Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
95 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-03-06
Study Completion Date
2023-10-30
Brief Summary
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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+).
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Detailed Description
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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.
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.
Conditions
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Pediatric Obesity
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Aim 2 includes randomization to a comparison group - 48 parent-child dyads (96 individuals) anticipated for enrollment.
Aim 2 was the small pilot RCT
Aim 2 was the small pilot RCT
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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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.
Group Type
EXPERIMENTAL
ADAPT+
Intervention Type
BEHAVIORAL
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.
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.
Group Type
ACTIVE_COMPARATOR
EUC
Intervention Type
BEHAVIORAL
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.
Interventions
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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.
Intervention Type
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.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
8 Years
Maximum Eligible Age
12 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Sponsor Role
collaborator
University of South Florida
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Marilyn Stern, PhD
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Locations
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Hispanic Services Council
Tampa, Florida, United States
Site Status
Countries
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United States
References
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DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Pro00039979
Identifier Type: -
Identifier Source: org_study_id
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