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

NCT ID: NCT00628030

Last Updated: 2015-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2010-07-31

Brief 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.

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).

Conditions

Pediatric Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NOURISH

The first 2 waves and second 2 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 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.

Group Type: EXPERIMENTAL

NOURISH

Intervention Type: BEHAVIORAL

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

Wellness Group

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.

Group Type: PLACEBO_COMPARATOR

Wellness Group

Intervention Type: OTHER

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.

Interventions

NOURISH

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzanne E. Mazzeo, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

1R03HD056050-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PT101376

Identifier Type: -

Identifier Source: org_study_id