Adapting Diet and Action for Everyone (ADAPT+) (ADAPT+)

March 20, 2024 updated by: University of South Florida

ADAPT+: Optimizing an Intervention to Promote Healthy Behaviors in Rural, Latino Youth With Obesity and Their Parents, Using Mindfulness Strategies

The purpose of this study is to refine and optimize an obesity intervention with rural underserved Latino children and their parents that combines a standard family-based behavioral approach, the "gold standard" for pediatric obesity treatment, with a mindfulness approach focusing on stress reduction (now ADAPT+).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Latino youth have the highest prevalence of obesity as compared to Black or White youth, and are at high risk for adult obesity-related complications including cardiovascular disease. Moreover, Latino youth living in rural communities have an increased risk of adult obesity and mortality due to obesity-related chronic disease than Latinos living elsewhere. The investigators synthesized the prior childhood obesity intervention and tailored the evidence informed, theory-based, multi-family behavioral intervention, Adapting Diet and Action for Everyone (ADAPT), to the acculturation status, language, and national origin of the target population - obese, school-aged (8-12 years old) Latino youth and their parents living in rural areas. However, because the role of parent stress on obesity has not been adequately addressed in interventions aimed at reducing obesity in Latino youth, it is argued that mindfulness parent stress reduction strategies may be a key component to improving eating and physical activity (PA) behaviors in both children and their parents. This study proposes a refinement and optimization of the original ADAPT obesity intervention protocol to include mindfulness parent stress reduction strategies (now ADAPT+) and feasibility assessment of ADAPT+ implementation.

Aim 1: Refinement of ADAPT+ (ADAPT + mindfulness parent stress reduction). Aim 1A and Aim 1B were focus groups with promotoras from the target communities and parents. The intervention manual was refined based on the qualitative feedback. Aim 1C further refines the manual via a small one parent-child cohort. Data collected at Aim 1C was used to finalize and optimize a culturally acceptable ADAPT+ evaluated in Aim 2.

Aim 2: Feasibility and Acceptability trial. A randomized trial testing feasibility of ADAPT+ vs. Enhanced Usual Care (EUC) conducted in two rural communities. It is anticipated that compared to EUC, ADAPT+ dyads will have a lower attrition rate and will report greater satisfaction. The investigators also explore whether the eating and stress indices are sensitive to the intervention.

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33614
        • Hispanic Services Council

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Child with a BMI %ile of 85 or higher.
  • The target parent is at least 18 years old, is the main meal preparer, speaks and reads Spanish at a minimum of a 4th grade reading level (able to follow basic instructions in Spanish), and able to perform simple physical exercises.

Exclusion Criteria:

  • A child who has a medical/developmental condition that precludes weight loss using conventional diet and PA methods.
  • A child has been on antibiotics or steroids in the previous three months.
  • The parent is ineligible if he/she is non-ambulatory, is pregnant, or has a medical condition that may be negatively impacted by PA.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Feasibility and acceptability of ADAPT+
ADAPT+ is a family-based obesity intervention for high-risk Latino youth and their parents living in rural communities that incorporates culture-specific components and mindfulness-based approaches to promote adaptive health behaviors in a high-risk and underserved population.
Behavioral: ADAPT+
ADAPT+ is designed as an 6-week intervention. For each session, children and parents participate in separate 1.5-hour group meetings, followed by a joint goal setting session. Practical strategies related to improving diet and physical activity as well as the role of dealing with parent stress-related factors related to making long-lasting behavioral changes in the family are addressed.
Active Comparator: Enhanced Usual Care (EUC)
Enhanced Usual Care (EUC) provides publicly available material in both English and Spanish on the role of diet and exercise in pediatric obesity in a one-time information session.
Behavioral: EUC
Enhanced Usual Care is an abbreviated version of the full ADAPT+ intervention in which parents are engaged in a one-time, two hour information session to also learn knowledge and skills to improve the health and lifestyle behaviors for their child and for themselves.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: 6 weeks after baseline

Acceptability was measured by a program satisfaction survey at the end of the intervention. Items were rated on a scale from 1 (Not at all) to 4 (Very) enjoyable, comfortable, receptive, relevant, or helpful, depending on the item's content. A mean score was calculated using all items to reflect overall satisfaction, with higher scores indicating greater satisfaction. Only parents completed the program satisfaction survey.

