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:
Information provided by (Responsible Party):
University of Tennessee
ClinicalTrials.gov Identifier:
NCT01358448
First received: May 17, 2011
Last updated: July 24, 2014
Last verified: July 2014
  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 2015
Estimated Primary Completion Date: March 2015 (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
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: NCT01358448

Locations
United States, Tennessee
Healthy Eating and Activity Laboratory
Knoxville, Tennessee, United States, 37996
Knoxville Pediatric Associates
Knoxville, Tennessee, United States, 37923
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: July 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tennessee:
Treatment of childhood obesity

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014