Clinical trial NCT01361243: NOURISH+: Nourishing Our Understanding of Role Modeling to Improve Support and Health
Official title: NOURISHing Families to Promote Healthy Eating and Exercise in Overweight Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Pediatric Overweight
Pediatric Obesity
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2011-05-26
Enrollment: 730
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Child BMI
timeFrame: baseline, post-testing, 4-month, and 10-month follow-up
Secondary outcomes:
measure: Child dietary intake, quality of life, and physical activity
timeFrame: baseline, post-testing, 4-month, and 10-month follow-up
measure: Parental BMI, dietary intake, and physical activity levels
timeFrame: baseline, post-testing, 4-month, and 10-month follow-up
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Suzanne E Mazzeo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.