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

NCT00628030 | Completed Results DMC

• 2 other identifiers: PT1013761R03HD056050-01A1
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity

Keywords

Behavioral intervention; Obesity prevention

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Child Feeding

  Basline, Posttest

• Child Quality of Life

  Basline, Posttest

• Parental BMI

  Baseline, Posttest

• Parental Dietary Intake of Fat

  Baseline, Posttest

Study Arms (2)

NOURISH

EXPERIMENTAL

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.

Behavioral: NOURISH

Wellness Group

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. Control participants will also be sent home one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.

Other: Wellness Group

Interventions

NOURISH BEHAVIORAL

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

NOURISH

Wellness Group 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.

Wellness Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Caregivers are ineligible if they are:
• non-ambulatory,
• pregnant,
• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Suzanne E Mazzeo, Professor of Psychology
• Organization: Virginia Commonwealth University

semazzeo@vcu.edu

804-827-9211

Study Officials

• Suzanne E. Mazzeo, Ph.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2008
• First Posted: March 4, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: July 1, 2010
• Last Updated: January 19, 2015
• Results First Posted: January 9, 2015

Record last verified: 2015-01

Locations

US (1)