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

August 1, 2017 updated by: Jamy Ard, MD, University of Alabama at Birmingham
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Weight Loss
Participants receive Exercise and Reduced Calorie Diet Interventions
Behavioral: Exercise
Participants will participate in supervised exercise sessions
Behavioral: Reduced Calorie Diet
Participants will follow a reduced calorie diet
Active Comparator: Control
Participants receive Exercise Intervention
Behavioral: Exercise
Participants will participate in supervised exercise sessions
Active Comparator: Weight Maintenance
Participants receive Exercise and a Weight Maintenance Diet Interventions
Behavioral: Exercise
Participants will participate in supervised exercise sessions
Behavioral: Weight Maintenance Diet
Participants will follow a weight maintenance diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Abdominal Fat Mass
Time Frame: Baseline to 1 year
Visceral adipose tissue (cm3) by MRI. Change is calculated as value at baseline minus value at 1 year
Baseline to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiometabolic Risk Factors
Time Frame: Baseline to 1 year
We are reporting change in blood glucose. Change is calculated as value at baseline minus value at 1 year
Baseline to 1 year
Weight Change/Maintenance
Time Frame: Baseline to 1 year
The change in body weight at follow up of 1 year. Change is calculated as value at baseline minus value at 1 year
Baseline to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Julie Locher, PhD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

August 6, 2009

First Submitted That Met QC Criteria

August 7, 2009

First Posted (Estimate)

August 10, 2009

Study Record Updates

Last Update Posted (Actual)

September 5, 2017

Last Update Submitted That Met QC Criteria

August 1, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F090430012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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