Behavior Change Family Counseling to Reduce Rate of Weight Gain in At-Risk Children

Obesity Clinical Trial

Official title:

Primary Care Obesity Prevention: One or Multiple Targets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241891
• Other study ID #: 2005-7-4442
• Secondary ID: R01HL084056
• Status: Completed
• Phase: N/A
• First received: October 17, 2005
• Last updated: April 6, 2015
• Start date: July 2006
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will train primary care providers to counsel families on behavior change that is aimed at reducing the rate of weight gain in at-risk children.

Description:

BACKGROUND:

In addition to family, school, and community, primary care is a promising setting for childhood obesity prevention. However, most pediatric primary care providers are not trained to deliver behavior modification interventions and, according to preliminary data, are less likely to address obesity prevention when they perceive insufficient time during well-care visits.

DESIGN NARRATIVE:

This is a controlled study of obesity prevention, with group randomization of two standardized 12-month intervention strategies at the practice level. The intervention strategies are based on the behavioral economics theory and will be delivered by primary care providers after training in behavior modification. The first strategy will target change in multiple behaviors, while the second strategy will target only one behavior (beverage consumption). These two interventions will be compared to an active control intervention that is unrelated to weight (bullying prevention). Six to seven primary care practices will be randomized to each arm with 21 patients per practice, for a total of 17 practices and 350 patients. The primary aim is to demonstrate that either obesity prevention intervention will result in less body mass index (BMI) increase (adjusted using z-score) in children age 8 to 12 years who are at risk for overweight (BMI 50th-95th percentile), as compared to a control intervention. The study also hypothesizes that the multiple-behavior intervention, the single-behavior intervention, or both will result in less adjusted BMI increase than the control intervention at 24 months post-randomization, with no a priori assumption in differences between the two obesity prevention strategies. Blood pressure, insulin resistance, dyslipidemia, and oral health status will be secondary outcomes. Intermediate behavioral outcomes and process data will be collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: February 2015
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• Sought care at the participating practices at least once in the 3 years prior to study entry

• Children "at risk for overweight" at their last clinical visit (according to the Center for Disease Control and Prevention [CDC] definition of a BMI at or above the 50th percentile, but less than the 95th percentile)

• Children who consume at least 28 oz of sweetened beverages per week (i.e., an average of 4 oz per day) as assessed during the telephone screening by selected components of a validated food frequency questionnaire

• The following conditions will be acceptable if they have been well controlled in the 3 months prior to study entry: hypertension, dyslipidemia, sleep apnea, asthma, and insulin resistance without diabetes

Exclusion Criteria:

• Developmental delay requiring special education

• Depression

• Psychosis

• Eating disorder

• Significant orthopedic problems interfering with physical activity

• Diabetes

• Any significant chronic condition potentially interfering with nutrition or physical activity

• Treated with a drug known to affect weight gain

• Measured BMI z-score at first visit higher than +2.0 Standard Deviations (97.7th percentile)

• Families who are uninterested or unable to participate

• Home-schooled

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Obesity

Intervention

Behavioral:
• Single behavior intervention
Focused on changing beverage choices which may have a significant impact on weight.
• Multiple behavior interventions
Focused on multiple behaviors (nutrition, beverages, physical activity, and sedentary lifestyle) which may have a significant impact on weight.
• Control Intervention unrelated to weight
Focused on standard intervention strategies unrelated to weight including bullying prevention.

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in BMI z-score		Measured at Month 12	No