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

July 27, 2015 updated by: University of Wisconsin, Madison
The overall purpose of this study is to develop and implement an effective intervention program designed to prevent and treat obesity in young children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53717
        • UW Health West Towne Pediatrics
      • Madison, Wisconsin, United States, 53704
        • UW East Towne Clinic
      • Madison, Wisconsin, United States, 53716
        • UW Pediatrics at 20 S. Park St

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Active Comparator: Intervention Group
Behavioral: face-to-face meetings and access to a website
The intervention group will have 6 weekly face-to-face meetings and will have access to a website.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Ellen R Wald, MD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

March 8, 2012

First Submitted That Met QC Criteria

March 12, 2012

First Posted (Estimate)

March 13, 2012

Study Record Updates

Last Update Posted (Estimate)

July 29, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD068783

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on face-to-face meetings and access to a website

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe