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

Primary Purpose

Obesity, Diabetes, Hypertension

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Exercise

Reduced Calorie Diet

Weight Maintenance Diet

About this trial

This is an interventional prevention trial for Obesity focused on measuring glucose, insulin, lipids, C-reactive protein, adiponectin, leptin, TNF alpha, IL-6, Quality of Life, functional status

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts 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

Sites / Locations

University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Weight Loss

Control

Weight Maintenance

Arm Description

Participants receive Exercise and Reduced Calorie Diet Interventions

Participants receive Exercise Intervention

Participants receive Exercise and a Weight Maintenance Diet Interventions

Outcomes

Primary Outcome Measures

Change in Abdominal Fat Mass

Visceral adipose tissue (cm3) by MRI. Change is calculated as value at baseline minus value at 1 year

Secondary Outcome Measures

Cardiometabolic Risk Factors

We are reporting change in blood glucose. Change is calculated as value at baseline minus value at 1 year

Weight Change/Maintenance

The change in body weight at follow up of 1 year. Change is calculated as value at baseline minus value at 1 year

Full Information

NCT ID

NCT00955903

First Posted

August 6, 2009

Last Updated

August 1, 2017

Sponsor

University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT00955903

Brief Title

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

Acronym

CROSSROADS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Diabetes, Hypertension, Hyperlipidemia

Keywords

glucose, insulin, lipids, C-reactive protein, adiponectin, leptin, TNF alpha, IL-6, Quality of Life, functional status

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

167 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Weight Loss

Arm Type

Experimental

Arm Description

Participants receive Exercise and Reduced Calorie Diet Interventions

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Participants receive Exercise Intervention

Arm Title

Weight Maintenance

Arm Type

Active Comparator

Arm Description

Participants receive Exercise and a Weight Maintenance Diet Interventions

Intervention Type

Behavioral

Intervention Name(s)

Exercise

Intervention Description

Participants will participate in supervised exercise sessions

Intervention Type

Behavioral

Intervention Name(s)

Reduced Calorie Diet

Intervention Description

Participants will follow a reduced calorie diet

Intervention Type

Behavioral

Intervention Name(s)

Weight Maintenance Diet

Intervention Description

Participants will follow a weight maintenance diet

Primary Outcome Measure Information:

Title

Change in Abdominal Fat Mass

Description

Visceral adipose tissue (cm3) by MRI. Change is calculated as value at baseline minus value at 1 year

Time Frame

Baseline to 1 year

Secondary Outcome Measure Information:

Title

Cardiometabolic Risk Factors

Description

We are reporting change in blood glucose. Change is calculated as value at baseline minus value at 1 year

Time Frame

Baseline to 1 year

Title

Weight Change/Maintenance

Description

The change in body weight at follow up of 1 year. Change is calculated as value at baseline minus value at 1 year

Time Frame

Baseline to 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jamy D Ard, MD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Julie Locher, PhD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35654771

Citation

Senkus KE, Crowe-White KM, Bolland AC, Locher JL, Ard JD. Changes in adiponectin:leptin ratio among older adults with obesity following a 12-month exercise and diet intervention. Nutr Diabetes. 2022 Jun 2;12(1):30. doi: 10.1038/s41387-022-00207-1.

Results Reference

derived

PubMed Identifier

35471192

Citation

Senkus KE, Crowe-White KM, Locher JL, Ard JD. Relative fat mass assessment estimates changes in adiposity among female older adults with obesity after a 12-month exercise and diet intervention. Ann Med. 2022 Dec;54(1):1160-1166. doi: 10.1080/07853890.2022.2067352.

Results Reference

derived

PubMed Identifier

34486528

Citation

Bragg AE, Crowe-White KM, Ellis AC, Studer M, Phillips F, Samsel S, Parton J, Locher JL, Ard JD. Changes in Cardiometabolic Risk Among Older Adults with Obesity: An Ancillary Analysis of a Randomized Controlled Trial Investigating Exercise Plus Weight Maintenance and Exercise Plus Intentional Weight Loss by Caloric Restriction. J Acad Nutr Diet. 2022 Feb;122(2):354-362. doi: 10.1016/j.jand.2021.07.009. Epub 2021 Sep 1.

Results Reference

derived

PubMed Identifier

31145045

Citation

Crowe-White KM, Ellis AC, Mehta T, Locher JL, Ard JD. Dietary Quality Assessed by the HEI-2010 and Biomarkers of Cardiometabolic Disease: An Exploratory Analysis. J Am Coll Nutr. 2019 Sep-Oct;38(7):640-647. doi: 10.1080/07315724.2019.1580168. Epub 2019 May 30.

Results Reference

derived

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

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