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

Phase 3

Completed

• Conditions: Overweight; Obesity; Child
• Interventions: Behavioral: face-to-face meetings and access to a website

• Registration Number: NCT01552642
• Lead Sponsor: University of Wisconsin, Madison

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).

Study Timeline

• Study First Submitted: 2012-03-08
• Study First Submitted QC: 2012-03-12
• Study First Posted: 2012-03-13
• Study Start: 2013-02
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	face-to-face meetings and access to a website	Intervention Group

Primary Outcome Measures

Name	Time	Method
Feasibility	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	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.

Trial Locations

Locations (3)

UW East Towne Clinic; 🇺🇸 Madison, Wisconsin, United States

UW Pediatrics at 20 S. Park St; 🇺🇸 Madison, Wisconsin, United States

UW Health West Towne Pediatrics; 🇺🇸 Madison, Wisconsin, United States