Wellness Action Plan Trial Addressing Childhood Obesity

Childhood Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02185248
• Other study ID #: 363990-4
• Status: Completed
• Phase: N/A
• First received: July 2, 2014
• Last updated: March 20, 2015
• Start date: March 2013
• Est. completion date: November 2013

Study information

• Verified date: March 2015
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board, Children's Hospital of Wisconsin
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Months to 14 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Downtown Health Center	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Roohi Kharofa, MD, MPH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No