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

Not Applicable

Completed

• Conditions: Childhood Obesity; Feeding Behavior; Physical Activity
• Interventions: Behavioral: Behavior-based parental intervention

• Registration Number: NCT03487614
• Lead Sponsor: Spectrum Health Hospitals

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-01
• Study First Submitted: 2018-03-21
• Study First Submitted QC: 2018-03-27
• Study First Posted: 2018-04-04
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavior-based parental intervention	Behavior-based parental intervention	The study intervention included two primary components: 1) physician-family health behavior conversations during well-child visits, and 2) four monthly visits with a RDN to evaluate, educate, and implement improved feeding habits and nutritional choices. A third optional component of the intervention included counseling sessions with a social worker to help families overcome barriers to change, such as food security, family relationships, and general parenting strategies.

Primary Outcome Measures

Name	Time	Method
FNPA	Change from baseline to follow-up at 6 months	Family Nutrition and Physical Activity screening tool
Anthropometry	Change from baseline to follow-up at 6 months	Age- and sex-specific body mass index such as percent of the 95th BMI percentile
FPSQ	Change from baseline to follow-up at 6 months	Feeding Practices and Structure Questionnaire