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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01358448
Enrollment
22
Registered
2011-05-23
Start date
2011-04-30
Completion date
2014-07-31
Last updated
2018-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Treatment of childhood obesity

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.

Interventions

BEHAVIORALgrowth monitoring

Caretakers will be encouraged to monitor child growth monthly.

BEHAVIORALGrowth Monitoring plus Family-based Behavioral Counseling

Caretakers will monitor growth monthly in addition participating in family-based behavioral counseling

Sponsors

The University of Tennessee, Knoxville
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Weight StatusBaseline and 6-monthBMI z-score
Dietary Intakebaseline and 6-monthsdietary intake (sweetened beverages, fruits and vegetables, energy, and percent energy from fat)
Leisure-time BehaviorsBaseline and 6-monthsleisure-time behaviors (moderate-intense physical activity and television viewing)
Caretaker Feeding BehaviorsBaseline and 6-monthsCaretaker feeding behaviors (authoritative, authoritarian, permissive, restrictive) assessed by questionnaires

Secondary

MeasureTime frameDescription
Cost Effectiveness6-monthsThe total program cost per 0.1 change in BMI z-score

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026