Medifast 5 & 1 Plan

Summary

The purpose of this study is to compare the effectiveness of the Medifast 5 \& 1 Plan to a food-based, reduced-energy diet plan. The study will be conducted over 52 weeks, including a 26-week weight-loss phase and a 26-week weight-maintenance phase. 120 participants will be enrolled, with 60 randomized to the Medifast 5 \& 1 Plan and 60 randomized to food-based, reduced-energy diet plan. Multiple measures will be performed at baseline, 26 weeks, and 52 weeks, including anthropometry, body composition, blood pressure, blood assays, and appetite sensations.

Conditions

• Obesity
• Body Weight
• Weight Loss
• Overweight
• Nutrition Disorders

Interventions

BEHAVIORAL

Food-based, Reduced Energy Diet Plan

Control participants will be provided with a 1000-kcal/d meal plan based on regular foods selected and procured by participants. Food lists, sample menus, and portion size references will be provided.

OTHER

Medifast 5 & 1 Plan

Participants randomized to the Medifast group will enroll online in the Medifast 5 \& 1 Plan. This plan consists of 5 portion-controlled, nutritionally-balanced Medifast Meals plus one Lean \& Green Meal each day. Medifast Meals come in individual packets that are mixed with water and microwaved or refrigerated, and are available in a wide variety of foods and flavors. There are \>70 Medifast Meal choices, and Medifast Meals may be used interchangeably, so any five Medifast Meals can be chosen for the 5 \& 1 Plan. The Medifast 5 \& 1 Plan provides approximately 800 to 1,000 kcal/d. The Lean \& Green Meal consists of a lean meat plus salad and/or vegetables selected by the participant. Intervention participants will have online access to Medifast dietitians, Medifast trainers, a Medifast message board, and a Medifast chat room, allowing them to interact with others on the Medifast 5 \& 1 Plan.

Sponsors & Collaborators

• Medifast, Inc.

  collaborator INDUSTRY

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• David B. Allison, PhD. · University of Alabama at Birmingham

• James M. Shikany, DrPH · University of Alabama at Birmingham

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-10-31

Primary Completion

2012-02-29

Completion

2013-04-30

Countries

• United States

Study Locations