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

The University of Alabama at Birmingham

Status and phase: Completed; Phase 3

Conditions: Hypertension; Diabetes; Hyperlipidemia; Obesity

Treatments: Behavioral: Weight Maintenance Diet; Behavioral: Reduced Calorie Diet; Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT00955903

F090430012

Details and patient eligibility

About

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.

Enrollment: 167 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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167 participants in 3 patient groups

Weight Loss

Experimental group

Description:

Participants receive Exercise and Reduced Calorie Diet Interventions

Treatment:

Behavioral: Reduced Calorie Diet

Behavioral: Exercise

Control

Active Comparator group

Description:

Participants receive Exercise Intervention

Treatment:

Behavioral: Exercise

Weight Maintenance

Active Comparator group

Description:

Participants receive Exercise and a Weight Maintenance Diet Interventions

Treatment:

Behavioral: Weight Maintenance Diet

Behavioral: Exercise