N/A
N=95
Adapting Diet and Action for Everyone (ADAPT+)
Pediatric Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04800432 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Acceptability — 3.91; 3.85 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ADAPT+ (Behavioral); EUC (Behavioral)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- University of South Florida
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability |
3.91; 3.85 | — |
| PRIMARY Feasibility - Accrual Rates |
24; 24 | — |
| PRIMARY Feasibility - Number of Participants Attending 75%+ Sessions |
38; 48 | — |
| PRIMARY Retention Over Time (From Baseline to Post-assessment) |
44; 35 | — |
| PRIMARY Retention Over Time (From Baseline to 3-month Follow-up) |
41; 35 | — |
| SECONDARY Child BMI z Score (Post-Assessment) |
2.28; 1.48 | — |
| SECONDARY Child BMI z Score (3-month Follow-up) |
2.30; 1.58 | — |
| SECONDARY Child Waist-to-Hip Ratio (Post-Assessment) |
.92; .92 | — |
| SECONDARY Child Waist-to-Hip Ratio (3-month Follow-up) |
.94; .90 | — |
| SECONDARY Child Sugar Sweet Beverage and Fast Food Intake Instrument (Post-Assessment) |
7.18; 6.53; 3.09; 3.15; 2.23; 1.71 | — |
| SECONDARY Child Sugar Sweet Beverage and Fast Food Intake Instrument (3-month Follow-up) |
5.84; 6.88; 2.95; 3.25; 1.63; 1.75 | — |
| SECONDARY Parent BMI (Post-Assessment) |
31.29; 30.86 | — |
| SECONDARY Parent BMI (3-month Follow-up) |
31.06; 31.41 | — |
| SECONDARY Parent Waist-to-Hip Ratio (Post-Assessment) |
.87; .88 | — |
| SECONDARY Parent Waist-to-Hip Ratio (3-month Follow-up) |
.88; .88 | — |
| SECONDARY Latino Dietary Behaviors Questionnaire (Post-Assessment) |
27.41; 26.00 | — |
| SECONDARY Latino Dietary Behaviors Questionnaire (3-month Follow-up) |
26.59; 24.50 | — |
| SECONDARY Perceived Stress Scale (PSS) [Post-Assessment] |
16.27; 15.33 | — |
| SECONDARY Perceived Stress Scale (PSS) [3-month Follow-up] |
15.36; 18.44 | — |
| SECONDARY Recognize Subscale of the Mindful Eating Questionnaire (Post-Assessment) |
30.55; 29.72 | — |
| SECONDARY Recognize Subscale of the Mindful Eating Questionnaire (3-month Follow-up) |
31.14; 29.13 | — |
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+).
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.
Data sourced from ClinicalTrials.gov (NCT04800432). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.