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Motivational Interviewing in NOURISH for Parents of Overweight Children (NOURISH+MI)

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle counseling
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring motivational interviewing, obesity, parent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • parents/caregivers must be at least 18 years old
  • have a child between the ages of 5 and 11
  • have a child with a BMI > the 85th%ile
  • the eligible child primarily resides in the caregiver's home
  • English speaking

Exclusion Criteria:

  • non-ambulatory
  • pregnant
  • have a medical condition that might be negatively impacted by exercise have a psychiatric diagnosis that would impair their ability to respond to assessments or participate in a group
  • Parents whose children have a medical or developmental condition that precludes weight loss using conventional diet and exercise methods are also ineligible

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lifestyle counseling

Arm Description

NOURISH+ plus motivational interviewing

Outcomes

Primary Outcome Measures

Number of sessions attended

Secondary Outcome Measures

Baseline child dietary intake and change in intake
Baseline child physical activity and change in activity
Baseline child BMI percentile and change in BMI
Baseline parent BMI and change in BMI
Baseline parent dietary intake and change in intake
Baseline parent physical activity and change in activity

Full Information

First Posted
June 28, 2013
Last Updated
September 23, 2015
Sponsor
Virginia Commonwealth University
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT01912989
Brief Title
Motivational Interviewing in NOURISH for Parents of Overweight Children
Acronym
NOURISH+MI
Official Title
Motivational Interviewing in NOURISH for Parents of Overweight Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
American Heart Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate if a brief, motivational interviewing intervention (NOURISH+MI) can improve retention and treatment adherence for parents enrolled in an intervention for their child's overweight (NOURISH+). The investigators hypothesize that children whose parents participate in NOURISH+MI will demonstrate lower attrition and greater adherence with NOURISH+, ultimately leading to greater treatment effects, compared with children whose parents are randomized to NOURISH+ or a control group.
Detailed Description
There is an urgent need for innovative approaches to pediatric obesity prevention and treatment. There is also a demand for targeted strategies that reduce attrition and improve compliance with obesity treatment. Intervening exclusively with parents of overweight children is a novel treatment approach, with demonstrated efficacy in reducing child body mass index (BMI) percentile. Motivational interviewing (MI), a brief communication style for exploring and resolving ambivalence about change, may enhance treatment engagement when implemented as part of obesity interventions. Further research investigating MI within pediatric obesity treatments is needed. In the current application, the investigators are examining whether MI implemented with parents for the treatment of their children's overweight can improve treatment effects. NOURISH+, a recently funded R01 (Nourishing Our Understanding of Role modeling to Improve Support and Health; PI, Mazzeo), is a culturally tailored parent intervention for overweight children ages 5-11. NOURISH+ targets lower-income, African American participants, a group at increased risk for pediatric overweight and associated complications, and builds on pilot work which yielded significant reductions in child BMI percentile. The investigators are adding an MI treatment into NOURISH+. Specifically, we will randomly select 60 parents at enrollment and investigate if adding two brief MI sessions prior to the NOURISH+ group intervention will enhance treatment effects. The investigators will be able to compare NOURISH+MI with participants from the two R01 treatment conditions (NOURISH+ and Control), matched on child ethnicity and gender. The investigators hypothesize that children whose parents participate in NOURISH+ MI will demonstrate lower attrition and greater compliance with NOURISH+, ultimately leading to greater treatment effects, compared with children whose parents are randomized to NOURISH+ or a control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
motivational interviewing, obesity, parent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
NOURISH+ plus motivational interviewing
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counseling
Intervention Description
Parents will participate in one telephone and one in person session of motivational interviewing prior to their participation in an 8 week parent-exclusive treatment focusing on parenting skills to improve their child's overweight.
Primary Outcome Measure Information:
Title
Number of sessions attended
Time Frame
8 weeks and 4-month follow up
Secondary Outcome Measure Information:
Title
Baseline child dietary intake and change in intake
Time Frame
baseline, 8 weeks, 4 month post
Title
Baseline child physical activity and change in activity
Time Frame
baseline, 8 weeks, 4-month post
Title
Baseline child BMI percentile and change in BMI
Time Frame
baseline, 8 weeks, 4-month post
Title
Baseline parent BMI and change in BMI
Time Frame
baseline, 8 weeks, 4-month post
Title
Baseline parent dietary intake and change in intake
Time Frame
baseline, 8 weeks, 4-month post
Title
Baseline parent physical activity and change in activity
Time Frame
baseline, 8 weeks, 4-month post

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: parents/caregivers must be at least 18 years old have a child between the ages of 5 and 11 have a child with a BMI > the 85th%ile the eligible child primarily resides in the caregiver's home English speaking Exclusion Criteria: non-ambulatory pregnant have a medical condition that might be negatively impacted by exercise have a psychiatric diagnosis that would impair their ability to respond to assessments or participate in a group Parents whose children have a medical or developmental condition that precludes weight loss using conventional diet and exercise methods are also ineligible
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie K Bean, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24530488
Citation
Bean MK, Jeffers AJ, Tully CB, Thornton LM, Mazzeo SE. Motivational interviewing with parents of overweight children: study design and methods for the NOURISH + MI study. Contemp Clin Trials. 2014 Mar;37(2):312-21. doi: 10.1016/j.cct.2014.02.001. Epub 2014 Feb 12.
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Motivational Interviewing in NOURISH for Parents of Overweight Children

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