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Completed

NCT Number: NCT01358448

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Healthy Eating and Activity Laboratory, Knoxville, Tennessee, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

growth monitoring

Behavioral

Caretakers will be encouraged to monitor child growth monthly.

Growth Monitoring plus Family-based Behavioral Counseling

Behavioral

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

Primary outcomes

  1. Weight Status

    Time frame: Baseline and 6-month

    BMI z-score

  2. Dietary Intake

    Time frame: baseline and 6-months

    dietary intake (sweetened beverages, fruits and vegetables, energy, and percent energy from fat)

  3. Leisure-time Behaviors

    Time frame: Baseline and 6-months

    leisure-time behaviors (moderate-intense physical activity and television viewing)

  4. Caretaker Feeding Behaviors

    Time frame: Baseline and 6-months

    Caretaker feeding behaviors (authoritative, authoritarian, permissive, restrictive) assessed by questionnaires

Secondary outcomes

  1. Cost Effectiveness

    Time frame: 6-months

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

Sponsors and collaborators

Lead sponsor

The University of Tennessee, Knoxville

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 23, 2011
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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