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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01361243
First Posted: May 26, 2011
Last Update Posted: July 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Virginia Commonwealth University
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: NOURISHing Families to Promote Healthy Eating and Exercise in Overweight Children

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 ]

Secondary Outcome Measures:
  • Child dietary intake, quality of life, and physical activity [ Time Frame: 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 ]

Estimated Enrollment: 800
Study Start Date: April 2011
Estimated Study Completion Date: February 1, 2018
Estimated Primary Completion Date: February 1, 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361243


Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
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

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01361243     History of Changes
Other Study ID Numbers: R01HD066216-01A1 ( U.S. NIH Grant/Contract )
First Submitted: May 24, 2011
First Posted: May 26, 2011
Last Update Posted: July 18, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Virginia Commonwealth University:
Pediatric Overweight
Pediatric Obesity

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms