Wellness Action Plan Trial Addressing Childhood Obesity

Overview

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.

Full Title of Study: “Randomized Controlled Trial of a Wellness Action Plan to Address the Childhood Obesity Epidemic”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2013

Interventions

  • Behavioral: 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.

Arms, Groups and Cohorts

  • No Intervention: Control Group
    • General clinical counseling in regards to child’s BMI category and necessary changes to diet and activity regimen.
  • Experimental: Wellness Plan
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Diet plan recall/follow-through 1 month post visit
    • Time Frame: 4 weeks after primary 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
    • Time Frame: 12 weeks after primary 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
    • Time Frame: 4 weeks after primary 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
    • Time Frame: 12 weeks after primary 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
    • Time Frame: On day of primary 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
    • Time Frame: 4 weeks after primary 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
    • Time Frame: 12 weeks after primary 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 30 Months

Maximum Age: 14 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Roohi Kharofa, MD, MPH
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Roohi Kharofa, MD, MPH, Primary Care Research Fellow – Medical College of Wisconsin
  • Overall Official(s)
    • John R Meurer, MD, MBA, Principal Investigator, Medical College of Wisconsin

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