Clinical Study Findings & Weight Loss Claims

What are the new claims?


Claim One: 

  • “Lose more weight than dieting on your own.*”

    • This claim must be closely followed with the disclaimer: “*In a clinical study, the group on the Optimal Weight 5 & 1 Plan® lost 10x more weight than the self-directed group.”


Claim Two:

  • “Average fat loss is 10 pounds (4.5 kg).*”

    • This claim must be closely followed with the disclaimer: “*In a clinical study, the group on the Optimal Weight 5 & 1 Plan® lost 17x more fat than the self-directed control group.”


Claim Three:

  • “Talking with your OPTAVIA coach more often may help you lose twice as much weight.*”

    • This claim must be closely followed with the disclaimer: “*Based on the results of a 16-week clinical study, those who participated in at least 75% of their 23 assigned OPTAVIA Coaching calls lost 15.2 lbs. (7kg) compared to 6.7 pounds lbs.(3kg) for those participating in fewer calls."


Do you have any templates I can use to get started?

Yes, please visit COACH ANSWERS for new before and after templates you are free to use, and share with your Coach Teams.


What is the definition of a claim, testimonial and a disclaimer?

The following are the definitions of a claim, testimonial and a disclaimer:

  • Claim: Any statement made by a company or consumer that conveys the expected experience another consumer will have with the product. 
  • Testimonial: A consumer’s endorsement or statement that described their experience with the product.
  • Disclaimer: The language used after a weight loss testimonial or other statement, in order to prevent the advertisement or statement from being misleading to a consumer.


When did these clinical studies take place?

In 2016, Medifast® began conducting a new clinical study designed to produce data in support of weight loss claims and disclaimers specific to the OPTAVIA 5 & 1 Plan® and the OPTAVIA Coaching model.


Who conducted the clinical tests?

Medifast partnered with a world-class clinical research facility to conduct randomized, controlled design, testing, which lasted 16 weeks with clinic visits for participants scheduled at two, four, eight, 12 and 16 weeks. There were also 23 telephone contacts to these participants in 16 weeks.


Who participated in this study?

Participants included generally healthy men and women, who were overweight and obese with a BMI between 27-42 kg/m2 that matched OPTAVIA’s Client base. The study targeted 66 participants in each group including a Control group and an OPTAVIA group.


What did the Control Group receive to aid their weight loss?

The Control group consumed a reduced calorie diet using conventional foods, received customized meal plan targeting 7% weight loss, were self-directed (no coaching), and referred to the USDA ChooseMyPlate website.


What did the OPTAVIA group receive to aid their weight loss?

Those in the OPTAVIA group followed the Optimal Weight 5 & 1 Plan, had OPTAVIA style coaching, and other OPTAVIA materials to reference, such as the Habits of Health® System, guides, monthly eNewsletter, and more. While it was our goal to replicate the OPTAVIA experience to the best of our ability, there were certain aspects that we weren’t able to replicate including the OPTAVIA Community and social media within the OPTAVIA Community.


Were participants in the OPTAVIA group similar to OPTAVIA Clients?

Yesparticipants in the OPTAVIA group matched OPTAVIA’s Client base and other factors including mean weight, mean BMI and mean age.


Was there a summary of findings?

All told, there were significantly greater reductions in weight, fat mass, and weight circumference. There was also greater weight loss associated with more frequent coaching contacts. In addition, the following results were experienced by study participants:

  • Individuals who talked with their OPTAVIA Coach more often lost twice as much weight,
  • Emphasis by participants on Habits of Health, not just weight loss, and
  • Exercising more, sleeping better, and clothes fitting better.