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

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT00955903
• Collaborator: (none)
• Enrollment: 167
• Location: 1
• Arms: 3
• Duration (Months): 50
• Patients Per Site Per Month: 3.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Diabetes; Hypertension; Hyperlipidemia	Behavioral: Exercise; Behavioral: Reduced Calorie Diet; Behavioral: Weight Maintenance Diet	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 167 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Abdominal Fat Mass [Baseline to 1 year]

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

Secondary Outcome Measures

1. Cardiometabolic Risk Factors [Baseline to 1 year]

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

2. Weight Change/Maintenance [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: Jamy D Ard, MD, University of Alabama at Birmingham
• Principal Investigator: Julie Locher, PhD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jamy Ard, MD, Associate Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT00955903
• Other Study ID Numbers: F090430012
• First Posted: Aug 10, 2009
• Last Update Posted: Sep 5, 2017
• Last Verified: Aug 1, 2017

• Keywords provided by Jamy Ard, MD, Associate Professor, University of Alabama at Birmingham: glucose; insulin; lipids; C-reactive protein; adiponectin; leptin; TNF alpha; IL-6; Quality of Life; functional status
• Additional relevant MeSH terms: Hyperlipidemias

Study Results

Participant Flow

Pre-assignment Detail	3 participants were subsequently diagnosed with cancer after enrollment and thus disqualified from continuing in the trial. They were dropped from the analysis.

Arm/Group Title	Weight Loss	Control	Weight Maintenance
Arm/Group Description	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	Participants receive Exercise Only Intervention Exercise Only: Participants will participate in supervised exercise sessions	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
Period Title: Overall Study
STARTED	55	54	55
COMPLETED	49	51	48
NOT COMPLETED	6	3	7

Baseline Characteristics

Arm/Group Title	Weight Loss	Control	Weight Maintenance	Total
Arm/Group Description	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	Participants receive Exercise Only Intervention Exercise Only: Participants will participate in supervised exercise sessions	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	Total of all reporting groups
Overall Participants	55	54	55	164
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.3 (4.8)	69.9 (4.5)	70.5 (4.8)	70.3 (4.7)
Sex: Female, Male (Count of Participants)
Female	32 58.2%	37 68.5%	33 60%	102 62.2%
Male	23 41.8%	17 31.5%	22 40%	62 37.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	1 1.8%	0 0%	0 0%	1 0.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	12 21.8%	15 27.8%	12 21.8%	39 23.8%
White	42 76.4%	39 72.2%	43 78.2%	124 75.6%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	55 100%	54 100%	55 100%	164 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Weight Loss	Control	Weight Maintenance
Arm/Group Description	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	Participants receive Exercise Only Intervention Exercise Only: Participants will participate in supervised exercise sessions	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
Measure Participants	55	54	55
Mean (Standard Deviation) [Cubic cm]	-192.6 (185.2)	-21.9 (173.7)	-275 (189.2)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Weight Loss	Control	Weight Maintenance
Arm/Group Description	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	Participants receive Exercise Only Intervention Exercise Only: Participants will participate in supervised exercise sessions	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
Measure Participants	55	54	55
Mean (Standard Deviation) [mg/dL]	-7.2 (2.8)	1.2 (2.5)	-1.2 (2.5)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Weight Loss	Control	Weight Maintenance
Arm/Group Description	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	Participants receive Exercise Only Intervention Exercise Only: Participants will participate in supervised exercise sessions	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
Measure Participants	55	54	55
Mean (Standard Deviation) [Kg]	-3.9 (0.7)	-1.3 (0.7)	-0.9 (0.7)

Adverse Events

Arm/Group Title	Weight Loss		Control		Weight Maintenance
Arm/Group Description	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		Participants receive Exercise Only Intervention Exercise Only: Participants will participate in supervised exercise sessions		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
All Cause Mortality
	Weight Loss		Control		Weight Maintenance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Weight Loss		Control		Weight Maintenance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/55 (14.5%)		11/54 (20.4%)		12/55 (21.8%)
Cardiac disorders
Chest pain	0/55 (0%)	0	0/54 (0%)	0	1/55 (1.8%)	1
Heart rate and blood pressure abnormalities	1/55 (1.8%)	1	1/54 (1.9%)	1	1/55 (1.8%)	1
Musculoskeletal and connective tissue disorders
Joint surgery	1/55 (1.8%)	1	3/54 (5.6%)	3	1/55 (1.8%)	1
Broken bone	2/55 (3.6%)	2	0/54 (0%)	0	2/55 (3.6%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer	0/55 (0%)	0	2/54 (3.7%)	2	2/55 (3.6%)	2
Nervous system disorders
Pain	2/55 (3.6%)	2	1/54 (1.9%)	1	1/55 (1.8%)	1
Renal and urinary disorders
Urinary symptoms	0/55 (0%)	0	3/54 (5.6%)	3	1/55 (1.8%)	1
Reproductive system and breast disorders
Vaginal bleeding	1/55 (1.8%)	1	0/54 (0%)	0	0/55 (0%)	0
Surgical and medical procedures
Complications related to surgery	1/55 (1.8%)	1	1/54 (1.9%)	1	3/55 (5.5%)	3
Other (Not Including Serious) Adverse Events
	Weight Loss		Control		Weight Maintenance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	36/55 (65.5%)		36/54 (66.7%)		40/55 (72.7%)
Cardiac disorders
Cardiovascular	8/55 (14.5%)	8	14/54 (25.9%)	14	10/55 (18.2%)	10
Gastrointestinal disorders
Gastrointestinal	12/55 (21.8%)	12	6/54 (11.1%)	6	12/55 (21.8%)	12
General disorders
General, Constitutional	4/55 (7.3%)	4	3/54 (5.6%)	3	9/55 (16.4%)	9
Musculoskeletal and connective tissue disorders
Muscle and bone issues	34/55 (61.8%)	34	35/54 (64.8%)	35	35/55 (63.6%)	35
Nervous system disorders
Nervous system	8/55 (14.5%)	8	7/54 (13%)	7	7/55 (12.7%)	7
Psychiatric disorders
Psychiatric and mood changes	5/55 (9.1%)	5	4/54 (7.4%)	4	4/55 (7.3%)	4
Renal and urinary disorders
Genitourinary	1/55 (1.8%)	1	5/54 (9.3%)	5	3/55 (5.5%)	3

Limitations/Caveats

This trial was completed in older adults (age 65+) with at least one major risk factor for heart disease.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.