NOURISH: Nourishing Our Understanding of Role Modeling to Improve Support and Health - Full Text View

Sponsored by:	Virginia Commonwealth University
Information provided by:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00628030

Purpose

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.

Condition	Intervention
Pediatric Overweight Pediatric Obesity	Behavioral: NOURISH

MedlinePlus related topics: Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Parent Skills Training to Enhance Weight Loss in Overweight Children

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:

Child BMI [ Time Frame: Baseline, Posttest (12 weeks), 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Child dietary intake [ Time Frame: Baseline, Posttest (12 weeks), 6 months ] [ Designated as safety issue: No ]
Child quality of life [ Time Frame: Basline, Posttest (12 weeks), 6 months ] [ Designated as safety issue: No ]
Parental BMI [ Time Frame: Baseline, Posttest (12 weeks), 6 months ] [ Designated as safety issue: No ]
Parental dietary intake [ Time Frame: Baseline, Posttest (12 weeks), 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive a 12 week face-to-face intervention, NOURISH. The intervention is grounded in Social Cognitive Theory (SCT). Throughout the intervention, the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) will be emphasized. Weekly topics provide information about implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents will receive pedometers (and instructions on their use) for themselves and 1 of their children.	Behavioral: NOURISH 1 of 2 groups:One has 12 weekly face-to-face sessions and the other has a face-to-face and information provided on a regular basis via mail. Both groups will be followed up for 6 months.
2: Placebo Comparator The placebo control group will attend a group session moderated by an independent interventionist. This interventionist will be blinded to the Specific Aims and hypotheses of this study. The session will address the role of diet and exercise in pediatric overweight. In addition, control parents will receive pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants will be mailed publicly available brochures on pediatric overweight on 2 occasions during the study.	Behavioral: NOURISH 1 of 2 groups:One has 12 weekly face-to-face sessions and the other has a face-to-face and information provided on a regular basis via mail. Both groups will be followed up for 6 months.

Arms

Assigned Interventions

1: Experimental

Participants will receive a 12 week face-to-face intervention, NOURISH. The intervention is grounded in Social Cognitive Theory (SCT). Throughout the intervention, the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) will be emphasized. Weekly topics provide information about implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents will receive pedometers (and instructions on their use) for themselves and 1 of their children.

Behavioral: NOURISH

1 of 2 groups:One has 12 weekly face-to-face sessions and the other has a face-to-face and information provided on a regular basis via mail. Both groups will be followed up for 6 months.

2: Placebo Comparator

The placebo control group will attend a group session moderated by an independent interventionist. This interventionist will be blinded to the Specific Aims and hypotheses of this study. The session will address the role of diet and exercise in pediatric overweight. In addition, control parents will receive pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants will be mailed publicly available brochures on pediatric overweight on 2 occasions during the study.

Behavioral: NOURISH

1 of 2 groups:One has 12 weekly face-to-face sessions and the other has a face-to-face and information provided on a regular basis via mail. Both groups will be followed up for 6 months.

Detailed 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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628030

Contacts

Contact: Suzanne E Mazzeo, Ph.D.

804-827-9211

semazzeo@vcu.edu

Locations

United States, Virginia
Virginia Commonwealth University	Recruiting
Richmond, Virginia, United States, 23284
Contact: Suzanne E. Mazzeo, Ph.D. 804-827-9211 semazzeo@vcu.edu
Contact: Marilyn Stern, Ph.D. 804-827-0400 mstern@vcu.edu

Sponsors and Collaborators

Virginia Commonwealth University

Investigators

Principal Investigator:

Suzanne E. Mazzeo, Ph.D.

Virginia Commonwealth University

More Information

Responsible Party:	Virginia Commonwealth University ( Suzanne E. Mazzeo, Ph.D., Associate Professor )
Study ID Numbers:	PT101376, 1r03hd056050-01a1
Study First Received:	February 22, 2008
Last Updated:	April 11, 2008
ClinicalTrials.gov Identifier:	NCT00628030
Health Authority:	United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:

Behavioral intervention
Obesity prevention

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Nutrition Disorders
Overnutrition
Overweight

ClinicalTrials.gov processed this record on January 16, 2009