ObesityWENCT02652845
Wellness Engagement Project, Petersburg
A study testing Wellness Engagement Program in people with Obesity, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This study tests the feasibility of a health and wellness trial designed with community input. This 12-week program will be tested over a 24-week period using a delayed treatment control group. Read more about this study
- Who is it for?
- Ages 12 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Wellness Engagement Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Aug 2015
- 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 12 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age between 18-65 years.
- Must have a school going child between 12-17 living in the home.
- BMI between 25 and 50 kg/m2.
Who cannot join
- report not being able to walk 2 blocks (1/4 mile) without stopping
- currently participating in another weight loss program
- taking a weight loss medication
- have a history of bariatric surgery
- pregnant or plan to become pregnant during the intervention timeframe
- report an unsupervised heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire
Show all 9Show fewer
- report a medical condition that would jeopardize their safety if involved in a weight management program with diet and exercise guidelines (e.g., uncontrolled heart problem)
- fail medical screening by study medical staff)
- report conditions that, in the judgment of the PI, would render the participant unlikely to follow the study protocol (e.g., planned move from the area, dementia, substance abuse).
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
This study tests the feasibility of a health and wellness trial designed with community input. This 12-week program will be tested over a 24-week period using a delayed treatment control group.
Read the detailed description
This 12-week program was designed based on input from Petersburg, VA community residents, collected through various methods over a two-year period. The 12 week program is designed to impact three levels: individual, family and community. At the individual level, participants receive print material lessons related to healthy eating and increasing physical activity, as well as videos that model these lessons; participants will also have access to a peer support coach who will contact them on a biweekly basis and are trained to help them identify and reach their own personal health goals. At the family level, participants are encouraged to share all of the information they receive as a part of this program with the rest of their family, and are asked to begin walking regularly and to attend fitness and nutrition classes held within their neighborhood (by the WE program) with family members. On a community level, local church groups and neighborhood organizations will receive assistance in launching walking clubs, and all community residents are invited to attend the physical activity and nutrition classes that the WE project hosts within the community.
- Conditions
- Obesity
- Being tested
- Wellness Engagement Program
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness Engagement ProgramBehavioural
This intervention is an evidence based and community informed program designed to stimulate physical activity and increase healthy food choices among participants. The intervention includes weekly lessons, personal support in the form of biweekly check in calls with a peer support coach and weekly physical activity and nutrition classes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention-Wellness Engagement Program | Experimental | The group assigned to the intervention arm will receive treatment as described below for a twelve week period:
Weekly lessons related to healthy eating and physical activity Biweekly check-in calls with a trained peer support coach Access to neighborhood wide physical activity and nutritional education events Receives: Behavioral: Wellness Engagement Program |
| Delayed treatment control group | No intervention | The delayed treatment control group will not receive the intervention for measurement purposes; however the intervention as described will be administered to this group upon conclusion of the 12 week period for the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement in WE activities
Number of community events attended
Measured: 4-weeks
Video lessons
Number of video lessons viewed as reported to Wellness Ambassadors
Measured: 4 weeks
Peer Support
number of check-in phone calls completed with Peer Support Coaches
Measured: 4 weeks
Self-monitoring logs
number of self-monitoring logs completed
Measured: 4 weeks
Value of the program
Perceived value of the program
Measured: 4 weeks
Effectiveness of peer support
Perception of the effectiveness of the peer support received from peer coaches
Measured: 4 weeks
Secondary outcomes (4)
Uptake of key behaviors promoted in the WE program
Engagement in recommended health behaviors
Measured: 4-weeks
Weight
Weight will be measured in kg
Measured: 4-weeks
Dietary changes
Dietary practices will be assessed using the Behavioral Risk Factor Surveillance System (BRFSS)
Measured: 4-weeks
Height
height measured in meters
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startMar 2015
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Study Design was changed - no longer prospectively assigning participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Pathways-VA Inc, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Maghboeba Mosavel, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652845
- Sponsor's protocol ID
- 5R24MD008128
- Other IDs
- 1R24MD008128
- Acronym
- WE
- Status last verified
- Jan 2016
- First submitted
- 5 Jun 2015
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wellness Engagement Project, Petersburg
- ClinicalTrials.gov ID
- NCT02652845
- Acronym / sponsor ID
- WE / 5R24MD008128
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study Design was changed - no longer prospectively assigning participants
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Pathways-VA Inc, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Mar 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 12 Jan 2016 (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.
