Childhood Obesity Treatment: A Maintenance Approach (COMPASS)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
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| 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 | |
| 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: | March 28, 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 Overnutrition |
Nutrition Disorders Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013