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

This study is currently recruiting participants.
Verified March 2013 by University of Alabama at Birmingham
Sponsor:
Information provided by (Responsible Party):
Jamy Ard, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00955903
First received: August 6, 2009
Last updated: March 15, 2013
Last verified: March 2013
History of Changes
  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 and Diet in Older Adults
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

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 will participate in supervised exercise sessions plus follow a reduced calorie diet
 Behavioral: Exercise and Diet in Older Adults
Participants will participate in a behavioral intervention involving exercise only for the control group, weight maintenance diet and exercise for one intervention, and weight loss diet with exercise for the final group.
Active Comparator: Control
Participants are involved in exercise only intervention
 Behavioral: Exercise and Diet in Older Adults
Participants will participate in a behavioral intervention involving exercise only for the control group, weight maintenance diet and exercise for one intervention, and weight loss diet with exercise for the final group.
Active Comparator: Weight Maintenance
participants are involved in exercise and a weight maintenance diet
 Behavioral: Exercise and Diet in Older Adults
Participants will participate in a behavioral intervention involving exercise only for the control group, weight maintenance diet and exercise for one intervention, and weight loss diet with exercise for the final group.

  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

Contacts
Contact: Marilyn Hass 205-934-7918 mhaas@uabmc.edu
Contact: Brooks C Wingo, PhD 205-996-5029 bcwingo@uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Principal Investigator: Jamy D Ard, MD            
Principal Investigator: Julie L Locher, PhD MSPH            
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: Jamy Ard, MD, Associate Professor, 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: March 15, 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 May 19, 2013