search
Back to results

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

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single behavior intervention
Multiple behavior interventions
Control Intervention unrelated to weight
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • The Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Healthy Lifestyle (Active Intervention)

Healthy Drinks (Active Intervention)

Social and Leadership Skills (Control Intervention)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Changes in BMI z-score

Secondary Outcome Measures

Full Information

First Posted
October 17, 2005
Last Updated
April 6, 2015
Sponsor
Children's Hospital of Philadelphia
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00241891
Brief Title
Behavior Change Family Counseling to Reduce Rate of Weight Gain in At-Risk Children
Official Title
Primary Care Obesity Prevention: One or Multiple Targets
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Lifestyle (Active Intervention)
Arm Type
Other
Arm Description
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.
Arm Title
Healthy Drinks (Active Intervention)
Arm Type
Other
Arm Description
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.
Arm Title
Social and Leadership Skills (Control Intervention)
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Single behavior intervention
Other Intervention Name(s)
Focused on changing beverage choices with the goal
Intervention Description
Focused on changing beverage choices which may have a significant impact on weight.
Intervention Type
Behavioral
Intervention Name(s)
Multiple behavior interventions
Intervention Description
Focused on multiple behaviors (nutrition, beverages, physical activity, and sedentary lifestyle) which may have a significant impact on weight.
Intervention Type
Behavioral
Intervention Name(s)
Control Intervention unrelated to weight
Intervention Description
Focused on standard intervention strategies unrelated to weight including bullying prevention.
Primary Outcome Measure Information:
Title
Changes in BMI z-score
Time Frame
Measured at Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Leff, PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25251166
Citation
Stettler N, Wrotniak BH, Hill DL, Kumanyika SK, Xanthopoulos MS, Nihtianova S, Shults J, Leff SS, Pinto A, Berkowitz RI, Faith MS. Prevention of excess weight gain in paediatric primary care: beverages only or multiple lifestyle factors. The Smart Step Study, a cluster-randomized clinical trial. Pediatr Obes. 2015 Aug;10(4):267-74. doi: 10.1111/ijpo.260. Epub 2014 Sep 24.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs