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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Virginia Commonwealth University
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01361243
First received: May 24, 2011
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Overweight and Obesity
Behavioral: NOURISH+
Behavioral: Wellness Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: NOURISHing Families to Promote Healthy Eating and Exercise in Overweight Children

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Child BMI [ Time Frame: baseline, post-testing, 4-month, and 10-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Child dietary intake, quality of life, and physical activity [ Time Frame: baseline, post-testing, 4-month, and 10-month follow-up ] [ Designated as safety issue: No ]
  • Parental BMI, dietary intake, and physical activity levels [ Time Frame: baseline, post-testing, 4-month, and 10-month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: April 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361243

Contacts
Contact: Rachel W Gow, Ph.D. 804-827-9211 nourish@vcu.edu
Contact: Meg Harney, Ph.D. 804-827-9211 mbharney@vcu.edu

Locations
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23284
Principal Investigator: Suzanne E Mazzeo, Ph.D.         
Sponsors and Collaborators
Virginia Commonwealth University
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Suzanne E Mazzeo, Ph.D. Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01361243     History of Changes
Other Study ID Numbers: R01HD066216-01A1
Study First Received: May 24, 2011
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Pediatric Overweight
Pediatric Obesity

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014