N/A
Completed N=372
Retrospective Chart Review of the 5 & 2 & 2 and 4 & 2 & 1 Plans
Source: ClinicalTrials.gov NCT02150837 ↗Enrolled (actual)
372
Serious AEs
3.0%
Results posted
Sep 2019
Primary outcomePrimary: Body Weight — -28.35; -23.95 Pounds — p=<0.0001
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. 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Weight |
-29.25; -23.34 | — |
| SECONDARY Percentage of Subjects Who Lose at Least 5% of Baseline Body Weight |
75.7; 85.4 | — |
| SECONDARY Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight |
29.0; 39.9 | — |
| SECONDARY Lean Mass |
-14.35; -6.79 | — |
| SECONDARY Fat Mass |
-56.88; -32.00 | — |
| SECONDARY Abdominal Circumference |
-4.83; -5.98 | — |
| SECONDARY Waist Circumference |
-3.92; -5.35 | — |
| SECONDARY Hip Circumference |
-5.17; -4.92 | — |
| SECONDARY Blood Pressure |
-16.96; -9.52; -7.08; -5.64 | — |
| SECONDARY Pulse |
-2.29; -2.29 | — |
| SECONDARY Blood Pressure Categorical |
53.8; 49.1 | — |
| SECONDARY Resting Metabolic Rate |
10; -216.67 | — |
| SECONDARY Adherence |
82.41; 85.26 | — |
| SECONDARY Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight |
62.9; 69.6 | — |
| SECONDARY Body Weight |
-29.25; -23.34 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02150837). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.