Seattle Children's
Seattle, Washington, 98121, United States
NCT Number: NCT02580162
This study evaluates and compares the efficacy of professional versus peer-based delivery of family-based treatment for childhood overweight and obesity in elementary school aged children. Families will be randomized to receive treatment from professionals or to receive treatment from professionally-trained peer interventionists. Some parents will then be invited to serve as peer interventionists for the next group of families.
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Notify Me7 year–11 year
All sexes
Interventional
Not applicable
Seattle, Washington, 98121, United States
The high prevalence of pediatric overweight and obesity in the U.S. necessitates the development of efficacious, but cost-effective and easily disseminable interventions that improve and sustain better pediatric weight outcomes. Accumulated evidence finds initial and long-term efficacy of moderate-to-high intensity (>25 contact hours) family-based treatment (FBT) for elementary school-aged children, but such treatment is prohibitively expensive because of high personnel costs (delivery by behavioral health professionals) and therefore limited in availability, reach, and impact. Very few overweight/obese children receive evidence-based treatment to improve their weight status or health.
The pilot data suggest a new model, peer-based delivery FBT with FBT-treated parents trained and subsequently delivering FBT to other families, is feasible and demonstrates initial efficacy. This delivery model could dramatically reduce FBT costs and increase FBT availability. Preliminary data also suggest that serving as a peer interventionist may also benefit the peers themselves and their children in better sustaining their own weight outcomes. The present study aims to provide a more definitive test of the short- and long-term efficacy of peer- versus professionally-delivered FBT on child weight outcomes. Embedded in this comparison is an examination of the feasibility of peer-based FBT delivery, investigating the impact of serving as a peer interventionist on the peers' own and their child's long- term weight status, and a more comprehensive examination of differential costs of professional- versus peer- based FBT delivery.
The present study will also test potential dissemination and sustainability by examining the efficacy of peer-delivered FBT among peer interventionists who themselves received FBT from other peers and not from professional interventionists. Moderation of treatment outcome is also examined, focusing on peer interventionist and child characteristics. This multi-phase trial will enroll 304 families with 7-11 year old overweight/obese children in multiple sites throughout the region, and include short-term (post-treatment) and long-term (up through 1 year after treatment cessation) assessments. This investigation of an innovative approach that could significantly reduce FBT delivery costs, while also improving the maintenance of treatment effects, is critical to improving the health of the many already overweight children at risk for chronic disease.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change. This 20 week treatment is adapted from our existing evidence-based interventions and is delivered by PROFESSIONAL interventionists.
This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change. This 20 week treatment is adapted from our existing evidence-based interventions and is provided by PEER interventionists.
Parents who receive FBT complete 6 weeks of training and then serve as peer interventionists to a new group of families.
Time frame: Baseline, 20 Weeks (post treatment), 6 and 12 months post treatment
BMI will be calculated as kg/m2 and children's BMI z-scores will be calculated using CDC growth charts.
Time frame: 20 weeks
Direct and indirect costs of associated with intervention using peer or professional interventionists. Direct costs will be estimated using hours spent providing treatment of both peers and professionals who will track their time using an online application. Costs associated with hours spent will be based on professional salaries or stipends provided to peer interventionists.
Time frame: Baseline, 20 Weeks (post treatment), 6 and 12 months post treatment
BMI of parent will be calculated as kg/m2.
Seattle Children's Hospital
Other
Parents as Peer Interventionists in Treatment for Pediatric Weight Management
Acronym: SHIFT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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