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

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00628030
First received: February 22, 2008
Last updated: January 9, 2015
Last verified: January 2015

February 22, 2008
January 9, 2015
April 2008
April 2010   (final data collection date for primary outcome measure)
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 BMI [ Time Frame: Baseline, Posttest (12 weeks), 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00628030 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
Not Provided
Not Provided
 
NOURISH: Nourishing Our Understanding of Role Modeling to Improve Support and Health
Parent Skills Training to Enhance Weight Loss in Overweight Children
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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pediatric Obesity
  • Behavioral: NOURISH
    Participants in the NOURISH intervention will have 6 weekly face-to-face parent group sessions regarding healthy eating and physical activity.
  • 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.
  • Experimental: 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.
    Intervention: Behavioral: NOURISH
  • 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.
    Intervention: Other: Wellness Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
184
July 2010
April 2010   (final data collection date for primary outcome measure)

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.

Both
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00628030
PT101376, 1R03HD056050-01A1
Yes
Not Provided
Not Provided
Virginia Commonwealth University
Virginia Commonwealth University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Suzanne E. Mazzeo, Ph.D. Virginia Commonwealth University
Virginia Commonwealth University
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP