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Childhood Obesity Treatment: A Maintenance Approach (COMPASS)

This study has been completed.
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Seattle Children’s Hospital Research Institute
University of Florida
State University of New York at Buffalo
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00759746
First received: September 23, 2008
Last updated: February 20, 2017
Last verified: February 2017
History of Changes
September 23, 2008
February 20, 2017
October 2009
March 2013   (Final data collection date for primary outcome measure)
Child percent overweight [ Time Frame: 1 year ]
Child percent overweight [ Time Frame: 5 years ]
Complete list of historical versions of study NCT00759746 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Childhood Obesity Treatment: A Maintenance Approach
Childhood Obesity Treatment: A Maintenance Approach
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.
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 Weight Maintenance 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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
  • Childhood Overweight
  • Childhood Obesity
  • Behavioral: 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.
  • Behavioral: Weight Maintenance Education
    The Weight Maintenance 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.
  • Behavioral: 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.
  • Active Comparator: Weight Maintenance Education
    Participants assigned to this group will receive the Weight Maintenance 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.
    Intervention: Behavioral: Weight Maintenance Education
  • Experimental: SFM+ Low Dose
    Participants assigned to this group will receive the SFM+ Low Dose.
    Intervention: Behavioral: SFM+ Low Dose
  • Experimental: SFM+ High Dose
    Participants assigned to this group will receive the SFM+ High Dose.
    Intervention: Behavioral: SFM+ High Dose

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
482
March 2013
March 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children will be between the ages of 7 and 11 and at or above the 85th percentile for weight.
  • 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.
  • Participants must be able to speak and comprehend English.

Exclusion Criteria:

  • Participating parent or child having a thought disorder, suicidality, bipolar disorder, or drug or alcohol dependence.
  • Participating parent or child having 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 being on a medication regimen that affects weight.
  • Participating parent or child being involved in active psychiatric treatment for an ongoing problem that causes either social or occupational impairment.
  • Parents (participating and nonparticipating) and children having an eating disorder (i.e., anorexia nervosa, bulimia nervosa, binge eating disorder) or having subclinical levels of eating disturbance (i.e., reporting key eating disorder behaviors of purging, fasting, or binge eating more than two times per month).
Sexes Eligible for Study: All
7 Years to 11 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00759746
201107083
2R01HD036904 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Washington University School of Medicine
Washington University School of Medicine
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Seattle Children’s Hospital Research Institute
  • University of Florida
  • State University of New York at Buffalo
Principal Investigator: Denise E Wilfley, PhD Washington University School of Medicine
Principal Investigator: Brian Saelens, Ph.D. Seattle Children’s Hospital Research Institute
Washington University School of Medicine
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP