This trial is active, not recruiting.

Conditions obesity, diabetes, hypertension, hyperlipidemia
Treatments exercise only, reduced calorie diet, weight maintenance diet
Phase phase 3
Sponsor University of Alabama at Birmingham
Start date June 2010
End date January 2014
Trial size 180 participants
Trial identifier NCT00955903, F090430012


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model factorial assignment
Masking open label
Primary purpose prevention
Participants receive Exercise Only and Reduced Calorie Diet Interventions
exercise only
Participants will participate in supervised exercise sessions
reduced calorie diet
Participants will follow a reduced calorie diet
(Active Comparator)
Participants receive Exercise Only Intervention
exercise only
Participants will participate in supervised exercise sessions
(Active Comparator)
Participants receive Exercise Only and a Weight Maintenance Diet Interventions
exercise only
Participants will participate in supervised exercise sessions
weight maintenance diet
Participants will follow a weight maintenance diet

Primary Outcomes

Change in abdominal fat mass
time frame: 1 year

Secondary Outcomes

cardiometabolic risk factors
time frame: 1 year
weight change/maintenance
time frame: 1 year

Eligibility Criteria

Male or female participants at least 65 years old.

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

Additional Information

Official title Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults
Principal investigator Jamy D Ard, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by University of Alabama at Birmingham.