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Clinical Trials/NCT02185248
NCT02185248
Completed
Not Applicable

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

Roohi Kharofa, MD, MPH1 site in 1 country181 target enrollmentStarted: March 2013Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Roohi Kharofa, MD, MPH
Enrollment
181
Locations
1
Primary Endpoint
Diet plan recall directly after visit

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
30 Months to 14 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Diet plan recall directly after visit

Time Frame: On day of primary 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

Time Frame: On day of primary visit, directly after seeing physician

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 Outcomes

  • Diet plan recall/follow-through 3 months post visit(12 weeks after primary visit)
  • Activity plan recall/follow-through 1 month post visit(4 weeks after primary visit)
  • BMI category identification directly after the visit(On day of primary visit)
  • BMI category identification 3 months post visit(12 weeks after primary visit)
  • Diet plan recall/follow-through 1 month post visit(4 weeks after primary visit)
  • BMI category identification 1 month post visit(4 weeks after primary visit)
  • Activity plan recall/follow-through 3 months post visit(12 weeks after primary visit)

Investigators

Sponsor
Roohi Kharofa, MD, MPH
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Roohi Kharofa, MD, MPH

Primary Care Research Fellow

Medical College of Wisconsin

Study Sites (1)

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