Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults - Full Text View

Sponsored by:	University of Alabama at Birmingham
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00955903

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
Blood Pressure Cardiometabolic Risk	Behavioral: Exercise and Diet in Older Adults	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Factorial Assignment

Resource links provided by NLM:

MedlinePlus related topics: Diets Exercise and Physical Fitness Weight Control

U.S. FDA Resources

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

Primary Outcome Measures:

maintenance of muscle and bone bass [ 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:	January 2010
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Weight Loss: Experimental 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.
Control: Active Comparator 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.
Weight Maintenance: Active Comparator 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 30-40 kg/m x m
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: Catherine B Dempsey, MA, RD, LD	205-975-4907	cbdempsey@uab.edu
Contact: Wendy K Jefferson, MA	205-996-4697	wendykjefferson@uab.edu

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294

Sponsors and Collaborators

University of Alabama at Birmingham

More Information

No publications provided

Responsible Party:	University of Alabama at Birmingham ( Jamy Ard, MD )
Study ID Numbers:	F090430012
Study First Received:	August 6, 2009
Last Updated:	August 7, 2009
ClinicalTrials.gov Identifier:	NCT00955903 History of Changes
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

Study placed in the following topic categories:

Quality of Life
Insulin

ClinicalTrials.gov processed this record on September 11, 2009