ObesityPhase 3CROSSROADSNCT00955903
Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults
A Phase 3 study testing Exercise, Reduced Calorie Diet and Weight Maintenance Diet in people with Obesity and Diabetes, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes, Hypertension
- What is being tested?
- Exercise, Reduced Calorie Diet and Weight Maintenance Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Aug 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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.
- Conditions
- Obesity, Diabetes, Hypertension, Hyperlipidemia
- Being tested
- Exercise, Reduced Calorie Diet, Weight Maintenance Diet
- Keywords
- glucose, insulin, lipids, C-reactive protein, adiponectin, leptin, TNF alpha, IL-6, Quality of Life, functional status
- Medical subject headings
- Obesity, Diabetes Mellitus, Hypertension, Hyperlipidemias, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Participants will participate in supervised exercise sessions
Reduced Calorie DietBehavioural
Participants will follow a reduced calorie diet
Weight Maintenance DietBehavioural
Participants will follow a weight maintenance diet
| Study group | Role | What they receive |
|---|---|---|
| Weight Loss | Experimental | Participants receive Exercise and Reduced Calorie Diet Interventions Receives: Behavioral: Exercise; Behavioral: Reduced Calorie Diet |
| Control | Active comparator | Participants receive Exercise Intervention Receives: Behavioral: Exercise |
| Weight Maintenance | Active comparator | Participants receive Exercise and a Weight Maintenance Diet Interventions Receives: Behavioral: Exercise; Behavioral: Weight Maintenance Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Abdominal Fat Mass
Visceral adipose tissue (cm3) by MRI. Change is calculated as value at baseline minus value at 1 year
Measured: Baseline to 1 year
Secondary outcomes (2)
Cardiometabolic Risk Factors
We are reporting change in blood glucose. Change is calculated as value at baseline minus value at 1 year
Measured: Baseline to 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
Measured: Baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startJun 2010
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamy Ard, MD, University of Alabama at Birmingham
- Investigators
- Jamy D Ard, MD, Principal investigator, University of Alabama at BirminghamJulie Locher, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955903
- Sponsor's protocol ID
- F090430012
- Acronym
- CROSSROADS
- Status last verified
- Aug 2017
- First submitted
- 6 Aug 2009
- Last updated
- 5 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
DiNatale JC, Ellis AC, Ard JD, Locher JL, Crowe-White KM. The Visceral Adiposity Index (VAI) as a predictor for metabolic syndrome in a sample of older adults with obesity. Nutrition. 2026 Jul;147:113158. doi: 10.1016/j.nut.2026.113158. Epub 2026 Feb 10.
PubMed 41832848Senkus 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.
PubMed 35654771Senkus 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.
PubMed 35471192Bragg 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.
PubMed 34486528Crowe-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.
PubMed 31145045
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults
- ClinicalTrials.gov ID
- NCT00955903
- Acronym / sponsor ID
- CROSSROADS / F090430012
- Conditions
- Obesity, Diabetes, Hypertension, Hyperlipidemia
- Keywords
- glucose, insulin, lipids, C-reactive protein, adiponectin, leptin, TNF alpha, IL-6
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Aug 2009 (estimated)
- Results
- Posted 28 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Weight Loss | Experimental | Behavioral: Exercise, Behavioral: Reduced Calorie DietParticipants receive Exercise and Reduced Calorie Diet Interventions |
| Control | Active comparator | Behavioral: ExerciseParticipants receive Exercise Intervention |
| Weight Maintenance | Active comparator | Behavioral: Exercise, Behavioral: Weight Maintenance DietParticipants receive Exercise and a Weight Maintenance Diet Interventions |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseParticipants will participate in supervised exercise sessions | Behavioural | Control, Weight Loss, Weight Maintenance |
| Reduced Calorie DietParticipants will follow a reduced calorie diet | Behavioural | Weight Loss |
| Weight Maintenance DietParticipants will follow a weight maintenance diet | Behavioural | Weight Maintenance |
Primary outcome
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
2 secondary outcomes
Cardiometabolic Risk Factors
Time frame: Baseline to 1 year
Weight Change/Maintenance
Time frame: Baseline to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41832848DiNatale JC, Ellis AC, Ard JD, Locher JL, Crowe-White KM. The Visceral Adiposity Index (VAI) as a predictor for metabolic syndrome in a sample of older adults with obesity. Nutrition. 2026 Jul;147:113158. doi: 10.1016/j.nut.2026.113158. Epub 2026 Feb 10.
- Derived from this study: PubMed 35654771Senkus 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.
- Derived from this study: PubMed 35471192Senkus 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.
- Derived from this study: PubMed 34486528Bragg 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.
- Derived from this study: PubMed 31145045Crowe-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamy D Ard, MD principal investigator
University of Alabama at Birmingham
Julie Locher, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exercise, Reduced Calorie Diet and Weight Maintenance Diet in people with Obesity and Diabetes, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Abdominal Fat Mass (time frame: Baseline to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00955903, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017.