Childhood Obesity Treatment: A Maintenance Approach (COMPASS)

February 20, 2017 updated by: Washington University School of Medicine
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
482

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Washington
      • Seattle, Washington, United States, 98121
        • Seattle Children's Hospital Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
Experimental: SFM+ Low Dose
Participants assigned to this group will receive the SFM+ Low Dose.
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.
Experimental: SFM+ High Dose
Participants assigned to this group will receive the SFM+ High Dose.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Child percent overweight
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Florida
State University of New York at Buffalo
Seattle Children's Hospital Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brian Saelens, Ph.D., Seattle Children's Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201107083
  • 2R01HD036904 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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