Wellness Action Plan Trial Addressing Childhood Obesity

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

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 Overview

• Status: Completed
• Conditions: Childhood Obesity
• Intervention / Treatment: Behavioral: Wellness Action Plan

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53233
      • Downtown Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

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

Collaborators and Investigators

• Sponsor: Roohi Kharofa, MD, MPH
• Investigators: Principal Investigator: John R Meurer, MD, MBA, Medical College of Wisconsin

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 6, 2014
• First Posted (Estimate): July 9, 2014

Study Record Updates

• Last Update Posted (Estimate): March 24, 2015
• Last Update Submitted That Met QC Criteria: March 20, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Counseling; Body Mass Index; Health Behavior; Pediatric Obesity; Weight Perception
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 363990-4