A Pilot Study of the Efficacy and Program Cost-effectiveness of Prevention Plus for Childhood Obesity

Study Overview
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Brief Summary
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In 2007 the Expert Committee published recommendations on the prevention and treatment of childhood obesity. These recommendations outlined four interventions intended for advancement based on the child's age, body mass index (BMI), and response to treatment. The initial stage, Prevention Plus, is to be implemented in the primary care setting and focuses on primary care providers monitoring growth monthly and delivering intervention messages that target dietary and leisure-time behaviors that most contribute to energy imbalance in children. Little research has evaluated the efficacy of these recommendations. Thus the primary goal of the proposed pilot study is to test the feasibility of the Prevention Plus stage for treating childhood overweight and obesity in a primary care setting. As the cost of interventions is a large barrier to the translation of evidence-based research into primary care settings, a second goal of the project is to evaluate program cost-effectiveness.

Official Title
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A Pilot Study of the Efficacy and Program Cost-effectiveness of Prevention Plus for Childhood Obesity

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: growth monitoring
* Behavioral: Growth Monitoring plus Family-based Behavioral Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between 4 to 8 years of age at the start of the intervention overweight or obese (≥85th BMI-for-age percentile) have no medical conditions that effect growth, intake or physical activity (e.g., Prader Willi Syndrome, type 2 diabetes, etc.) not currently participating in a weight loss program and/or taking weight loss medication have a primary caretaker willing to participate in the research study, receive monthly newsletters and be randomized to one of the three conditions caretaker must be able to read, speak and understand English and the child speak English have transportation to their child's primary care provider office family does not plan to move out of the area before March 2012

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Newsletter<br> | |
| Experimental: Growth Monitoring<br> | Behavioral: growth monitoring<br>* Caretakers will be encouraged to monitor child growth monthly.<br>|
| Experimental: Growth Monitoring plus Family-based Behavioral Counseling<br> | Behavioral: Growth Monitoring plus Family-based Behavioral Counseling<br>* Caretakers will monitor growth monthly in addition participating in family-based behavioral counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Status | BMI z-score | Baseline and 6-month | 
| Dietary Intake | dietary intake (sweetened beverages, fruits and vegetables, energy, and percent energy from fat) | baseline and 6-months | 
| Leisure-time Behaviors | leisure-time behaviors (moderate-intense physical activity and television viewing) | Baseline and 6-months | 
| Caretaker Feeding Behaviors | Caretaker feeding behaviors (authoritative, authoritarian, permissive, restrictive) assessed by questionnaires | Baseline and 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost Effectiveness | The total program cost per 0.1 change in BMI z-score | 6-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment of childhood obesity