An Interactive Web-based Intervention to Achieve Healthy Weight in Young Children
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|ClinicalTrials.gov Identifier: NCT01552642|
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : July 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Child Obesity Overweight||Behavioral: face-to-face meetings and access to a website||Phase 3|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
No Intervention: Control Group
- 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.
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 ClinicalTrials.gov 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|
|Principal Investigator:||Ellen R Wald, MD||University of Wisconsin, Madison|