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

Primary Purpose

Childhood Obesity, Feeding Behavior, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Behavior-based parental intervention
Sponsored by
Spectrum Health Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Obesity focused on measuring pediatric obesity, preschool children, non-responsive feeding, body mass index, parenting

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Behavior-based parental intervention

    Control

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Anthropometry
    Age- and sex-specific body mass index such as percent of the 95th BMI percentile
    FNPA
    Family Nutrition and Physical Activity screening tool
    FPSQ
    Feeding Practices and Structure Questionnaire

    Secondary Outcome Measures

    Full Information

    First Posted
    March 21, 2018
    Last Updated
    July 24, 2023
    Sponsor
    Spectrum Health Hospitals
    Collaborators
    Blue Care Network of Michigan, We Are For Children, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03487614
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2014 (Actual)
    Primary Completion Date
    May 1, 2023 (Actual)
    Study Completion Date
    May 1, 2023 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Spectrum Health Hospitals
    Collaborators
    Blue Care Network of Michigan, We Are For Children, LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Childhood Obesity, Feeding Behavior, Physical Activity
    Keywords
    pediatric obesity, preschool children, non-responsive feeding, body mass index, parenting

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    184 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Behavior-based parental intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Behavior-based parental intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Anthropometry
    Description
    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
    Title
    FNPA
    Description
    Family Nutrition and Physical Activity screening tool
    Time Frame
    Change from baseline to follow-up at 6 months
    Title
    FPSQ
    Description
    Feeding Practices and Structure Questionnaire
    Time Frame
    Change from baseline to follow-up at 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jared M Tucker, PhD
    Organizational Affiliation
    Spectrum Health Hospitals
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Data sharing is a possibility upon approval from IRB.

    Learn more about this trial

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

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