Clinical trial NCT00746629: Familial Overweight: Comparing Use of Strategies
Official title: Behavioral Skill Adherence in Pediatric Obesity Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-09-04
Enrollment: 72
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Child age: 7-11 years.
* English-speaking.
* Parent is willing and able to actively participate in treatment.
* Overweight child: at or above 85th percentile for age- and gender-specific BMI, but not more than 175% above median BMI for age and gender.
* Overweight parent: BMI≥ 25.
* Live within 50 miles of Children's Hospital and Regional Medical Center.

Exclusion Criteria:

* Medical condition known to promote obesity (e.g. Prader-Willi syndrome, Cushing's syndrome).
* Already involved with another weight control program.
* Consistently engaging in weight-affecting behaviors (e.g. child: smoking)
* Significant diagnosed obesity-related co-morbidities (e.g. Type 2 diabetes)
* Taking weight-affecting medications (e.g. Ritalin)
* Participating parent or child: an existing thought disorder, suicidality, substance abuse disorder, or other psychological or medical conditions that may preclude full participation.
* Participating parent or child: Disability or illness that would preclude them from engaging in at least moderate intensity physical activity.
* Participating parent or child: Current or prior diagnosed eating disturbance.

Primary outcomes:
measure: Child weight status, physical activity, & diet.
timeFrame: 6 Months
Secondary outcomes:
measure: Secondary outcomes will include parents' BMI, and parents' physical activity and eating behaviors and covariates will include child age, gender, and household income.
timeFrame: 6 Months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital Research Institute
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Brian E Saelens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saelens BE, Lozano P, Scholz K. A randomized clinical trial comparing delivery of behavioral pediatric obesity treatment using standard and enhanced motivational approaches. J Pediatr Psychol. 2013 Oct;38(9):954-64. doi: 10.1093/jpepsy/jst054. Epub 2013 Jul 31.