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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
growth monitoring
Growth Monitoring plus Family-based Behavioral Counseling
Sponsored by
The University of Tennessee, Knoxville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Treatment of childhood obesity

Eligibility Criteria

4 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Knoxville Pediatric Associates
  • Healthy Eating and Activity Laboratory

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Newsletter

Growth Monitoring

Growth Monitoring plus Family-based Behavioral Counseling

Arm Description

Outcomes

Primary Outcome Measures

Weight Status
BMI z-score
Dietary Intake
dietary intake (sweetened beverages, fruits and vegetables, energy, and percent energy from fat)
Leisure-time Behaviors
leisure-time behaviors (moderate-intense physical activity and television viewing)
Caretaker Feeding Behaviors
Caretaker feeding behaviors (authoritative, authoritarian, permissive, restrictive) assessed by questionnaires

Secondary Outcome Measures

Cost Effectiveness
The total program cost per 0.1 change in BMI z-score

Full Information

First Posted
May 17, 2011
Last Updated
April 3, 2018
Sponsor
The University of Tennessee, Knoxville
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1. Study Identification

Unique Protocol Identification Number
NCT01358448
Brief Title
A Pilot Study of the Efficacy and Program Cost-effectiveness of Prevention Plus for Childhood Obesity
Official Title
A Pilot Study of the Efficacy and Program Cost-effectiveness of Prevention Plus for Childhood Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 2011 (Actual)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Tennessee, Knoxville

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Treatment of childhood obesity

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Newsletter
Arm Type
No Intervention
Arm Title
Growth Monitoring
Arm Type
Experimental
Arm Title
Growth Monitoring plus Family-based Behavioral Counseling
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
growth monitoring
Intervention Description
Caretakers will be encouraged to monitor child growth monthly.
Intervention Type
Behavioral
Intervention Name(s)
Growth Monitoring plus Family-based Behavioral Counseling
Intervention Description
Caretakers will monitor growth monthly in addition participating in family-based behavioral counseling
Primary Outcome Measure Information:
Title
Weight Status
Description
BMI z-score
Time Frame
Baseline and 6-month
Title
Dietary Intake
Description
dietary intake (sweetened beverages, fruits and vegetables, energy, and percent energy from fat)
Time Frame
baseline and 6-months
Title
Leisure-time Behaviors
Description
leisure-time behaviors (moderate-intense physical activity and television viewing)
Time Frame
Baseline and 6-months
Title
Caretaker Feeding Behaviors
Description
Caretaker feeding behaviors (authoritative, authoritarian, permissive, restrictive) assessed by questionnaires
Time Frame
Baseline and 6-months
Secondary Outcome Measure Information:
Title
Cost Effectiveness
Description
The total program cost per 0.1 change in BMI z-score
Time Frame
6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Knoxville Pediatric Associates
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Facility Name
Healthy Eating and Activity Laboratory
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37996
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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