NOURISH: Nourishing Our Understanding of Role Modeling to Improve Support and Health (NOURISH)
|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|
- Child BMI [ Time Frame: Basline, Posttest ] [ Designated as safety issue: No ]Children's height and weight were measured and then plotted on the CDC Growth Charts to obtain BMI%ile for age and gender.
- Child Feeding [ Time Frame: Basline, Posttest ] [ Designated as safety issue: No ]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).
- Child Quality of Life [ Time Frame: Basline, Posttest ] [ Designated as safety issue: No ]
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.
- Parental BMI [ Time Frame: Baseline, Posttest ] [ Designated as safety issue: No ]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.
- Parental Dietary Intake of Fat [ Time Frame: Baseline, Posttest ] [ Designated as safety issue: No ]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.
|Study Start Date:||April 2008|
|Study Completion Date:||July 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
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.
Participants in the NOURISH intervention will have 6 weekly face-to-face parent group sessions regarding healthy eating and physical activity.
Placebo Comparator: 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.
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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00628030
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23284|
|Principal Investigator:||Suzanne E. Mazzeo, Ph.D.||Virginia Commonwealth University|