Familial Overweight: Comparing Use of Strategies (FOCUS)

Seattle Children's Healthcare System

Status: Completed

Conditions: Overweight and Obesity

Treatments: Behavioral: FOCUS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00746629

1R21DK095676 (U.S. NIH Grant/Contract)

HD54871 (completed)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 7 to 11 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

Prescribed Skills

Active Comparator group

Description:

Behavioral skills are all prescribed and considered necessary tools expected to be used consistently, completely, and uniformly by all participants throughout treatment

Treatment:

Behavioral: FOCUS

Self-Directed Skills

Experimental group

Description:

Behavioral skills are considered a tool box from which families are encouraged to select skills that best apply to that family's situation in attempts to help their child make eating and activity change.

Treatment:

Behavioral: FOCUS