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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02185248
Other study ID # 363990-4
Secondary ID
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


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
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