OverweightPhase 2NCT00288145
Statewide (Rhode Island and Neighboring States) Partnerships for Worksite Weight Management
A Phase 2 study testing WOW, Working On Wellness weight management in people with Overweight and Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
The project is designed to test the effectiveness of a multilevel worksite wellness program, based in Rhode Island and nearby neighboring states to impact employee weight, dietary intake and physical activity, compared to an attention placebo condition. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- WOW, Working On Wellness weight management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,700 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Aug 2012
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Worksite
- worksite located in Rhode Island or neighboring state
- has food service on site
- approximately 200 - 500 employees
- low rate of employee turnover
Who cannot join
- worksites outside New England
- Cohort participants:
- permanent employee, who works 20 or more hours on site
- speaks/reads some English at level to complete survey eval items
- able to walk at a brisk pace
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Statewide Partnerships for Worksite Weight Management
The project is designed to test the effectiveness of a multilevel worksite wellness program, based in Rhode Island and nearby neighboring states to impact employee weight, dietary intake and physical activity, compared to an attention placebo condition.
Read the detailed description
Accomplishment of the specific aim will be determined by a two group randomized effectiveness study (Treatment vs. Comparison) utilizing 24 RI worksites with randomization by site. The specific impact and outcome evaluation measures (BMI, DHQ-FFQ, and 7-day PAR) will be collected at Baseline, 12, and 24 months on a longitudinal cohort selected at random from the employee lists of each participating worksite. Extensive process evaluation and a mediating variable framework are also included to identify the mechanisms in successful change at both the worksite and individual level, which will maximize the potential for dissemination and generalization of the intervention as well as advance theory and improve intervention practice and policy.
Primary outcome measure will be weight (BMI).
- Conditions
- Overweight, Obesity
- Being tested
- WOW, Working On Wellness weight management
- Keywords
- worksite, weight gain prevention (among adults), obesity (among adults), physical activity, nutrition
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WOW, Working On Wellness weight managementBehavioural
Treatment site, worksite-based health promotion activities such as self-directed campaigns, lectures, small group programs, online programs, environment interventions (food service and physical)--all with focus on nutrition, physical activity and/or weight management.
| Study group | Role | What they receive |
|---|---|---|
| T | Active comparator | Treatment arm comprises one worksite in a matched site pair; one site assigned to treatment, the other site assigned to comparison. Treatment site worksite-based health promotion activities such as self-directed campaigns, lectures, small group programs, online programs, environment interventions (food service and physical)--all with focus on nutrition, physical activity and/or weight management. Receives: Behavioral: WOW, Working On Wellness weight management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight (BMI)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startJun 2006
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,700 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Kim Gans, Brown University
- Investigators
- Kim M Gans, PhD MPH LDN, Principal investigator, Brown University, Institute for Community Health Promotion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288145
- Sponsor's protocol ID
- R18DK071946
- Status last verified
- Apr 2013
- First submitted
- 6 Feb 2006
- Last updated
- 1 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Proper KI, Koning M, van der Beek AJ, Hildebrandt VH, Bosscher RJ, van Mechelen W. The effectiveness of worksite physical activity programs on physical activity, physical fitness, and health. Clin J Sport Med. 2003 Mar;13(2):106-17. doi: 10.1097/00042752-200303000-00008.
PubMed 12629429Hallam JS, Petosa R. The long-term impact of a four-session work-site intervention on selected social cognitive theory variables linked to adult exercise adherence. Health Educ Behav. 2004 Feb;31(1):88-100. doi: 10.1177/1090198103259164.
PubMed 14768660
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statewide Partnerships for Worksite Weight Management
- ClinicalTrials.gov ID
- NCT00288145
- Acronym / sponsor ID
- R18DK071946
- Conditions
- Overweight, Obesity
- Keywords
- worksite, weight gain prevention (among adults), obesity (among adults), physical activity, nutrition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,700 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Jun 2006
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 7 Feb 2006 (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 project is designed to test the effectiveness of a multilevel worksite wellness program, based in Rhode Island and nearby neighboring states to impact employee weight, dietary intake and physical activity, compared to an attention placebo condition.
Detailed description
Accomplishment of the specific aim will be determined by a two group randomized effectiveness study (Treatment vs. Comparison) utilizing 24 RI worksites with randomization by site. The specific impact and outcome evaluation measures (BMI, DHQ-FFQ, and 7-day PAR) will be collected at Baseline, 12, and 24 months on a longitudinal cohort selected at random from the employee lists of each participating worksite. Extensive process evaluation and a mediating variable framework are also included to identify the mechanisms in successful change at both the worksite and individual level, which will maximize the potential for dissemination and generalization of the intervention as well as advance theory and improve intervention practice and policy.
Primary outcome measure will be weight (BMI).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T | Active comparator | Behavioral: WOW, Working On Wellness weight managementTreatment arm comprises one worksite in a matched site pair; one site assigned to treatment, the other site assigned to comparison. Treatment site worksite-based health promotion activities such as self-directed campaigns, lectures, small group programs, online programs, environment interventions (food service and physical)--all with focus on nutrition, physical activity and/or weight management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Worksite
- worksite located in Rhode Island or neighboring state
- has food service on site
- approximately 200 - 500 employees
- low rate of employee turnover
Key exclusion criteria (5 listed)
- worksites outside New England
- permanent employee, who works 20 or more hours on site
- speaks/reads some English at level to complete survey eval items
- able to walk at a brisk pace
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 |
|---|---|---|
| WOW, Working On Wellness weight managementTreatment site, worksite-based health promotion activities such as self-directed campaigns, lectures, small group programs, online programs, environment interventions (food service and physical)--all with focus on nutrition, physical activity and/or weight management. | Behavioural | T |
Primary outcome
Weight (BMI)
Time frame: 24 months
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 1 May 2013.
- Background: PubMed 12629429Proper KI, Koning M, van der Beek AJ, Hildebrandt VH, Bosscher RJ, van Mechelen W. The effectiveness of worksite physical activity programs on physical activity, physical fitness, and health. Clin J Sport Med. 2003 Mar;13(2):106-17. doi: 10.1097/00042752-200303000-00008.
- Background: PubMed 14768660Hallam JS, Petosa R. The long-term impact of a four-session work-site intervention on selected social cognitive theory variables linked to adult exercise adherence. Health Educ Behav. 2004 Feb;31(1):88-100. doi: 10.1177/1090198103259164.
- American Council on Fitness and Nutrition websiteLink provided by the sponsor.
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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.
Kim M Gans, PhD MPH LDN principal investigator
Brown University, Institute for Community Health Promotion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WOW, Working On Wellness weight management in people with Overweight and Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 5 inclusion and 5 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 1 May 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Weight (BMI) (time frame: 24 months). 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 NCT00288145, which also lists 2 linked publications.
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 1 May 2013.