Trial Outcomes & Findings for Weight Loss Using the Take Shape For Life Program or the Medifast Direct Program Versus a Self-Directed Diet (NCT NCT02835092)

Last Updated: 2019-01-22

Results Overview

Body weight (in gown, without shoes) was measured at each clinic visit on a medical quality digital scale (Health-o-meter 349KLX, Pelstar, McCook, IL) following a 10-14-hr fast. The relevant time points to determine body weight change were baseline and 16 weeks. The value for body weight at 16 weeks minus the value at baseline was the calculation used to determine body weight change.

Recruitment status

COMPLETED

Study phase

Target enrollment

198 participants

Primary outcome timeframe

16 weeks

Results posted on

2019-01-22

Participant Flow

Participant milestones

Participant milestones
Measure	Self-directed Control Self-directed Control: The Self-directed Control Group will be assigned to a food-based, reduced calorie diet consistent with the 2015 Dietary Guidelines for Americans.	Take Shape For Life Program Take Shape For Life Program: The Take Shape For Life (TSFL) Program group will be assigned to the Optimal Weight 5 \& 1 Plan™ for weight loss. This group will have scheduled coaching sessions with a TSFL coach for the duration of the study.	Medifast Direct Program Medifast Direct Program: The Medifast Direct Program (MEDD) group will be assigned to the Medifast Achieve™ Plan (4 \& 2 \& 1 Plan®) for weight loss. MEDD participants will have access to the services of the Medifast Nutrition Support Team.
Overall Study STARTED	66	65	67
Overall Study COMPLETED	63	57	64
Overall Study NOT COMPLETED	3	8	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Self-directed Control Self-directed Control: The Self-directed Control Group will be assigned to a food-based, reduced calorie diet consistent with the 2015 Dietary Guidelines for Americans.	Take Shape For Life Program Take Shape For Life Program: The Take Shape For Life (TSFL) Program group will be assigned to the Optimal Weight 5 \& 1 Plan™ for weight loss. This group will have scheduled coaching sessions with a TSFL coach for the duration of the study.	Medifast Direct Program Medifast Direct Program: The Medifast Direct Program (MEDD) group will be assigned to the Medifast Achieve™ Plan (4 \& 2 \& 1 Plan®) for weight loss. MEDD participants will have access to the services of the Medifast Nutrition Support Team.
Overall Study Withdrawal by Subject	3	6	3
Overall Study Lost to Follow-up	0	2	0

Baseline Characteristics

Weight Loss Using the Take Shape For Life Program or the Medifast Direct Program Versus a Self-Directed Diet

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Self-directed Control n=66 Participants Self-directed Control: The Self-directed Control Group will be assigned to a food-based, reduced calorie diet consistent with the 2015 Dietary Guidelines for Americans.	Take Shape For Life Program n=65 Participants Take Shape For Life Program: The Take Shape For Life (TSFL) Program group will be assigned to the Optimal Weight 5 \& 1 Plan™ for weight loss. This group will have scheduled coaching sessions with a TSFL coach for the duration of the study.	Medifast Direct Program n=67 Participants Medifast Direct Program: The Medifast Direct Program (MEDD) group will be assigned to the Medifast Achieve™ Plan (4 \& 2 \& 1 Plan®) for weight loss. MEDD participants will have access to the services of the Medifast Nutrition Support Team.	Total n=198 Participants Total of all reporting groups
Age, Continuous	46.3 years n=5 Participants	45.2 years n=7 Participants	45.7 years n=5 Participants	45.7 years n=4 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	52 Participants n=7 Participants	54 Participants n=5 Participants	160 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	13 Participants n=7 Participants	13 Participants n=5 Participants	38 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	13 Participants n=7 Participants	10 Participants n=5 Participants	34 Participants n=4 Participants
Race (NIH/OMB) White	50 Participants n=5 Participants	45 Participants n=7 Participants	54 Participants n=5 Participants	149 Participants n=4 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants
Weight	93.90 kg n=5 Participants	95.51 kg n=7 Participants	95.80 kg n=5 Participants	95.07 kg n=4 Participants
Body Mass Index (BMI)	33.81 kg/m^2 n=5 Participants	34.49 kg/m^2 n=7 Participants	34.20 kg/m^2 n=5 Participants	34.16 kg/m^2 n=4 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Intent-to-Treat population, includes all participants randomized into the study.

Outcome measures

Outcome measures
Measure	Self-directed Control n=66 Participants Self-directed Control: The Self-directed Control Group will be assigned to a food-based, reduced calorie diet consistent with the 2015 Dietary Guidelines for Americans.	Take Shape For Life Program n=65 Participants Take Shape For Life Program: The Take Shape For Life (TSFL) Program group will be assigned to the Optimal Weight 5 \& 1 Plan™ for weight loss. This group will have scheduled coaching sessions with a TSFL coach for the duration of the study.	Medifast Direct Program n=67 Participants Medifast Direct Program: The Medifast Direct Program (MEDD) group will be assigned to the Medifast Achieve™ Plan (4 \& 2 \& 1 Plan®) for weight loss. MEDD participants will have access to the services of the Medifast Nutrition Support Team.
Body Weight Change	-0.23 kg Standard Error 0.39	-5.13 kg Standard Error 0.86	-4.98 kg Standard Error 0.69

Adverse Events

Self-directed Control

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Take Shape For Life Program

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Medifast Direct Program

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Self-directed Control n=66 participants at risk Self-directed Control: The Self-directed Control Group will be assigned to a food-based, reduced calorie diet consistent with the 2015 Dietary Guidelines for Americans.	Take Shape For Life Program n=65 participants at risk Take Shape For Life Program: The Take Shape For Life (TSFL) Program group will be assigned to the Optimal Weight 5 \& 1 Plan™ for weight loss. This group will have scheduled coaching sessions with a TSFL coach for the duration of the study.	Medifast Direct Program n=67 participants at risk Medifast Direct Program: The Medifast Direct Program (MEDD) group will be assigned to the Medifast Achieve™ Plan (4 \& 2 \& 1 Plan®) for weight loss. MEDD participants will have access to the services of the Medifast Nutrition Support Team.
Nervous system disorders Vertigo and Neck Strain	1.5% 1/66 • Number of events 1 • 16 weeks All intervention-emergent adverse events (AEs) occurring after randomization were collected at each clinic visit for assessment of safety.	0.00% 0/65 • 16 weeks All intervention-emergent adverse events (AEs) occurring after randomization were collected at each clinic visit for assessment of safety.	0.00% 0/67 • 16 weeks All intervention-emergent adverse events (AEs) occurring after randomization were collected at each clinic visit for assessment of safety.
Renal and urinary disorders Urinary Retention	0.00% 0/66 • 16 weeks All intervention-emergent adverse events (AEs) occurring after randomization were collected at each clinic visit for assessment of safety.	0.00% 0/65 • 16 weeks All intervention-emergent adverse events (AEs) occurring after randomization were collected at each clinic visit for assessment of safety.	1.5% 1/67 • Number of events 1 • 16 weeks All intervention-emergent adverse events (AEs) occurring after randomization were collected at each clinic visit for assessment of safety.
Surgical and medical procedures Tonsillectomy	0.00% 0/66 • 16 weeks All intervention-emergent adverse events (AEs) occurring after randomization were collected at each clinic visit for assessment of safety.	1.5% 1/65 • Number of events 1 • 16 weeks All intervention-emergent adverse events (AEs) occurring after randomization were collected at each clinic visit for assessment of safety.	0.00% 0/67 • 16 weeks All intervention-emergent adverse events (AEs) occurring after randomization were collected at each clinic visit for assessment of safety.
Surgical and medical procedures Partial Knee Orthoplasty	0.00% 0/66 • 16 weeks All intervention-emergent adverse events (AEs) occurring after randomization were collected at each clinic visit for assessment of safety.	1.5% 1/65 • Number of events 1 • 16 weeks All intervention-emergent adverse events (AEs) occurring after randomization were collected at each clinic visit for assessment of safety.	0.00% 0/67 • 16 weeks All intervention-emergent adverse events (AEs) occurring after randomization were collected at each clinic visit for assessment of safety.

Other adverse events

Other adverse events
Measure	Self-directed Control n=66 participants at risk Self-directed Control: The Self-directed Control Group will be assigned to a food-based, reduced calorie diet consistent with the 2015 Dietary Guidelines for Americans.	Take Shape For Life Program n=65 participants at risk Take Shape For Life Program: The Take Shape For Life (TSFL) Program group will be assigned to the Optimal Weight 5 \& 1 Plan™ for weight loss. This group will have scheduled coaching sessions with a TSFL coach for the duration of the study.	Medifast Direct Program n=67 participants at risk Medifast Direct Program: The Medifast Direct Program (MEDD) group will be assigned to the Medifast Achieve™ Plan (4 \& 2 \& 1 Plan®) for weight loss. MEDD participants will have access to the services of the Medifast Nutrition Support Team.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Infections	22.7% 15/66 • Number of events 15 • 16 weeks All intervention-emergent adverse events (AEs) occurring after randomization were collected at each clinic visit for assessment of safety.	13.8% 9/65 • Number of events 9 • 16 weeks All intervention-emergent adverse events (AEs) occurring after randomization were collected at each clinic visit for assessment of safety.	11.9% 8/67 • Number of events 8 • 16 weeks All intervention-emergent adverse events (AEs) occurring after randomization were collected at each clinic visit for assessment of safety.
Gastrointestinal disorders Decreased frequency of bowel movements	0.00% 0/66 • 16 weeks All intervention-emergent adverse events (AEs) occurring after randomization were collected at each clinic visit for assessment of safety.	0.00% 0/65 • 16 weeks All intervention-emergent adverse events (AEs) occurring after randomization were collected at each clinic visit for assessment of safety.	6.0% 4/67 • Number of events 4 • 16 weeks All intervention-emergent adverse events (AEs) occurring after randomization were collected at each clinic visit for assessment of safety.

Additional Information

Linda Arterburn, VP Scientific & Clinical Affairs

Medifast

Phone: 443-379-5191

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER