Retrospective Chart Review of the 5 & 2 & 2 and 4 & 2 & 1 Plans

NCT02150837 | Completed Results

• 1 other identifier: MED 017
• Study Type: observational
• Target: 372
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

Obesity; Weight Loss; Meal replacements; Weight maintenance

Outcome Measures

Primary Outcomes (1)

• 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.).

  12 weeks

Secondary Outcomes (82)

• Percentage of Subjects Who Lose at Least 5% of Baseline Body Weight

  12 weeks

• Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight

  12 weeks

• Lean Mass

  12 weeks

• Fat Mass

  12 weeks

• Abdominal Circumference

  12 weeks

Study Arms (2)

5 & 2 & 2 Plan

MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss.

Other: 5 & 2 & 2 Plan

4 & 2 & 1 Plan

MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss.

Other: 4 & 2 & 1 Plan

Interventions

5 & 2 & 2 Plan OTHER

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.

5 & 2 & 2 Plan

4 & 2 & 1 Plan OTHER

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.

4 & 2 & 1 Plan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medifast, Inc.: lead

Study Sites (1)

Medifast, Inc.

Owings Mills, Maryland, 21117, United States

Location

Related Publications (1)

• 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.

  PMID: 26245279 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Results Point of Contact

• Title: Chris Coleman
• Organization: Medifast

ccoleman@choosemedifast.com

410-504-8161

Study Officials

• Linda M Aterburn, PhD

  Medifast, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 30, 2014
• Study Start: January 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: September 13, 2019
• Results First Posted: September 13, 2019

Record last verified: 2019-09

Locations

US (1)