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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL093221 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This research study is being done: 1) to determine if the MGH Be Fit program helps employees to change their nutrition and exercise habits and lower their risk for chronic diseases, such as heart disease and diabetes and 2) to determine if a maintenance program following the Be Fit 12 week program will help employees to keep the positive health changes.
The main objectives of this trial are to determine if employees who participate in the Be Fit 12 week program and are randomized to a 9 month maintenance program are more likely to maintain weight loss, physical activity level, and reduction of other clinical risk factors for disease compared to the control group. Secondary objectives are to determine if employees who participate in the maintenance intervention have fewer chronic diseases related to lifestyle factors and lower health care costs at 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet-based maintenance program | Experimental | 9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs |
|
| Control | No Intervention | No maintenance program provided |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-based maintenance program | Behavioral | The Be Fit maintenance program is a randomized controlled trial of a 9 month intervention to maintain weight loss and physical activity after completion of the 12 week wellness program. Six teams of 25 participants will be randomized to the intervention or to usual care. There are 2 key elements to the maintenance program: personal contact and Internet contact. The personal contact enables the participants to continue receiving face-to-face support from a Be Fit nutritionist and trainer. The Internet interface is an opportunity for the participants to self-monitor their own progress while still under the guidance of the program. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | Mean number of pounds lost at the end of the 10-week program and 9-month maintenance program | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne N Thorndike, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22704742 | Result | Thorndike AN, Sonnenberg L, Healey E, Myint-U K, Kvedar JC, Regan S. Prevention of weight gain following a worksite nutrition and exercise program: a randomized controlled trial. Am J Prev Med. 2012 Jul;43(1):27-33. doi: 10.1016/j.amepre.2012.02.029. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Internet-based Maintenance Program | 9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs Internet-based maintenance program: The Be Fit maintenance program is a randomized controlled trial of a 9 month intervention to maintain weight loss and physical activity after completion of the 12 week wellness program. Six teams of 25 participants will be randomized to the intervention or to usual care. There are 2 key elements to the maintenance program: personal contact and Internet contact. The personal contact enables the participants to continue receiving face-to-face support from a Be Fit nutritionist and trainer. The Internet interface is an opportunity for the participants to self-monitor their own progress while still under the guidance of the program. |
| FG001 | Control | No maintenance program provided |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Internet-based Maintenance Program | 9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs Internet-based maintenance program: The Be Fit maintenance program is a randomized controlled trial of a 9 month intervention to maintain weight loss and physical activity after completion of the 12 week wellness program. Six teams of 25 participants will be randomized to the intervention or to usual care. There are 2 key elements to the maintenance program: personal contact and Internet contact. The personal contact enables the participants to continue receiving face-to-face support from a Be Fit nutritionist and trainer. The Internet interface is an opportunity for the participants to self-monitor their own progress while still under the guidance of the program. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight Loss | Mean number of pounds lost at the end of the 10-week program and 9-month maintenance program | Posted | Mean | Standard Deviation | pounds | 1 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Internet-based Maintenance Program | 9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs Internet-based maintenance program: The Be Fit maintenance program is a randomized controlled trial of a 9 month intervention to maintain weight loss and physical activity after completion of the 12 week wellness program. Six teams of 25 participants will be randomized to the intervention or to usual care. There are 2 key elements to the maintenance program: personal contact and Internet contact. The personal contact enables the participants to continue receiving face-to-face support from a Be Fit nutritionist and trainer. The Internet interface is an opportunity for the participants to self-monitor their own progress while still under the guidance of the program. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anne Thorndike | Massachusetts General Hospital | 617-724-4608 | athorndike@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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|
| Left employment |
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| Pregnancy |
|
| BG001 | Control | No maintenance program provided |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
|
| Married or living with significant other | Count of Participants | Participants |
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| Employment at MGH > 5 years | Count of Participants | Participants |
|
| BMI greater than 25 | Count of Participants | Participants |
|
| Current smoking | Count of Participants | Participants |
|
| Amount of physical activity/week | Median | Inter-Quartile Range | hours |
|
| OG001 | Control | No maintenance program provided |
|
|
|
| 0 |
| 174 |
| 0 |
| 174 |
| 0 |
| 174 |
| EG001 | Control | No maintenance program provided | 0 | 156 | 0 | 156 | 0 | 156 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001519 | Behavior |