Clinical trial NCT03487614: Evaluation of a Primary Care Weight Management Program in Children Aged 2 to 5 Years
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Feeding Behavior
Physical Activity
Keywords: pediatric obesity
preschool children
non-responsive feeding
body mass index
parenting
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
Collaborators: name: Blue Care Network of Michigan
name: We Are For Children, LLC
First posted: 2018-04-04
Enrollment: 184
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Anthropometry
timeFrame: Change from baseline to follow-up at 6 months
measure: FNPA
timeFrame: Change from baseline to follow-up at 6 months
measure: FPSQ
timeFrame: Change from baseline to follow-up at 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Spectrum Health Hospitals
name: Jared M Tucker, PhD
role: PRINCIPAL_INVESTIGATOR
References: