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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2023
Source Spectrum Health Hospitals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

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

Study Design


Intervention

Behavioral:
Behavior-based parental intervention
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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Spectrum Health Hospitals Blue Care Network of Michigan, We Are For Children, LLC

Outcome

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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