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Effect of High Protein Weight Loss for Seniors

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ClinicalTrials.gov Identifier: NCT02730988
Recruitment Status : Completed
First Posted : April 7, 2016
Results First Posted : January 23, 2019
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
Wake Forest University Health Sciences
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Obesity
Weight Loss
Intervention Behavioral: Weight Stable Group
Enrollment 96
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Weight Loss Lifestyle Counseling Weight Stable Lifestyle Counseling
Hide Arm/Group Description The high protein weight loss group follows the Medifast 4 & 2 & 1 Plan™, a 1200 calorie, high protein diet targeting ~10% weight loss over 24-weeks through a combination of meal replacement products (MRPs), meal plans, and individual nutrition/behavioral counseling. The weight stable control group is monitored bi-weekly by study staff to ensure weight stability over the course of the study. During group sessions, participants are weighed and encouraged to maintain weight within ±5% of baseline. They also receive non-weight loss health related topics presented by study staff.
Period Title: Overall Study
Started 47 49
Completed 43 39
Not Completed 4 10
Arm/Group Title Weight Loss Lifestyle Counseling Weight Stable Lifestyle Counseling Total
Hide Arm/Group Description The high protein weight loss group follows the Medifast 4 & 2 & 1 Plan™, a 1200 calorie, high protein diet targeting ~10% weight loss over 24-weeks through a combination of meal replacement products (MRPs), meal plans, and individual nutrition/behavioral counseling. The weight stable control group is monitored bi-weekly by study staff to ensure weight stability over the course of the study. During group sessions, participants are weighed and encouraged to maintain weight within ±5% of baseline. They also receive non-weight loss health related topics presented by study staff. Total of all reporting groups
Overall Number of Baseline Participants 47 49 96
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 49 participants 96 participants
71.4  (3.9) 69.2  (3.1) 70.3  (3.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 49 participants 96 participants
Female
35
  74.5%
36
  73.5%
71
  74.0%
Male
12
  25.5%
13
  26.5%
25
  26.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 49 participants 96 participants
African American
14
  29.8%
14
  28.6%
28
  29.2%
Caucasian
33
  70.2%
35
  71.4%
68
  70.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 47 participants 49 participants 96 participants
47
 100.0%
49
 100.0%
96
 100.0%
1.Primary Outcome
Title Change in 400 Meter Gait Walk Speed
Hide Description Participants were asked to walk 10 laps of a 40-meter course (20 meters out and 20 meters back). The time it took to complete the 400 meters was calculated and reported in meters/second.
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number analyzed reflects those who completed both baseline and 24 week followup testing since both trials needed to show change in 400 meter walk distance and speed.
Arm/Group Title Weight Loss Lifestyle Counseling Weight Stable Lifestyle Counseling
Hide Arm/Group Description:
The high protein weight loss group follows the Medifast 4 & 2 & 1 Plan™, a 1200 calorie, high protein diet targeting ~10% weight loss over 24-weeks through a combination of meal replacement products (MRPs), meal plans, and individual nutrition/behavioral counseling.
The weight stable control group is monitored bi-weekly by study staff to ensure weight stability over the course of the study. During group sessions, participants are weighed and encouraged to maintain weight within ±5% of baseline. They also receive non-weight loss health related topics presented by study staff.
Overall Number of Participants Analyzed 42 38
Mean (95% Confidence Interval)
Unit of Measure: meters/second
0.01
(-0.02 to 0.04)
-0.02
(-0.05 to 0.01)
2.Secondary Outcome
Title Change in 24-week Lean Mass Body Composition
Hide Description Lean mass assessed by whole-body DXA and reported in kg
Time Frame Baseline and 24-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
in order to see degree of change, analysis includes participants who obtained DXA scans at both baseline and 24 weeks. Not all participants completed the baseline and final, 24-week follow-up scans.
Arm/Group Title Weight Loss Lifestyle Counseling Weight Stable Lifestyle Counseling
Hide Arm/Group Description:
The high protein weight loss group follows the Medifast 4 & 2 & 1 Plan™, a 1200 calorie, high protein diet targeting ~10% weight loss over 24-weeks through a combination of meal replacement products (MRPs), meal plans, and individual nutrition/behavioral counseling.
The weight stable control group is monitored bi-weekly by study staff to ensure weight stability over the course of the study. During group sessions, participants are weighed and encouraged to maintain weight within ±5% of baseline. They also receive non-weight loss health related topics presented by study staff.
Overall Number of Participants Analyzed 41 39
Mean (95% Confidence Interval)
Unit of Measure: kg
-0.81
(-1.40 to -0.23)
-0.24
(-0.85 to 0.36)
Time Frame 6 months from baseline
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Weight Loss Lifestyle Counseling Weight Stable Lifestyle Counseling
Hide Arm/Group Description The high protein weight loss group follows the Medifast 4 & 2 & 1 Plan™, a 1200 calorie, high protein diet targeting ~10% weight loss over 24-weeks through a combination of meal replacement products (MRPs), meal plans, and individual nutrition/behavioral counseling. The weight stable control group is monitored bi-weekly by study staff to ensure weight stability over the course of the study. During group sessions, participants are weighed and encouraged to maintain weight within ±5% of baseline. They also receive non-weight loss health related topics presented by study staff.
All-Cause Mortality
Weight Loss Lifestyle Counseling Weight Stable Lifestyle Counseling
Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)      0/49 (0.00%)    
Hide Serious Adverse Events
Weight Loss Lifestyle Counseling Weight Stable Lifestyle Counseling
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/47 (4.26%)      2/49 (4.08%)    
Ear and labyrinth disorders     
Vertigo/ear infection   0/47 (0.00%)  0 1/49 (2.04%)  1
Gastrointestinal disorders     
Bowel obstruction   1/47 (2.13%)  1 0/49 (0.00%)  0
Colitis   0/47 (0.00%)  0 1/49 (2.04%)  1
Musculoskeletal and connective tissue disorders     
Knee replacement   1/47 (2.13%)  1 0/49 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Weight Loss Lifestyle Counseling Weight Stable Lifestyle Counseling
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/47 (10.64%)      5/49 (10.20%)    
Gastrointestinal disorders     
Digestive   4/47 (8.51%)  2/49 (4.08%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal   1/47 (2.13%)  3/49 (6.12%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kristen Beavers
Organization: Wake Forest University
Phone: 3367585855
EMail: beaverkm@wfu.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences ( Wake Forest University )
ClinicalTrials.gov Identifier: NCT02730988    
Other Study ID Numbers: IRB00033428
First Submitted: February 21, 2016
First Posted: April 7, 2016
Results First Submitted: July 12, 2018
Results First Posted: January 23, 2019
Last Update Posted: January 23, 2019