Back to resultsWellness Action Plan Trial Addressing Childhood Obesity
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wellness Action Plan
Sponsored by
About this trial
This is an interventional prevention trial for Childhood Obesity focused on measuring Pediatric Obesity, Body Mass Index, Weight Perception, Counseling, Health Behavior
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.
Sites / Locations
- Downtown Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Wellness Plan
Arm Description
General clinical counseling in regards to child's BMI category and necessary changes to diet and activity regimen.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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).
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).
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).
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).
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02185248
Brief Title
Wellness Action Plan Trial Addressing Childhood Obesity
Official Title
Randomized Controlled Trial of a Wellness Action Plan to Address the Childhood Obesity Epidemic
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Roohi Kharofa, MD, MPH
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Pediatric Obesity, Body Mass Index, Weight Perception, Counseling, Health Behavior
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
181 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
General clinical counseling in regards to child's BMI category and necessary changes to diet and activity regimen.
Arm Title
Wellness Plan
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Wellness Action Plan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diet plan recall directly after visit
Description
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.
Time Frame
On day of primary visit
Title
Activity plan recall directly after visit
Description
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.
Time Frame
On day of primary visit, directly after seeing physician
Secondary Outcome Measure Information:
Title
Diet plan recall/follow-through 1 month post visit
Description
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).
Time Frame
4 weeks after primary visit
Title
Diet plan recall/follow-through 3 months post visit
Description
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).
Time Frame
12 weeks after primary visit
Title
Activity plan recall/follow-through 1 month post visit
Description
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).
Time Frame
4 weeks after primary visit
Title
Activity plan recall/follow-through 3 months post visit
Description
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).
Time Frame
12 weeks after primary visit
Title
BMI category identification directly after the visit
Description
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.
Time Frame
On day of primary visit
Title
BMI category identification 1 month post visit
Description
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.
Time Frame
4 weeks after primary visit
Title
BMI category identification 3 months post visit
Description
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.
Time Frame
12 weeks after primary visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Months
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R Meurer, MD, MBA
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Downtown Health Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26844166
Citation
Kharofa RY, Copeland KA, Sucharew H, Meurer JR. Randomized controlled trial of a Wellness Action Plan to promote healthy diet and activity in pediatric primary care. Prev Med Rep. 2015 Oct 21;2:899-905. doi: 10.1016/j.pmedr.2015.10.008. eCollection 2015.
Results Reference
derived
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Wellness Action Plan Trial Addressing Childhood Obesity
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