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Choosing a Weight Loss Program?

Ask Yourself These Six Weight Loss Questions:
Have there been any studies completed?

–  Many companies make very enticing claims, but fail to provide anything to back them up! Always ask if the program has an Institutional Review Board approved, double-blind randomized placebo, controlled trial.

Is the Program Safe?

– Are there any studies or certifications showing that the program has been reviewed and certified safe?

“ Cookie Cutter” or “One Size Fits All “Programs DO NOT WORK!

Ask if the program is personalized to your unique individual needs and requirements– Does the program create Personalized Food Lists?

– Does the program utilize personalized supportive nutritional supplements?

Does the program utilize natural, whole foods and whole food nutritional supplements?
How safe is the program? Does it require shots or Surgery?

– No Prepackaged Food

– No Binders, Preservatives

Do it Yourself programs DON’T WORK!

Does your program provide Personal Coaching & Resources so that you are never alone?

– Access to a personal Coach

 – 24 Hour Virtual Intelligent text coaching and advanced email support

– Member only Client Portal that has  an abundance of resources and support

Does the program protect YOU the consumer with a Consumer Guarantee?

– What assurances come with such an important decision?

BLINDED RANDOMIZED CONTROLLED TRIAL
vs.
PROSPECTIVE CASE STUDY

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Overview of the RESULTS of the Prospective Case Study:

  • The top 10% lost over 33.5 pounds in 40 days with an average of 39.6 pounds lost
  • The majority of participants lost over 20 pounds in 40 days

Overview of the IRB Approved Blinded Randomized Placebo Controlled Trial

  • This RCT was for a non-personalized Weight Loss Direct program. Weight Loss Direct utilizes the underlying Weight Loss Direct program as the foundation but then adds to the program with personalized foods, supplements, client portal and other resources as well as personal coaching.
  • The RCT showed that the program safely and effectively affected weight loss.
  • The Active group lost approximately twice as much weight as the controlled group.
  • This was a fairly small sample size with the top 10% losing an average of 24.25 pounds

As discussed in the chart below, there are a number of reasons that the Prospective Case Study results were better than the Randomized Control Trial Randomized .

BLINDED RANDOMIZED CONTROLLED TRIAL

To demonstrate the efficacy of the weight loss direct program we commissioned both an Institutional Review Board approved Blinded Randomized Placebo Controlled Trial and a Prospective Case Study.

The chart below is an explanation of the difference of the 2 types of Clinical Trials that were done for the Weight Loss Direct Program with the Advantages and Disadvantages listed.

Volunteers are paid
Cannot be a “personalized program”
Researchers collect data
Participant guidance is limited
Blind Study
Size of the Trial 116 Participants were accepted into the trial, only half of which were in the active group. Of those 58 in the active group, 36 completed the trial.
Study Protocols and Parameters
Advantages
Volunteers are paid
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Cannot be a “personalized program”
-----
Researchers collect data
Controlled gathering of information without an attempt to intervene
Participant guidance is limited
The guidance is controlled with little more than a black and white professional manual to follow
Blind Study
Participants do not know if they are in the active weight loss group or the controlled weight loss group
Size of the Trial 116 Participants were accepted into the trial, only half of which were in the active group. Of those 58 in the active group, 36 completed the trial.
the size is acceptable and is considered a good sample size for a controlled weight loss trial. Also there was a controlled weight loss program which was compared to the active program
Study Protocols and Parameters
Study Protocols and Parameters were approved by the institutional review board and either meet or exceed the FTC guidelines and requirements for a clinical trial
Disadvantages
Volunteers are paid
Less Incentive to follow the program and may be doing the study as a source of income. Participants were free to choose their degree of participation since they were not confined or fed.
Cannot be a “personalized program”
by definition, a controlled trial must be standardized with each participant in the group receiving the exact same program and protocols. This particular study used a foundational list of foods and supplements that are foundational to the Weight Loss Direct Program Researchers question participants and collect data
Researchers collect data
Not as knowledgeable as a coach of the program. Researchers do not intervene during the trial even if they suspect the participant is not following the program
Participant guidance is limited
It is difficult to determine how well the participant understands and follows the program
Blind Study
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Size of the Trial 116 Participants were accepted into the trial, only half of which were in the active group. Of those 58 in the active group, 36 completed the trial.
Much smaller sample size compared to the case study
Study Protocols and Parameters
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PROSPECTIVE CASE STUDY

Participants paid for the service
Participants received a “personalized program”
Coaches help the participant
Participants have many tools to help guide them
Size of the Case Study Trial 626 Participants in the study all of which were actively intervened to lose weight.
Study Protocols and Parameters
Advantages
Participants paid for the service
Paying participants tend to follow the protocols and have a greater desire for successpaying adds an incentive not able to be taken into consideration in a controlled trial
Participants received a “personalized program”
Used personalization in both foods and supplements to help optimize the results for each individual participant. In addition to the foundational supplements, additional nutritional supplements were added determined by various parameters to personalize the program. The foundational food list was utilized but was further ranked as to which would be most acceptable for that individual.
Coaches help the participant
Coaches not only gather information and watch, but they are knowledgeable in how to make modifications that can help optimize the result for the participant
Participants have many tools to help guide them
The participants received a customized report, a community portal with recipes, weekly personal coaching with a knowledgeable coach, automated daily emails that follow the program, daily text messages that take the participants daily results into account in a way to guide, inspire and motivate, open access to their personal coach to ask any questions, more thorough manuals and journals. Essentially, nearly everything possible to successfully guide the participant successfully through the program
Size of the Case Study Trial 626 Participants in the study all of which were actively intervened to lose weight.
The sample size was considerably larger than the Controlled trial especially in regards to the number that
Study Protocols and Parameters
Study Protocols and Parameters were not approved by the institutional review board for they do not meet the guidelines and requirements of the IRB or the FTC for a blinded randomized clinical trial
Disadvantages
Participants paid for the service
paying adds an incentive not able to be taken into consideration in a controlled trial
Participants received a “personalized program”
-----
Coaches help the participant
Coaching prevents the trial from being controlled, blinded or randomized
Participants have many tools to help guide them
------
Size of the Case Study Trial 626 Participants in the study all of which were actively intervened to lose weight.
No controlled weight loss group, all participants actively intervened to lose weight.
Study Protocols and Parameters
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