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

This study is currently recruiting participants.
Verified June 2012 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: June 21, 2012
Last verified: June 2012
History of Changes
  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:

MedlinePlus related topics: Obesity
U.S. FDA Resources

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.

  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
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: Elizabeth Cotter, Ph.D. 804-827-9211 ecotter@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: June 21, 2012
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 May 16, 2013