Familial Overweight: Comparing Use of Strategies

Overweight and Obesity Clinical Trial

— FOCUS  

Official title:

Behavioral Skill Adherence in Pediatric Obesity Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746629
• Other study ID #: HD54871 (completed)
• Secondary ID: 1R21DK095676
• Status: Completed
• Phase: N/A
• First received: September 3, 2008
• Last updated: May 19, 2015
• Start date: May 2008
• Est. completion date: December 2012

Study information

• Verified date: May 2015
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 11 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Seattle Children's Hospital Research Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child weight status, physical activity, & diet.		6 Months	No
Secondary	Secondary outcomes will include parents' BMI, and parents' physical activity and eating behaviors and covariates will include child age, gender, and household income.		6 Months	No