ClinicalTrials.gg
CompletedNCT03487614Updated Jul 25, 2023

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

An interventional study of Behavior-based parental intervention in Childhood Obesity, Feeding Behavior and Physical Activity, sponsored by Spectrum Health Hospitals. Completed. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2023-07-25.

Sponsored by Spectrum Health Hospitals · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 8 months after the study started (first participant enrolled Jul 2014, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
184
Allocation
Non-randomized
Ages
2 Years to 5 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Childhood Obesity
  • Feeding Behavior
  • Physical Activity

Keywords

  • pediatric obesity
  • preschool children
  • non-responsive feeding
  • body mass index
  • parenting
03

In context

Pediatric Obesity

1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.

This study's enrollment of 184 is above the median of 100 across 870 interventional studies indexed under Pediatric Obesity.

Browse Pediatric Obesity studies →

Lead sponsor

Spectrum Health Hospitals is the lead sponsor of 38 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 2 and 5 years
  • ≥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

Exclusion Criteria:

  • Known disorder of the HPA axis
  • Use of medication
  • Non-English speaking
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

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05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
184 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralBehavior-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.

06

What researchers measure

Primary outcomes

  1. Anthropometry

    Age- and sex-specific body mass index such as percent of the 95th BMI percentile

    Time frame: Change from baseline to follow-up at 6 months

  2. FNPA

    Family Nutrition and Physical Activity screening tool

    Time frame: Change from baseline to follow-up at 6 months

  3. FPSQ

    Feeding Practices and Structure Questionnaire

    Time frame: Change from baseline to follow-up at 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Data sharing is a possibility upon approval from IRB.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03487614
Lead sponsor
Spectrum Health Hospitals
Collaborators
Blue Care Network of Michigan, We Are For Children, LLC
Responsible party
Jared Tucker (Epidemiologist, Spectrum Health Hospitals) — Principal investigator
First posted
Apr 4, 2018
Start date
Jul 1, 2014
Primary completion
May 1, 2023
Completion
May 1, 2023
Last update
Jul 25, 2023

Study contacts

Jared M Tucker, PhD
principal investigator · Spectrum Health Hospitals

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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