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Primary Care Child Obesity Intervention Targeting Parents

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent education / behavioral counseling
Usual Care
Sponsored by
East Tennessee State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring overweight, obesity, rural, primary care

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI >= 85th percentile
  • age 5-11 years
  • one parent or other primary care giver agrees to participate in the study

Exclusion Criteria:

  • current participation in another weight management program by child or parent/caregiver
  • presence of a diagnosed psychiatric/psychological disorder in the parent or child
  • presence of an underlying condition affecting weight status
  • current dietary or physical activity limitations
  • parents who do not have phone accessibility

Sites / Locations

  • East Tennessee State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Parent education / behavioral counseling

Usual Care

Arm Description

Parents of children in the intervention group will be invited to participate in four group visits and two individual visits with their primary care provider as well as four follow-up phone calls with study personnel (project coordinator or registered dietician). Providers and study personnel will be trained in the use of the NIH We Can! curriculum for group visits and brief motivational interviewing for individual visits and follow-up phone calls.

Parents of children in the control group will receive usual care from their primary care provider as well as a copy of the NIH We Can! Parent Handbook.

Outcomes

Primary Outcome Measures

child body mass index percentile

Secondary Outcome Measures

Parent report of knowledge, attitudes, perceptions, intentions, and behaviors related to eating and physical activity

Full Information

First Posted
November 15, 2012
Last Updated
November 23, 2015
Sponsor
East Tennessee State University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01729910
Brief Title
Primary Care Child Obesity Intervention Targeting Parents
Official Title
Primary Care Child Obesity Intervention Targeting Parents
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
East Tennessee State University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Child overweight has become one of today's most important public health concerns. Engaged and skilled parenting that models, values, and encourages healthy eating habits and a physically active lifestyle can play a key role in childhood overweight prevention and reduction. Primary care providers are well positioned to intervene with children and their parents, but face many barriers in addressing child overweight. A child overweight treatment approach is proposed for the primary care setting to facilitate parents' active involvement and self-efficacy in promoting healthy eating habits and physical activity for their children. We will test the following hypotheses: Hypothesis I (primary hypothesis): Children assigned to the intervention group will improve more in weight status (measured by BMI percentile) than children in the control group. Hypothesis II: Primary care providers assigned to the intervention group will improve more in their competence in addressing child overweight than the providers in the control group. Hypothesis III: After the intervention, parents in the intervention group will have more involvement and self-efficacy in promoting healthy weight for their children than parents in the control group. Hypothesis IV: Compared to the control group, the intervention group will improve more in family diet and eating, physical activity behaviors, as well as parental attitude and beliefs. Eighty children five to eleven years old who are overweight or obese will be recruited from two pediatric and two family practice clinics in southern Appalachia. Children will be randomly assigned to intervention and control groups based on clinic affiliation. Parents of children in the intervention group will participate in four clinic-based group sessions using the NIH We Can! curriculum moderated by a trained clinic provider, two individual brief motivational interviewing visits with their clinic provider, and four follow-up phone calls with the project coordinator or registered dietician. Parenting behaviors and attitudes, and family eating and activity habits, and children's weight status will be assessed at baseline, at the completion of the intervention, and at six months after the intervention. Changes in the assessments will be compared between treatment and control groups. Changes in provider and parent attitudes and perceptions about this treatment approach,adherence to the program, and estimates of associated time will be measured.
Detailed Description
Specific aims of this project are: 1) to establish a primary care based and parent-mediated childhood overweight intervention program based on the Chronic Care Model in the primary care setting, 2) to explore the efficacy of this intervention in improving the weight status of children, 3) to examine the acceptability and feasibility of the approach among primary care providers and parents. Clinic providers and study personnel will be trained in the use of brief motivational interviewing (brief MI) for the visits and phone calls. The American Academy of Pediatrics 15-Minute Obesity Prevention Protocol will be used for individual visits while the NIH We Can! curriculum and materials will be used for group visits. Parents in the control group will receive the We Can! Parent Handbook and usual care. The intervention is designed to facilitate efficient communication of advice about behavior change, nutrition, and physical activity to parents. Partnership of primary care providers with parents and use of brief intervention techniques and group visits can be a practical approach. If proven to be effective, this approach can serve as an exportable model to other primary care practices and will reach a large proportion of the population and have far-reaching effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
overweight, obesity, rural, primary care

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Parent education / behavioral counseling
Arm Type
Experimental
Arm Description
Parents of children in the intervention group will be invited to participate in four group visits and two individual visits with their primary care provider as well as four follow-up phone calls with study personnel (project coordinator or registered dietician). Providers and study personnel will be trained in the use of the NIH We Can! curriculum for group visits and brief motivational interviewing for individual visits and follow-up phone calls.
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
Parents of children in the control group will receive usual care from their primary care provider as well as a copy of the NIH We Can! Parent Handbook.
Intervention Type
Behavioral
Intervention Name(s)
Parent education / behavioral counseling
Intervention Description
Providers and study personnel will be trained in the use of the NIH We Can! curriculum for group visits and brief motivational interviewing for individual visits and follow-up phone calls. Training will be conducted by the PI and Co-Investigators using a combination of online, self-study, and face-to-face formats totally at least/approximately 8 hours. At least one project team member will attend each group visit. Specifically, the American Academy of Pediatrics 15-minute Obesity Prevention Protocol will be utilized during individual visits. The intervention is designed to take place over a period of 10-12 weeks in the primary care office.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Parents of children in the control group will receive usual care from their primary care provider as well as a copy of the NIH We Can! Parent Handbook.
Primary Outcome Measure Information:
Title
child body mass index percentile
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Parent report of knowledge, attitudes, perceptions, intentions, and behaviors related to eating and physical activity
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Health care provider knowledge, attitudes, and practices related to child obesity management
Time Frame
6-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI >= 85th percentile age 5-11 years one parent or other primary care giver agrees to participate in the study Exclusion Criteria: current participation in another weight management program by child or parent/caregiver presence of a diagnosed psychiatric/psychological disorder in the parent or child presence of an underlying condition affecting weight status current dietary or physical activity limitations parents who do not have phone accessibility
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen E Schetzina, MD, MPH
Organizational Affiliation
East Tennessee State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Tennessee State University
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37614
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21777701
Citation
Dalton WT 3rd, Schetzina KE, Holt N, Fulton-Robinson H, Ho AL, Tudiver F, McBee MT, Wu T. Parent-Led Activity and Nutrition (PLAN) for healthy living: design and methods. Contemp Clin Trials. 2011 Nov;32(6):882-92. doi: 10.1016/j.cct.2011.07.004. Epub 2011 Jul 18.
Results Reference
background
PubMed Identifier
21119559
Citation
Holt N, Schetzina KE, Dalton WT 3rd, Tudiver F, Fulton-Robinson H, Wu T. Primary care practice addressing child overweight and obesity: a survey of primary care physicians at four clinics in southern Appalachia. South Med J. 2011 Jan;104(1):14-9. doi: 10.1097/SMJ.0b013e3181fc968a.
Results Reference
result

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Primary Care Child Obesity Intervention Targeting Parents

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