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Childhood Obesity Treatment: A Maintenance Approach (COMPASS)

Primary Purpose

Childhood Overweight, Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SFM+ Low Dose
Weight Maintenance Education
SFM+ High Dose
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Overweight focused on measuring Weight loss maintenance

Eligibility Criteria

7 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Washington University School of Medicine
  • Seattle Children's Hospital Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Weight Maintenance Education

SFM+ Low Dose

SFM+ High Dose

Arm Description

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.

Participants assigned to this group will receive the SFM+ Low Dose.

Participants assigned to this group will receive the SFM+ High Dose.

Outcomes

Primary Outcome Measures

Child percent overweight

Secondary Outcome Measures

Full Information

First Posted
September 23, 2008
Last Updated
February 20, 2017
Sponsor
Washington University School of Medicine
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
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1. Study Identification

Unique Protocol Identification Number
NCT00759746
Brief Title
Childhood Obesity Treatment: A Maintenance Approach
Acronym
COMPASS
Official Title
Childhood Obesity Treatment: A Maintenance Approach
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Overweight, Childhood Obesity
Keywords
Weight loss maintenance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
482 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weight Maintenance Education
Arm Type
Active Comparator
Arm Description
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.
Arm Title
SFM+ Low Dose
Arm Type
Experimental
Arm Description
Participants assigned to this group will receive the SFM+ Low Dose.
Arm Title
SFM+ High Dose
Arm Type
Experimental
Arm Description
Participants assigned to this group will receive the SFM+ High Dose.
Intervention Type
Behavioral
Intervention Name(s)
SFM+ Low Dose
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Weight Maintenance Education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SFM+ High Dose
Intervention Description
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.
Primary Outcome Measure Information:
Title
Child percent overweight
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise E Wilfley, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brian Saelens, Ph.D.
Organizational Affiliation
Seattle Children's Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Seattle Children's Hospital Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98121
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27601189
Citation
Hayes JF, Altman M, Kolko RP, Balantekin KN, Holland JC, Stein RI, Saelens BE, Welch RR, Perri MG, Schechtman KB, Epstein LH, Wilfley DE. Decreasing food fussiness in children with obesity leads to greater weight loss in family-based treatment. Obesity (Silver Spring). 2016 Oct;24(10):2158-63. doi: 10.1002/oby.21622. Epub 2016 Sep 7.
Results Reference
result
PubMed Identifier
25963602
Citation
Altman M, Cahill Holland J, Lundeen D, Kolko RP, Stein RI, Saelens BE, Welch RR, Perri MG, Schechtman KB, Epstein LH, Wilfley DE. Reduction in food away from home is associated with improved child relative weight and body composition outcomes and this relation is mediated by changes in diet quality. J Acad Nutr Diet. 2015 Sep;115(9):1400-7. doi: 10.1016/j.jand.2015.03.009. Epub 2015 May 8.
Results Reference
result
PubMed Identifier
24458836
Citation
Holland JC, Kolko RP, Stein RI, Welch RR, Perri MG, Schechtman KB, Saelens BE, Epstein LH, Wilfley DE. Modifications in parent feeding practices and child diet during family-based behavioral treatment improve child zBMI. Obesity (Silver Spring). 2014 May;22(5):E119-26. doi: 10.1002/oby.20708. Epub 2014 Mar 25.
Results Reference
result
PubMed Identifier
22924332
Citation
Best JR, Theim KR, Gredysa DM, Stein RI, Welch RR, Saelens BE, Perri MG, Schechtman KB, Epstein LH, Wilfley DE. Behavioral economic predictors of overweight children's weight loss. J Consult Clin Psychol. 2012 Dec;80(6):1086-1096. doi: 10.1037/a0029827. Epub 2012 Aug 27.
Results Reference
result
PubMed Identifier
34549372
Citation
Fowler LA, Litt MD, Rotman SA, Conlon RPK, Jakubiak J, Stein RI, Balantekin KN, Welch RR, Perri MG, Epstein LH, Wilfley DE. Relation of social network support to child health behaviors among children in treatment for overweight/obesity. Eat Weight Disord. 2022 Jun;27(5):1669-1678. doi: 10.1007/s40519-021-01303-4. Epub 2021 Sep 21.
Results Reference
derived
PubMed Identifier
32914852
Citation
Grammer AC, Best JR, Fowler LA, Balantekin KN, Stein RI, Conlon RPK, Saelens BE, Welch RR, Perri MG, Epstein LH, Wilfley DE. General and Eating Disorder Psychopathology in Relation to Short- and Long-Term Weight Change in Treatment-Seeking Children: A Latent Profile Analysis. Ann Behav Med. 2021 Jun 28;55(7):698-704. doi: 10.1093/abm/kaaa076.
Results Reference
derived
PubMed Identifier
32720457
Citation
Fowler LA, Grammer AC, Ray MK, Balantekin KN, Stein RI, Kolko Conlon RP, Welch RR, Perri MG, Epstein LH, Wilfley DE. Examining the interdependence of parent-child dyads: Effects on weight loss and maintenance. Pediatr Obes. 2021 Jan;16(1):e12697. doi: 10.1111/ijpo.12697. Epub 2020 Jul 28.
Results Reference
derived
PubMed Identifier
31829732
Citation
Rotman SA, Fowler LA, Ray MK, Stein RI, Hayes JF, Kolko RP, Balantekin KN, Engel A, Saelens BE, Welch RR, Perri MG, Epstein LH, Wilfley DE. Family Encouragement of Healthy Eating Predicts Child Dietary Intake and Weight Loss in Family-Based Behavioral Weight-Loss Treatment. Child Obes. 2020 Apr;16(3):218-225. doi: 10.1089/chi.2019.0119. Epub 2019 Dec 12.
Results Reference
derived
PubMed Identifier
29084318
Citation
Wilfley DE, Saelens BE, Stein RI, Best JR, Kolko RP, Schechtman KB, Wallendorf M, Welch RR, Perri MG, Epstein LH. Dose, Content, and Mediators of Family-Based Treatment for Childhood Obesity: A Multisite Randomized Clinical Trial. JAMA Pediatr. 2017 Dec 1;171(12):1151-1159. doi: 10.1001/jamapediatrics.2017.2960.
Results Reference
derived
PubMed Identifier
28984076
Citation
Balantekin KN, Hayes JF, Sheinbein DH, Kolko RP, Stein RI, Saelens BE, Hurst KT, Welch RR, Perri MG, Schechtman KB, Epstein LH, Wilfley DE. Patterns of Eating Disorder Pathology are Associated with Weight Change in Family-Based Behavioral Obesity Treatment. Obesity (Silver Spring). 2017 Dec;25(12):2115-2122. doi: 10.1002/oby.22028. Epub 2017 Oct 6.
Results Reference
derived

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Childhood Obesity Treatment: A Maintenance Approach

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