NCT01211301

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2010

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

1.3 years

First QC Date

September 28, 2010

Last Update Submit

June 17, 2013

Conditions

ObesityBody WeightWeight LossOverweightNutrition Disorders

Keywords

obesityoverweightweight lossrandomized controlled trialMedifast

Outcome Measures

Primary Outcomes (1)

  • Body weight

    26 and 52 weeks

Secondary Outcomes (12)

  • Waist circumference

    26 and 52 weeks

  • Body composition as measured by bioelectrical impedence (BIA)

    26 and 52 weeks

  • Body mass index

    26 and 52 weeks

  • Low-density lipoprotein cholesterol (LDL)

    26 and 52 weeks

  • High-density lipoprotein cholesterol (HDL)

    26 and 52 weeks

  • +7 more secondary outcomes

Study Arms (2)

Food-based, Reduced Energy Diet Plan

ACTIVE COMPARATOR
Behavioral: Food-based, Reduced Energy Diet Plan

Medifast 5 & 1 Plan

EXPERIMENTAL
Other: Medifast 5 & 1 Plan

Interventions

Food-based, Reduced Energy Diet PlanBEHAVIORAL

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.

Food-based, Reduced Energy Diet Plan
Medifast 5 & 1 PlanOTHER

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.

Medifast 5 & 1 Plan

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 35-50 kg/m2
  • Interested in weight loss
  • Computer with internet access
  • Any race or ethnicity
  • Fasting glucose \<126 mg/dL at screening

You may not qualify if:

  • Participation in any weight-reduction program, weight-loss diet, or other special diet within the previous 3 months.
  • Weight loss or gain of \>5% body weight in past 6 months for any reason except post-partum weight loss.
  • Currently taking any medication that suppresses or stimulates appetite.
  • History of prior surgical procedure for weight control or liposuction.
  • Current smoker or quit smoking less than 6 months prior.
  • Any major disease, including:
  • Active cancer or cancer requiring treatment in the past 2 years (except nonmelanoma skin cancer).
  • Active or chronic infections, including self-reported HIV positivity and active tuberculosis.
  • Active cardiovascular disease or event including hospitalization or therapeutic procedures for treatment of heart disease (e.g., coronary artery bypass, percutaneous transluminal coronary angioplasty) in the past 6 months; New York Heart Association Functional Class \>2 with respect to congestive heart failure; stroke or transient ischemic attack in the past 6 months.
  • Uncontrolled hypertension: systolic blood pressure \>160 mm Hg or diastolic blood pressure \>95 mm Hg on treatment.
  • Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
  • Active kidney disease.
  • Lung disease: chronic obstructive airway disease requiring use of oxygen.
  • Diagnosed diabetes (type 1 or 2), fasting hyperglycemia (blood glucose \>126 mg/dL), or use of any anti-diabetic medications.
  • Uncompensated or uncontrolled psychiatric disease (such as schizophrenia and bipolar disorder) that, in opinion of the investigators, would impede conduct of the trial or completion of procedures.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham Division of Preventive Medicine

Birmingham, Alabama, 35205, United States

Location

Related Publications (1)

  • Shikany JM, Thomas AS, Beasley TM, Lewis CE, Allison DB. Randomized controlled trial of the Medifast 5 & 1 Plan for weight loss. Int J Obes (Lond). 2013 Dec;37(12):1571-8. doi: 10.1038/ijo.2013.43. Epub 2013 Apr 9.

    PMID: 23567927RESULT

MeSH Terms

Conditions

ObesityBody WeightWeight LossOverweightNutrition Disorders

Condition Hierarchy (Ancestors)

OvernutritionNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • David B. Allison, PhD.

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

  • James M. Shikany, DrPH

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof/Assoc Dean

Study Record Dates

First Submitted

September 28, 2010

First Posted

September 29, 2010

Study Start

October 1, 2010

Primary Completion

February 1, 2012

Study Completion

April 1, 2013

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

US(1)