-intervention for both parent and child via the Automated Self-administered 24-Hour Dietary Recall (ASA24) [57], a computer-assisted dietary recall. Parents will complete a detailed 1- day dietary log for themselves and their child, and study staff will enter the information into the ASA24 website. For reliability and triangulation, children will complete a self-report of their typical sugary beverages and fast food consumed per week via the Child Sugar Sweet Beverage and Fast Food Intake Instrument [58]. Parents will report on their own eating, healthy dietary changes, use of artificial sweeteners, number of meals/day, and fat consumption via the Latino Dietary Behaviors Questionnaire [59].

4.5. Stress-related Indicators

Parents will report both at baseline and post-intervention subjective stress by completing the Perceived Stress Scale (PSS), a 14-item self-report scale [60]. Mindfulness skills are assessed using the 15-item Mindfulness Attention Awareness Scale (MAAS) [61].

4.6. Exit Survey

All parents will complete a quantitative brief exit survey to assess their overall satisfaction with the intervention (ADAPT+ or EUC), their opinion of its impact on their knowledge of childhood obesity, healthy eating, physical activity behaviors, and mindfulness parent stress reduction approaches, as well as how well the content fit their needs and cultural values. Participants will be asked what they liked/disliked about the intervention, what additional information they might have wanted, and the extent to which they felt they increased their understanding of healthy lifestyle behaviors and stress reduction strategies.

4.6. Interviews

We will obtain qualitative data on satisfaction with the intervention and perception of barriers to behavior change they and/or their child faced post-intervention. Interviews will be recorded, transcribed, and coded by two condition naïve study staff to establish inter-coder reliability and consistency. The grounded theory method [62] will guide coding and theme identification. Results will be triangulated with the end-of-intervention exit survey responses. Semi-structured standardized cognitive interviews [63] will be conducted with parents at the 1-month post-intervention phone check-in with all RCT parents (Aim 2).

5. Data Analytic Plan

This project focuses on acceptability and feasibility testing of ADAPT+ with the goal of gathering information to inform a larger RCT of ADAPT+ with a rural migrant Latino population. Feasibility testing focuses on the process of intervention development [64] and includes investigation of intervention acceptability and implementation, and preliminary evaluation of participant responses [64–66].

5.1. Generalized Estimating Equations (GEE)

For Aim 2, GEE will be used to examine acceptability and feasibility and to explore intervention assessment sensitivity. Sample sizes between 24–50 have been recommended for feasibility trials [67, 68] and our proposed sample of 48–60 is well-within this range. Formal testing of the conceptual and proposed mechanisms of change is not appropriate for the treatment development phase; however, we will explore participant responses as a function of pilot study intervention. Based on our prior work and using zBMI as our primary outcome measure [43, 44], a sample size of 96 participants (48 children, 49 parents), an alpha level of .05, and an intraclass correlation of .80, this project is powered at 0.97 and is potentially capable to detect medium effects on our key outcomes (equivalent to Cohen’s d of 0.50) and demonstrate feasibility of a larger scale RCT that will be the basis for addressing weaknesses in prior research. Key outcomes include anthropometric measures (adult BMI, child BMI z-score), and secondary outcomes include parent and child WHR, BP, average daily steps, dietary intake, and parent perceived stress and mindful attention.

5.2. Quality Control

A bilingual RA will review information obtained from all participants at each phase of data collection to check for accuracy and completion. We will primarily use paper and pencil measures to be subsequently uploaded by research assistants into our database.

5.3. Preliminary Analyses

Preliminary analyses will include descriptive statistics to examine and to understand the characteristics (e.g., age) of the participants in relation to feasibility and acceptability assessments. Variability in responses will be examined for all analyses related to acceptability, demand, and implementation.

5.4. Acceptability of the Intervention

For all acceptability outcomes, variables first will be compared across ADAPT+ and EUC using the full range of participant responses, followed by examination of recoded binary variables reflecting responses of 4 or 5 (high acceptability) on the Likert scales ranging from 1 or 5 versus all other responses. GEE and associated confidence intervals will be used to account for site effects and to examine the proportion of participants positively endorsing aspects of the intervention (i.e., ratings of 4 or 5) across ADAPT+ and EUC. For all acceptability outcomes, we will determine the percentage of participants reporting positive feedback, which reflects acceptability (see Table 3). Responses from parents and children will be examined separately. Specific topics will include general intervention satisfaction, skill use, cultural appropriateness of the program, and intervention utility. In general, we hypothesize that our measures of intervention acceptability will suggest that participants who complete ADAPT+ will find the intervention more favorable than those who complete EUC.

