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

Tracking Information

First Received Date ^ICMJE

August 6, 2009

Last Updated Date

March 15, 2013

Start Date ^ICMJE

June 2010

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

maintenance of muscle and bone bass [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00955903 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Obesity
Diabetes
Hypertension
Hyperlipidemia

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: Weight Loss
Participants will participate in supervised exercise sessions plus follow a reduced calorie diet

Intervention: Behavioral: Exercise and Diet in Older Adults
Active Comparator: Control
Participants are involved in exercise only intervention

Intervention: Behavioral: Exercise and Diet in Older Adults
Active Comparator: Weight Maintenance
participants are involved in exercise and a weight maintenance diet

Intervention: Behavioral: Exercise and Diet in Older Adults

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

180

Completion Date

Not Provided

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

65 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00955903

Other Study ID Numbers ^ICMJE

F090430012

Has Data Monitoring Committee

Responsible Party

Jamy Ard, MD, University of Alabama at Birmingham

Study Sponsor ^ICMJE

University of Alabama at Birmingham

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Jamy D Ard, MD	University of Alabama at Birmingham
Principal Investigator:	Julie Locher, PhD	University of Alabama at Birmingham

Information Provided By

University of Alabama at Birmingham

Verification Date

March 2013

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

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