- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03487614
Evaluation of a Primary Care Weight Management Program in Children Aged 2 to 5 Years
July 24, 2023 updated by: Jared Tucker, Spectrum Health Hospitals
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
184
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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 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
Time Frame: Change from baseline to follow-up at 6 months
|
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
Time Frame: Change from baseline to follow-up at 6 months
|
Family Nutrition and Physical Activity screening tool
|
Change from baseline to follow-up at 6 months
|
FPSQ
Time Frame: Change from baseline to follow-up at 6 months
|
Feeding Practices and Structure Questionnaire
|
Change from baseline to follow-up at 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jared M Tucker, PhD, Spectrum Health Hospitals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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