Valued EpiGenetic Glycemic ImprovEments Through Weight Loss
Condition: Obesity; Pre-diabetes
MeSH terms: Prediabetic State; Glucose Intolerance; Weight Loss
Study type: Interventional

Summary: 
      This randomized controlled clinical trial will use methylomic and transcriptomic profiling to
      examine the effects of a weight loss intervention on the cholesterol metabolism gene network
      in monocytes and adipocytes and investigate the longitudinal relationship between these
      modifications and glycemic improvements.
    

Detailed description: 
      The investigators plan to recruit a total of 200 middle-aged (40-65 years) obese (BMI=30-39.9
      kg/m2), sedentary, pre-diabetic participants who will be randomized to either a 18-week
      dietary weight loss (n=100) followed by a 8-week transition and then 26 weeks of maintenance
      (Weight Loss group) or a delayed weight loss (Control group, n=100) intervention.

      During the screening visit, eligible participants who provided informed consent will complete
      a 3-day food record and then start a 3-day run-in period using the Medifast® meal replacement
      products to be used for the weight loss intervention. At the next visit the participant will
      meet with the Registered Dietitian (RD) to undergo an assessment of Readiness to Change (18).
      All participants must be approved for eligibility by the RD based on her clinical judgment of
      likelihood of success for weight loss, likelihood of compliance to the Medifast® meal plan,
      and willingness to be randomized to either group.

      Control/Delayed Weight Loss Group: (18 weeks) Participants randomized to the delayed weight
      loss intervention (n=100) will serve as a no-weight loss control to the weight loss group
      during the first 18 weeks of the study. During the control (18 weeks) phase these
      participants will receive a monthly phone call visit from staff to maintain contact and
      interest in the study. At the end of the initial 18 weeks participants will complete all
      follow up assessments prior to being offered the opportunity to participate in a weight loss
      program. This weight loss program will involve 18 weekly, group dietary and exercise sessions
      led by the study staff in which participants will follow a modified Diabetes Prevention
      Program. Participants will be given an individual introduction session to the weight loss
      program by study staff and will be guided by the RD on their food purchasing and preparation
      of their meals, but no meal replacements or supplements will be provided.

      Weight Loss group: Phase 1 (18 weeks): Participants assigned to this group will undergo a
      dietary intervention for the first 18 weeks of the study designed to elicit an approximate
      8-10% weight loss. The intervention will incorporate partial meal replacements, nutrition
      education, and some behavior modification.

      This level of weight loss will be achieved through the combination of a partial meal
      replacement (MR) program and individual and group nutrition/behavioral counseling.
      Participants will be provided with and asked to consume 4 Medifast® MR per day. All
      participants will follow the Medifast Achieve TM 4 & 2 & 1 Plan® which includes the 4 MR
      products per day, with the addition of 2 Lean and Green™ Meals and 1 Healthy Snack. The Lean
      and Green™ Meals will be prepared by the participants and each will consist of 5-7 oz. lean
      protein, 3 servings of non-starchy vegetables and up to 2 servings of healthy fat. The
      Healthy Snack will consist of one serving of fruit, dairy, or grain. Each MR from Medifast®
      contains ~90-110 kcals and 10-15 g protein. Participants will be given an individual
      introduction on the meal plan prior to starting and will be guided by the RD on their food
      purchasing and preparation of the other Lean and Green TM meals. They are encouraged to
      consume only what is approved on the Medifast Achieve TM 4 & 2 & 1 Plan®.

      Phase 2 (8 weeks): After completion of the active weight loss phase, participants in this
      group will attend bimonthly group meetings to discuss increasing their activity. The goal is
      for participants to slowly increase their activity to 150 minutes per week and then continue
      at 150 minutes per week to help them maintain their weight. Activity logs will be dispensed
      and topics such as tracking activity, finding time for fitness and getting active will be
      discussed.

      Participants will have the option to transition off the meal replacements and potentially
      continue on a select few during the transition phase. Additional dietary guidance will be
      available to help participants transition off MR and maintain their weight. The RD will
      calculate individual maintenance calorie goals to be discuss with participants at a brief
      individual session prior to starting the transition phase. At this session an introduction to
      the transition phase and information on how to track their activity will also be discussed.

      Phase 3 (26 weeks): After completion of phase 2, participants will be called monthly for 26
      weeks and then asked to return for a maintenance visit at the end of the 52 weeks from study
      start. Participants will be offered an optional session with a staff member at the time of
      their exit to discuss long term goals and strategies and provide closure.
    

Intervention name(s): Weight Loss Group; Delayed Weight Loss
Intervention type(s): Behavioral; Behavioral
Intervention description(s): All participants will follow the Medifast Achieve TM 4 & 2 & 1 Plan® which includes the 4 MR products per day, with the addition of 2 Lean and Green™ Meals and 1 Healthy Snack; 18 weekly, group dietary and exercise sessions led by the study staff in which participants will follow a modified Diabetes Prevention Program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: obesity; pre-diabetes; overweight; lifestyle change; glucose