Type 2 diabetes
Item
1. participant reported diagnosis of type ii diabetes
boolean
C0011860 (UMLS CUI [1])
HbA1c
Item
2. hba1c between 7 ‐ 11 percent (inclusive)
boolean
C0474680 (UMLS CUI [1])
Fasting blood glucose
Item
3. fasting blood glucose < 240. if a potential participant has a fbg above the inclusion criteria it is acceptable to re‐test this potential participant within one week of the original test.
boolean
C0428568 (UMLS CUI [1])
Body mass index
Item
4. bmi 27‐50 kg/m2 (inclusive)
boolean
C1305855 (UMLS CUI [1])
Age
Item
5. age range - 18 - 70 (inclusive)
boolean
C0001779 (UMLS CUI [1])
Medical clearance clinical investigator | incl. EKG
Item
6. clearance on medical exam by study physician including ekg
boolean
C4483684 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C1623258 (UMLS CUI [2])
No recent weight loss
Item
7. no weight loss over the previous 3 months (5kg loss is acceptable with physician discretion)
boolean
C1262477 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Stable status of all recent medication regimens
Item
8. and 9. on stable regimen of all medications (including diabetes) for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted, all diabetes medications are permitted including insulin.)
boolean
C0013227 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Willingness and ability to commit to regular physical activity
Item
10. willing and able to commit to regular physical activity (e.g. walking) five days per week
boolean
C0024501 (UMLS CUI [1,1])
C0026606 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
C0600109 (UMLS CUI [1,4])
C0024501 (UMLS CUI [2,1])
C0026606 (UMLS CUI [2,2])
C0205272 (UMLS CUI [2,3])
C0085732 (UMLS CUI [2,4])
Willingness and ability to study protocol compliance w.r.t. scheduled appointments
Item
11. willingness and ability to make all scheduled appointments required by study protocol
boolean
C0525058 (UMLS CUI [1,1])
C0030675 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2,1])
C0030675 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Willingness to participate in weight watchers program
Item
12. willingness to attend weekly weight watchers meetings in the community and to participate in weight watchers online program, if so randomized
boolean
C0679823 (UMLS CUI [1,1])
C3179079 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Willingness to comply with study protocol
Item
13. willing to follow requirements of study protocol
boolean
C0600109 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
Willingness and ability to provide email address
Item
14. willing and able to provide a valid email address for use in the study
boolean
C1705961 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C1705961 (UMLS CUI [2,1])
C0085732 (UMLS CUI [2,2])
Able to communicate in English
Item
15. must be able to communicate (oral and written) in english
boolean
C2364293 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Under the care of a physician for diabetes | willing to provide contact to MD | MD agrees to study participation
Item
16. under the care of a physician for diabetes and willing to give release to contact the md and request md's agreement for participant to participate -
boolean
C0583348 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C1880174 (UMLS CUI [2,1])
C0033131 (UMLS CUI [2,2])
C1999230 (UMLS CUI [2,3])
C0600109 (UMLS CUI [2,4])
C2348568 (UMLS CUI [3,1])
C0033131 (UMLS CUI [3,2])
C0680240 (UMLS CUI [3,3])
Type 1 diabetes
Item
1. type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Cardiovascular disease | coronary heart disease | recent mi or cva | tia | clinically significant arrhythmias | uncontrolled hypertension determined by blood pressure
Item
2. cardiovascular/coronary heart disease [e.g., mi or cva within last 6 months, tia, clinically significant arrhythmias, uncontrolled hypertension (defined as blood pressure over 160/110); physician's discretion may be more conservative]
boolean
C0007222 (UMLS CUI [1])
C0010068 (UMLS CUI [2])
C0027051 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
C0038454 (UMLS CUI [4,1])
C0332185 (UMLS CUI [4,2])
C0007787 (UMLS CUI [5])
C0003811 (UMLS CUI [6,1])
C2985739 (UMLS CUI [6,2])
C0020538 (UMLS CUI [7,1])
C0205318 (UMLS CUI [7,2])
C0005824 (UMLS CUI [8])
Current severe depression | severe depression within previous year | based on dsm‐iv‐tr criteria
Item
3. current severe depression or history of severe depression within the previous year, based on dsm‐iv‐tr criteria for major depressive episode
boolean
C0011581 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C0011581 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C3887293 (UMLS CUI [2,3])
C0220952 (UMLS CUI [3,1])
C1269683 (UMLS CUI [3,2])
Weight loss medication prescribed recent | Weight loss medication otc recent
Item
4. taking prescription or otc weight loss medications within last 4 weeks
boolean
C0376606 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0376606 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
Currently on medication that affect weight | paroxetine | tricyclics | anti‐psychotics
Item
5. currently taking other medications that affect weight (e.g., paroxetine, tricyclics, anti‐psychotics)
boolean
C0013227 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0005910 (UMLS CUI [1,4])
C0070122 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
C0003290 (UMLS CUI [3,1])
C0521116 (UMLS CUI [3,2])
C0040615 (UMLS CUI [4,1])
C0521116 (UMLS CUI [4,2])
Recent use of chromium supplements or nutrition supplements or herbal products as weight-loss agent | agreement to dietary supplement continuation
Item
6. within the last 4 weeks, use of chromium supplements or any nutrition supplements or herbal products claimed to have a weight loss effect. participants using other non‐excluded nutrition supplements or herbal products must agree to continue at their current level of use throughout the study.
