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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00955903
First received: August 6, 2009
Last updated: November 18, 2013
Last verified: November 2013

August 6, 2009
November 18, 2013
June 2010
January 2014   (final data collection date for primary outcome measure)
Change in abdominal fat mass [ Time Frame: 1 year ] [ Designated as safety issue: No ]
maintenance of muscle and bone bass [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00955903 on ClinicalTrials.gov Archive Site
  • cardiometabolic risk factors [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • weight change/maintenance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
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: Open Label
Primary Purpose: Prevention
  • Obesity
  • Diabetes
  • Hypertension
  • Hyperlipidemia
  • Behavioral: Exercise Only
    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 Only and Reduced Calorie Diet Interventions
    Interventions:
    • Behavioral: Exercise Only
    • Behavioral: Reduced Calorie Diet
  • Active Comparator: Control
    Participants receive Exercise Only Intervention
    Intervention: Behavioral: Exercise Only
  • Active Comparator: Weight Maintenance
    Participants receive Exercise Only and a Weight Maintenance Diet Interventions
    Interventions:
    • Behavioral: Exercise Only
    • 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.
 
Active, not recruiting
180
Not Provided
January 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
Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00955903
F090430012
No
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
November 2013

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