An Interactive Web-based Intervention to Achieve Healthy Weight in Young Children
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 77
- Locations
- 6
- Primary Endpoint
- Feasibility
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- 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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported