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Clinical Trials/NCT01552642
NCT01552642
Completed
Phase 3

An Interactive Web-based Intervention to Achieve Healthy Weight in Young Children

University of Wisconsin, Madison3 sites in 1 country77 target enrollmentFebruary 2013

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Child
Sponsor
University of Wisconsin, Madison
Enrollment
77
Locations
3
Primary Endpoint
Feasibility
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The overall purpose of this study is to develop and implement an effective intervention program designed to prevent and treat obesity in young children.

Detailed Description

Study procedures and interventions: Pre-intervention: a full-day training will occur with a physician and nurse from each clinic site to be trained as "champions" in counseling. Intervention: A letter of introduction will be mailed to potential subjects whose child was seen in the last 6 months for a well-child exam whose BMI is greater than or equal to the 85th percentile. After informed consent is obtained, the subjects will be randomized to the intervention or control group. One parent may join the study. Groups of 10 to 12 parents of overweight and obese 3 to 6 year olds will meet once weekly for 6 weeks at 5:30 to 6:30 pm with the "nurse champion" in the primary care office. Topics to be presented and discussed include authoritative parenting, using the food plan "Go, Slow, and Whoa", increasing physical activity, and behavior change strategies. Sessions will be audiotaped and independently audited to confirm program fidelity. Parenting skills will be discussed at every session. The intervention group will have access to a website. This site will include information services (instant library with health topics related to nutrition and physical activity and answers to frequently asked questions), web links to other pre-screened sources of information on nutrition and physical activity, local resources for current activities for children and families, personal stories (emphasizing authoritative parenting), interactive discussion group and Ask the Expert (questions will be answered within 48 hours and usually sooner).

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
May 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • one parent of a 3-6 year old child with a BMI greater than or equal to the 85th percentile
  • Internet access
  • English speaking

Exclusion Criteria

  • Children with a developmental disorder
  • Children with a chronic underlying disease that may contribute to obesity
  • Children taking medication that may interfere with a healthy weight

Outcomes

Primary Outcomes

Feasibility

Time Frame: 1 year

To assess the feasibility of an intervention combining 6 'in-person' group counseling sessions with a 1-year longitudinal web-based component to help parents of overweight children promote healthy behavior change.

Efficacy

Time Frame: 1 year

To assess the effectiveness of this intervention program to assist parents of overweight and obese 3-6 year olds in promoting: (a) a modest reduction of child BMI-z scores, (b) healthy behavior changes (related to nutrition and physical activity) for their children, and (c) improved parenting skills.

Study Sites (3)

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