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Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults (CROSSROADS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00955903
First Posted: August 10, 2009
Last Update Posted: September 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jamy Ard, MD, University of Alabama at Birmingham
Results First Submitted: April 17, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Obesity
Diabetes
Hypertension
Hyperlipidemia
Interventions: Behavioral: Exercise
Behavioral: Reduced Calorie Diet
Behavioral: Weight Maintenance Diet

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
3 participants were subsequently diagnosed with cancer after enrollment and thus disqualified from continuing in the trial. They were dropped from the analysis.

Reporting Groups
  Description
Weight Loss

Participants receive Exercise Only and Reduced Calorie Diet Interventions

Exercise Only: Participants will participate in supervised exercise sessions

Reduced Calorie Diet: Participants will follow a reduced calorie diet

Control

Participants receive Exercise Only Intervention

Exercise Only: Participants will participate in supervised exercise sessions

Weight Maintenance

Participants receive Exercise Only and a Weight Maintenance Diet Interventions

Exercise Only: Participants will participate in supervised exercise sessions

Weight Maintenance Diet: Participants will follow a weight maintenance diet


Participant Flow:   Overall Study
    Weight Loss   Control   Weight Maintenance
STARTED   55   54   55 
COMPLETED   49   51   48 
NOT COMPLETED   6   3   7 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Weight Loss

Participants receive Exercise Only and Reduced Calorie Diet Interventions

Exercise Only: Participants will participate in supervised exercise sessions

Reduced Calorie Diet: Participants will follow a reduced calorie diet

Control

Participants receive Exercise Only Intervention

Exercise Only: Participants will participate in supervised exercise sessions

Weight Maintenance

Participants receive Exercise Only and a Weight Maintenance Diet Interventions

Exercise Only: Participants will participate in supervised exercise sessions

Weight Maintenance Diet: Participants will follow a weight maintenance diet

Total Total of all reporting groups

Baseline Measures
   Weight Loss   Control   Weight Maintenance   Total 
Overall Participants Analyzed 
[Units: Participants]
 55   54   55   164 
Age 
[Units: Years]
Mean (Standard Deviation)
 70.3  (4.8)   69.9  (4.5)   70.5  (4.8)   70.3  (4.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      32  58.2%      37  68.5%      33  60.0%      102  62.2% 
Male      23  41.8%      17  31.5%      22  40.0%      62  37.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      1   1.8%      0   0.0%      0   0.0%      1   0.6% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      12  21.8%      15  27.8%      12  21.8%      39  23.8% 
White      42  76.4%      39  72.2%      43  78.2%      124  75.6% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
       
United States   55   54   55   164 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Abdominal Fat Mass   [ Time Frame: Baseline to 1 year ]

2.  Secondary:   Cardiometabolic Risk Factors   [ Time Frame: Baseline to 1 year ]

3.  Secondary:   Weight Change/Maintenance   [ Time Frame: Baseline to 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This trial was completed in older adults (age 65+) with at least one major risk factor for heart disease.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jamy Ard, MD
Organization: Wake Forest School of Medicine
phone: 3367169837
e-mail: jard@wakehealth.edu



Responsible Party: Jamy Ard, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00955903     History of Changes
Other Study ID Numbers: F090430012
First Submitted: August 6, 2009
First Posted: August 10, 2009
Results First Submitted: April 17, 2017
Results First Posted: June 28, 2017
Last Update Posted: September 4, 2017