Minimum score: 1 Maximum score: 4 Higher scores mean better outcomes.
6 weeks after baseline
Feasibility - Accrual Rates
Time Frame: 6 weeks after baseline
Percent of families approached who agreed to participate. This was done at the parent/dyad level.
6 weeks after baseline
Feasibility - Number of Participants Attending 75%+ Sessions
Time Frame: 6 weeks after baseline
Number of participants who completed at least 75% of the program sessions. This was done at the parent/dyad level.
6 weeks after baseline
Retention Over Time (From Baseline to Post-assessment)
Time Frame: From baseline to post-assessment (6-weeks)
Percentage of families retained for post-intervention assessment
From baseline to post-assessment (6-weeks)
Retention Over Time (From Baseline to 3-month Follow-up)
Time Frame: From baseline to 3-month follow-up
Percentage of families retained for 3-month follow-up assessment
From baseline to 3-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child BMI z Score (Post-Assessment)
Time Frame: Post-Assessment (6 weeks after Baseline)

Height (to the nearest 1/4 inch) using a metal ruler and weight (to the nearest 1/4 pound) using a scale will be measured by study staff.

Z Body Mass Index (BMI). 0 represents the population mean. The higher the score, the higher the BMI, based on age and gender. There are no established clinically relevant thresholds for z-BMI.
Post-Assessment (6 weeks after Baseline)
Child BMI z Score (3-month Follow-up)
Time Frame: 3-month Follow-up (3 months after Post-Assessment)

Height (to the nearest 1/4 inch) using a metal ruler and weight (to the nearest 1/4 pound) using a scale will be measured by study staff.

Z Body Mass Index (BMI). 0 represents the population mean. The higher the score, the higher the BMI, based on age and gender. There are no established clinically relevant thresholds for z-BMI.
3-month Follow-up (3 months after Post-Assessment)
Child Waist-to-Hip Ratio (Post-Assessment)
Time Frame: Post-Assessment (6 weeks after Baseline)
Circumference of the hip (girth of hips above the gluteal fold) and waist (narrowest part of torso above the umbilicus and below the xiphoid process) will be measured by study staff using an anthropometric measuring tape and used to calculate continuous Waist-to-Hip Ratio.
Post-Assessment (6 weeks after Baseline)
Child Waist-to-Hip Ratio (3-month Follow-up)
Time Frame: 3-month Follow-up (3 months after Post-Assessment)
Circumference of the hip (girth of hips above the gluteal fold) and waist (narrowest part of torso above the umbilicus and below the xiphoid process) will be measured by study staff using an anthropometric measuring tape and used to calculate continuous Waist-to-Hip Ratio.
3-month Follow-up (3 months after Post-Assessment)
Child Sugar Sweet Beverage and Fast Food Intake Instrument (Post-Assessment)
Time Frame: Post-Assessment (6 weeks after Baseline)

The questionnaire consists of 11 questions on food and physical activity behaviors for youth participants in the study. This was adapted from the Youth Expanded Food and Nutrition Education Program (EFNEP) evaluation tool, the EFNEP 3rd-5th Grade Survey, which was designed and tested by Purdue University Extension Program. It will take approximately 5 minutes to complete. Below are presented the minimum and maximum values for each subscale reported.

Fruit & Veg Frequency: 0-15, higher scores mean fruits and veggies consumed more frequently.

Fruit & Veg Quantity: 0-5, higher scores mean larger fruit and veggie quantity consumed.

Sugar-Sweetened Beverage Frequency: 0-8, higher scores mean SSB consumed more frequently.

Sugar-Sweetened Beverage Quantity: 0-5, higher scores mean larger quantities of SSB consumed.

Fast Food Frequency: 0-4, higher scores mean fast food consumed more frequently.

Fast Food Quantity: 0-16, higher scores mean larger quantities of fast food consumed.
Post-Assessment (6 weeks after Baseline)
Child Sugar Sweet Beverage and Fast Food Intake Instrument (3-month Follow-up)
Time Frame: 3-month Follow-up (3 months after Post-Assessment)

The questionnaire consists of 11 questions on food and physical activity behaviors for youth participants in the study. This was adapted from the USDA Youth Expanded Food and Nutrition Education Program (EFNEP) evaluation tool, the EFNEP 3rd-5th Grade Survey, which was designed and tested by Purdue University Extension Program. It will take approximately 5 minutes to complete. Below are presented the minimum and maximum values for each subscale reported.

Fruit & Veg Frequency: 0-15, higher scores mean fruits and veggies consumed more frequently.

Fruit & Veg Quantity: 0-5, higher scores mean larger fruit and veggie quantity consumed.

Sugar-Sweetened Beverage Frequency: 0-8, higher scores mean SSB consumed more frequently.

Sugar-Sweetened Beverage Quantity: 0-5, higher scores mean larger quantities of SSB consumed.

Fast Food Frequency: 0-4, higher scores mean fast food consumed more frequently.

