NOURISH+: Nourishing Our Understanding of Role Modeling to Improve Support and Health (NOURISH+)
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NOURISH+
Wellness Group
Sponsored by

About this trial
This is an interventional treatment trial for Overweight and Obesity focused on measuring Pediatric Overweight, Pediatric Obesity
Eligibility 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
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NOURISH+
Wellness Group
Arm Description
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.
Participants will receive an in-person "Family Wellness Night" followed by 6 mailings of information regarding pediatric overweight and obesity.
Outcomes
Primary Outcome Measures
Child BMI
Secondary Outcome Measures
Child dietary intake, quality of life, and physical activity
Parental BMI, dietary intake, and physical activity levels
Full Information
NCT ID
NCT01361243
First Posted
May 24, 2011
Last Updated
February 21, 2018
Sponsor
Virginia Commonwealth University
Collaborators
University of North Carolina, Chapel Hill, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT01361243
Brief Title
NOURISH+: Nourishing Our Understanding of Role Modeling to Improve Support and Health
Acronym
NOURISH+
Official Title
NOURISHing Families to Promote Healthy Eating and Exercise in Overweight Children
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
January 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
University of North Carolina, Chapel Hill, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Pediatric Overweight, Pediatric Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
730 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NOURISH+
Arm Type
Experimental
Arm Description
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.
Arm Title
Wellness Group
Arm Type
Placebo Comparator
Arm Description
Participants will receive an in-person "Family Wellness Night" followed by 6 mailings of information regarding pediatric overweight and obesity.
Intervention Type
Behavioral
Intervention Name(s)
NOURISH+
Intervention Description
6 week face-to-face parent intervention.
Intervention Type
Behavioral
Intervention Name(s)
Wellness Group
Intervention Description
1 week face-to-face family group followed by 6 informational mailings on childhood overweight and obesity.
Primary Outcome Measure Information:
Title
Child BMI
Time Frame
baseline, post-testing, 4-month, and 10-month follow-up
Secondary Outcome Measure Information:
Title
Child dietary intake, quality of life, and physical activity
Time Frame
baseline, post-testing, 4-month, and 10-month follow-up
Title
Parental BMI, dietary intake, and physical activity levels
Time Frame
baseline, post-testing, 4-month, and 10-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne E Mazzeo, Ph.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23284
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27544283
Citation
Kwitowski M, Bean MK, Mazzeo SE. An exploration of factors influencing attrition from a pediatric weight management intervention. Obes Res Clin Pract. 2017 Mar-Apr;11(2):233-240. doi: 10.1016/j.orcp.2016.08.002. Epub 2016 Aug 17.
Results Reference
derived
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NOURISH+: Nourishing Our Understanding of Role Modeling to Improve Support and Health
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