Primary Care Pediatrics Learning Activity and Nutrition With Families
Pediatric Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02873715 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Family-based treatment (Behavioral); Usual Care (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- State University of New York at Buffalo
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Composition Measures of Targeted Child. Percent Change Over the Median BMI |
10.2; 3.4 | <0.05 sig |
| SECONDARY Body Composition Measures of Participating Parent. BMI (kg/m^2) Change From Baseline to 24 Month |
-0.03; -0.62 | 0.001 sig |
| SECONDARY Body Composition Measures, Siblings |
8.3; 6.6 | — |
| SECONDARY Delay Discounting |
-5.98; -6.14; -6.45; -6.75; -4.37; -4.22 | 0.65 |
Summary
Eligibility Criteria
Inclusion criteria
The participating child will be between the ages of 6 and 12 and have a BMI above the 85th percentile for age and sex. The participating child will have at least one parent who has overweight or obesity (BMI>25) and who must agree to attend all parent/child treatment meetings as the participating parent. For families in which one parent has overweight/obesity, this parent will be required to be the participating parent in order for the family to be eligible for the study; if two parents have overweight/obesity, the family will choose one parent to enroll in the study. Similarly, if two children in the family have overweight/obesity, it will be encouraged that the older sibling be the primary participant, as it is more likely the younger sibling will model the older sibling. Though only the child who has overweight/obesity and the participating parent will be required to attend treatment sessions, all family members living in the household, including other adults and siblings, will be encouraged to participate indirectly by supporting changes in the family's lifestyle. Because a secondary aim of the study involves the tracking of treatment effects through the household to non-targeted siblings, heights and weights of at least one sibling with overweight/obesity (BMI>85th percentile for age and sex)in the family will be collected, if applicable. Only siblings ages 2- 18 would qualify. All participants must be able to speak and comprehend English at a first-grade level.
Exclusion Criteria
The participating parent or child will not have had a concussion in the past three months; will not have any significant developmental delays or intellectual disabilities; will not be receiving treatment for a Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-5) disorder that interferes with treatment delivered as part of the intervention; will not have a physical disability or diagnosis that prevents performance of physical activity at a level equivalent to a brisk walk or that places severe restriction on diet; will not be on a medication regimen that affects weight; will not have a medical condition that alters nutritional status, intestinal absorption, or affects weight; will not have undergone weight loss surgery; and will not be participating in an alternate weight control program. Families in which either the participating child or parent is actively involved in other weight-loss treatment, is using weight-affecting medications, or has an impairing psychiatric or medical condition that would hinder participation in the study will be excluded as identified by the screening assessments. Families that are planning to move or in which the participating parent is pregnant or is planning on becoming pregnant during the 2 year study period will also be excluded.
Data sourced from ClinicalTrials.gov (NCT02873715). 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.