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

This study has been completed.
Sponsor:
Information provided by:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00628030
First received: February 22, 2008
Last updated: May 24, 2011
Last verified: May 2011
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Parent Skills Training to Enhance Weight Loss in Overweight Children

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

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

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

Enrollment: 183
Study Start Date: April 2008
Study Completion Date: July 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
The first two waves and second two waves of participants will receive a 12 and 6 week face-to-face intervention (NOURISH), respectively. The interventions differ only in duration. They cover the same concepts, which are grounded in Social Cognitive Theory (SCT). Throughout the interventions, 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. A one-hour booster session will be available for all intervention participants 2 months after completion of the interventions.
Behavioral: NOURISH
1 of 2 groups:One has 12 (or 6) 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.
Placebo Comparator: 2
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. Control participants will also be sent home one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
Behavioral: NOURISH
1 of 2 groups:One has 12 (or 6) 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Suzanne E. Mazzeo, Ph.D. Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Suzanne E. Mazzeo, Ph.D., Associate Professor, Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00628030     History of Changes
Other Study ID Numbers: PT101376, 1r03hd056050-01a1
Study First Received: February 22, 2008
Last Updated: May 24, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Behavioral intervention
Obesity prevention

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014