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

Overweight and Obesity Clinical Trial

— NOURISH+  

Official title:

NOURISHing Families to Promote Healthy Eating and Exercise in Overweight Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01361243
• Other study ID #: HM13468
• Secondary ID: R01HD066216-01A1
• Status: Completed
• Phase: N/A
• First received: May 24, 2011
• Last updated: February 21, 2018
• Start date: April 2011
• Est. completion date: January 31, 2018

Study information

• Verified date: February 2018
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 730
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• NOURISH+
6 week face-to-face parent intervention.
• Wellness Group
1 week face-to-face family group followed by 6 informational mailings on childhood overweight and obesity.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child BMI		baseline, post-testing, 4-month, and 10-month follow-up
Secondary	Child dietary intake, quality of life, and physical activity		baseline, post-testing, 4-month, and 10-month follow-up
Secondary	Parental BMI, dietary intake, and physical activity levels		baseline, post-testing, 4-month, and 10-month follow-up