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

Pediatric Obesity Clinical Trial

— NOURISH  

Official title:

Parent Skills Training to Enhance Weight Loss in Overweight Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628030
• Other study ID #: PT101376
• Secondary ID: 1R03HD056050-01A
• Status: Completed
• Phase: N/A
• First received: February 22, 2008
• Last updated: January 9, 2015
• Start date: April 2008
• Est. completion date: July 2010

Study information

• Verified date: January 2015
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The percentage of overweight children between the ages of 6 and 11 has nearly tripled in the last three decades, and rates are even higher among African Americans.Overweight children are at-risk for numerous health problems, thus effective treatments are urgently needed. This study will evaluate an innovative intervention for ethnically diverse parents (NOURISH), which focuses on helping parents role model and teach their children healthy behaviors.

Description:

Pediatric overweight is a national public health concern. The percentage of overweight children in the U.S. between the ages of 6 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 6-11 (NOURISH—Nourishing Our Understanding of Role Modeling to Improve Support and Health).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: July 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• To qualify for participation, parents/caregivers must have a child between the ages of 6 and 11 with a BMI > the 85th percentile [128].

• This child must also primarily reside in the participating caregiver's home.

• Participants also need to speak English fluently, and be able to understand and follow basic instructions and perform simple exercises.

Exclusion Criteria:

• Caregivers are ineligible if they are:

1. non-ambulatory,

2. pregnant,

3. or have a clinical diagnosis that may be negatively impacted by exercise.

• Parents whose children have a medical condition or developmental disorder that precludes weight loss using conventional diet and exercise methods are also ineligible for participation.

All parents meeting study criteria will be offered participation in the randomized trial comparing NOURISH with a control group.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pediatric Obesity

Intervention

Behavioral:
• NOURISH
Participants in the NOURISH intervention will have 6 weekly face-to-face parent group sessions regarding healthy eating and physical activity.

Other:
• Wellness Group
Participants in the Wellness Group will have one face-to-face group meeting and information regarding healthy eating and physical activity will be provided on a regular basis via mail.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child BMI	Children's height and weight were measured and then plotted on the CDC Growth Charts to obtain BMI%ile for age and gender.	Basline, Posttest	No
Secondary	Child Feeding	The Child Feeding Questionnaire (CFQ) measured parental approaches to and attitudes about feeding their children and the subscale "concern about child's weight" is reported below in the table. The subscale score was calculated by averaging the items (subscale score range: 3 to 15, higher scores represent greater risk). To compare groups, change scores were calculated by subtracting post-test values from baseline values (negative scores indicate decline in parental concern from baseline to post-test).	Basline, Posttest	No
Secondary	Child Quality of Life	Pediatric Health-Related Quality of Life (PedsQL4.0) change scores from baseline to posttest; We reported the Total Score. The PedsQL4.0 response scale ranges from 0 - 4. The items are reverse-scored for interpretability and higher scores indicate higher quality of life.; We used the Total Score, or the mean computed as the sum of all the items over the number of items answered on all the Scales.; The current report did not provide subscores.	Basline, Posttest	No
Secondary	Parental BMI	Height and weight were measured by trained staff and used to calculate BMI. Change scores of parental BMI from baseline to posttest were calculated to show difference between treatment arms.	Baseline, Posttest	No
Secondary	Parental Dietary Intake of Fat	Parents completed a 3 day dietary record which was reviewed by a dietitian and analyzed using the Nutrition Data System Software (NDS-R) to calculate parental fat intake. Change scores were calculated by subtracting post-test values from baseline values; thus, a negative score indicates a greater reduction in fat intake at post-testing.	Baseline, Posttest	No