Workplace-Sponsored Diet and Exercise Program to Reduce Obesity
Recruitment status was Active, not recruiting
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 21, 2005 | ||||
| Last Updated Date | April 10, 2009 | ||||
| Start Date ICMJE | September 2004 | ||||
| Estimated Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Body mass index [ Time Frame: Measured at Months 12 and 24 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00123526 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Workplace-Sponsored Diet and Exercise Program to Reduce Obesity | ||||
| Official Title ICMJE | Active Living and Healthy Diet at the Workplace | ||||
| Brief Summary | This study will evaluate the effectiveness of an environmental worksite intervention to reduce obesity among hospital employees. |
||||
| Detailed Description | BACKGROUND: Obesity is a significant public health problem in the United States, prompting policy makers and researchers to call for action against the epidemic. Obesity and associated health conditions affect all age groups and both genders, yet disproportionately affect racial and ethnic minorities. Health consequences of obesity include high blood pressure, high cholesterol, hyperinsulinemia, type 2 diabetes, heart disease, stroke, gallbladder disease, arthritis, sleep disturbances, breathing problems, and certain types of cancer. Hospitals are important worksite environments that employ large numbers of people in diverse job categories from diverse educational and socioeconomic backgrounds. DESIGN NARRATIVE: The purpose of this study is to promote weight loss among those who are overweight and obese, and prevent weight gain among those of normal weight through an environmental intervention targeted to all employees at six hospitals in central Massachusetts. The hospitals will be matched according to size, and within each matched pair randomly assigned to either the intervention or control group. The intervention will promote active living, in which physical activity is incorporated into each participants' daily routine. Participants will also follow a healthy diet, characterized by higher intakes of fruits, vegetables, fish, poultry, legumes, and whole grains. Participants will consume less high fat foods and refined grains, and reduce their total caloric intake through smaller portion sizes. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 899 | ||||
| Estimated Completion Date | June 2008 | ||||
| Estimated Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00123526 | ||||
| Other Study ID Numbers ICMJE | 223, R01 HL079483 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Stephenie Lemon, University of Massachusetts Medical School | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | April 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||