Clinical trial NCT00241891: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Heart Diseases
Obesity
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-10-19
Enrollment: 158
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Changes in BMI z-score
timeFrame: Measured at Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Stephen Leff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.