ObesityPhase 3NCT00146107
Weight Loss and Exercise in Obese, Physically Limited, Older Women and Men
A Phase 3 study testing Diet, Exercise and Weight Loss and Exercise in people with Obesity, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of weight loss and exercise on physical function, body fat and muscle mass, bone strength, and quality of life. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Obesity
- What is being tested?
- Diet, Exercise and Weight Loss and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Dec 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Obese (BMI 30 or greater)
- Elderly (age 65 years or older)
- Frailty
Who cannot join
- Major chronic disease or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results.
- Examples include cardiopulmonary disease, unstable disease, severe orthopedic or neuromuscular impairments, dementia, history of malignancy during the past 5 years, or current use of bone acting drugs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63131
About this study
Official title: Weight Loss and Exercise in Frail Obese Elderly Subjects
The purpose of this study is to determine the effect of weight loss and exercise on physical function, body fat and muscle mass, bone strength, and quality of life.
Read the detailed description
Obesity causes serious medical complications and impairs quality of life. Moreover, in elderly persons, obesity can lead to frailty by exacerbating the decline in strength, endurance, balance and mobility associated with aging and physical inactivity. The primary objectives of the proposed research are to evaluate the independent and combined effects of weight loss and exercise on physical function, body composition, bone and muscle metabolism, and quality of life in frail, obese elderly men and women. The central hypothesis is that in frail obese elderly subjects, weight loss will improve physical function and quality of life, while the addition of exercise will not only augment improvement in these outcomes, but also attenuate the adverse effects of weight loss on bone and muscle masses. To test this hypothesis, 110 elderly (65-85 years old) obese men and women (body mass index [BMI] > 30 kg/m2) with physical frailty will be randomized to 4 treatment groups: 1) control, 2) 10% weight loss, 3) exercise training, and 4) 10% weight loss plus exercise training.
- Conditions
- Obesity
- Being tested
- Diet, Exercise, Weight Loss and Exercise
- Keywords
- obesity, aging, exercise, diet, weight loss, physical function, Obesity in the Elderly
- Medical subject headings
- Obesity, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietBehavioural
10 percent weight loss through diet and behavioral modification
ExerciseOther
Multicomponent (resistance, aerobic, balance) exercise three times a week
Weight Loss and ExerciseOther
10% weight loss through diet and exercise plus multicomponent exercise training three times a week
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Not described |
| 2 | Experimental | Weight loss Receives: Behavioral: Diet |
| 3 | Experimental | Exercise Receives: Other: Exercise |
| 4 | Experimental | Weight loss and exercise Receives: Other: Weight Loss and Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical function
Measured: one year
Secondary outcomes (6)
body composition
Measured: one year
muscle protein synthesis
Measured: one year
quality of life
Measured: one year
cognition and mood
Measured: one year
metabolism
Measured: one year
bone mineral density
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis T. Villareal, Washington University School of Medicine
- Investigators
- Dennis T Villareal, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146107
- Sponsor's protocol ID
- R01AG025501-01
- Other IDs
- R01AG025501
- Status last verified
- Apr 2013
- First submitted
- 1 Sep 2005
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Villareal DT, Banks M, Siener C, Sinacore DR, Klein S. Physical frailty and body composition in obese elderly men and women. Obes Res. 2004 Jun;12(6):913-20. doi: 10.1038/oby.2004.111.
PubMed 15229329Colleluori G, Chen R, Napoli N, Aguirre LE, Qualls C, Villareal DT, Armamento-Villareal R. Fat Mass Follows a U-Shaped Distribution Based on Estradiol Levels in Postmenopausal Women. Front Endocrinol (Lausanne). 2018 Jul 2;9:315. doi: 10.3389/fendo.2018.00315. eCollection 2018.
PubMed 30013511Colleluori G, Napoli N, Phadnis U, Armamento-Villareal R, Villareal DT. Effect of Weight Loss, Exercise, or Both on Undercarboxylated Osteocalcin and Insulin Secretion in Frail, Obese Older Adults. Oxid Med Cell Longev. 2017;2017:4807046. doi: 10.1155/2017/4807046. Epub 2017 Aug 23.
PubMed 28951766Napoli N, Shah K, Waters DL, Sinacore DR, Qualls C, Villareal DT. Effect of weight loss, exercise, or both on cognition and quality of life in obese older adults. Am J Clin Nutr. 2014 Jul;100(1):189-98. doi: 10.3945/ajcn.113.082883. Epub 2014 Apr 30.
PubMed 24787497Shah K, Armamento-Villareal R, Parimi N, Chode S, Sinacore DR, Hilton TN, Napoli N, Qualls C, Villareal DT. Exercise training in obese older adults prevents increase in bone turnover and attenuates decrease in hip bone mineral density induced by weight loss despite decline in bone-active hormones. J Bone Miner Res. 2011 Dec;26(12):2851-9. doi: 10.1002/jbmr.475.
PubMed 21786319Villareal DT, Chode S, Parimi N, Sinacore DR, Hilton T, Armamento-Villareal R, Napoli N, Qualls C, Shah K. Weight loss, exercise, or both and physical function in obese older adults. N Engl J Med. 2011 Mar 31;364(13):1218-29. doi: 10.1056/NEJMoa1008234.
