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| Name | Class |
|---|---|
| BioFortis | OTHER |
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The study evaluates the effects of two commercially available weight loss programs, the TSFL and the MEDD programs, each compared to a self-directed control diet, on changes in body weight over a 16-week weight loss phase, in apparently healthy overweight and obese men and women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-directed Control | Active Comparator |
| |
| Take Shape For Life Program | Experimental |
| |
| Medifast Direct Program | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Take Shape For Life Program | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight Change | 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. | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chad Cook, PhD | Biofortis Innovation Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis Innovation Services | Addison | Illinois | 60101 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Take Shape For Life Program |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Body Weight Change | 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. | Intent-to-Treat population, includes all participants randomized into the study. | Posted | Mean | Standard Error | kg | 16 weeks |
|
16 weeks
All intervention-emergent adverse events (AEs) occurring after randomization were collected at each clinic visit for assessment of safety.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo and Neck Strain | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infections | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Arterburn, VP Scientific & Clinical Affairs | Medifast | 443-379-5191 | linda.arterburn@medifastinc.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 12, 2017 | Jun 25, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jun 21, 2016 | Jun 26, 2018 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Medifast Direct Program | Other | 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. |
|
| Self-directed Control | Other | 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: 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.
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight | Mean | Full Range | kg |
|
| Body Mass Index (BMI) | Mean | Full Range | kg/m^2 |
|
| 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. |
| OG002 | 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. |
|
|
| 0 |
| 66 |
| 1 |
| 66 |
| 15 |
| 66 |
| EG001 | 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. | 0 | 65 | 2 | 65 | 9 | 65 |
| EG002 | 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. | 0 | 67 | 1 | 67 | 12 | 67 |
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
|
| Tonsillectomy | Surgical and medical procedures | Systematic Assessment |
|
| Partial Knee Orthoplasty | Surgical and medical procedures | Systematic Assessment |
|
| Decreased frequency of bowel movements | Gastrointestinal disorders | Systematic Assessment |
|
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |