Familial Overweight: Comparing Use of Strategies (FOCUS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Brian Saelens, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT00746629
First received: September 3, 2008
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Overweight and Obesity
Behavioral: FOCUS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Behavioral Skill Adherence in Pediatric Obesity Treatment

Resource links provided by NLM:


Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • Child weight status, physical activity, & diet. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 72
Study Start Date: May 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prescribed Skills
Behavioral skills are all prescribed and considered necessary tools expected to be used consistently, completely, and uniformly by all participants throughout treatment
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.
Experimental: Self-Directed Skills
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.
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.

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

Ages Eligible for Study:   7 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746629

Locations
United States, Washington
Seattle Children's Hospital Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
Principal Investigator: Brian E Saelens, PhD Seattle Children’s Hospital Research Institute
  More Information

No publications provided

Responsible Party: Brian Saelens, Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT00746629     History of Changes
Other Study ID Numbers: HD54871 (completed), 1R21DK095676
Study First Received: September 3, 2008
Last Updated: February 10, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014