Familial Overweight: Comparing Use of Strategies (FOCUS)
| Tracking Information | |||||
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| First Received Date ICMJE | September 3, 2008 | ||||
| Last Updated Date | December 11, 2012 | ||||
| Start Date ICMJE | May 2008 | ||||
| Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Child weight status, physical activity, & diet. [ Time Frame: 6 Months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00746629 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Secondary outcomes will include parents' BMI, and parents' physical activity and eating behaviors and covariates will include child age, gender, and household income. [ Time Frame: 6 Months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Familial Overweight: Comparing Use of Strategies | ||||
| Official Title ICMJE | Behavioral Skill Adherence in Pediatric Obesity Treatment | ||||
| Brief Summary | The purpose of this study is to compare the efficacy of two different approaches (prescribed & self-directed) to the treatment of childhood obesity and their relative impact on child weight status, physical activity, and diet. |
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| Detailed Description | Pediatric obesity is a highly prevalent problem, requiring both treatment and prevention efforts to reduce cardiovascular disease risk and metabolic consequences among affected children and the child population. The efficacy of family-based behavioral pediatric obesity treatment is likely compromised by non-optimal parent and child behavioral skills use (BSU). In pediatric obesity treatment trials, BSU assessment is infrequent, incomplete, and has unknown reliability. Poor and incomplete BSU measurement precludes improving behavioral interventions for pediatric obesity. Furthermore, different approaches to help families initiate and sustain BSU during and following treatment have not been tested. This study aims to investigate 1) prospective relations between BSU measured during and following treatment and change in child weight status, physical activity, and diet, and 2) differences in BSU trajectory between two different implementation approaches during and following treatment. Eighty-two parent-child (7-11 y.o.) pairs will participate in a 20-week treatment with follow-up at 3 and 6 months. Participants will be randomly assigned to receive either a prescriptive or self-directed implementation approach to family-based behavioral pediatric obesity treatment. BSU (monitoring, contingency management, environmental control) will be reported or assessed at pre-treatment, at the 5th, 10th, and 15th treatment sessions, at post-treatment and at the 3-month and 6-month follow-ups by the parent, interventionist, and supplemental evaluator. Prospective associations between BSU, measured multiple times and by multiple informant/formats, and change in child weight status (z-BMI) and weight-related behaviors (diet, physical activity) over the course of treatment and throughout follow up will be examined. This proposal will provide important information about the type of BSU and its measurement that is most related to short- and long-term treatment efficacy, and provide pilot data on the relative efficacy of different implementation approaches to initiate and sustain BSU in pediatric obesity intervention. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE | Overweight and Obesity | ||||
| Intervention ICMJE | Behavioral: FOCUS
Treatment will be delivered over a 20-week period. Participating children and at least one of their parents will attend weekly in-person clinic sessions. Treatment will consist of 20-25 minute meetings between the assigned interventionist and each child/parent pair to individualize treatment, with an emphasis on helping the family change eating and activity behaviors. Family meetings will be followed by separate child and parent group meetings lasting approximately 35-45 minutes. In both approaches, parents serve as primary implementers of the treatment for the child and, if overweight, for themselves. Group sessions provide education in diet and physical activity, parenting, and behavioral skills, although conditions differ in whether skills are "prescribed" or "self-directed". Children and parents will be weighed at each clinic visit. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 82 | ||||
| Estimated Completion Date | December 2014 | ||||
| Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 7 Years to 11 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00746629 | ||||
| Other Study ID Numbers ICMJE | HD54871 (completed), 1R21DK095676 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Brian Saelens, Seattle Children's Hospital | ||||
| Study Sponsor ICMJE | Seattle Children's Hospital | ||||
| Collaborators ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||
| Investigators ICMJE |
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| Information Provided By | Seattle Children's Hospital | ||||
| Verification Date | December 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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