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A randomized controlled trial to compare the reach, effectiveness, and maintenance of two family-based childhood obesity treatment programs in a medically underserved region
Investigator (PI): Zoellner, Jamie; Estabrooks, Paul
Performing Organization (PO): (Current): University of Virginia, School of Medicine, Department of Public Health Sciences / (434) 924-8430
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2017
Final Year: 2021
Record Source/Award ID: PCORI/AD-1602-34489
Funding: Total Award Amount: $2,035,357
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: By engaging local community and clinical stakeholders and parents of overweight 8- to 12-year-old children in the planning, conduct, and dissemination of the proposed research, the long term objective of our proposal is to reduce childhood obesity disparities in the Dan River Region--a federally designated, medically underserved area/population relative to state and national rates. The purpose of this study is to compare two evidence- and family-based childhood obesity programs: iChoose+ versus Family Connections. iChoose+ involves 12 biweekly family sessions, 24 interactive voice response (IVR) calls, and 48 exercise sessions over six months, followed by six months of biweekly IVR calls. Family Connections has fewer sessions and fewer IVR support calls over a shorter period of time: two parent sessions spaced one week apart and 10 interactive voice response calls over six months. Family Connections delivers intervention to parents only and promotes physical activity, but does not include structured exercise sessions. The primary aim is to determine which program is most effective in reducing child BMI z-scores at six months post-baseline. Additional BMI assessments will occur at three and 12 months post-baseline. The secondary aims are to examine parent weight, parent and child eating and physical activity behaviors, reach, fidelity, costs of implementation, and the local community capacity to implement and sustain these two childhood obesity programs. Building from recent success, we will continue to engage a community advisory board (CAB) and parent advisory team (PAT) in all phases on the proposed study. The CAB includes decision makers and program staff from the City of Danville Parks & Recreation and Children's Healthcare Center and three supporting organizations. The PAT includes parents/caregivers whose lived experience is representative of the population of interest in a particular study. These patient partners are from the target population, share common demographics and cultural traits, and have already experienced a family-based childhood obesity treatment program. This research is important to the region because childhood obesity is estimated at three times higher than state averages and increased rates of obesity in children are related to "adult" diseases such as type 2 diabetes and hypertension. Furthermore, there are no other evidence-based childhood obesity treatment programs locally available to families. The CAB and PAT will participate in planning the study, drafting study materials and protocols, recruiting families, implementing both programs, serving as a safety net for families to encourage participation and retention, collecting data, interpreting data, and helping share findings in both scientific and community friendly formats. The locally relevant evidence generated and shared from this trial will allow stakeholders and parents to make informed decisions about childhood obesity treatment programs in the region.
MeSH Terms:
  • Body Mass Index
  • Child
  • Community Health Services /organization & administration
  • Comparative Effectiveness Research
  • Decision Making
  • Evidence-Based Medicine
  • Exercise
  • Exercise Therapy
  • Health Promotion /*methods
  • Humans
  • * Medically Underserved Area
  • Parent-Child Relations
  • Parents
  • Patient Education as Topic
  • Pediatric Obesity /*therapy
  • Program Development
  • Program Evaluation
  • Randomized Controlled Trials as Topic
  • Reminder Systems
  • Virginia
Country: United States
State: Virginia
Zip Code: 22908
UI: 20181353
CTgovId: NCT03245775
Project Status: Ongoing