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

NCT ID: NCT01361243

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 730 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2018-01-31

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).

Conditions

Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

NOURISH+

Intervention Type: BEHAVIORAL

6 week face-to-face parent intervention.

Wellness Group

Participants will receive an in-person "Family Wellness Night" followed by 6 mailings of information regarding pediatric overweight and obesity.

Group Type: PLACEBO_COMPARATOR

Wellness Group

Intervention Type: BEHAVIORAL

1 week face-to-face family group followed by 6 informational mailings on childhood overweight and obesity.

Interventions

NOURISH+

6 week face-to-face parent intervention.

Intervention Type: BEHAVIORAL

Wellness Group

1 week face-to-face family group followed by 6 informational mailings on childhood overweight and obesity.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzanne E Mazzeo, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27544283 (View on PubMed)

Other Identifiers

R01HD066216-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM13468

Identifier Type: -

Identifier Source: org_study_id