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Clinical Trials/NCT00628030
NCT00628030CompletedNot Applicable

Parent Skills Training to Enhance Weight Loss in Overweight Children

Virginia Commonwealth University1 site in 1 country184 target enrollmentStarted: April 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
184
Locations
1
Primary Endpoint
Child BMI

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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:
  • •non-ambulatory,
  • •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.

Arms & Interventions

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.

Intervention: NOURISH (Behavioral)

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.

Intervention: Wellness Group (Other)

Outcomes

Primary Outcomes

Child BMI

Time Frame: Basline, Posttest

Children's height and weight were measured and then plotted on the CDC Growth Charts to obtain BMI%ile for age and gender.

Secondary Outcomes

  • Child Feeding(Basline, Posttest)
  • Parental Dietary Intake of Fat(Baseline, Posttest)
  • Child Quality of Life(Basline, Posttest)
  • Parental BMI(Baseline, Posttest)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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