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Completed

NCT Number: NCT01361243

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NOURISH+

Behavioral

6 week face-to-face parent intervention.

Wellness Group

Behavioral

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

Primary outcomes

  1. Child BMI

    Time frame: baseline, post-testing, 4-month, and 10-month follow-up

Secondary outcomes

  1. Child dietary intake, quality of life, and physical activity

    Time frame: baseline, post-testing, 4-month, and 10-month follow-up

  2. Parental BMI, dietary intake, and physical activity levels

    Time frame: baseline, post-testing, 4-month, and 10-month follow-up

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of North Carolina, Chapel Hill

Registry information

Official study title

NOURISHing Families to Promote Healthy Eating and Exercise in Overweight Children

Acronym: NOURISH+

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
May 26, 2011
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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