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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03487614
• Other study ID #: WAFC25
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Childhood Obesity
• Feeding Behavior
• Pediatric Obesity
• Physical Activity

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