Adapting Diet and Action for Everyone (ADAPT+)

University of South Florida

Status: Completed

Conditions: Pediatric Obesity

Treatments: Behavioral: EUC; Behavioral: ADAPT+

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04800432

Pro00039979

R34AT010661 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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+).

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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95 participants in 2 patient groups

Feasibility and acceptability of ADAPT+

Experimental group

Description:

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.

Treatment:

Behavioral: ADAPT+

Enhanced Usual Care (EUC)

Active Comparator group

Description:

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.

Treatment:

Behavioral: EUC