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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00241891
First received: October 17, 2005
Last updated: April 3, 2014
Last verified: March 2014
  Purpose

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 Intervention
Cardiovascular Diseases
Heart Diseases
Obesity
Behavioral: Diet
Behavioral: Physical Activity
Behavioral: Bullying prevention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Primary Care Obesity Prevention: One or Multiple Targets

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Changes in BMI z-score [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: July 2006
Estimated Study Completion Date: March 2015
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Intervention that will target change in multiple behaviors
Behavioral: Diet
Dietary intervention
Behavioral: Physical Activity
Physical activity intervention
Active Comparator: 2
Intervention that will target only one behavior (beverage consumption)
Behavioral: Diet
Dietary intervention
Active Comparator: 3
Active control intervention that is unrelated to weight (bullying prevention)
Behavioral: Bullying prevention
Bullying prevention intervention

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.

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241891

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Stephen Leff, PhD Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00241891     History of Changes
Other Study ID Numbers: 2005-7-4442, R01HL084056, R01 HL84056
Study First Received: October 17, 2005
Last Updated: April 3, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 19, 2014