Childhood ObesityNCT02185248
Wellness Action Plan Trial Addressing Childhood Obesity
A study testing Wellness Action Plan in people with Childhood Obesity, run by Roohi Kharofa, MD, MPH at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 months to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Wellness Action Plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 months to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Patients in foster care
- Parents and patients who were non-English speaking
- Patients who were being seen by a specialist for weight management.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Childhood Obesity
- Being tested
- Wellness Action Plan
- Keywords
- Pediatric Obesity, Body Mass Index, Weight Perception, Counseling, Health Behavior
- Medical subject headings
- Pediatric Obesity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness Action PlanBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | General clinical counseling in regards to child's BMI category and necessary changes to diet and activity regimen. |
| Wellness Plan | Experimental | 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. Receives: Behavioral: Wellness Action Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: On day of primary visit, directly after seeing physician
Secondary outcomes (7)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks after primary visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startMar 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roohi Kharofa, MD, MPH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Roohi Kharofa, MD, MPH, Medical College of Wisconsin
- Investigators
- John R Meurer, MD, MBA, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185248
- Sponsor's protocol ID
- 363990-4
- Status last verified
- Mar 2015
- First submitted
- 2 Jul 2014
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Wellness Action Plan to Address the Childhood Obesity Epidemic
- ClinicalTrials.gov ID
- NCT02185248
- Acronym / sponsor ID
- 363990-4
- Conditions
- Childhood Obesity
- Keywords
- Pediatric Obesity, Body Mass Index, Weight Perception, Counseling, Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Roohi Kharofa, MD, MPHUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –General clinical counseling in regards to child's BMI category and necessary changes to diet and activity regimen. |
| Wellness Plan | Experimental | Behavioral: Wellness Action PlanReceived 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. |
Who may qualify
- Ages
- 30 months to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Patients in foster care
- Parents and patients who were non-English speaking
- Patients who were being seen by a specialist for weight management.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wellness Action PlanThe 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. | Behavioural | Wellness Plan |
Primary outcome
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.
7 secondary outcomes
Diet plan recall/follow-through 1 month post visit
Time frame: 4 weeks after primary visit
Diet plan recall/follow-through 3 months post visit
Time frame: 12 weeks after primary visit
Activity plan recall/follow-through 1 month post visit
Time frame: 4 weeks after primary visit
Activity plan recall/follow-through 3 months post visit
Time frame: 12 weeks after primary visit
BMI category identification directly after the visit
Time frame: On day of primary visit
BMI category identification 1 month post visit
Time frame: 4 weeks after primary visit
BMI category identification 3 months post visit
Time frame: 12 weeks after primary visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
- Derived from this study: PubMed 26844166Kharofa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John R Meurer, MD, MBA principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellness Action Plan in people with Childhood Obesity, run by Roohi Kharofa, MD, MPH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet plan recall directly after visit (time frame: On day of primary visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02185248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015.