Childhood Obesity Treatment: A Maintenance Approach - Full Text View

Sponsor:	Washington University School of Medicine
Collaborators:	National Institutes of Health (NIH) Seattle Children’s Hospital Research Institute University of Florida State University of New York at Buffalo
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00759746

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.

Condition	Intervention
Childhood Overweight Childhood Obesity	Behavioral: Social Facilitation Maintenance (SFM) - Low Dose Behavioral: Current Standard of Care 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:

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

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 ]

Estimated Enrollment:	480
Study Start Date:	October 2009
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Group 1 - Current Standard of Care Participants in Group 1 will attend 16 interactive workshops that consist of providing families with information and education about how to maintain weight loss and live healthy lives, after taking part in the family-based weight loss program. Workshops will include presentations, activities, and question/answer sessions on topics related to developing good communications and health habits. Parents and children will have chances to practice new communication skills and health habits in their everyday lives in between workshops.	Behavioral: Current Standard of Care Following the four month family-based weight loss treatment, participants in the Current Standard of Care group will attend 16 interactive workshops that focus on providing families with information and education about how to maintain weight loss and live healthy lives. Workshops will include presentations, activities, and question/answer sessions on topics related to developing good communications and health habits. Parents and children will have chances to practice new communication skills and health habits in their everyday lives in between workshops.
Experimental: Group 2 - Weight Maintenance Therapy (Lose Dose SFM) Participants in this group will attend sessions every two weeks, for a total of 16 sessions during the maintenance phase, to help families learn more weight loss maintenance skills after taking part in the family-based weight loss program. The SFM therapy presumes people need a social environment that supports continued weight control. The treatment guides parents to encourage their kids to be friends with physically active peers and to ensure that play dates with existing friends involve physical activity and healthy eating. Participants in Group 2 will meet less often than families in Group 3, giving them a greater opportunity to practice new skills between clinic visits.	Behavioral: Social Facilitation Maintenance (SFM) - Low Dose The Social Facilitation Maintenance (SFM) treatment will focus on helping families create a social environment that supports continued weight control after the initial family-based weight loss treatment phase. The SFM treatment guides parents to encourage their kids to be friends with physically active peers and to ensure that play dates with existing friends involve physical activity and healthy eating. Participants in SFM-Low Dose meet less often than families in SFM-High Dose, giving them a greater opportunity to practice new skills between clinic visits.
Experimental: Group 3 - Intensive Weight Maintenance Therapy (High Dose SFM) Participants who receive the intensive SFM therapy will continue to meet with behavioral interventionists and other participating families each week during the maintenance phase of the study, for a total of 32 sessions. The content of the intensive SFM therapy is similar to the less intensive version of the SFM program. Because participants in Group 3 will meet several times each month of the study, they will have more opportunity to practice new skills during clinic visits than families in Group 2.	Behavioral: Social Facilitation Maintenance (SFM) - High Dose Following the family-based weight loss program, participants who receive the intensive SFM-High Dose therapy will continue to meet with behavioral interventionists and other participating families each week during the maintenance phase of the study, for a total of 32 sessions. The content of the intensive SFM therapy is similar to the less intensive version of the SFM program, focusing on helping families create a social environment that supports a healthy lifestyle. Because participants in the SFM-High Dose treatment will meet several times each month, they will have more opportunity to practice new skills during clinic visits than families in SFM-Low Dose treatment.

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

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, 98101

Sponsors and Collaborators

Washington University School of Medicine

National Institutes of Health (NIH)

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

Responsible Party:	Wilfley, Denise E., PhD / Principal Investigator, Washington University
ClinicalTrials.gov Identifier:	NCT00759746 History of Changes
Other Study ID Numbers:	08-1014, 2R01HD036904-06A2
Study First Received:	September 23, 2008
Last Updated:	August 2, 2011
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 February 09, 2012