Completed

Medifast Plus for Diabetics vs Standard ADA Weight Loss Program in Type II Diabetes

Study Aim

This study aims to compare the effectiveness of the Medifast Plus diet versus the standard American Diabetes Association weight loss program in managing body weight for individuals with Type II Diabetes over a period of 52 weeks.

What is being tested

Data Collection

Who is being recruted

Body Weight+10

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 2

From 18 to 65 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: July 2002

See protocol details

Summary

Principal SponsorJohns Hopkins Bloomberg School of Public Health

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2002

Actual date on which the first participant was enrolled.

This study focuses on comparing the effectiveness of two diet plans, Medifast Plus for Diabetics and a standard American Diabetes Association (ADA) weight loss program, in helping people with Type II Diabetes lose weight and improve health. The study involves 80 participants, divided into two groups, and will last for 68-86 weeks. The main goal is to understand which diet plan works better for weight loss and maintaining a healthy weight, potentially improving care for those with Type II Diabetes. During the weight loss phase, one group will receive five Medifast Plus for Diabetics supplements and one small meal daily, while the other group will follow the standard ADA weight loss program using whole foods. Both groups will attend educational lessons every other week. Once participants reach their goal weight, they will enter the weight maintenance phase. Here, one group will follow a Medifast Plus for Diabetics maintenance diet for 26 weeks, then switch to a food-based maintenance diet for another 26 weeks. The second group will follow the reverse order. The control group will maintain a food-based, no supplement diet for the entire 52-week maintenance period. Participants are encouraged to report any adverse events or changes in medications at any time during the study.

Official TitleEfficacy of 2 Diet Plans Designed for People With Type II Diabetes on Weight and Health Measures

NCT00198757

Principal SponsorJohns Hopkins Bloomberg School of Public Health

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightDiabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionGlucose Metabolism DisordersOverweight

Criteria

9 inclusion criteria required to participate

Using an acceptable method of birth control (tubal ligation, abstinence, properly used condom or diaphragm, oral or implanted contraceptives, or intrauterine device) for women of childbearing potential

Age 18-65 years of age.

Overweight (Body Mass Index between 25-40) and desiring weight loss

Normal ECG (electrocardiogram) or abnormalities deemed medically acceptable (no acute ischemic changes or V-tach, eg)

Show More Criteria

2 exclusion criteria prevent from participating

Chronic uncontrolled health problems (not including obesity and diabetes). Participants may not have bulimia, laxative abuse, substance abuse, alcohol intake > 10 drinks per week, or have an uncontrolled psychiatric disorder (major depression, bipolar disorder, etc), as determined at screening

Breast-feeding or pregnant at screening by serum pregnancy test if female of childbearing capacity. To be considered not childbearing potential, participant must be at least one year post-menopausal or surgically sterile

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

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CompletedNo study centers