Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Pediatric Obesity
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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.Masking: Single (Outcomes Assessor)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 8 years and 12 years
Gender
Both males and females

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 obes...

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.

Tracking Information

NCT #
NCT04800432
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Marilyn Stern, PhD University of South Florida