A Pilot Study of the Efficacy and Program Cost-effectiveness of Prevention Plus for Childhood Obesity
This study is ongoing, but not recruiting participants.
Sponsor:
University of Tennessee
Information provided by (Responsible Party):
University of Tennessee
ClinicalTrials.gov Identifier:
NCT01358448
First received: May 17, 2011
Last updated: September 5, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity |
Behavioral: growth monitoring Behavioral: Growth Monitoring plus Family-based Behavioral Counseling |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of the Efficacy and Program Cost-effectiveness of Prevention Plus for Childhood Obesity |
Resource links provided by NLM:
Further study details as provided by University of Tennessee:
Primary Outcome Measures:
- Weight Status [ Time Frame: Baseline and 6-month ] [ Designated as safety issue: No ]BMI z-score
- Dietary Intake [ Time Frame: baseline and 6-months ] [ Designated as safety issue: No ]dietary intake (sweetened beverages, fruits and vegetables, energy, and percent energy from fat)
- Leisure-time Behaviors [ Time Frame: Baseline and 6-months ] [ Designated as safety issue: No ]leisure-time behaviors (moderate-intense physical activity and television viewing)
- Caretaker Feeding Behaviors [ Time Frame: Baseline and 6-months ] [ Designated as safety issue: No ]Caretaker feeding behaviors (authoritative, authoritarian, permissive, restrictive) assessed by questionnaires
Secondary Outcome Measures:
- Cost Effectiveness [ Time Frame: 6-months ] [ Designated as safety issue: No ]The total program cost per 0.1 change in BMI z-score
| Estimated Enrollment: | 33 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: Newsletter | |
| Experimental: Growth Monitoring |
Behavioral: growth monitoring
Caretakers will be encouraged to monitor child growth monthly.
|
| Experimental: Growth Monitoring plus Family-based Behavioral Counseling |
Behavioral: Growth Monitoring plus Family-based Behavioral Counseling
Caretakers will monitor growth monthly in addition participating in family-based behavioral counseling
|
Eligibility| Ages Eligible for Study: | 4 Years to 8 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358448
Locations
| United States, Tennessee | |
| Knoxville Pediatric Associates | |
| Knoxville, Tennessee, United States, 37923 | |
| Healthy Eating and Activity Laboratory | |
| Knoxville, Tennessee, United States, 37996 | |
Sponsors and Collaborators
University of Tennessee
More Information
No publications provided
| Responsible Party: | University of Tennessee |
| ClinicalTrials.gov Identifier: | NCT01358448 History of Changes |
| Other Study ID Numbers: | UT8433B |
| Study First Received: | May 17, 2011 |
| Last Updated: | September 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Tennessee:
|
Treatment of childhood obesity |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013