Summary

Eligibility
for people ages 8-12 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Amy L Beck, MD, MPH
Headshot of Amy L Beck
Amy L Beck

Description

Summary

To examine the extent to which participation in Bright Bodies within and across sites is associated with improved body mass index (BMI) and to assess the reach, adoption, maintenance, cost, and cost-effectiveness of the intervention and describe fidelity/adaptations to the intervention at participating sites.

Details

This study will evaluate the effectiveness of the Bright Bodies intervention in improving BMI among 8-12 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. 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 8-12 years with BMI ≥95th 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. Since Bright Bodies will be implemented as part of usual clinical care at each site, willingness to participate in the evaluation is not required to participate in the treatment program. 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. Using queried electronic health record (EHR) data, the investigators will identify children without access to Bright Bodies due to residential location and match them to intervention participants based on weight status, age, sex, race and ethnicity and insurance type. The investigators will use 1-to-1 matching of the comparator group participants to each child-participant (a total of 120 comparators). The primary outcome is change in BMI, defined as the percentage of age/sex-adjusted BMI above the 95th percentile 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 percentage of age/sex-adjusted BMI above the 95th percentile at three and six months using EHR data, (b) changes in parent BMI at three and six months using data collected as part of the Bright Bodies program and/or self-report on parent surveys, (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. The investigators will also describe implementation outcomes (reach, adoption, fidelity/adaptation, and cost) through qualitative and quantitative data collection from members of the study team throughout the process of implementation. Additional exploratory outcomes include blood pressure and laboratory tests for obesity-related co-occurring conditions (hemoglobin A1c, total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides, alanine transaminase) collected as part of routine clinical care and available in the EHR.

Keywords

Obesity, Childhood, Implementation science, Intensive lifestyle intervention, Pediatric obesity, Behavior modification, Body mass index, Obesity, Bright Bodies

Eligibility

You can join if…

Open to people ages 8-12

  • Children ages 8-12 years with BMI ≥95th 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.

You CAN'T join if...

  • 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

Locations

  • University of California San Francisco not yet accepting patients
    San Francisco California 94143 United States
  • University of Alabama at Birmingham not yet accepting patients
    Birmingham Alabama 35233-1711 United States

Lead Scientist at UCSF

  • Amy L Beck, MD, MPH
    Associate Professor, Pediatrics, School of Medicine. Authored (or co-authored) 18 research publications. Research interests: obesity prevention · diabetes prevention · pediatric primary care · Latino health · health disparities

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Yale University
ID
NCT05595161
Study Type
Interventional
Participants
Expecting 360 study participants
Last Updated