boolean
C0376606 (UMLS CUI [1,1])
C3661602 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0376606 (UMLS CUI [2,1])
C0242295 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C0376606 (UMLS CUI [3,1])
C1572271 (UMLS CUI [3,2])
C0332185 (UMLS CUI [3,3])
C0680240 (UMLS CUI [4,1])
C0242295 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Recent participation in weight control program
Item
7. participation in a weight control program within the past 3 months
boolean
C0679823 (UMLS CUI [1,1])
C3179079 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Prolonged QTc interval
Item
8. qtc interval >450 msec for males and qtc interval >470 msec for females
boolean
C1560305 (UMLS CUI [1])
PHQ‐9 total score
Item
9. phq‐9 total score > 15
boolean
C3828565 (UMLS CUI [1])
Thyroid disease untreated or with treatment changes in past 6 months | Except for thyroid disease with stable medication status
Item
10. thyroid disease for which the participant is untreated or has had treatment changed within the last 6 months. history of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 6 months is acceptable
boolean
C0040128 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0040128 (UMLS CUI [2,1])
C1299575 (UMLS CUI [2,2])
C3828652 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0040128 (UMLS CUI [3,2])
C0237125 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
Surgical bariatric procedure | gastroplasty | gastric bypass | gastrectomy or partial gastrectomy | adjustable banding | gastric sleeve
Item
11. history of a surgical procedure for weight loss at any time (e.g. gastroplasty, gastric by‐pass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve)
boolean
C1456587 (UMLS CUI [1])
C0017193 (UMLS CUI [2])
C0017125 (UMLS CUI [3])
C0017118 (UMLS CUI [4])
C0017118 (UMLS CUI [5,1])
C0728938 (UMLS CUI [5,2])
C1719687 (UMLS CUI [6])
C3160799 (UMLS CUI [7])
Major surgery recent | post enrollment
Item
12. history of major surgery within three months of enrollment
boolean
C0679637 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0679637 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C1516879 (UMLS CUI [2,3])
Implanted cardiac defibrillator
Item
13. presence of implanted cardiac defibrillator
boolean
C0850291 (UMLS CUI [1])
Orthopedic limitations interfering with ability of physical activity
Item
14. orthopedic limitations that would interfere with ability to engage in regular physical activity
boolean
C0029354 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0026606 (UMLS CUI [1,4])
Gastrointestinal disorders | chronic malabsorptive conditions | peptic ulcer disease | crohn's disease | chronic diarrhea | active gallbladder disease
Item
15. gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, crohn's disease, chronic diarrhea or active gallbladder disease
boolean
C0017178 (UMLS CUI [1])
C0024523 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0030920 (UMLS CUI [3])
C0010346 (UMLS CUI [4])
C0011991 (UMLS CUI [5,1])
C0205191 (UMLS CUI [5,2])
C0016977 (UMLS CUI [6])
Malign neoplasm | cancer treatment | exception basal cell carcinoma skin resected procedure successful
Item
16. current cancer or cancer treatment, or a history of cancer or cancer treatment within the last 3 years. persons with successfully resected basal cell carcinoma of the skin may be enrolled if treatment was completed more than 6 months prior to enrollment.
boolean
C0006826 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1123023 (UMLS CUI [3,3])
C1521996 (UMLS CUI [3,4])
C3258067 (UMLS CUI [3,5])
Eating disorder | anorexia nervosa | bulimia nervosa
Item
17. history, within the past five years, of clinically diagnosed eating disorders confidential march 30, 2012 9 including anorexia nervosa or bulimia nervosa.
boolean
C0013473 (UMLS CUI [1])
C0003125 (UMLS CUI [2])
C2267227 (UMLS CUI [3])
Pregnancy | breast feeding | pregnancy intent | unwilling to use birth control
Item
18. women who are pregnant, lactating , trying to become pregnant or unwilling to use an effective means of birth control
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
Recent participation in another clinical trial
Item
19. participation in another clinical trial within 30 days prior to enrollment.
boolean
C2348568 (UMLS CUI [1])
Alcohol units per week | unwilling to limit alcohol units per day
Item
20. currently consuming >14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and unwilling to limit intake to less than 3 drinks per drinking day during study participation
boolean
C0560579 (UMLS CUI [1])
C0439801 (UMLS CUI [2,1])
C0560578 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Drug abuse
Item
21. current or past drug abuse
boolean
C0013146 (UMLS CUI [1])
Study subject participation status household member
Item
22. participation in trial by another member of household
boolean
C2348568 (UMLS CUI [1,1])
C4330269 (UMLS CUI [1,2])
Recurrent severe hypoglycemic events | unless treating physician provides clearance for participation
Item
23. hypoglycemic events: a. evidence of more than 1 severe hypoglycemic event in the past 12 months, unless the participant's treating physician provides written clearance for participation.
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2945760 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0205540 (UMLS CUI [2,3])
C0033131 (UMLS CUI [2,4])
Other medical condition study subject participation status ineligible
Item
24. any other condition or factor which in the opinion of the study physician or investigator makes it inadvisable for the candidate to participate in the trial -
boolean
C0012634 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1512714 (UMLS CUI [1,4])
C0022423 (UMLS CUI [1,5])
C0008961 (UMLS CUI [1,6])