Fast Food Quantity: 0-16, higher scores mean larger quantities of fast food consumed.
3-month Follow-up (3 months after Post-Assessment)
Parent BMI (Post-Assessment)
Time Frame: Post-Assessment (6 weeks after Baseline)
Height (to the nearest 1/4 inch) using a metal ruler and weight (to the nearest 1/4 pound) using a scale will be measured by the study staff and used to calculate continuous adult BMI score.
Post-Assessment (6 weeks after Baseline)
Parent BMI (3-month Follow-up)
Time Frame: 3-month Follow-up (3 months after Post-Assessment)
Height (to the nearest 1/4 inch) using a metal ruler and weight (to the nearest 1/4 pound) using a scale will be measured by the study staff and used to calculate continuous adult BMI score.
3-month Follow-up (3 months after Post-Assessment)
Parent Waist-to-Hip Ratio (Post-Assessment)
Time Frame: Post-Assessment (6 weeks after Baseline)
Circumference of the hip (girth of hips above the gluteal fold) and waist (narrowest part of torso above the umbilicus and below the xiphoid process) will be measured by the study staff using an anthropometric measuring tape and used to calculate continuous Waist-to-Hip Ratio.
Post-Assessment (6 weeks after Baseline)
Parent Waist-to-Hip Ratio (3-month Follow-up)
Time Frame: 3-month Follow-up (3 months after Post-Assessment)
Circumference of the hip (girth of hips above the gluteal fold) and waist (narrowest part of torso above the umbilicus and below the xiphoid process) will be measured by the study staff using an anthropometric measuring tape and used to calculate continuous Waist-to-Hip Ratio.
3-month Follow-up (3 months after Post-Assessment)
Latino Dietary Behaviors Questionnaire (Post-Assessment)
Time Frame: Post-Assessment (6 weeks after Baseline)
The Latino Dietary Behaviors Questionnaire: This 13-item self-report survey of dietary habits (in Spanish) assesses 4 areas of eating behavior -- healthy dietary changes; types of drinks consumed, number of meals per day and fat consumption. Minimum and maximum scores possible for this scale range from 1 to 47. Higher scores reflect healthier eating behaviors.
Post-Assessment (6 weeks after Baseline)
Latino Dietary Behaviors Questionnaire (3-month Follow-up)
Time Frame: 3-month Follow-up (3 months after Post-Assessment)
The Latino Dietary Behaviors Questionnaire: This 13-item self-report survey of dietary habits (in Spanish) assesses 4 areas of eating behavior -- healthy dietary changes; types of drinks consumed, number of meals per day and fat consumption. Minimum and maximum scores possible for this scale range from 1 to 47. Higher scores reflect healthier eating behaviors.
3-month Follow-up (3 months after Post-Assessment)
Perceived Stress Scale (PSS) [Post-Assessment]
Time Frame: Post-Assessment (6 weeks after Baseline)
Parents complete the 14 item self-report scale that asks participants about their feelings in the past month. Minimum and maximum scores possible for this scale range from 0 to 40. Higher scores reflect greater perceived stress.
Post-Assessment (6 weeks after Baseline)
Perceived Stress Scale (PSS) [3-month Follow-up]
Time Frame: 3-month Follow-up (3 months after Post-Assessment)
Parents complete the 14 item self-report scale that asks participants about their feelings in the past month. Minimum and maximum scores possible for this scale range from 0 to 40. Higher scores reflect greater perceived stress.
3-month Follow-up (3 months after Post-Assessment)
Recognize Subscale of the Mindful Eating Questionnaire (Post-Assessment)
Time Frame: Post-Assessment (6 weeks after Baseline)
Parents will complete the Recognize subscale of the Mindful Eating Questionnaire. The subscale has 9 items and is designed to assess an individual's ability to stop eating when full. Minimum and maximum scores possible for this subscale range from 9 to 36. Higher scores reflect a greater degree of recognition of hunger and satiety cues.
Post-Assessment (6 weeks after Baseline)
Recognize Subscale of the Mindful Eating Questionnaire (3-month Follow-up)
Time Frame: 3-month Follow-up (3 months after Post-Assessment)
Parents will complete the Recognize subscale of the Mindful Eating Questionnaire. The subscale has 9 items and is designed to assess an individual's ability to stop eating when full. Minimum and maximum scores possible for this subscale range from 9 to 36. Higher scores reflect a greater degree of recognition of hunger and satiety cues.
3-month Follow-up (3 months after Post-Assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Marilyn Stern, PhD, University of South Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2021

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

October 30, 2023

Study Registration Dates

First Submitted

February 24, 2021

First Submitted That Met QC Criteria

March 12, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00039979
  • R34AT010661 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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