Clinical trial NCT05595161: Dissemination and Implementation of the Bright Bodies Intervention for Childhood Obesity
Official title: Dissemination and Implementation of the Bright Bodies Intervention for Childhood Obesity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Keywords: Implementation science
Intensive lifestyle intervention
Pediatric obesity
Behavior modification
Body mass index
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-10-26
Enrollment: 182
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effectiveness of the Bright Bodies intervention in improving body mass index (BMI) among 7-13 year-old children with obesity simultaneously with the impact of the implementation strategy on adoption, reach, fidelity, cost, and maintenance of the intervention in three heterogenous settings serving patients disproportionately affected by obesity.

Detailed description: The demonstrated efficacy of Bright Bodies in a well-designed randomized controlled trial (RCT) and a real-world effectiveness study reduce equipoise and challenge the ethics of a prospective RCT of implementing Bright Bodies in other settings. As such, this study is an observational, multiphase mixed methods design to evaluate effectiveness and implementation among three purposively selected heterogeneous sites serving low-income populations with racial and ethnic, rural-urban, and geographic diversity.

Children ages 7-13 years with BMI ≥85th percentile and their parent/caregivers hereafter referred to as parent will be recruited to participate in the evaluation study from among participants in the newly-established Bright Bodies programs at each of the three implementation sites. The aim is for each site to recruit approximately 40 children and their parents (a total of 120 children and 120 parents) to participate in the Bright Bodies program over the study's enrollment period. The primary outcome is change in BMI expressed as a percentage of the 95th percentile (%BMIp95) using EHR data collected as part of routine clinical care up to 36 months before and up to 15 months after enrollment in the intervention. Secondary outcomes include: (a) change in %BMIp95 at three and six months, (b) changes in parent BMI at three and six months, (d) parent-reported changes in health behaviors (sleep, physical activity, screen time, eating behaviors), via surveys at 3, 6 and 12 months, and (e) changes in parent-proxy reported weight-related quality of life, parent stress, and parent talk about weight via surveys at baseline, 6, and 12 months after enrollment. We will also describe implementation outcomes (reach, adoption, fidelity/adaptation, and cost) through qualitative and quantitative data collection from members of our study team throughout the process of implementation.

Eligibility criteria: Inclusion Criteria:

* Children ages 7-13 years with BMI ≥85th percentile and their parents;
* Child-parent dyads enrolled in the Bright Bodies intervention at each site will be eligible for inclusion in the evaluation study.

Exclusion Criteria:

* Children and/or parents who do not speak the language in which the program will be delivered at each site;
* Children and/or parents who plan to move away from the area within the next 15 months;
* Children with a history of purging and/or dramatic weight loss prior to the trial;
* Children who are currently participating in another high-intensity lifestyle intervention or other similar research study, or are planning to have bariatric surgery within the next six months
* Children whose EHR data cannot be accessed by the study teams;
* Children with chronic medical conditions limiting their ability to take food by mouth (e.g., g-tube fed, total parenteral nutrition), participate in physical activity (e.g., wheelchair bound), or meaningfully participate in group sessions (e.g., cognitive impairment);
* Children with a sibling enrolled in the trial
* Children who join the Bright Bodies program after the 4th week of a session (not including orientation)

Primary outcomes:
measure: Change in %BMIp95
timeFrame: Up to 36 months prior to baseline through up to 15 months after enrollment
Secondary outcomes:
measure: Change in parent BMI
timeFrame: Baseline through 6 months after enrollment
measure: Change in weight-related quality of life
timeFrame: Baseline through 12 months after enrollment
measure: Change in weight-related health behaviors.
timeFrame: Baseline through 12 months after enrollment
measure: Change in binge eating behaviors.
timeFrame: Baseline through 12 months after enrollment
measure: Change in parent conversations about weight.
timeFrame: Baseline through 12 months after enrollment
measure: Per patient cost for participation in Bright Bodies
timeFrame: From enrollment through 12 months after enrollment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
Study officials:
affiliation: Yale University
name: Mahnoosh (Mona) Sharifi, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: