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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity Diabetes Hypertension Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Weight Loss

Participants receive Exercise and Reduced Calorie Diet Interventions

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Participants will participate in supervised exercise sessions

Reduced Calorie Diet

Intervention Type BEHAVIORAL

Participants will follow a reduced calorie diet

Control

Participants receive Exercise Intervention

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type BEHAVIORAL

Participants will participate in supervised exercise sessions

Weight Maintenance

Participants receive Exercise and a Weight Maintenance Diet Interventions

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type BEHAVIORAL

Participants will participate in supervised exercise sessions

Weight Maintenance Diet

Intervention Type BEHAVIORAL

Participants will follow a weight maintenance diet

Interventions

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Exercise

Participants will participate in supervised exercise sessions

Intervention Type BEHAVIORAL

Reduced Calorie Diet

Participants will follow a reduced calorie diet

Intervention Type BEHAVIORAL

Weight Maintenance Diet

Participants will follow a weight maintenance diet

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes