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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Child, Obesity, Overweight

Intervention / Treatment
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* Behavioral: face-to-face meetings and access to a website


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Group<br>Intervention Group | Behavioral: face-to-face meetings and access to a website<br>* The intervention group will have 6 weekly face-to-face meetings and will have access to a website.<br>|
| No Intervention: Control Group<br>Control Group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | 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. | 1 year | 
| Efficacy | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Comprehensive Health Enhancement Support System (CHESS)