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About DELISH

1. What is the purpose of this study?

The DELISH study is designed to test a weight loss program that recommends a healthful dietary pattern. This includes eating foods with high-quality fats and high-quality carbohydrates often. Nuts, seeds, fish, and vegetable oils are foods with high-quality fats and whole grains, fruits, non-starchy vegetables, and beans are foods with high-quality carbohydrates. This dietary pattern is similar to the Mediterranean diet, and because we are testing it as part of a weight loss program in the southern part of the US, we call it the Med-South Weight Loss Program. This will be compared to WW™ (the new name for Weight Watchers™), an effective and widely available weight loss program.

2. Who can participate?

Adult patients cared for at UNC practices, ages 18-75, who are referred to this study by their primary care provider. Our plan is to have 360 participants.

3. How to get started?

We will ask you to complete several steps in order to participate. These steps are outlined in the attached flow diagram. In brief, we will:

  • Call you to answer questions you may have about the study, find out if you want to take part, and check to see if you qualify. If you qualify and are interested, we will do the following:
  • Call again to go over the consent form. We will ask you to sign the form (online or at your first visit).
  • Ask you to complete some surveys online or by phone.
  • Ask you to come to our research office in Chapel Hill to complete some study measures, receive your random assignment (like flipping a coin) to one of the study groups, and begin your first program visit with your counselor if in the Med-South group or receive information about WW™ if assigned to that group.

4. More on the weight loss programs

If you are in the Med-South group:

  • During the first 4 months: Attend 4 monthly lifestyle change sessions with your counselor (the first must be in-person, but the others can be in-person or by phone). You will also receive 4 shorter follow-up phone sessions. (As of June 2020, due to COVID-19, only the first visit will be in person. All others will be by phone or videoconferencing until further notice based on updated COVID-19 guidelines.)
  • During the next 8 months: Begin the weight loss program which includes 14 major counseling sessions with your counselor (each about 30 to 45 minutes). The first and your visit about 2 months later must be in-person, but the others can be in-person or by phone. There will also be some follow-up phone sessions. (As of June 2020, due to COVID-19, only the first visit and the visit 2 months later will be in person until further notice based on updated COVID-19 guidelines.)
  • During the next 12 months: This year of the program is focused on continued weight loss or maintaining the weight you have lost. The first visit is in-person and then you will receive at least one follow-up call each month. Around the mid-year point of this year we will ask you to come in for an in-person counseling session. (As of June 2020, due to COVID-19, only these visits will be in person until further notice based on updated COVID-19 guidelines.)

If you are in the WW™ group:

  • We will give you instructions on how to take part in the WW™ Program and will provide access to WW™ digital plus workshop for 2 years.
  • The Digital component includes unlimited access to the WW™ website and/or the smartphone App.
  • The Workshop component allows for attending weekly group meetings at a WW™ studio (local WW™ office). You are not required to attend these group sessions. You can decide how many sessions to attend. (As of June 2020, due to COVID-19, the workshop component will be available in a virtual videoconferencing [Zoom™] format until further notice based on updated COVID-19 guidelines.)

During this 2-year study, we will collect information from those who take part at the beginning of the study and again at 4, 12, and 24 months.

5. What will it cost me to participate?

You will receive the weight loss programs and all lab work free of charge. Your only costs will be traveling to the research site for DELISH counseling visits or traveling to WW™ workshop visits.

6. Will I receive money for taking part?

Yes, you will receive $60 for each of the 4 times we have you complete surveys and come in for a measurement visit. If you complete all the visits you will receive a total of $240 over the length of the study. There will be an option to submit stool samples 4 times during the study. If you do so, you will receive $30 for each sample. If you live more than 10 miles from the research office, we will reimburse for travel costs.

7. What happens next?

If you WANT to take part, please let us know by sending an email to delish@unc.edu or by calling 919-843-9563 (leave a message if we do not answer). Please let us know your preferred phone number and some good times to reach you by phone.

If you know you DO NOT want to take part, please let us know at the email or phone number above.

If we do not hear from you, we will try to reach you by phone within the next 2 weeks to answer any questions you might have about the study and to see if you would like to take part.