Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults
CROSSROADS
1 other identifier
interventional
167
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 obesity
Started Jun 2010
Longer than P75 for phase_3 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2009
CompletedFirst Posted
Study publicly available on registry
August 10, 2009
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
June 28, 2017
CompletedSeptember 5, 2017
August 1, 2017
4.2 years
August 6, 2009
April 17, 2017
August 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Abdominal Fat Mass
Visceral adipose tissue (cm3) by MRI. Change is calculated as value at baseline minus value at 1 year
Baseline to 1 year
Secondary Outcomes (2)
Cardiometabolic Risk Factors
Baseline to 1 year
Weight Change/Maintenance
Baseline to 1 year
Study Arms (3)
Weight Loss
EXPERIMENTALParticipants receive Exercise and Reduced Calorie Diet Interventions
Control
ACTIVE COMPARATORParticipants receive Exercise Intervention
Weight Maintenance
ACTIVE COMPARATORParticipants receive Exercise and a Weight Maintenance Diet Interventions
Interventions
Participants will participate in supervised exercise sessions
Participants will follow a weight maintenance diet
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Related Publications (4)
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.
PMID: 35654771DERIVEDSenkus 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.
PMID: 35471192DERIVEDBragg 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.
PMID: 34486528DERIVEDCrowe-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.
PMID: 31145045DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This trial was completed in older adults (age 65+) with at least one major risk factor for heart disease.
Results Point of Contact
- Title
- Jamy Ard, MD
- Organization
- Wake Forest School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Jamy D Ard, MD
University of Alabama at Birmingham
- PRINCIPAL INVESTIGATOR
Julie Locher, PhD
University of Alabama at Birmingham
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 6, 2009
First Posted
August 10, 2009
Study Start
June 1, 2010
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
September 5, 2017
Results First Posted
June 28, 2017
Record last verified: 2017-08