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

September 23, 2015 updated by: Virginia Commonwealth University
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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle counseling
NOURISH+ plus motivational interviewing
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of sessions attended
Time Frame: 8 weeks and 4-month follow up
8 weeks and 4-month follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Baseline child dietary intake and change in intake
Time Frame: baseline, 8 weeks, 4 month post
baseline, 8 weeks, 4 month post
Baseline child physical activity and change in activity
Time Frame: baseline, 8 weeks, 4-month post
baseline, 8 weeks, 4-month post
Baseline child BMI percentile and change in BMI
Time Frame: baseline, 8 weeks, 4-month post
baseline, 8 weeks, 4-month post
Baseline parent BMI and change in BMI
Time Frame: baseline, 8 weeks, 4-month post
baseline, 8 weeks, 4-month post
Baseline parent dietary intake and change in intake
Time Frame: baseline, 8 weeks, 4-month post
baseline, 8 weeks, 4-month post
Baseline parent physical activity and change in activity
Time Frame: baseline, 8 weeks, 4-month post
baseline, 8 weeks, 4-month post

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

June 28, 2013

First Submitted That Met QC Criteria

July 29, 2013

First Posted (Estimate)

July 31, 2013

Study Record Updates

Last Update Posted (Estimate)

September 24, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13CRP14570008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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