WW Study 2019

Dear Potential Participant:

We are pleased to invite you to volunteer to be considered for participation in an upcoming research study to test a modification to the WW (formerly Weight Watchers) program for weight loss in people who are overweight or obese and are otherwise generally healthy.

To participate in this study, you MUST own and have reliable access to an iPhone with iOS version 8.0 (or later) and at least 600 MB of available storage on your phone to use the study-provided app.

Your participation in this study would be for a little over 6 months. You will need to attend approximately 28 visits over that time. If accepted into this study, you would receive a WW program with access to study-specific weekly workshops (formerly meetings) led by WW Coaches and study specific digital tools via a mobile application (app). Weekly workshops (formerly meetings) would be held at the MUSC Weight Management Center (downtown Charleston) or at a separate meeting space elsewhere in the Charleston area. Three separate assessment visits will all be at the MUSC Weight Management Center downtown.

If you cannot commit to attending these 28 visits over the 6-month study, this study is not for you.

If you think you might be eligible and are interested in this study, you will be invited to attend an orientation session, which will be a group meeting. If you decide to apply for the study, you will be scheduled for a screening assessment visit at MUSC. If the results of this visit qualify you to be in the study, you will be scheduled for your first WW meeting.

You must be overweight but generally healthy, although certain medical conditions are allowed. To see if you might be eligible, please review the attached list of statements and the table of allowable weights. You must be able to answer TRUE to ALL of the items on the list below. Not all eligibility requirements are listed in the space below, and some are based on information gathered at the screening visits, so even if you can say “TRUE” to all the statements, there is no promise you will qualify for this study.


Sincerely,



Patrick O’Neil, Ph.D.
Professor,
Director, Weight Management Center




I may be eligible for enrollment in this study if I can answer TRUE to each and every one of the following criteria:

1. I am between 18 and 75 years old.

2. I weigh at least the following minimum for my height:

** This criterion is very important. If you are not sure how to read this chart, please call
(843) 792-5577 for assistance.

Height Minimum weight Maximum weight
4' 11" 124 212
5" 0" 128 220
5' 1" 132 227
5' 2" 136 235
5' 3" 141 242
5' 4" 145 250
5' 5" 150 258
5' 6" 155 266
5' 7" 159 274
5' 8" 164 282
5' 9" 169 291
5' 10" 174 299
5' 11" 179 308
6' 0" 184 316
6' 1" 189 325
6' 2" 194 334
6' 3" 200 343
6' 4" 205 353
6' 5" 210 362

If in doubt, or if you are shorter or taller than heights included on this chart, please call (843) 792-5577 for assistance.

3. I feel the need to lose weight.

4. I am willing to participate in this 6-month study and attend approximately 28 visits over a 26-week timeframe

5. I am willing to follow recommendations required by study protocol.

6. I own and have personal use of an iPhone on a daily basis.

7. I have an iPhone with Version iOS 8.0 or later (can be found in your Settings, under General, scroll down to Version and the number must be above version 8.0).

8. I have available storage of at least 600 MB in my iPhone to accommodate the size of the app (can be found in your Settings, under General, scroll down to Available. You must have at least 600 MB available, 1 GB=1,000 MB so if you have at least 1 GB you have enough storage for the app).

9. I am willing and able to navigate and use applications on my iPhone on a daily basis.

10. I have reliable home Wi-Fi access.

11. I am able to attend weekly meetings, 30-60 minutes in duration, at the same day and time each week for 24 consecutive weeks.

12. I am able to commit to 3 additional study visits at Weeks 0, 12 and 24, with each visit being 60-90 minutes in duration to complete assessments (height, weight, questionnaires, physical measures).

13. I am NOT currently, or within the last 6 months, trying to lose weight by following guidelines (e.g., self-initiated programs) or a structured weight-loss program (e.g., at a medical center, university, commercial programs).

14. I have NOT been a WW (formerly Weight Watchers) member within the past 12 months.

15. I am NOT involved in any other research studies at this time, and I will not join other research studies while in this study.

16. I am NOT pregnant, nursing, or planning on becoming pregnant over the next 9 months.

17. I have NOT lost more than 11 pounds in the previous 6 months.

18. I have NEVER been diagnosed clinically with an eating disorder.

19. I do NOT have health problems that make weight loss or unsupervised exercise unsafe or unreasonable (e.g., orthopedic limitations, heart problems).

20. I do NOT have untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 months.

21. I am NOT taking any prescription medication with known effects on appetite or weight (e.g., oral steroids; weight loss medications such as Qysmia, Contrave, etc.) with the exception of subjects on a stable dose of SSRIs for 6 months.

22. If I take a diuretic for high blood pressure, I have been on a stable dose for at least 30 days and take it on a regular, daily basis.

23. I do NOT have chronic/inflammatory gastrointestinal disorders (irritable bowel syndrome is acceptable).

24. I do NOT have a history of heart problems (e.g., angina, bypass surgery, myocardial infarction, etc.) within previous 6 months.

25. I do NOT have high blood pressure (greater than 160/100).

26. I do NOT have a diagnosis of type 1 or type 2 diabetes.

27. I have NEVER had a surgical procedure for weight loss.

28. I have NOT had a major surgery within the previous 6 months.

29. I do NOT have an implanted cardiac defibrillator or pacemaker.

30. I do NOT have a history of cancer within past 5 years or current treatment for cancer (completely resected basal or squamous cell carcinoma acceptable if treatment completed more than 6 months prior to enrollment).

31. I have NOT been hospitalized for psychiatric disorders during the past 12 months.

32. I do NOT currently use alcohol in excess (for males >14 standard drinks per week, for females >7 standard drinks per week) or have a diagnosis of Alcohol Use Disorder)

33. I am NOT planning to relocate in the next 9 months.

34. I know that there are other eligibility criteria that are not included in this list. (If you have any doubts about conditions or medications, please call (843)792-5577 and leave a message if necessary.)


If, after reading all of the material in this packet, you think you may be eligible for consideration, please call (843)792-5577 or email WWstudy@musc.edu to register for an orientation session. If you have any concerns about whether you qualify, please leave a message so that we can get back to you.