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

Sponsor

Children's Hospital of Philadelphia (Other)

Overall Status

Completed

CT.gov ID

NCT00241891

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

158

Enrollment

Location

Arms

103.1

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Heart Diseases Obesity	Behavioral: Single behavior intervention Behavioral: Multiple behavior interventions Behavioral: Control Intervention unrelated to weight	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

158 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Primary Care Obesity Prevention: One or Multiple Targets

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Healthy Lifestyle (Active Intervention) Parents and children in this program which will participate in a series of consultations and activities focused on multiple healthy interventions including healthy eating, drinking, and physical activity. The children will participate in a variety of age-appropriate games, activities and exercises that are focused on healthy eating, drinking, and physical activity. In addition, your child will receive information on developing healthy interpersonal and social skills.	Behavioral: Multiple behavior interventions Focused on multiple behaviors (nutrition, beverages, physical activity, and sedentary lifestyle) which may have a significant impact on weight.
Other: Healthy Drinks (Active Intervention) Parents and children in this program will participate in a series of consultations and activities focused on a single intervention, the effects of beverage choices on diet, general health and teeth health. The children will participate in a variety of age-appropriate games, activities and exercises that are focused on beverages and health. In addition, your child will receive information on healthy nutrition, physical activity, and interpersonal and social skills.	Behavioral: Single behavior intervention Focused on changing beverage choices which may have a significant impact on weight. Other Names: Focused on changing beverage choices with the goal
Other: Social and Leadership Skills (Control Intervention) Parents and children in this program will participate in a series of consultations that are designed to help your child learn strategies to make and keep friends, to express feelings appropriately, and to successfully decrease conflicts that often occur at school among children. The children will participate in a variety of age-appropriate games, activities and exercises that are focused on these friendship making strategies. In addition, your child will receive information on healthy nutrition and physical activity. There is o intervention with regards to healthy weight.	Behavioral: Control Intervention unrelated to weight Focused on standard intervention strategies unrelated to weight including bullying prevention.

Arm

Intervention/Treatment

Other: Healthy Lifestyle (Active Intervention)

Parents and children in this program which will participate in a series of consultations and activities focused on multiple healthy interventions including healthy eating, drinking, and physical activity. The children will participate in a variety of age-appropriate games, activities and exercises that are focused on healthy eating, drinking, and physical activity. In addition, your child will receive information on developing healthy interpersonal and social skills.

Behavioral: Multiple behavior interventions

Focused on multiple behaviors (nutrition, beverages, physical activity, and sedentary lifestyle) which may have a significant impact on weight.

Other: Healthy Drinks (Active Intervention)

Parents and children in this program will participate in a series of consultations and activities focused on a single intervention, the effects of beverage choices on diet, general health and teeth health. The children will participate in a variety of age-appropriate games, activities and exercises that are focused on beverages and health. In addition, your child will receive information on healthy nutrition, physical activity, and interpersonal and social skills.

Behavioral: Single behavior intervention

Focused on changing beverage choices which may have a significant impact on weight.

Other Names:

Focused on changing beverage choices with the goal

Other: Social and Leadership Skills (Control Intervention)

Parents and children in this program will participate in a series of consultations that are designed to help your child learn strategies to make and keep friends, to express feelings appropriately, and to successfully decrease conflicts that often occur at school among children. The children will participate in a variety of age-appropriate games, activities and exercises that are focused on these friendship making strategies. In addition, your child will receive information on healthy nutrition and physical activity. There is o intervention with regards to healthy weight.

Behavioral: Control Intervention unrelated to weight

Focused on standard intervention strategies unrelated to weight including bullying prevention.

Outcome Measures

Primary Outcome Measures

Changes in BMI z-score [Measured at Month 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

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

Investigators

Principal Investigator: Stephen Leff, PhD, Children's Hospital of Philadelphia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Children's Hospital of Philadelphia

ClinicalTrials.gov Identifier:

NCT00241891

Other Study ID Numbers:

2005-7-4442
R01HL084056

First Posted:

Oct 19, 2005

Last Update Posted:

Apr 7, 2015

Last Verified:

Apr 1, 2015

Additional relevant MeSH terms:

Cardiovascular Diseases

Heart Diseases

Obesity

Study Results

No Results Posted as of Apr 7, 2015