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CompletedNCT02185248Updated Mar 24, 2015

Wellness Action Plan Trial Addressing Childhood Obesity

An interventional study of Wellness Action Plan in Childhood Obesity, sponsored by Roohi Kharofa, MD, MPH. Completed at 1 site in United States. Open to participants aged 30 Months to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-24.

Sponsored by Roohi Kharofa, MD, MPH · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
181
Allocation
Randomized
Ages
30 Months to 14 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Childhood Obesity

Keywords

  • Pediatric Obesity
  • Body Mass Index
  • Weight Perception
  • Counseling
  • Health Behavior
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 181 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

This is the only study on the registry with Roohi Kharofa, MD, MPH as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Months to 14 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
181 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralWellness 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: On day of primary visit

  2. 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.

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

Secondary outcomes

  1. 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).

    Time frame: 4 weeks after primary visit

  2. 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).

    Time frame: 12 weeks after primary visit

  3. 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).

    Time frame: 4 weeks after primary visit

  4. 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).

    Time frame: 12 weeks after primary visit

  5. 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.

    Time frame: On day of primary visit

  6. 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.

    Time frame: 4 weeks after primary visit

  7. 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.

    Time frame: 12 weeks after primary visit

07

Study locations

1 site
  • Downtown Health Center
    Milwaukee, Wisconsin 53233, United States
08

References and documents

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. PubMed 26844166 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02185248
Lead sponsor
Roohi Kharofa, MD, MPH
Responsible party
Roohi Kharofa, MD, MPH (Primary Care Research Fellow, Medical College of Wisconsin) — Sponsor-investigator
First posted
Jul 9, 2014
Start date
Mar 2013
Primary completion
Nov 2013
Completion
Nov 2013
Last update
Mar 24, 2015

Study contacts

John R Meurer, MD, MBA
principal investigator · Medical College of Wisconsin

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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