NOURISH+: Nourishing Our Understanding of Role Modeling to Improve Support and Health (NOURISH+)

February 21, 2018 updated by: Virginia Commonwealth University

NOURISHing Families to Promote Healthy Eating and Exercise in Overweight Children

The purpose of this study is to evaluate the efficacy of a parent intervention (NOURISH+) aimed at reducing the problem of overweight and obesity in children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pediatric overweight is a national public health concern. The percentage of overweight children in the U.S. between the ages of 5 and 11 has nearly tripled in the last 3 decades. African American children are particularly at risk. Pediatric overweight is associated with numerous physical and psychological health problems. Moreover, overweight children are at significant risk for obesity in adulthood. Thus, a focus on pediatric overweight is an important step in the prevention of adult obesity.

Despite the urgent need for pediatric overweight interventions, outcomes of some of the most rigorous treatments are, at best, mixed. Although research has found that including parents in interventions for pediatric overweight has positive effects on outcomes, parental involvement is usually limited. Moreover, relatively few studies have included sufficient numbers of lower-SES, African American participants, a group at increased risk for pediatric overweight and associated complications. This study will evaluate the efficacy of an intensive intervention targeting ethnically diverse parents of overweight, children ages 5-11 (NOURISH-Nourishing Our Understanding of Role Modeling to Improve Support and Health).

Study Type

Interventional

Enrollment (Actual)

730

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

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23284
        • 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
  • Parents/caregivers must have a child between the ages of 5 and 11 with a BMI > the 85th percentile, who primarily resides in the caregiver's home
  • Parents/caregivers need to speak English, be able to follow basic instructions, and perform simple exercises

Exclusion Criteria:

  • Non-ambulatory parents/caregivers
  • Pregnant parents/caregivers
  • Parents/caregivers who have a medical condition that might be negatively impacted by exercise
  • Parents/caregivers who 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

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: NOURISH+
Participants will receive a 6-week face-to-face intervention, NOURISH+. Weekly topics teach parents skills to role model and encourage healthy lifestyle behaviors for their children.
Behavioral: NOURISH+
6 week face-to-face parent intervention.
PLACEBO_COMPARATOR: Wellness Group
Participants will receive an in-person "Family Wellness Night" followed by 6 mailings of information regarding pediatric overweight and obesity.
Behavioral: Wellness Group
1 week face-to-face family group followed by 6 informational mailings on childhood overweight and obesity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Child BMI
Time Frame: baseline, post-testing, 4-month, and 10-month follow-up
baseline, post-testing, 4-month, and 10-month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Child dietary intake, quality of life, and physical activity
Time Frame: baseline, post-testing, 4-month, and 10-month follow-up
baseline, post-testing, 4-month, and 10-month follow-up
Parental BMI, dietary intake, and physical activity levels
Time Frame: baseline, post-testing, 4-month, and 10-month follow-up
baseline, post-testing, 4-month, and 10-month follow-up

Collaborators and Investigators

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

Sponsor

Virginia Commonwealth University

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Suzanne E Mazzeo, Ph.D., Virginia Commonwealth University

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.

General Publications

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

April 1, 2011

Primary Completion (ACTUAL)

January 31, 2018

Study Completion (ACTUAL)

January 31, 2018

Study Registration Dates

First Submitted

May 24, 2011

First Submitted That Met QC Criteria

May 24, 2011

First Posted (ESTIMATE)

May 26, 2011

Study Record Updates

Last Update Posted (ACTUAL)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 21, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM13468
  • R01HD066216-01A1 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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