Physical Activity Clinical Trial
Official title:
Evaluation of a Primary Care Weight Management Program in Children Aged 2 to 5 Years: Changes in Feeding Practices, Health Behaviors, and Adiposity
NCT number | NCT03487614 |
Other study ID # | WAFC25 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2014 |
Est. completion date | May 1, 2023 |
Verified date | July 2023 |
Source | Spectrum Health Hospitals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 184 |
Est. completion date | May 1, 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 5 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Spectrum Health Hospitals | Blue Care Network of Michigan, We Are For Children, LLC |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anthropometry | Age- and sex-specific body mass index such as percent of the 95th BMI percentile | Change from baseline to follow-up at 6 months | |
Primary | FNPA | Family Nutrition and Physical Activity screening tool | Change from baseline to follow-up at 6 months | |
Primary | FPSQ | Feeding Practices and Structure Questionnaire | Change from baseline to follow-up at 6 months |
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