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| Sponsor: | University of Alabama at Birmingham |
|---|---|
| Collaborator: |
Medifast, Inc. |
| Information provided by: | University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT01211301 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity Body Weight Weight Loss Overweight Nutrition Disorders |
Behavioral: Food-based, Reduced Energy Diet Plan Other: Medifast 5 & 1 Plan |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Ranomized Controlled Trial of the Medifast 5 & 1 Plan |
| Estimated Enrollment: | 120 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Food-based, Reduced Energy Diet Plan |
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.
|
| Experimental: Medifast 5 & 1 Plan |
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.
|
Eligibility| Ages Eligible for Study: | 19 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Any major disease, including:
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham Division of Preventive Medicine | |
| Birmingham, Alabama, United States, 35205 | |
| Principal Investigator: | David B. Allison, PhD. | University of Alabama at Birmingham |
| Principal Investigator: | James M. Shikany, DrPH | University of Alabama at Birmingham |
More Information
| Responsible Party: | David B. Allison, PhD., University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT01211301 History of Changes |
| Other Study ID Numbers: | F100625001 |
| Study First Received: | September 28, 2010 |
| Last Updated: | November 22, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
obesity overweight weight loss randomized controlled trial Medifast |
|
Body Weight Nutrition Disorders Obesity Weight Loss |
Overweight Signs and Symptoms Overnutrition Body Weight Changes |