Clinical trial NCT01552642: An Interactive Web-based Intervention to Achieve Healthy Weight in Young Children
Official title: An Interactive Web-based Intervention to Achieve Healthy Weight in Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Child
Obesity
Overweight
Keywords: Comprehensive Health Enhancement Support System (CHESS)
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 77
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Feasibility
timeFrame: 1 year
measure: Efficacy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW East Towne Clinic
state: Wisconsin
city: Madison
country: United States
facility: UW Pediatrics at 20 S. Park St
state: Wisconsin
city: Madison
country: United States
facility: UW Health West Towne Pediatrics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ellen R Wald, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Savoye M, Shaw M, Dziura J, Tamborlane WV, Rose P, Guandalini C, Goldberg-Gell R, Burgert TS, Cali AM, Weiss R, Caprio S. Effects of a weight management program on body composition and metabolic parameters in overweight children: a randomized controlled trial. JAMA. 2007 Jun 27;297(24):2697-704. doi: 10.1001/jama.297.24.2697.
citation: Golley RK, Magarey AM, Baur LA, Steinbeck KS, Daniels LA. Twelve-month effectiveness of a parent-led, family-focused weight-management program for prepubertal children: a randomized, controlled trial. Pediatrics. 2007 Mar;119(3):517-25. doi: 10.1542/peds.2006-1746.
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