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

NCT03487614 | Completed

• 1 other identifier: WAFC25
• Study Type: interventional
• Target: 184
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Childhood Obesity; Feeding Behavior; Physical Activity

Keywords

pediatric obesity; preschool children; non-responsive feeding; body mass index; parenting

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Behavior-based parental intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Behavior-based parental intervention BEHAVIORAL

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.

Behavior-based parental intervention

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Corewell Health West: lead
• Blue Care Network of Michigan: collaborator
• We Are For Children, LLC: collaborator

MeSH Terms

Conditions

Pediatric Obesity; Feeding Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Jared M Tucker, PhD

  Corewell Health West

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Epidemiologist

Model Details: We Are for Children, LLC (WAFC), is a collaboration of non-profit pediatric practices in West Michigan formed to help members respond to healthcare needs. Four primary care pediatric offices from WAFC were selected to participate in the current study based on site interest and capacity. Participating pediatric offices were then matched into pairs based on similarities in office size (i.e. physician FTEs and patient load) and patient demographics characteristics, after which one of each matched pair was assigned as a treatment or control site.

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: April 4, 2018
• Study Start: July 1, 2014
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share