PubMed 21449785
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss and Exercise in Frail Obese Elderly Subjects
- ClinicalTrials.gov ID
- NCT00146107
- Acronym / sponsor ID
- R01AG025501-01
- Conditions
- Obesity
- Keywords
- obesity, aging, exercise, diet, weight loss, physical function, Obesity in the Elderly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of weight loss and exercise on physical function, body fat and muscle mass, bone strength, and quality of life.
Detailed description
Obesity causes serious medical complications and impairs quality of life. Moreover, in elderly persons, obesity can lead to frailty by exacerbating the decline in strength, endurance, balance and mobility associated with aging and physical inactivity. The primary objectives of the proposed research are to evaluate the independent and combined effects of weight loss and exercise on physical function, body composition, bone and muscle metabolism, and quality of life in frail, obese elderly men and women. The central hypothesis is that in frail obese elderly subjects, weight loss will improve physical function and quality of life, while the addition of exercise will not only augment improvement in these outcomes, but also attenuate the adverse effects of weight loss on bone and muscle masses. To test this hypothesis, 110 elderly (65-85 years old) obese men and women (body mass index [BMI] > 30 kg/m2) with physical frailty will be randomized to 4 treatment groups: 1) control, 2) 10% weight loss, 3) exercise training, and 4) 10% weight loss plus exercise training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | – |
| 2 | Experimental | Behavioral: DietWeight loss |
| 3 | Experimental | Other: ExerciseExercise |
| 4 | Experimental | Other: Weight Loss and ExerciseWeight loss and exercise |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Obese (BMI 30 or greater)
- Elderly (age 65 years or older)
- Frailty
Key exclusion criteria (2 listed)
- Major chronic disease or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results.
- Examples include cardiopulmonary disease, unstable disease, severe orthopedic or neuromuscular impairments, dementia, history of malignancy during the past 5 years, or current use of bone acting drugs.
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 |
|---|---|---|
| Diet10 percent weight loss through diet and behavioral modification | Behavioural | 2 |
| ExerciseMulticomponent (resistance, aerobic, balance) exercise three times a week | Other | 3 |
| Weight Loss and Exercise10% weight loss through diet and exercise plus multicomponent exercise training three times a week | Other | 4 |
Primary outcome
physical function
Time frame: one year
6 secondary outcomes
body composition
Time frame: one year
muscle protein synthesis
Time frame: one year
quality of life
Time frame: one year
cognition and mood
Time frame: one year
metabolism
Time frame: one year
bone mineral density
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
- Background: PubMed 15229329Villareal DT, Banks M, Siener C, Sinacore DR, Klein S. Physical frailty and body composition in obese elderly men and women. Obes Res. 2004 Jun;12(6):913-20. doi: 10.1038/oby.2004.111.
- Derived from this study: PubMed 30013511Colleluori G, Chen R, Napoli N, Aguirre LE, Qualls C, Villareal DT, Armamento-Villareal R. Fat Mass Follows a U-Shaped Distribution Based on Estradiol Levels in Postmenopausal Women. Front Endocrinol (Lausanne). 2018 Jul 2;9:315. doi: 10.3389/fendo.2018.00315. eCollection 2018.
- Derived from this study: PubMed 28951766Colleluori G, Napoli N, Phadnis U, Armamento-Villareal R, Villareal DT. Effect of Weight Loss, Exercise, or Both on Undercarboxylated Osteocalcin and Insulin Secretion in Frail, Obese Older Adults. Oxid Med Cell Longev. 2017;2017:4807046. doi: 10.1155/2017/4807046. Epub 2017 Aug 23.
- Derived from this study: PubMed 24787497Napoli N, Shah K, Waters DL, Sinacore DR, Qualls C, Villareal DT. Effect of weight loss, exercise, or both on cognition and quality of life in obese older adults. Am J Clin Nutr. 2014 Jul;100(1):189-98. doi: 10.3945/ajcn.113.082883. Epub 2014 Apr 30.
- Derived from this study: PubMed 21786319Shah K, Armamento-Villareal R, Parimi N, Chode S, Sinacore DR, Hilton TN, Napoli N, Qualls C, Villareal DT. Exercise training in obese older adults prevents increase in bone turnover and attenuates decrease in hip bone mineral density induced by weight loss despite decline in bone-active hormones. J Bone Miner Res. 2011 Dec;26(12):2851-9. doi: 10.1002/jbmr.475.
- Derived from this study: PubMed 21449785Villareal DT, Chode S, Parimi N, Sinacore DR, Hilton T, Armamento-Villareal R, Napoli N, Qualls C, Shah K. Weight loss, exercise, or both and physical function in obese older adults. N Engl J Med. 2011 Mar 31;364(13):1218-29. doi: 10.1056/NEJMoa1008234.
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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.
Dennis T Villareal, MD principal investigator
Washington University School of Medicine
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 Diet, Exercise and Weight Loss and Exercise in people with Obesity, run by Washington University School of Medicine 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 3 inclusion and 2 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 23 Apr 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
physical function (time frame: one 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 NCT00146107, which also lists 6 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 23 Apr 2013.