Adapting Diet and Action for Everyone (ADAPT+)

NCT04800432 | Completed Results

• 2 other identifiers: Pro00039979R34AT010661
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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+).

Conditions

Pediatric Obesity

Keywords

Latino; Rural Communities; Mindfulness

Outcome Measures

Primary Outcomes (5)

• Acceptability

  Acceptability was measured by a program satisfaction survey at the end of the intervention. Items were rated on a scale from 1 (Not at all) to 4 (Very) enjoyable, comfortable, receptive, relevant, or helpful, depending on the item's content. A mean score was calculated using all items to reflect overall satisfaction, with higher scores indicating greater satisfaction. Only parents completed the program satisfaction survey. Minimum score: 1 Maximum score: 4 Higher scores mean better outcomes.

  6 weeks after baseline

• Feasibility - Accrual Rates

  Percent of families approached who agreed to participate. This was done at the parent/dyad level.

  6 weeks after baseline

• Feasibility - Number of Participants Attending 75%+ Sessions

  Number of participants who completed at least 75% of the program sessions. This was done at the parent/dyad level.

  6 weeks after baseline

• Retention Over Time (From Baseline to Post-assessment)

  Percentage of families retained for post-intervention assessment

  From baseline to post-assessment (6-weeks)

• Retention Over Time (From Baseline to 3-month Follow-up)

  Percentage of families retained for 3-month follow-up assessment

  From baseline to 3-month follow-up

Secondary Outcomes (16)

• Child BMI z Score (Post-Assessment)

  Post-Assessment (6 weeks after Baseline)

• Child BMI z Score (3-month Follow-up)

  3-month Follow-up (3 months after Post-Assessment)

• Child Waist-to-Hip Ratio (Post-Assessment)

  Post-Assessment (6 weeks after Baseline)

• Child Waist-to-Hip Ratio (3-month Follow-up)

  3-month Follow-up (3 months after Post-Assessment)

• Child Sugar Sweet Beverage and Fast Food Intake Instrument (Post-Assessment)

  Post-Assessment (6 weeks after Baseline)

Study Arms (2)

Feasibility and acceptability of ADAPT+

EXPERIMENTAL

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+

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

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

Interventions

ADAPT+ 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.

Feasibility and acceptability of ADAPT+

EUC 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.

Enhanced Usual Care (EUC)

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Hispanic Services Council

Tampa, Florida, 33614, United States

Location

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MeSH Terms

Conditions

Pediatric Obesity

Interventions

Acclimatization

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adaptation, Physiological; Physiological Phenomena; Adaptation, Biological; Biological Phenomena

Limitations and Caveats

This study was a feasibility and acceptability pilot and was not powered to test the efficacy of our intervention, ADAPT+. The study results are preliminary in nature. Other key limitations are that participating parents primarily were mothers and that the study was geographically limited to only two rural communities where the project was implemented. COVID-19 also affected some of the recruitment efforts and did, at times, impact participant's attendance to sessions and assessments.

Results Point of Contact

• Title: Tatyana Harris
• Organization: University of South Florida

trharris1@usf.edu

(813) 974-7454

Study Officials

• Marilyn Stern, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Aim 2 includes randomization to a comparison group - 48 parent-child dyads (96 individuals) anticipated for enrollment. Aim 2 was the small pilot RCT

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 16, 2021
• Study Start: March 6, 2021
• Primary Completion: September 30, 2023
• Study Completion: October 30, 2023
• Last Updated: April 17, 2024
• Results First Posted: April 17, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)