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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
August 6, 2009
August 10, 2009
April 17, 2017
June 28, 2017
September 4, 2017
June 2010
August 2014   (Final data collection date for primary outcome measure)
Change in Abdominal Fat Mass [ Time Frame: Baseline to 1 year ]
Visceral adipose tissue (cm3) by MRI. Change is calculated as value at baseline minus value at 1 year
maintenance of muscle and bone bass [ Time Frame: 1 year ]
Complete list of historical versions of study NCT00955903 on ClinicalTrials.gov Archive Site
  • Cardiometabolic Risk Factors [ Time Frame: Baseline to 1 year ]
    We are reporting change in blood glucose. Change is calculated as value at baseline minus value at 1 year
  • Weight Change/Maintenance [ Time Frame: Baseline to 1 year ]
    The change in body weight at follow up of 1 year. Change is calculated as value at baseline minus value at 1 year
  • Cardiometabolic Risk Factors [ Time Frame: 1 year ]
  • Weight Change/Maintenance [ Time Frame: 1 year ]
Not Provided
Not Provided
 
Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults
Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults
The investigators want to determine if the benefits of weight loss outweigh the potential risk in a group of older adults. The investigators will test the hypothesis that changes in diet composition alone or in conjunction with weight loss will have a significant effect on fat stores, and as a result, improve cardiometabolic risk factors and functional status in adults 65 and older.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Obesity
  • Diabetes
  • Hypertension
  • Hyperlipidemia
  • Behavioral: Exercise
    Participants will participate in supervised exercise sessions
  • Behavioral: Reduced Calorie Diet
    Participants will follow a reduced calorie diet
  • Behavioral: Weight Maintenance Diet
    Participants will follow a weight maintenance diet
  • Experimental: Weight Loss
    Participants receive Exercise and Reduced Calorie Diet Interventions
    Interventions:
    • Behavioral: Exercise
    • Behavioral: Reduced Calorie Diet
  • Active Comparator: Control
    Participants receive Exercise Intervention
    Intervention: Behavioral: Exercise
  • Active Comparator: Weight Maintenance
    Participants receive Exercise and a Weight Maintenance Diet Interventions
    Interventions:
    • Behavioral: Exercise
    • Behavioral: Weight Maintenance Diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
167
August 2014
August 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • at least 65 years of age
  • BMI 27 - 42 kg/m2 - at increased health risk (taking at least 1 medication for hypertension, hyperlipidemia, or type 2 diabetes)

Exclusion Criteria:

  • difficulties chewing or swallowing food
  • digestive diseases that may affect the ability to follow a high fiber diet
  • cognitive impairment
  • depression
  • recent weight change (+/- 10 lbs in the last 12 months)
  • poorly controlled blood pressure
  • history of non-skin cancer in last 5 years
  • cardiovascular disease event in past 6 months or severe pulmonary disease or renal failure
  • major liver dysfunction
  • current smoker or quit less than months prior
  • history of prior surgical procedures for weight control or liposuction
  • use of estrogen or testosterone replacement therapy
  • current use of insulin or sulfonylurea agents
  • current use of corticosteroids > 5 days/month on average
  • current use of medications for treatment of psychosis or manic-depressive illness
  • use of weight-loss medications in previous 3 months
  • dependence on others for food procurement or preparation
  • ischemic changes on exercise treadmill test
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00955903
F090430012
No
Not Provided
Not Provided
Jamy Ard, MD, University of Alabama at Birmingham
University of Alabama at Birmingham
Not Provided
Principal Investigator: Jamy D Ard, MD University of Alabama at Birmingham
Principal Investigator: Julie Locher, PhD University of Alabama at Birmingham
University of Alabama at Birmingham
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP