Childhood Obesity Treatment: A Maintenance Approach

Not Applicable

Completed

• Conditions: Childhood Overweight; Childhood Obesity
• Interventions: Behavioral: SFM+ Low Dose; Behavioral: Weight Maintenance Education; Behavioral: SFM+ High Dose

• Registration Number: NCT00759746
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study First Submitted: 2008-09-23
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Study Start: 2009-10
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 482

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SFM+ Low Dose	SFM+ Low Dose	Participants assigned to this group will receive the SFM+ Low Dose.
Weight Maintenance Education	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.
SFM+ High Dose	SFM+ High Dose	Participants assigned to this group will receive the SFM+ High Dose.

Primary Outcome Measures

Name	Time	Method
Child percent overweight	1 year

Trial Locations

Locations (2)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States

Seattle Children's Hospital Research Institute; 🇺🇸 Seattle, Washington, United States