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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01552642
First received: March 8, 2012
Last updated: December 1, 2014
Last verified: December 2014
  Purpose

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 Intervention Phase
Child
Obesity
Overweight
Behavioral: face-to-face meetings and access to a website
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Interactive Web-based Intervention to Achieve Healthy Weight in Young Children

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Feasibility [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 156
Study Start Date: February 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552642

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

Publications:

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01552642     History of Changes
Other Study ID Numbers: HD068783
Study First Received: March 8, 2012
Last Updated: December 1, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on March 26, 2015