Wellness Action Plan Trial Addressing Childhood Obesity

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to determine the effectiveness of a novel Wellness Action Plan aimed at 1) improving parent recall of diet and activity plans 2) increasing follow-through with plans and 3) aiding parents in identifying their child's weight category.

Official Title
-----------------
Randomized Controlled Trial of a Wellness Action Plan to Address the Childhood Obesity Epidemic

Conditions
-----------------
Childhood Obesity

Intervention / Treatment
-----------------
* Behavioral: Wellness Action Plan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children between the ages of 2.5 and 14 years, regardless of baseline BMI Presented for a well child visit at a pediatric clinic serving primarily Medicaid-insured children in Milwaukee, Wisconsin Exclusion Criteria: Patients in foster care Parents and patients who were non-English speaking Patients who were being seen by a specialist for weight management.

Ages Eligible for Study
-----------------
Minimum Age: 30 Months
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>General clinical counseling in regards to child's BMI category and necessary changes to diet and activity regimen. | |
| Experimental: Wellness Plan<br>Received a wellness action plan. The plan included a color-coded BMI chart to help parents understand their child's weight category as well as a brief action planning worksheet to help families create personalized plans around healthy diet and activity changes. | Behavioral: Wellness Action Plan<br>* The plan included a color-coded BMI chart to help parents understand their child's weight category as well as a brief action planning worksheet to help families create personalized plans around healthy diet and activity changes.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet plan recall directly after visit | Parents are given a questionnaire which asks whether they made a diet plan with their physician for their child during the visit and whether they will attempt to follow-through with the plan made. | On day of primary visit | 
| Activity plan recall directly after visit | Parents are given a questionnaire which asks whether they made an activity plan with their physician for their child during the visit and whether they will attempt to follow-through with the plan made. | On day of primary visit, directly after seeing physician | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet plan recall/follow-through 1 month post visit | Parents are contacted 4 weeks after their primary visit and given a phone questionnaire which asks whether they made a diet plan with their physician for their child during the last visit and whether they can recall the plan. If parents can recall the plan, they are then asked if they followed-through with the plan (yes, no) and how successful they were with the changes (1-10 scale). | 4 weeks after primary visit | 
| Diet plan recall/follow-through 3 months post visit | Parents are contacted 12 weeks after their primary visit and given a phone questionnaire which asks whether they made a diet plan with their physician for their child during the last visit and whether they can recall the plan. If parents can recall the plan, they are then asked if they followed-through with the plan (yes, no) and how successful they were with the changes (1-10 scale). | 12 weeks after primary visit | 
| Activity plan recall/follow-through 1 month post visit | Parents are contacted 4 weeks after their primary visit and given a phone questionnaire which asks whether they made an activity plan with their physician for their child during the last visit and whether they can recall the plan. If parents can recall the plan, they are then asked if they followed-through with the plan (yes, no) and how successful they were with the changes (1-10 scale). | 4 weeks after primary visit | 
| Activity plan recall/follow-through 3 months post visit | Parents are contacted 12 weeks after their primary visit and given a phone questionnaire which asks whether they made an activity plan with their physician for their child during the last visit and whether they can recall the plan. If parents can recall the plan, they are then asked if they followed-through with the plan (yes, no) and how successful they were with the changes (1-10 scale). | 12 weeks after primary visit | 
| BMI category identification directly after the visit | Parents are given a questionnaire which asks whether their physician told them their child's weight category and asks whether they can identify that category. | On day of primary visit | 
| BMI category identification 1 month post visit | Parents are contacted 4 weeks after their primary visit and given a phone questionnaire which asks whether their physician told them their child's weight category and asks whether they can identify that category. | 4 weeks after primary visit | 
| BMI category identification 3 months post visit | Parents are contacted 12 weeks after their primary visit and given a phone questionnaire which asks whether their physician told them their child's weight category and asks whether they can identify that category. | 12 weeks after primary visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight Perception, Counseling, Health Behavior, Pediatric Obesity, Body Mass Index