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N/A N=1,010 Randomized Double-blind Treatment

Primary Care Pediatrics Learning Activity and Nutrition With Families

Pediatric Obesity

Enrolled (actual)
1,010
Serious AEs
6.2%
Results posted
Aug 2023
Primary outcome: Primary: Body Composition Measures of Targeted Child. Percent Change Over the Median BMI — 10.2; 3.4 percent change — p=<0.05

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

OutcomeResultp-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

This study is designed to translate an evidence-based family-based weight loss treatment for childhood obesity (FBT) into primary care settings using co-located interventionists to serve as a model for care delivered within a patient-centered medical home. FBT will be compared to usual care (UC), and the families will be followed for a 2 year period to assess between group differences in the targeted child and parent outcomes, weight changes in non-targeted siblings who are overweight/obese, parent and child changes in delay of gratification, and how these changes relate to weight loss, and the assessment of how provider attitudes predict their intention to use FBT in the future. The results of this study will inform future dissemination and implementation of FBT into primary care settings.

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.

View full record on ClinicalTrials.gov →

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.

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