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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01552642
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : July 29, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Child Obesity Overweight Behavioral: face-to-face meetings and access to a website Phase 3

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.


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  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Interactive Web-based Intervention to Achieve Healthy Weight in Young Children
Study Start Date : February 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Arm Intervention/treatment
Active Comparator: Intervention Group
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.
No Intervention: Control Group
Control Group

Primary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01552642

United States, Wisconsin
UW East Towne Clinic
Madison, Wisconsin, United States, 53704
UW Pediatrics at 20 S. Park St
Madison, Wisconsin, United States, 53716
UW Health West Towne Pediatrics
Madison, Wisconsin, United States, 53717
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Ellen R Wald, MD University of Wisconsin, Madison

Publications of Results:
Other Publications:

Responsible Party: University of Wisconsin, Madison Identifier: NCT01552642     History of Changes
Other Study ID Numbers: HD068783
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015

Keywords provided by University of Wisconsin, Madison:
Comprehensive Health Enhancement Support System (CHESS)

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms