ObesityNCT02150837
Retrospective Chart Review of the 5 & 2 & 2 and 4 & 2 & 1 Plans
An observational study of Obesity, run by Medifast, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to retrospectively and systematically review records of overweight and obese Medifast Weight Control Center (MWCC) members who have been assigned to the 5 \& 2 \& 2 Plan or the 4 \& 2 \& 1 Plan for weight loss to gain a better understanding of the effectiveness of these programs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- 5 & 2 & 2 Plan and 4 & 2 & 1 Plan
- How many people
- 372 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to May 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study is a systematic retrospective chart review of existing MWCC charts located in Maryland, Texas, Florida or Pennsylvania for MWCC members who used either the Medifast 5 \& 2 \& 2 Plan or the Medifast 4 \& 2 \& 1 Plan for weight loss. Charts will be reviewed for members that started either the 5 \& 2 \& 2 Plan or the 4 \& 2 \& 1 Plan on or after January 1, 2012. This start date was chosen because it represents the date when Medifast began using the current versions of the 5 \& 2 \& 2 Plan and the 4 \& 2 \& 1 Plan. Only charts of those members who are no longer in the active weight loss phase of their program at the MWCC will be considered for the study.
Who may be able to join
- Adult males and females, 18 years of age or older at the start of the weight loss program.
- Subject has a BMI ≥ 25 kg/m2.
- Subject started a weight management program at the MWCC location on or after January 1, 2012.
- Subject followed the 5 \& 2 \& 2 Plan or the 4 \& 2 \& 1 Plan for at least the first two weeks of their weight loss phase while an active member of the MWCC.
- Subject signed the Personal Health Information Consent Form.
Who cannot join
- Subject was concurrently following another weight loss program other than the 5 \& 2 \& 2 Plan or the 4 \& 2 \& 1 Plan while on that respective plan.
- Subject had documented use of prescription or over-the-counter weight loss pharmacotherapy (e.g., phentermine, Orlistat) concurrently with the 5 \& 2 \& 2 Plan or the 4 \& 2 \& 1 Plan.
- Subject completed initial consultation but did not participate in any follow-up visits.
- Subject is currently in the active weight loss phase of their program at the MWCC (Subjects in the transition or weight maintenance phases of their programs are eligible.)
- Written request by subject to revoke consent to use health information is present in subject chart.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Chart Review to Assess Weight Loss in Overweight and Obese Adults Using Either the 5 & 2 & 2 Meal Replacement Plan or the 4 & 2 & 1 Meal Replacement Plan at Medifast Weight Control Centers
The purpose of this study is to retrospectively and systematically review records of overweight and obese Medifast Weight Control Center (MWCC) members who have been assigned to the 5 \& 2 \& 2 Plan or the 4 \& 2 \& 1 Plan for weight loss to gain a better understanding of the effectiveness of these programs. The study will describe demographics of this population, along with weight loss, anthropometrics, body composition and effects on available cardiovascular parameters. Adherence to the plans will also be examined.
The study hypothesis is that the 5 \& 2 \& 2 Meal Replacement Plan and the 4 \& 2 \& 1 Meal Replacement Plan are both effective programs for weight loss in overweight and obese adults.
- Conditions
- Obesity
- Being tested
- 5 & 2 & 2 Plan, 4 & 2 & 1 Plan
- Keywords
- Obesity, Weight Loss, Meal replacements, Weight maintenance
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 & 2 & 2 PlanOther
Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.
4 & 2 & 1 PlanOther
Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
| Study group | Role | What they receive |
|---|---|---|
| 5 & 2 & 2 Plan | MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. Receives: Other: 5 & 2 & 2 Plan | |
| 4 & 2 & 1 Plan | MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. Receives: Other: 4 & 2 & 1 Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
The primary endpoint in this study is weight and the primary outcome is change from baseline body weight at 12 weeks for each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans). Change from baseline will also be examined at other predetermined time points (e.g., 1, 2, 4, 8, 16, 20 and 24 weeks, and final weight loss visit - the mean length of time from baseline to the final weight loss visit was 18.06 weeks for the 5 \& 2 \& 2 Plan and 17.35 weeks for the 4 \& 2 \& 1 Plan.).
Measured: 12 weeks
Secondary outcomes (82)
Percentage of Subjects Who Lose at Least 5% of Baseline Body Weight
The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).
Measured: 12 weeks
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).
Measured: 12 weeks
Lean Mass
Lean mass expressed as an absolute change from baseline.
Measured: 12 weeks
Fat Mass
Fat mass expressed as an absolute change from baseline.
Measured: 12 weeks
Abdominal Circumference
Abdominal circumference expressed as an absolute change from baseline.
Measured: 12 weeks
Waist Circumference
Waist circumference expressed as an absolute change from baseline.
Measured: 12 weeks
Hip Circumference
Hip circumference expressed as an absolute change from baseline.
Measured: 12 weeks
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Measured: 12 weeks
Pulse
Pulse expressed as an absolute change from baseline.
Measured: 12 weeks
Blood Pressure Categorical
Blood pressure expressed as a categorical variable (normotensive, pre-hypertensive and hypertensive based on National Institute of Health Guidelines) with the percent of participants that improved (e.g. from hypertensive to pre-hypertensive or normal) their blood pressure category from baseline to 12 weeks.
Measured: 12 weeks
Resting Metabolic Rate
Resting metabolic rate expressed as an absolute change from baseline to final weight loss visit (The average length of time from baseline to the final weight loss visit was 18 weeks for the 5 \& 2 \& 2 Plan and 17 weeks for the 4 \& 2 \& 1 Plan.).
Measured: Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)
Adherence
Adherence will be assessed through attendance at weekly visits and documented use of meal replacements at each visit. (Meal replacement adherence=average number of self-reported daily meal replacements through 12 weeks/nuber of prescribed meal replacements; Attendance adherence=number of visits/number of weeks on plan
Measured: 12 weeks
Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).
Measured: 1 weeks
Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).
Measured: 2 weeks
Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).
Measured: 4 weeks
Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).
Measured: 8 weeks
Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).
Measured: 16 weeks
Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).
Measured: 20 weeks
Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).
Measured: 24 weeks
Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans) at their final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 \& 2 \& 2 Plan and 17 weeks for the 4 \& 2 \& 1 Plan.).
Measured: Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).
Measured: 1 weeks
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).
Measured: 2 weeks
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).
Measured: 4 weeks
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).
Measured: 8 weeks
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).
Measured: 16 weeks
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).
Measured: 20 weeks
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).
Measured: 24 weeks
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans) at their final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 \& 2 \& 2 Plan and 17 weeks for the 4 \& 2 \& 1 Plan.).
Measured: Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)
Lean Mass
Lean mass expressed as an absolute change from baseline.
Measured: 4 weeks
Lean Mass
Lean mass expressed as an absolute change from baseline.
Measured: 8 weeks
Lean Mass
Lean mass expressed as an absolute change from baseline.
Measured: 16 weeks
Lean Mass
Lean mass expressed as an absolute change from baseline.
Measured: 20 weeks
Lean Mass
Lean mass expressed as an absolute change from baseline.
Measured: 24 weeks
Fat Mass
Fat mass expressed as an absolute change from baseline.
Measured: 4 weeks
Fat Mass
Fat mass expressed as an absolute change from baseline.
Measured: 8 weeks
Fat Mass
Fat mass expressed as an absolute change from baseline.
Measured: 16 weeks
Fat Mass
Fat mass expressed as an absolute change from baseline.
Measured: 20 weeks
Abdominal Circumference
Abdominal circumference expressed as an absolute change from baseline.
Measured: 4 weeks
Abdominal Circumference
Abdominal circumference expressed as an absolute change from baseline.
Measured: 8 weeks
Abdominal Circumference
Abdominal circumference expressed as an absolute change from baseline.
Measured: 16 weeks
Abdominal Circumference
Abdominal circumference expressed as an absolute change from baseline.
Measured: 20 weeks
Abdominal Circumference
Abdominal circumference expressed as an absolute change from baseline.
Measured: 24 weeks
Waist Circumference
Waist circumference expressed as an absolute from baseline.
Measured: 4 weeks
Waist Circumference
Waist circumference expressed as an absolute change from baseline.
Measured: 8 weeks
Waist Circumference
Waist circumference expressed as an absolute change from baseline.
Measured: 16 weeks
Waist Circumference
Waist circumference expressed as an absolute change from baseline.
Measured: 20 weeks
Waist Circumference
Waist circumference expressed as an absolute change from baseline.
Measured: 24 weeks
Hip Circumference
Hip circumference expressed as an absolute change from baseline.
Measured: 4 weeks
Hip Circumference
Hip circumference expressed as an absolute change from baseline.
Measured: 8 weeks
Hip Circumference
Hip circumference expressed as an absolute change from baseline.
Measured: 16 weeks
Hip Circumference
Hip circumference expressed as an absolute change from baseline.
Measured: 20 weeks
Hip Circumference
Hip circumference expressed as an absolute change from baseline.
Measured: 24 weeks
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Measured: 1 weeks
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Measured: 2 weeks
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Measured: 4 weeks
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Measured: 8 weeks
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Measured: 16 weeks
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Measured: 20 weeks
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Measured: 24 weeks
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline to final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 \& 2 \& 2 Plan and 17 weeks for the 4 \& 2 \& 1 Plan.).
Measured: Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)
Pulse
Pulse expressed as an absolute change from baseline.
Measured: 1 weeks
Pulse
Pulse expressed as an absolute change from baseline.
Measured: 2 weeks
Pulse
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Measured: 4 weeks
Pulse
Pulse expressed as an absolute change from baseline.
Measured: 8 weeks
Pulse
Pulse expressed as an absolute change from baseline.
Measured: 16 weeks
Pulse
Pulse expressed as an absolute change from baseline.
Measured: 20 weeks
Pulse
Pulse expressed as an absolute change from baseline.
Measured: 24 weeks
Pulse
Pulse expressed as an absolute change from baseline to final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 \& 2 \& 2 Plan and 17 weeks for the 4 \& 2 \& 1 Plan.).
Measured: Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)
Adherence
Adherence will be assessed through documented use of meal replacements at each visit.
Measured: 4 weeks
Adherence
Adherence will be assessed through documented use of meal replacements at each visit.
Measured: 8 weeks
Adherence
Adherence will be assessed through documented use of meal replacements at each visit.
Measured: 16 weeks
Adherence
Adherence will be assessed through documented use of meal replacements at each visit.
Measured: 20 weeks
Adherence
Adherence will be assessed through documented use of meal replacements at each visit.
Measured: 24 weeks
Adherence
Adherence will be assessed through documented use of meal replacements at each visit from baseline (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 \& 2 \& 2 Plan and 17 weeks for the 4 \& 2 \& 1 Plan.).
Measured: Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)
Body Weight
Change in body weight from baseline reported as absolute change.
Measured: 1 week
Body Weight
Change in body weight from baseline reported as absolute change from baseline.
Measured: 2 weeks
Body Weight
Change in body weight from baseline reported absolute change from baseline.
Measured: 4 weeks
Body Weight
Change in body weight from baseline reported as absolute change.
Measured: 8 weeks
Body Weight
Change in body weight from baseline reported as absolute change.
Measured: 16 weeks
Body Weight
Change in body weight from baseline reported as absolute change.
Measured: 20 weeks
Body Weight
Change in body weight from baseline to final weight loss visit reported as absolute change. (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 \& 2 \& 2 Plan and 17 weeks for the 4 \& 2 \& 1 Plan.)
Measured: Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)
Fat Mass
Fat mass expressed as an absolute change from baseline.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medifast, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linda M Aterburn, PhD, Principal investigator, Medifast, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150837
- Sponsor's protocol ID
- MED 017
- Status last verified
- Sep 2019
- First submitted
- 21 May 2014
- Last updated
- 13 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Coleman CD, Kiel JR, Mitola AH, Langford JS, Davis KN, Arterburn LM. Effectiveness of a Medifast meal replacement program on weight, body composition and cardiometabolic risk factors in overweight and obese adults: a multicenter systematic retrospective chart review study. Nutr J. 2015 Aug 6;14:77. doi: 10.1186/s12937-015-0062-8.
PubMed 26245279
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Chart Review to Assess Weight Loss in Overweight and Obese Adults Using Either the 5 & 2 & 2 Meal Replacement Plan or the 4 & 2 & 1 Meal Replacement Plan at Medifast Weight Control Centers
- ClinicalTrials.gov ID
- NCT02150837
- Acronym / sponsor ID
- MED 017
- Conditions
- Obesity
- Keywords
- Obesity, Weight Loss, Meal replacements, Weight maintenance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- Medifast, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Posted 13 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to retrospectively and systematically review records of overweight and obese Medifast Weight Control Center (MWCC) members who have been assigned to the 5 \& 2 \& 2 Plan or the 4 \& 2 \& 1 Plan for weight loss to gain a better understanding of the effectiveness of these programs. The study will describe demographics of this population, along with weight loss, anthropometrics, body composition and effects on available cardiovascular parameters. Adherence to the plans will also be examined.
The study hypothesis is that the 5 \& 2 \& 2 Meal Replacement Plan and the 4 \& 2 \& 1 Meal Replacement Plan are both effective programs for weight loss in overweight and obese adults.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 & 2 & 2 Plan | – | Other: 5 & 2 & 2 PlanMWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. |
| 4 & 2 & 1 Plan | – | Other: 4 & 2 & 1 PlanMWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study is a systematic retrospective chart review of existing MWCC charts located in Maryland, Texas, Florida or Pennsylvania for MWCC members who used either the Medifast 5 \& 2 \& 2 Plan or the Medifast 4 \& 2 \& 1 Plan for weight loss. Charts will be reviewed for members that started either the 5 \& 2 \& 2 Plan or the 4 \& 2 \& 1 Plan on or after January 1, 2012. This start date was chosen because it represents the date when Medifast began using the current versions of the 5 \& 2 \& 2 Plan and the 4 \& 2 \& 1 Plan. Only charts of those members who are no longer in the active weight loss phase of their program at the MWCC will be considered for the study.
Key inclusion criteria (5 listed)
- Adult males and females, 18 years of age or older at the start of the weight loss program.
- Subject has a BMI ≥ 25 kg/m2.
- Subject started a weight management program at the MWCC location on or after January 1, 2012.
- Subject followed the 5 \& 2 \& 2 Plan or the 4 \& 2 \& 1 Plan for at least the first two weeks of their weight loss phase while an active member of the MWCC.
- Subject signed the Personal Health Information Consent Form.
Key exclusion criteria (5 listed)
- Subject was concurrently following another weight loss program other than the 5 \& 2 \& 2 Plan or the 4 \& 2 \& 1 Plan while on that respective plan.
- Subject had documented use of prescription or over-the-counter weight loss pharmacotherapy (e.g., phentermine, Orlistat) concurrently with the 5 \& 2 \& 2 Plan or the 4 \& 2 \& 1 Plan.
- Subject completed initial consultation but did not participate in any follow-up visits.
- Subject is currently in the active weight loss phase of their program at the MWCC (Subjects in the transition or weight maintenance phases of their programs are eligible.)
- Written request by subject to revoke consent to use health information is present in subject chart.
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 |
|---|---|---|
| 5 & 2 & 2 PlanMedifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit. | Other | 5 & 2 & 2 Plan |
| 4 & 2 & 1 PlanMedifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit. | Other | 4 & 2 & 1 Plan |
Primary outcome
Body Weight
Time frame: 12 weeks
The primary endpoint in this study is weight and the primary outcome is change from baseline body weight at 12 weeks for each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans). Change from baseline will also be examined at other predetermined time points (e.g., 1, 2, 4, 8, 16, 20 and 24 weeks, and final weight loss visit - the mean length of time from baseline to the final weight loss visit was 18.06 weeks for the 5 \& 2 \& 2 Plan and 17.35 weeks for the 4 \& 2 \& 1 Plan.).
82 secondary outcomes
Percentage of Subjects Who Lose at Least 5% of Baseline Body Weight
Time frame: 12 weeks
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
Time frame: 12 weeks
Lean Mass
Time frame: 12 weeks
Fat Mass
Time frame: 12 weeks
Abdominal Circumference
Time frame: 12 weeks
Waist Circumference
Time frame: 12 weeks
Hip Circumference
Time frame: 12 weeks
Blood Pressure
Time frame: 12 weeks
Pulse
Time frame: 12 weeks
Blood Pressure Categorical
Time frame: 12 weeks
Resting Metabolic Rate
Time frame: Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)
Adherence
Time frame: 12 weeks
Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
Time frame: 1 weeks
Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
Time frame: 2 weeks
Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
Time frame: 4 weeks
Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
Time frame: 8 weeks
Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
Time frame: 16 weeks
Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
Time frame: 20 weeks
Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
Time frame: 24 weeks
Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
Time frame: Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
Time frame: 1 weeks
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
Time frame: 2 weeks
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
Time frame: 4 weeks
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
Time frame: 8 weeks
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
Time frame: 16 weeks
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
Time frame: 20 weeks
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
Time frame: 24 weeks
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
Time frame: Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)
Lean Mass
Time frame: 4 weeks
Lean Mass
Time frame: 8 weeks
Lean Mass
Time frame: 16 weeks
Lean Mass
Time frame: 20 weeks
Lean Mass
Time frame: 24 weeks
Fat Mass
Time frame: 4 weeks
Fat Mass
Time frame: 8 weeks
Fat Mass
Time frame: 16 weeks
Fat Mass
Time frame: 20 weeks
Abdominal Circumference
Time frame: 4 weeks
Abdominal Circumference
Time frame: 8 weeks
Abdominal Circumference
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26245279Coleman CD, Kiel JR, Mitola AH, Langford JS, Davis KN, Arterburn LM. Effectiveness of a Medifast meal replacement program on weight, body composition and cardiometabolic risk factors in overweight and obese adults: a multicenter systematic retrospective chart review study. Nutr J. 2015 Aug 6;14:77. doi: 10.1186/s12937-015-0062-8.
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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.
Linda M Aterburn, PhD principal investigator
Medifast, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Medifast, Inc. at 1 site in United States.
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 5 inclusion and 5 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 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 13 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02150837, which also lists 1 linked publication.
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 13 Sep 2019.