Cardiovascular DiseasesNCT00123019
Work, Weight, and Wellness Program: The 3W Program
A study testing Exercise and diet, Diet, Weight Reducing and Level 1 in people with Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
The purpose of this study is to increase physical activity, improve diet, and reduce obesity of hotel employees. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Obesity
- What is being tested?
- Exercise and diet, Diet, Weight Reducing and Level 1
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Oct 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Employed at the hotel
Who cannot join
- Unable to read English, Korean, or Chinese
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Center for Health Research, Hawaii
Honolulu, Hawaii, 96713
About this study
Official title: Overweight and Obesity Control in Worksites
The purpose of this study is to increase physical activity, improve diet, and reduce obesity of hotel employees.
Read the detailed description
BACKGROUND:
In Hawaii, as in many other states, tourism is a large industry. Most hotel jobs require little education or training, and hotels employ large numbers of persons and immigrants with low socioeconomic status. Hawaii, with the world's most ethnically diverse population, has high rates of obesity and diabetes, particularly among those of Polynesian ancestry (about 20-22% of the population). This study will include a comprehensive lifestyle change program delivered through worksites in partnership with a large health care system.
DESIGN NARRATIVE:
Thirty-one hotels employing 11,000 persons on the island of Oahu are pair-matched. One member of each pair is assigned to a high intensity intervention and the other to a low intensity intervention. Both interventions are intended to reduce BMI through an emphasis on a healthy diet and increased physical activity. All employees are assessed annually for three consecutive years. The assessment includes a survey on lifestyle habits, stage of change, and attitudes toward weight, as well as measurement of BMI. The high intensity intervention hotels receive the following: 1) environmental changes to support lifestyle change and obesity control; 2) worksite based groups that offer state-of-the-art behavioral interventions; and 3) after-hours "Re-Invent Yourself" groups designed for persons who want to lose at least 25 pounds and are highly committed to doing it. These interventions incorporate all the elements that produce sustained weight loss and an innovative decision tutorial based on decision theory. The primary outcome is the mean difference between hotels in the high intensity and low intensity interventions in change in BMI from baseline to 12 and 24 months. Secondary outcomes address effects of the intervention on ethnic and occupational subgroups stage of change, absentee days, and worker compensation claims.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Being tested
- Exercise and diet, Diet, Weight Reducing, Level 1, Level 2
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and dietBehavioural
Advice and measurement only
Diet, Weight ReducingBehavioural
Measurement, advice, environmental and behavioral group interventions
Level 1Behavioural
Annual assessment of weight and waist circumference, questionnaire on work, health issues, advice on diet, physical activity and other health issues.
Level 2Behavioural
All Level 1 activities plus ongoing environmental interventions in worksite and weight management groups in worksite over a 24 month period.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Minimal intervention; annual weight/waist assessment, questionnaire, and advice Receives: Behavioral: Exercise and diet; Behavioral: Level 1 |
| 2 | Experimental | Intensive intervention. All arm 1 activities plus ongoing environmental and group interventions in worksite for two years. Receives: Behavioral: Diet, Weight Reducing; Behavioral: Level 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI
Measured: Measured at Months 12 and 24
Secondary outcomes (1)
Effects of the intervention on ethnic and occupational subgroups, stage of change, and other issues
Measured: Measured at Months 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startSep 2004
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,100 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Thomas Vogt, MD, MPH, Study chair, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123019
- Sponsor's protocol ID
- 230
- Other IDs
- R01HL079505
- Status last verified
- Feb 2009
- First submitted
- 20 Jul 2005
- Last updated
- 12 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overweight and Obesity Control in Worksites
- ClinicalTrials.gov ID
- NCT00123019
- Acronym / sponsor ID
- 230
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,100 participants (estimated)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 2004
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 22 Jul 2005 (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 purpose of this study is to increase physical activity, improve diet, and reduce obesity of hotel employees.
Detailed description
BACKGROUND:
In Hawaii, as in many other states, tourism is a large industry. Most hotel jobs require little education or training, and hotels employ large numbers of persons and immigrants with low socioeconomic status. Hawaii, with the world's most ethnically diverse population, has high rates of obesity and diabetes, particularly among those of Polynesian ancestry (about 20-22% of the population). This study will include a comprehensive lifestyle change program delivered through worksites in partnership with a large health care system.
DESIGN NARRATIVE:
Thirty-one hotels employing 11,000 persons on the island of Oahu are pair-matched. One member of each pair is assigned to a high intensity intervention and the other to a low intensity intervention. Both interventions are intended to reduce BMI through an emphasis on a healthy diet and increased physical activity. All employees are assessed annually for three consecutive years. The assessment includes a survey on lifestyle habits, stage of change, and attitudes toward weight, as well as measurement of BMI. The high intensity intervention hotels receive the following: 1) environmental changes to support lifestyle change and obesity control; 2) worksite based groups that offer state-of-the-art behavioral interventions; and 3) after-hours "Re-Invent Yourself" groups designed for persons who want to lose at least 25 pounds and are highly committed to doing it. These interventions incorporate all the elements that produce sustained weight loss and an innovative decision tutorial based on decision theory. The primary outcome is the mean difference between hotels in the high intensity and low intensity interventions in change in BMI from baseline to 12 and 24 months. Secondary outcomes address effects of the intervention on ethnic and occupational subgroups stage of change, absentee days, and worker compensation claims.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Exercise and diet, Behavioral: Level 1Minimal intervention; annual weight/waist assessment, questionnaire, and advice |
| 2 | Experimental | Behavioral: Diet, Weight Reducing, Behavioral: Level 2Intensive intervention. All arm 1 activities plus ongoing environmental and group interventions in worksite for two years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Employed at the hotel
Key exclusion criteria (1 listed)
- Unable to read English, Korean, or Chinese
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 |
|---|---|---|
| Exercise and dietAdvice and measurement only | Behavioural | 1 |
| Diet, Weight ReducingMeasurement, advice, environmental and behavioral group interventions | Behavioural | 2 |
| Level 1Annual assessment of weight and waist circumference, questionnaire on work, health issues, advice on diet, physical activity and other health issues. | Behavioural | 1 |
| Level 2All Level 1 activities plus ongoing environmental interventions in worksite and weight management groups in worksite over a 24 month period. | Behavioural | 2 |
Primary outcome
Change in BMI
Time frame: Measured at Months 12 and 24
1 secondary outcome
Effects of the intervention on ethnic and occupational subgroups, stage of change, and other issues
Time frame: Measured at Months 12 and 24
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 12 Jul 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.
Thomas Vogt, MD, MPH study chair
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and diet, Diet, Weight Reducing and Level 1 in people with Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) 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 1 inclusion and 1 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 12 Jul 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 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?
Change in BMI (time frame: Measured at Months 12 and 24). 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 Jul 2016.