5.5. Assessment of Intervention Implementation

Intervention implementation will be assessed via evaluation of recruitment, enrollment, retention, and measure completion (see Table 3). We will calculate the percentage of eligible families approached who enrolled in the study, using a master tracking log for eligible families; examine the number of sessions completed using the attendance log for participating families; and identify the extent to which participants completed weekly eating and physical activity goals in ADAPT+ sessions by reviewing the goal completion checklist.

5.6. Preliminary Evaluation of Participants’ Response to the Interventions

While evaluation of outcomes is more appropriate for a fully powered R01, we will examine variance and effect sizes of key outcomes from pre- to end-of-intervention, as well as end-of-intervention to 3-month follow-up using non-parametric tests and confidence intervals. Analyses will explore potential patterns related to attrition. Every effort will be made to collect follow-up data from all participants, regardless of whether they completed the intervention.

6. Discussion

Determining acceptability and feasibility of implementing a multi-faceted intervention that incorporates stress reduction strategies to address the limitations of current obesity interventions for this underserved, minority population is vital. The present study will attempt to identify factors that can increase intervention effectiveness among this unique population. This study specifically tests whether this refined and optimized ADAPT protocol that includes mindfulness strategies is acceptable and feasible in a rural Latino population with the aim of increasing accessibility to integrative health modalities. We argue that it is important to learn whether mindfulness strategies plus our original ADAPT protocol can bolster lifestyle change outcomes [26] by also addressing parent stress in this “double disparity” population.

A strength of our study is that we use Promotoras as group facilitators. As community dissemination is a key end-goal of this project, the partnership with HSC is crucial. Developing and testing ADAPT+ in collaboration with the Promotoras will contribute not only to its feasibility and acceptability to the rural Latino community, but also to its disseminability by the Promotoras as part of the HSC’s offerings. If a program does not resonate with community facilitators, or is too complex to lead, the program is unlikely to be sustainable. Our goal is to develop an obesity intervention that demonstrates feasibility and acceptability across both community facilitators and community participants.

There are several potential limitations that we must acknowledge. (1) Cultural acceptability: (a) We recognize potential for limited buy-in for mindfulness parent stress reduction approaches in this population. We minimize this risk by having well-trained Promotoras assist in the development, refinement, and implementation of our intervention, and by conducting multiple focus groups with a variety of stakeholders to better refine and optimize our protocol. (b) We also recognize that our program does not address all factors contributing to obesity in Latino families living in rural communities. For example, families with transportation barriers might not be able to easily participate in the program, thereby limiting generalizability. (2) Limitation of our aims: By its very nature as a study with a primary aim of establishing acceptability, feasibility, and refinement of our intervention ADAPT+, intervention efficacy is not considered. Instead, we aim to establish the basis for a fully powered RCT to test the efficacy of ADAPT+ by examining the feasibility of collecting outcome measures over time in our target population and determining the sensitivity of our measures to capture intervention effects. (3) Alternative study designs: We considered several types of comparison groups, including attention only, but decided that it was important to provide all participants relevant information (as we do in EUC). An active control group in this feasibility study is an optimal comparison as a basis for the development of our planned larger scale RCT. (4) Measurement limitations: (a) We recognize that fitness trackers are a less expensive, less rigorously tested physical activity assessment tool than other possibilities (e.g., actigraphs). Nonetheless, fitness trackers are common (which may increase adherence) and will still provide us with important acceptability and feasibility data. We expect to incorporate actigraphy assessment in a larger efficacy trial. (b) Although dyadic parent-child communication is vital for child behavior change, assessing this is beyond the scope and aims of this feasibility study and will be included in a larger clinical trial aimed at assessing efficacy. (c) Biomarkers of obesity (including inflammation and vascular markers) are important indicators of cardiovascular and other chronic diseases but are not assessed in the present study. We assess standard outcomes associated with diet and physical activity, including several anthropometric measures and blood pressure, to evaluate changes in children and their parents over time. The current pilot feasibility study will provide important data for future larger scale iterations of our study.

The scientific premise of our project reflects the overwhelming evidence of the public health urgency of addressing the obesity epidemic among Latino youth living in rural communities. Our project is innovative as it implements a unique intervention that addresses many current limitations of obesity interventions in Latino youth living in rural areas, and employs a rigorous scientific mixed-methods approach, including both measured and self-report outcome measures. Critical to future dissemination, we also partner with a community-based organization and use their well-trained and connected Promotoras as group facilitators, which should increase buy-in from participants [69] and allow greater accessibility to integrative health approaches in this population. Study results will create the infrastructure and guide the development of a large-scale, multi-site RCT covering rural areas throughout Florida, and possibly elsewhere to assess ADAPT+ effectiveness and seek to identify mechanisms of action.