ObesityNCT00198757
Efficacy of 2 Diet Plans Designed for People With Type II Diabetes on Weight and Health Measures
A study testing Medifast Plus for Diabetics Meal Replacement Supplements and Standard ADA recommended diet for type 2 diabetics in people with Obesity and Type 2 Diabetes Mellitus, run by Johns Hopkins Bloomberg School of Public Health.
Trial summary
The objective of this study is to evaluate the efficacy of Medifast Plus for Diabetics compared to a standard weight loss treatment program, in terms of changes in weight loss in overweight men and women over an 86 week active weight loss and weight maintenance program. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes Mellitus
- What is being tested?
- Medifast Plus for Diabetics Meal Replacement Supplements and Standard ADA recommended diet for type 2 diabetics
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jul 2002to Jan 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
- Not using appetite-affecting medications (e.g., Prozac or other SSRIs, synthroid, steroids) unless on established and stable dose
- Not using weight loss drugs (phentermine, sibutramine, orlistat, eg)
- Willing and able to comply with the protocol requirements
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- Willing and able to give informed consent
- Have a regular source of health care and permission of primary care provider
- 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
Who cannot join
- 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
About this study
The objective of this study is to evaluate the efficacy of Medifast Plus for Diabetics compared to a standard weight loss treatment program, in terms of changes in weight loss in overweight men and women over an 86 week active weight loss and weight maintenance program. There will be up to 34 weeks active weight loss and 52 weeks weight maintenance. The planned sample size is 80 overweight (BMI 25-40) males and females aged 18-65 with type 2 diabetes. It is anticipated that pre-packaged meal replacements will provide an advantage to those desiring weight loss.
Read the detailed description
This study will test the efficacy of Medifast Plus for Diabetics compared to a standard American Diabetes Association (ADA) weight loss treatment program using whole foods in 80 participants (randomized into 2 groups of 40) during an active weight loss and weight maintenance program lasting 68-86 weeks. The study data collection will occur in two phases, active weight loss (phase 1) and weight maintenance (phase 2). Transition into phase 2 will be individually timed by participant attainment of a goal 'healthy' weight following a minimum of 16 weeks, or week 34, whichever comes first. A dietitian will prescribe an individualized weight loss and weight maintenance calorie levels for participants based on the Harris Benedict equation (RMR x AF x Deficit; RMR=resting metabolic rate, AF=activity factor). All participants will have a goal 'healthy' weight determined at baseline by a combination of personal participant goals, Harris Benedict equation predictions, body composition goals, and BMI range, but in no case will participants be prescribed a goal weight that would result in an BMI of less than 24. For the weight loss phase, participants will be randomly assigned to one of 2 groups, Medifast Plus for Diabetics or standard ADA weight loss treatment program. Both groups will attend educational lessons every other week during weight loss, and once every four weeks during the maintenance phase. Data collection visits will occur when goal weight is reached, at week 26 of maintenance, and week 52 of maintenance. During the weight loss phase, group 1 will receive 5 Medifast Plus for Diabetics supplements and one small meal to consume every day. As participants reach their goal weights, they will be re-randomize according to weight loss success and gender categories into two different maintenance plans. One maintenance group will first receive 26 weeks of Medifast Plus for Diabetics maintenance diet, still receiving 5 supplements/day but with a larger portion of calories coming from whole foods, followed by 26 weeks of a purely food-based maintenance diet (the same as the control group, where participants will choose all foods and receive no supplements). The second group will be a reversal of the order of maintenance diets (first the food-based maintenance for 26 weeks, and then the Medifast Plus for Diabetics maintenance for 26 weeks). The control group will remain on a food-based, no supplement maintenance diet for the entire 52-week maintenance period. Participants will be encouraged to report any adverse events or changes in medications at any time during the study
- Conditions
- Obesity, Type 2 Diabetes Mellitus
- Being tested
- Medifast Plus for Diabetics Meal Replacement Supplements, Standard ADA recommended diet for type 2 diabetics
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medifast Plus for Diabetics Meal Replacement SupplementsBehavioural
Standard ADA recommended diet for type 2 diabeticsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight (change from baseline through attaining goal or week 34,
at 26 weeks of maintenance,
at 52 weeks of maintenance
Secondary outcomes (4)
percent body fat (at baseline vs. at attainment of goal weight or at week 34, and at weeks 26 and 52 of maintenance,
blood pressure,
blood values including hemoglobin A1C, glucose, cholesterol, and triglycerides;
changes in medication costs and health related quality of life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2002
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Medifast, Inc.
- Investigators
- Lawrence J Cheskin, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198757
- Sponsor's protocol ID
- MEDI2002-01
- Status last verified
- May 2005
- First submitted
- 13 Sep 2005
- Last updated
- 20 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 2 Diet Plans Designed for People With Type II Diabetes on Weight and Health Measures
- ClinicalTrials.gov ID
- NCT00198757
- Acronym / sponsor ID
- MEDI2002-01
- Conditions
- Obesity, Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Medifast, Inc.
- Study start
- Jul 2002
- Study completion
- Jan 2005
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the efficacy of Medifast Plus for Diabetics compared to a standard weight loss treatment program, in terms of changes in weight loss in overweight men and women over an 86 week active weight loss and weight maintenance program. There will be up to 34 weeks active weight loss and 52 weeks weight maintenance. The planned sample size is 80 overweight (BMI 25-40) males and females aged 18-65 with type 2 diabetes. It is anticipated that pre-packaged meal replacements will provide an advantage to those desiring weight loss.
Detailed description
This study will test the efficacy of Medifast Plus for Diabetics compared to a standard American Diabetes Association (ADA) weight loss treatment program using whole foods in 80 participants (randomized into 2 groups of 40) during an active weight loss and weight maintenance program lasting 68-86 weeks. The study data collection will occur in two phases, active weight loss (phase 1) and weight maintenance (phase 2). Transition into phase 2 will be individually timed by participant attainment of a goal 'healthy' weight following a minimum of 16 weeks, or week 34, whichever comes first. A dietitian will prescribe an individualized weight loss and weight maintenance calorie levels for participants based on the Harris Benedict equation (RMR x AF x Deficit; RMR=resting metabolic rate, AF=activity factor). All participants will have a goal 'healthy' weight determined at baseline by a combination of personal participant goals, Harris Benedict equation predictions, body composition goals, and BMI range, but in no case will participants be prescribed a goal weight that would result in an BMI of less than 24. For the weight loss phase, participants will be randomly assigned to one of 2 groups, Medifast Plus for Diabetics or standard ADA weight loss treatment program. Both groups will attend educational lessons every other week during weight loss, and once every four weeks during the maintenance phase. Data collection visits will occur when goal weight is reached, at week 26 of maintenance, and week 52 of maintenance. During the weight loss phase, group 1 will receive 5 Medifast Plus for Diabetics supplements and one small meal to consume every day. As participants reach their goal weights, they will be re-randomize according to weight loss success and gender categories into two different maintenance plans. One maintenance group will first receive 26 weeks of Medifast Plus for Diabetics maintenance diet, still receiving 5 supplements/day but with a larger portion of calories coming from whole foods, followed by 26 weeks of a purely food-based maintenance diet (the same as the control group, where participants will choose all foods and receive no supplements). The second group will be a reversal of the order of maintenance diets (first the food-based maintenance for 26 weeks, and then the Medifast Plus for Diabetics maintenance for 26 weeks). The control group will remain on a food-based, no supplement maintenance diet for the entire 52-week maintenance period. Participants will be encouraged to report any adverse events or changes in medications at any time during the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
- Not using appetite-affecting medications (e.g., Prozac or other SSRIs, synthroid, steroids) unless on established and stable dose
- Not using weight loss drugs (phentermine, sibutramine, orlistat, eg)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medifast Plus for Diabetics Meal Replacement Supplements | Behavioural | – |
| Standard ADA recommended diet for type 2 diabetics | Behavioural | – |
Primary outcome
Body weight (change from baseline through attaining goal or week 34,
at 26 weeks of maintenance,
at 52 weeks of maintenance
4 secondary outcomes
percent body fat (at baseline vs. at attainment of goal weight or at week 34, and at weeks 26 and 52 of maintenance,
blood pressure,
blood values including hemoglobin A1C, glucose, cholesterol, and triglycerides;
changes in medication costs and health related quality of life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence J Cheskin, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
Questions about this trial
What is this clinical trial studying?
A study testing Medifast Plus for Diabetics Meal Replacement Supplements and Standard ADA recommended diet for type 2 diabetics in people with Obesity and Type 2 Diabetes Mellitus, run by Johns Hopkins Bloomberg School of Public Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (change from baseline through attaining goal or week 34,. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2005.