Clinical trial NCT04800432: Adapting Diet and Action for Everyone (ADAPT+)
Official title: ADAPT+: Optimizing an Intervention to Promote Healthy Behaviors in Rural, Latino Youth With Obesity and Their Parents, Using Mindfulness Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: Latino
Rural Communities
Mindfulness
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2021-03-16
Enrollment: 95
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Aim 2 includes randomization to a comparison group - 48 parent-child dyads (96 individuals) anticipated for enrollment.

Aim 2 was the small pilot RCT
Primary purpose: SUPPORTIVE_CARE

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+).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability
timeFrame: 6 weeks after baseline
measure: Feasibility - Accrual Rates
timeFrame: 6 weeks after baseline
measure: Feasibility - Number of Participants Attending 75%+ Sessions
timeFrame: 6 weeks after baseline
measure: Retention Over Time (From Baseline to Post-assessment)
timeFrame: From baseline to post-assessment (6-weeks)
measure: Retention Over Time (From Baseline to 3-month Follow-up)
timeFrame: From baseline to 3-month follow-up
Secondary outcomes:
measure: Child BMI z Score (Post-Assessment)
timeFrame: Post-Assessment (6 weeks after Baseline)
measure: Child BMI z Score (3-month Follow-up)
timeFrame: 3-month Follow-up (3 months after Post-Assessment)
measure: Child Waist-to-Hip Ratio (Post-Assessment)
timeFrame: Post-Assessment (6 weeks after Baseline)
measure: Child Waist-to-Hip Ratio (3-month Follow-up)
timeFrame: 3-month Follow-up (3 months after Post-Assessment)
measure: Child Sugar Sweet Beverage and Fast Food Intake Instrument (Post-Assessment)
timeFrame: Post-Assessment (6 weeks after Baseline)
measure: Child Sugar Sweet Beverage and Fast Food Intake Instrument (3-month Follow-up)
timeFrame: 3-month Follow-up (3 months after Post-Assessment)
measure: Parent BMI (Post-Assessment)
timeFrame: Post-Assessment (6 weeks after Baseline)
measure: Parent BMI (3-month Follow-up)
timeFrame: 3-month Follow-up (3 months after Post-Assessment)
measure: Parent Waist-to-Hip Ratio (Post-Assessment)
timeFrame: Post-Assessment (6 weeks after Baseline)
measure: Parent Waist-to-Hip Ratio (3-month Follow-up)
timeFrame: 3-month Follow-up (3 months after Post-Assessment)
measure: Latino Dietary Behaviors Questionnaire (Post-Assessment)
timeFrame: Post-Assessment (6 weeks after Baseline)
measure: Latino Dietary Behaviors Questionnaire (3-month Follow-up)
timeFrame: 3-month Follow-up (3 months after Post-Assessment)
measure: Perceived Stress Scale (PSS) [Post-Assessment]
timeFrame: Post-Assessment (6 weeks after Baseline)
measure: Perceived Stress Scale (PSS) [3-month Follow-up]
timeFrame: 3-month Follow-up (3 months after Post-Assessment)
measure: Recognize Subscale of the Mindful Eating Questionnaire (Post-Assessment)
timeFrame: Post-Assessment (6 weeks after Baseline)
measure: Recognize Subscale of the Mindful Eating Questionnaire (3-month Follow-up)
timeFrame: 3-month Follow-up (3 months after Post-Assessment)
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Hispanic Services Council
state: Florida
Study officials:
affiliation: University of South Florida
name: Marilyn Stern, PhD
role: PRINCIPAL_INVESTIGATOR
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