Efficacy of 2 Diet Plans Designed for People With Type II Diabetes on Weight and Health Measures
Condition: Obesity; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the efficacy of Medifast Plus for Diabetics
      compared to a standard weight loss treatment program, in terms of changes in weight loss in
      overweight men and women over an 86 week active weight loss and weight maintenance program.
      There will be up to 34 weeks active weight loss and 52 weeks weight maintenance. The planned
      sample size is 80 overweight (BMI 25-40) males and females aged 18-65 with type 2 diabetes.
      It is anticipated that pre-packaged meal replacements will provide an advantage to those
      desiring weight loss.
    

Detailed description: 
      This study will test the efficacy of Medifast Plus for Diabetics compared to a standard
      American Diabetes Association (ADA) weight loss treatment program using whole foods in 80
      participants (randomized into 2 groups of 40) during an active weight loss and weight
      maintenance program lasting 68-86 weeks. The study data collection will occur in two phases,
      active weight loss (phase 1) and weight maintenance (phase 2). Transition into phase 2 will
      be individually timed by participant attainment of a goal 'healthy' weight following a
      minimum of 16 weeks, or week 34, whichever comes first. A dietitian will prescribe an
      individualized weight loss and weight maintenance calorie levels for participants based on
      the Harris Benedict equation (RMR x AF x Deficit; RMR=resting metabolic rate, AF=activity
      factor). All participants will have a goal 'healthy' weight determined at baseline by a
      combination of personal participant goals, Harris Benedict equation predictions, body
      composition goals, and BMI range, but in no case will participants be prescribed a goal
      weight that would result in an BMI of less than 24. For the weight loss phase, participants
      will be randomly assigned to one of 2 groups, Medifast Plus for Diabetics or standard ADA
      weight loss treatment program. Both groups will attend educational lessons every other week
      during weight loss, and once every four weeks during the maintenance phase. Data collection
      visits will occur when goal weight is reached, at week 26 of maintenance, and week 52 of
      maintenance. During the weight loss phase, group 1 will receive 5 Medifast Plus for Diabetics
      supplements and one small meal to consume every day. As participants reach their goal
      weights, they will be re-randomize according to weight loss success and gender categories
      into two different maintenance plans. One maintenance group will first receive 26 weeks of
      Medifast Plus for Diabetics maintenance diet, still receiving 5 supplements/day but with a
      larger portion of calories coming from whole foods, followed by 26 weeks of a purely
      food-based maintenance diet (the same as the control group, where participants will choose
      all foods and receive no supplements). The second group will be a reversal of the order of
      maintenance diets (first the food-based maintenance for 26 weeks, and then the Medifast Plus
      for Diabetics maintenance for 26 weeks). The control group will remain on a food-based, no
      supplement maintenance diet for the entire 52-week maintenance period. Participants will be
      encouraged to report any adverse events or changes in medications at any time during the
      study
    

Intervention name(s): Medifast Plus for Diabetics Meal Replacement Supplements; Standard ADA recommended diet for type 2 diabetics
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment