Adapting Diet and Action for Everyone (ADAPT+)

Sponsor

University of South Florida (Other)

Overall Status

Recruiting

CT.gov ID

NCT04800432

Collaborator

National Center for Complementary and Integrative Health (NCCIH) (NIH)

108

Enrollment

Location

Arms

18.8

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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+).

Condition or Disease	Intervention/Treatment	Phase
Pediatric Obesity	Behavioral: ADAPT+ Behavioral: EUC	N/A

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) intervention through a one group pilot. 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 (reported in Clinical Trials) pilots the revised intervention manual with one parent-child cohort. Data collected at Aim 1C will be used to finalize and optimize a culturally acceptable ADAPT+ to be further 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, PA and stress indices are sensitive to the intervention.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Aim 1C does not include a comparison group - 6 parent-child dyads (12 individuals) anticipated for enrollment. Aim 2 includes randomization to a comparison group - 48 parent-child dyads (96 individuals) anticipated for enrollment. This reflects the total enrollment number of 112.Aim 1C does not include a comparison group - 6 parent-child dyads (12 individuals) anticipated for enrollment. Aim 2 includes randomization to a comparison group - 48 parent-child dyads (96 individuals) anticipated for enrollment. This reflects the total enrollment number of 112.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 6, 2021

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

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 8-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.

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 8-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.

Outcome Measures

Primary Outcome Measures

Acceptability [8 weeks after baseline]
An exit survey will be administered to measure thoughts about the duration, frequency, and number of sessions; perceived benefits and barriers to implementing the intervention goals; comfort with group leaders and members; overall satisfaction; and suggestions for improvement. Participants in Aim 1C will be asked about their willingness to be randomized.
Feasibility - Accrual Rates [8 weeks after baseline]
Benchmark of 75% of eligible families approached, will agree to participate
Feasibility - Number of Sessions Completed [8 weeks after baseline]
Benchmark of >60% of all participants will complete all 8 sessions and at least 75% will complete between 4 to 8 sessions
Feasibility - Physical Activity Goals [8 weeks after baseline]
Benchmark that 75% of participants will report that they met their physical activity goal at least 4/7 days

Secondary Outcome Measures

Child BMI z score [Through study completion, at study initiation, two months, three months, and five months]
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.
Child Waist-to-Hip Ratio [Through study completion, at study initiation, two months, three months, and five months]
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.
Child Step count [Through study completion, at study initiation, two months, three months, and five months]
Fitness trackers will assess physical activity. Participants will be trained to wear a downloadable activity tracker that measures number of steps walked consecutively for 7 days for each assessment.
Child Food and PA Questionnaire [Through study completion, at study initiation, two months, three months, and five months]
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.
Parent BMI [Through study completion, at study initiation, two months, three months, and five months]
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.
Parent Waist-to-Hip Ratio [Through study completion, at study initiation, two months, three months, and five months]
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.
Parent Step Count [Through study completion, at study initiation, two months, three months, and five months]
Fitness trackers will assess physical activity. Participants will be trained to wear a downloadable activity tracker that measures number of steps walked consecutively for 7 days for each assessment.
Dietary Habits [Through study completion, at study initiation, two months, three months, and five months]
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.
Perceived Stress Scale (PSS) [Through study completion, at study initiation, two months, three months, and five months]
Parents complete the 14 item self-report scale that asks participants about their feelings in the past month.
Mindfulness Attention Awareness Scale (MAAS) [Through study completion, at study initiation, two months, three months, and five months]
Parents will complete the MAAS. The MAAS is a 15-item scale designed to assess a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hispanic Services Council	Tampa	Florida	United States	33614

Sponsors and Collaborators

University of South Florida
National Center for Complementary and Integrative Health (NCCIH)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University of South Florida

ClinicalTrials.gov Identifier:

NCT04800432

Other Study ID Numbers:

Pro00039979
R34AT010661

First Posted:

Mar 16, 2021

Last Update Posted:

May 5, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of South Florida

Latino

Rural Communities

Mindfulness

Additional relevant MeSH terms:

Obesity

Pediatric Obesity

Study Results

No Results Posted as of May 5, 2021