Meal Replacement with SolleLean Green:
A Prospective, Randomized, Controlled Cohort Study
This is information and instructions for the SolleLean Green study. Please read the following carefully. If you did not want to be enrolled in this study, please email me asap at Alison@caldwellandrews.com and I’ll remove you from the database.
The purpose of this study is to identify the effects of drinking the SolleLean Greens shake as a meal replacement daily for six weeks. We hypothesize that drinking this as a meal replacement daily will result in positive effects on mood, physical activity and health, and mental health.
Previous investigations have already indicated that meal replacements are a generally effective and established method of losing weight and improving metabolic variables. These studies have focused primarily on calorie restriction as a method to create these outcomes. Our focus is on the nutrition, tonic herbs and adaptogenic herbs in the SolleLean drink.
Each participant will be randomized into one of three groups. This means that you are assigned to one of these groups by chance. We will use a software program to randomly assign you to a group. You will be randomized to a group AFTER you complete the first three weeks of weekly questionnaires. Your questionnaire answers will have no effect on your assignment to a group.
DESCRIPTION OF THE GROUPS
Group One: This group will use the meal replacement drink daily for any meal of their choice. There is no associated exercise or meditation intervention. However, anyone in this group is free to continue, stop or start exercising anytime during the study, or to continue, stop or start meditation at any time in the study.
Group Two: This group will use the meal replacement drink daily for the same meal daily (their choice of which meal). This group will also be given a 20-minute exercise routine to follow throughout the 6-week study. The exercise can be done at any time during the day, 5 times per week. The exercise routine is designed by our own Fitness Master, Kayla Hudman.
Group Three: This group will use the meal replacement drink daily for the same meal daily (their choice of which meal). This group will also engage in at least 30 minute of slow, relaxing rest and stretching directly after drinking the meal replacement. This group will receive specific instructions about how to do the slow stretching and restful time after each meal replacement.
After you have been randomized to a group, you will receive an email indicating your group assignment. Please do not request to change groups, as this will problematically affect the study. If you think you are not able or willing to be in any one of the groups, please let us know so that we can remove you from the study.
WHAT DO I NEED TO DO?
To participate in the study, you’ll need to agree to do the following. (There is also a simplified checklist of what to do at the end of this letter):
- a) FIRST QUESTIONNAIRE You’ll be emailed a questionnaire titled: “SolleLean study Basic Information.” This and all of the other questionnaires will be sent to you through Survey Monkey. (Be sure your email doesn’t reject or junk emails from Survey Monkey.) You’ll receive this questionnaire by March 18. Complete this questionnaire by March 25 and make sure you press “DONE” to submit it. The questionnaire takes about 20 minutes (on average) to complete.
**IMPORTANT: Completing this questionnaire indicates that you consent to be in the study. If we don’t receive a submitted questionnaire by midnight on March 25, we will assume you no longer want to be in the study.
- b) WEEKLY QUESTIONS Complete a weekly baseline questionnaire every Saturday, starting April 8, for 3 weeks. This short questionnaire will take 5 minutes or less. These 3 weeks of baseline questionnaires will happen BEFORE using the SolleLean drink. The purpose of these first three weekly questionnaires is to establish a baseline. You’ll then complete six more weekly questionnaires on Saturdays during the time you are using the SolleLean drink.
COOL FEATURE! There is an incentive for you to finish the weekly questionnaire on the Saturday of that week —-you can earn 5 Solle Rewards for each of the 9 weeks! That is, for every one of the weekly questionnaires that you complete and submit on the Saturday of that week, you will receive 5 Solle Rewards in your account. If you complete all of the 9 questionnaires on every Saturday of that week, you’ll end up with 45 Solle Rewards! Great incentive because this can get you a free product. NOTE: You will need to be a Solle Member (no cost to become a member) in order to receive Solle Rewards. To become a member, ask the person who told you about the study about how to sign up or you can go to SolleNaturals.com.
- c) WHICH GROUP You will receive instructions about the group you were assigned to after you complete the first three weekly questionnaires. Follow the instructions you’ll receive for the group to which you’ll be randomly assigned. For example, if you are assigned to the exercise group, follow the instructions for that group. You’ll get these instructions sent to you after the first three weeks of weekly questionnaires. If you lose the instruction email, you’ll be able to find the instructions on the website: http://mindbodytotalhealth.com/sollelean-green-study/
- d) BUYING THE DRINK You will need to purchase the drink after you complete the second weekly questionnaire. Purchase the SolleLean drink by calling the Solle Naturals office team to place your order. Their number is 888-787-0665. The drink cannot be purchased through the website. We will let you know when the drink will be available for purchase (it is not available yet). This will be around April 15. As a study participant you’ll receive the drink at half price (about $25 per 3 week supply, or $50 for the entire study). You don’t have to be a member to purchase the drink. However, there is no cost to become a member — and unless you are a member, you can’t use the Solle Rewards you’re earning at this point.
NOTE: The only people who will be able to purchase SolleLean Green at the study price and during the study period are people who are enrolled in the study.
- e) END OF STUDY AND LAST QUESTIONNAIRE After the 6th and final week of using the SolleLean drink, complete an Exit questionnaire. This questionnaire will take you about 15 minutes or less. You’ll be emailed this questionnaire just like the others, and you’ll receive it a few days after the end of the study.
Finally, we would like to contact you six months after the end of the study for some follow-up questions. There will be a place on the exit questionnaire to indicate if we can contact you to do a very short follow-up questionnaire in 6 months (again, less than 5 minutes).
If you have any questions regarding the study, please contact the lead investigator, Dr. Alison Caldwell-Andrews by email or text:
text: (860) 538-3266
You can also check the study website for answers and for a copy of this information form.
- Read the above letter; make sure that your email isn’t set to automatically junk or reject emails from Survey Monkey. If you have any questions about these procedures after reading the letter, please email Alison@caldwellandrews.com
- On or before March 18, you’ll be emailed a questionnaire through Survey Monkey titled: “SolleLean study Basic Information.” Complete this questionnaire by March 25 and make sure you press “DONE” to submit it. Completing this questionnaire indicates that you consent to be in the study. If we don’t receive a submitted questionnaire by March 25, we will assume you no longer want to be in the study.
- The next questionnaire (the first weekly baseline questionnaire, taking about 5 minutes or less) will be emailed to you on April 8. Complete and submit on April 8 for 5 Solle Rewards! This questionnaire will ask you about the week prior to April 8.
- The next two weekly baseline questionnaires will be emailed to you on April 15 and April 22. Complete and submit them on each of those dates for another 5 Solle Rewards!
- You’ll receive an email around April 15 instructing you that it’s time to purchase the SolleLean drink. You can then purchase by calling the Solle Office (details in the letter above). The drink will not be available before that time. You must call to order.
- You will also receive instructions about the group to which you were randomly assigned. Follow the instructions for the group you are in for the next 6 weeks. On each Saturday during those 6 weeks, you’ll be emailed another weekly questionnaire and you’ll be able to earn 5 Solle Rewards for every questionnaire you submit on the day it’s received.
- Within a few days of the final week of using the SolleLean drink, you will also receive an Exit Questionnaire. This questionnaire will take you about 15 minutes.