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OpenTrials
Completed

NCT Number: NCT03487614

Evaluation of a Primary Care Weight Management Program in Children Aged 2 to 5 Years

Primary care offers a promising setting for promoting parenting practices that shape healthy eating and physical activity behaviors of young children. This study assessed the impact of a parent-based, primary care intervention on the feeding habits, health behaviors, and body mass index (BMI) of 2-5 year olds with elevated or rapidly-increasing BMI. Four private pediatric offices in West Michigan were assigned as control (n=2) or intervention (n=2) sites based on patient load and demographics. Treatment families were recruited at well-child visits to receive physician health-behavior counseling and four visits with a registered dietitian nutritionist (RDN) over a 6-month period. Outcomes included percent of the 95th BMI percentile (%BMI95), the Family Nutrition and Physical Activity survey (FNPA), and the Feeding Practices and Structure Questionnaire (FPSQ).

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 2 and 5 years
  • BMI ≥85th percentile for age and sex, using the 2000 CDC growth chart, or BMI percentile increase within the past year equivalent to crossing at least two growth chart lines per year on a standard CDC growth chart, excluding the 5th percentile (e.g., 10th & 25th, 25th & 50th, 50th & 75th, 75th & 85th). This rate of increase is equivalent to ≥0.67 standard deviations per year (BMI z-score), and, when occurring in this age group, has been shown to increase risk of adult obesity

Exclusion criteria

  • Known disorder of the HPA axis
  • Use of glucocorticoid medication
  • Non-English speaking

Treatment and study plan

Behavior-based parental intervention

Behavioral

Behavioral intervention designed to promote healthy feeding behaviors in parents of 2-5 year olds, and to modify parenting practices in a way that encourages adequate physical activity, sufficient sleep, and healthy nutrition, while limiting sedentary behaviors.

Primary outcomes

  1. Anthropometry

    Time frame: Change from baseline to follow-up at 6 months

    Age- and sex-specific body mass index such as percent of the 95th BMI percentile

  2. FNPA

    Time frame: Change from baseline to follow-up at 6 months

    Family Nutrition and Physical Activity screening tool

  3. FPSQ

    Time frame: Change from baseline to follow-up at 6 months

    Feeding Practices and Structure Questionnaire

Sponsors and collaborators

Lead sponsor

Corewell Health West

Other

Collaborators

  • Blue Care Network of Michigan
  • We Are For Children, LLC

Registry information

Official study title

Evaluation of a Primary Care Weight Management Program in Children Aged 2 to 5 Years: Changes in Feeding Practices, Health Behaviors, and Adiposity

Important dates

Study start
2014
Primary completion
2023
Study completion
2023
First posted
Apr 4, 2018
Registry last updated
Jul 25, 2023

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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