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
  Purpose

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.


Condition Intervention Phase
Obesity
Diabetes
Hypertension
Hyperlipidemia
Behavioral: Exercise Only
Behavioral: Reduced Calorie Diet
Behavioral: Weight Maintenance Diet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Change in abdominal fat mass [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cardiometabolic risk factors [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • weight change/maintenance [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: June 2010
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Weight Loss
Participants receive Exercise Only and Reduced Calorie Diet Interventions
Behavioral: Exercise Only
Participants will participate in supervised exercise sessions
Behavioral: Reduced Calorie Diet
Participants will follow a reduced calorie diet
Active Comparator: Control
Participants receive Exercise Only Intervention
Behavioral: Exercise Only
Participants will participate in supervised exercise sessions
Active Comparator: Weight Maintenance
Participants receive Exercise Only and a Weight Maintenance Diet Interventions
Behavioral: Exercise Only
Participants will participate in supervised exercise sessions
Behavioral: Weight Maintenance Diet
Participants will follow a weight maintenance diet

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955903

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Jamy D Ard, MD University of Alabama at Birmingham
Principal Investigator: Julie Locher, PhD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00955903     History of Changes
Other Study ID Numbers: F090430012
Study First Received: August 6, 2009
Last Updated: November 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
glucose
insulin
lipids
C-reactive protein
adiponectin
leptin
TNF alpha
IL-6
Quality of Life
functional status

Additional relevant MeSH terms:
Hyperlipidemias
Hypertension
Obesity
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014