Childhood Obesity Treatment: A Maintenance Approach (COMPASS)

This study has been completed.
Sponsor:
Collaborators:
Seattle Children’s Hospital Research Institute
University of Florida
State University of New York at Buffalo
Information provided by (Responsible Party):
Denise Wilfley, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00759746
First received: September 23, 2008
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to determine the effect of dose and content of an enhanced weight maintenance treatment on children's ability to maintain weight loss following a standard weight loss treatment.


Condition Intervention
Childhood Overweight
Childhood Obesity
Behavioral: Social Facilitation Maintenance (SFM) - Low Dose
Behavioral: Health Education
Behavioral: Social Facilitation Maintenance (SFM) - High Dose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Childhood Obesity Treatment: A Maintenance Approach

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Child percent overweight [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 482
Study Start Date: October 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Current Standard of Care
Participants assigned to this group will receive the Health Education intervention. They will meet every other week during the maintenance phase of the study for a total of 16 sessions over 8 months. During the visit, participants will participate in a series of interactive workshops within child and parent groups to learn general information about healthy eating and physical activity.
Behavioral: Health Education
The Health Education intervention will help participants in parent and child groups to learn more about healthy eating and physical activity in a group setting. Participants will also learn about exercise and exercise safety, hydration during exercise, and stress management. Parent and child groups will combine for particular on-site and off-site activities, such as cooking demonstrations, grocery store tours, gym tours, and dance lessons.
Experimental: Weight Maintenance Therapy
Participants assigned to this group will receive the Social Facilitation Maintenance (SFM) - Low Dose intervention. They will meet every other week during the maintenance phase of the study for a total of 16 sessions over 8 months. During the visits, participants will meet with a behavioral interventionist and participate in child and parent groups to learn new weight maintenance skills.
Behavioral: Social Facilitation Maintenance (SFM) - Low Dose
The SFM intervention assumes people need a social environment that supports changes in eating and physical activity for continued weight maintenance. Therefore, the SFM intervention will focus on helping families create a social environment that supports weight maintenance (e.g., children being friends with physically active peers). Participants in this group will meet less often than families that receive the Social Facilitation Maintenance (SFM) - High Dose intervention, giving them more opportunities to practice new skills between clinic visits.
Experimental: Intensive Weight Maintenance Therapy
Participants assigned to this group will receive the Social Facilitation Maintenance (SFM) - High Dose intervention. They will meet every week during the maintenance phase of the study for a total of 32 sessions over 8 months. During the visits, participants will meet with a behavioral interventionist and participate in child and parent groups to learn new weight maintenance skills.
Behavioral: Social Facilitation Maintenance (SFM) - High Dose
The SFM intervention assumes people need a social environment that supports changes in eating and physical activity for continued weight maintenance. Therefore, the SFM intervention will focus on helping families create a social environment that supports weight maintenance (e.g., children being friends with physically active peers). Participants in this group will meet more often than families that receive the Social Facilitation Maintenance (SFM) - Low Dose intervention, allowing for more in-depth discussion and practice of key skills and concepts related to creating a social environment that supports a healthy lifestyle. These participants will receive more feedback and reinforcement from fellow group members, family interventionists, and group leaders for practicing their new behaviors.

Detailed Description:

Childhood Obesity (CO) prevalence in the United States has tripled in recent decades, and nearly 30% of children aged 6 to 11 are overweight or obese. CO is a serious public health problem, and is associated with both immediate and long-term health problems (e.g., hypertension, type 2 diabetes, asthma) and psychosocial problems (e.g., social isolation, depression, eating disorder symptomatology). Furthermore, CO is a significant risk factor for adult obesity with several prospective studies showing that, if untreated, about half of overweight grade-school children remain obese as adults. Fortunately, children respond favorably to family-based behavioral weight loss treatment (FBT), the most well-established intervention for the treatment of overweight in children 7 to 12 years old. Weight loss treatments for overweight children have been associated with significant physical and psychosocial health benefits; however, despite initial success with lifestyle interventions, considerable relapse often occurs once treatment ends. Clearly, CO is a significant public health problem, and long-term maintenance of weight loss remains a priority to stem the increased costs to the individual and society. Therefore, we propose to conduct a multi-site randomized controlled trial with overweight children (N=241) and their parents (N=241) [for a total N=482]. All participants will complete 4 months of FBT and then be randomized to one of three, 8-month maintenance conditions: (1) Weight Maintenance Therapy, who will receive SFM - Low Dose [LOW] (16 sessions over 8 months), (2) Intensive Weight Maintenance Therapy, who will receive SFM - High Dose [HIGH] (32 sessions over 8 months), or (3) Current Standard of Care, who will receive Health Education (16 sessions over 8 months). Relative weight and associated outcomes will be assessed at 0 (pre-weight loss), 4 (post-weight loss), 12 (post-maintenance treatment),18 months and 24 months. Additionally, brief assessments will be conducted at four points during the course of maintenance treatment to measure presumed mediators.

  Eligibility

Ages Eligible for Study:   7 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children will be between the ages of 7 and 11 and above the 85th percentile for weight, with a BMI at least 20% greater than the median BMI for sex and age.
  • At least one parent of the participating child must be overweight (BMI > 25).
  • One parent must agree to attend all parent/child treatment meetings as the participating parent.

Exclusion Criteria:

  • Participants must be able to speak and comprehend English.
  • Participating parent or child will not suffer from a thought disorder, suicidality, bipolar disorder, or drug or alcohol dependence.
  • Participating parent or child will not a physical disability or illness that prevents performance of physical activity at level equivalent to a brisk walk or that places severe restriction on diet.
  • Participating parent or child will not be on a medication regimen that affects weight.
  • Participating parent or child will not be involved in active psychiatric treatment for an ongoing problem that causes either social or occupational impairment.
  • Parents (participating and nonparticipating) and children will not have an eating disorder (i.e., anorexia nervosa, bulimia nervosa, binge eating disorder) or have subclinical levels of eating disturbance (i.e., reporting key eating disorder behaviors of purging, fasting, or binge eating more than two times per month).
  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: NCT00759746

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Washington
Seattle Children's Hospital Research Institute
Seattle, Washington, United States, 98121
Sponsors and Collaborators
Washington University School of Medicine
Seattle Children’s Hospital Research Institute
University of Florida
State University of New York at Buffalo
Investigators
Principal Investigator: Denise E Wilfley, PhD Washington University in St. Louis, School of Medicine
Principal Investigator: Brian Saelens, Ph.D. Seattle Children’s Hospital Research Institute
  More Information

No publications provided by Washington University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Denise Wilfley, Professor of Psychiatry, Medicine, Pediatrics and Psychology, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00759746     History of Changes
Other Study ID Numbers: 08-1014, 2R01HD036904-06A2
Study First Received: September 23, 2008
Last Updated: September 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Weight loss maintenance

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

ClinicalTrials.gov processed this record on October 22, 2014