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

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

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).

Study Overview

• Status: Completed
• Conditions: Physical Activity; Childhood Obesity; Feeding Behavior
• Intervention / Treatment: Behavioral: Behavior-based parental intervention

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Control; Control parents signed the informed consent document and then completed all baseline assessments during their child's medical visit. Control participants then received their usual medical care. Follow-up evaluations, including child anthropometry and completion of study surveys were assessed approximately 6 months later during a second office visit. For children <3 years of age at baseline, follow up visits coincided with their subsequent well-child visit (i.e. 30-month or 3-year appointment) as per AAP visit frequency recommendations. For patients ≥3 years of age, families attended a separate office visit 6 months after their baseline visit in order to complete follow-up study assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
FNPA	Family Nutrition and Physical Activity screening tool	Change from baseline to follow-up at 6 months
FPSQ	Feeding Practices and Structure Questionnaire	Change from baseline to follow-up at 6 months

Collaborators and Investigators

• Sponsor: Spectrum Health Hospitals
• Collaborators: Blue Care Network of Michigan; We Are For Children, LLC
• Investigators: Principal Investigator: Jared M Tucker, PhD, Spectrum Health Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (Actual): April 4, 2018

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: body mass index; parenting; preschool children; pediatric obesity; non-responsive feeding
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: WAFC25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data sharing is a possibility upon approval from IRB.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No