This study tests the feasibility of a health and wellness trial designed with community input. This 12-week program will be tested over a 24-week period using a delayed treatment control group.
Detailed description
This 12-week program was designed based on input from Petersburg, VA community residents, collected through various methods over a two-year period. The 12 week program is designed to impact three levels: individual, family and community. At the individual level, participants receive print material lessons related to healthy eating and increasing physical activity, as well as videos that model these lessons; participants will also have access to a peer support coach who will contact them on a biweekly basis and are trained to help them identify and reach their own personal health goals. At the family level, participants are encouraged to share all of the information they receive as a part of this program with the rest of their family, and are asked to begin walking regularly and to attend fitness and nutrition classes held within their neighborhood (by the WE program) with family members. On a community level, local church groups and neighborhood organizations will receive assistance in launching walking clubs, and all community residents are invited to attend the physical activity and nutrition classes that the WE project hosts within the community.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention-Wellness Engagement Program | Experimental | Behavioral: Wellness Engagement ProgramThe group assigned to the intervention arm will receive treatment as described below for a twelve week period: Weekly lessons related to healthy eating and physical activity Biweekly check-in calls with a trained peer support coach Access to neighborhood wide physical activity and nutritional education events |
| Delayed treatment control group | No intervention | –The delayed treatment control group will not receive the intervention for measurement purposes; however the intervention as described will be administered to this group upon conclusion of the 12 week period for the intervention group. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18-65 years.
- Must have a school going child between 12-17 living in the home.
- BMI between 25 and 50 kg/m2.
Key exclusion criteria (9 listed)
- report not being able to walk 2 blocks (1/4 mile) without stopping
- currently participating in another weight loss program
- taking a weight loss medication
- have a history of bariatric surgery
- pregnant or plan to become pregnant during the intervention timeframe
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 Engagement ProgramThis intervention is an evidence based and community informed program designed to stimulate physical activity and increase healthy food choices among participants. The intervention includes weekly lessons, personal support in the form of biweekly check in calls with a peer support coach and weekly physical activity and nutrition classes. | Behavioural | Intervention-Wellness Engagement Program |
Primary outcome
Engagement in WE activities
Time frame: 4-weeks
Number of community events attended
Video lessons
Time frame: 4 weeks
Number of video lessons viewed as reported to Wellness Ambassadors
Peer Support
Time frame: 4 weeks
number of check-in phone calls completed with Peer Support Coaches
Self-monitoring logs
Time frame: 4 weeks
number of self-monitoring logs completed
Value of the program
Time frame: 4 weeks
Perceived value of the program
Effectiveness of peer support
Time frame: 4 weeks
Perception of the effectiveness of the peer support received from peer coaches
4 secondary outcomes
Uptake of key behaviors promoted in the WE program
Time frame: 4-weeks
Weight
Time frame: 4-weeks
Dietary changes
Time frame: 4-weeks
Height
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Study Design was changed - no longer prospectively assigning participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
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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.
Maghboeba Mosavel, PhD principal investigator
Virginia Commonwealth University
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 Engagement Program in people with Obesity, run by Virginia Commonwealth University 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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 12 Jan 2016. 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 was stopped early (reason given: Study Design was changed - no longer prospectively assigning participants). Results are not available in the source record.
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?
Engagement in WE activities (time frame: 4-weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2016.