NCT01211301

Medifast 5 & 1 Plan

Randomized Controlled Trial of the Medifast 5 & 1 Plan

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-02-01
• Completion: 2013-04-01
• First posted: 2010-09-29
• Last updated: 2013-06-19

Locations

1 site across 1 country: United States