OsteoarthritisNCT00381290
Intensive Diet and Exercise for Improving Knee Osteoarthritis in Obese and Overweight Older Adults
A study testing Diet and Exercise in people with Osteoarthritis, run by Wake Forest University at 1 site in United States.
Trial summary
The purpose of this study is to compare the effects of a calorie-restricting diet, exercise, and a combination of both in reducing knee inflammation and compressive forces in obese and overweight adults with knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Diet and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 454 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jun 2011
- Phase
- Interventional
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grade II to III radiographic tibiofemoral OA of one or both knees
- Body mass index (BMI) of 27 to 37
- Sedentary lifestyle, defined as not participating in more than 30 minutes of formal exercise per week within the 6 months prior to study entry
Who cannot join
- Significant comorbidity that may pose a safety risk to the participant or otherwise interfere with the study. More information about this criterion can be found in the protocol.
- Previous acute knee injury
- Knee injection within 1 month of study entry
- Knee surgery within 6 months of study entry
- Knee OA other than tibiofemoral OA
- Unwilling or unable to change eating and physical activity habits due to environment
Show all 11Show fewer
- Cannot speak or read English
- Excess alcohol use (21 or more drinks per week)
- Unable to finish the 18-month study or unlikely to comply with the study
- Unable to undergo MRI of the knee
- Significant cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University/Wake Forest University Forest School of Medicine
Winston-Salem, North Carolina, 27109
About this study
Official title: Intensive Diet and Exercise for Arthritis
The purpose of this study is to compare the effects of a calorie-restricting diet, exercise, and a combination of both in reducing knee inflammation and compressive forces in obese and overweight adults with knee osteoarthritis (OA).
Read the detailed description
OA, the most common form of arthritis, occurs in about 21 million Americans. Of all the weight-bearing joints, the knee is most commonly affected by OA. Knee OA leads to physical changes to the entire joint structure, including cartilage, neighboring bone, and ligaments. Such structural changes to the knee alter joint function during movement, resulting in pain. The pain typically leads to less physical activity, leading to weight gain, followed by impaired physical function and disability.
Excessive body weight adds to the compressive forces on the knee joint and is a risk factor for OA. While there is no cure for OA, weight loss is the best nonpharmacologic way to slow OA progression. The amount of weight loss necessary to alter OA progression is unknown. The purpose of this study is to compare the effects of significant dietary restriction, exercise, and a combination of both in reducing knee inflammation and compressive forces in obese and overweight adults with knee OA. The study will also examine how diet and exercise affect everyday function and pain levels, as well as the extent of weight loss necessary for slowing OA disease progression.
This study will last 18 months. Four, 2-hour screening visits will include various questionnaires, physical exams, physical performance tests, x-rays, and blood and urine collection. Half of the participants will also undergo additional x-rays, magnetic resonance imaging (MRI), and a CT scan. Eligible participants will be randomly assigned to one of three intervention groups:
- Group 1 participants will follow a calorie-restricted diet
- Group 2 participants will follow an exercise regimen
- Group 3 participants will follow a calorie-restricted diet and an exercise regimen
Group 1 and 3 participants will aim to lose at least 10% of their body weight and drop to the next lower body mass index (BMI) class level; Group 2 participants will aim to maintain their weight. Group 1 and 3 participants will follow the prescribed diet, which will include traditional healthy food and up to two meal replacement supplements. Initially, the diet will be set to result in an overall loss of 800 to 1000 calories per day. Body weight will be monitored during weekly nutritional education and behavioral sessions. For the first 6 months, Group 1 and 3 participants will attend one individual session and three group sessions per month. During Months 7 through 18, participants will attend group sessions once every two weeks and individual sessions once every 3 months. Throughout the study, participants will record food and beverage intake in daily logs that will be collected monthly.
Group 2 and 3 participants will partake in three, 60-minute exercise sessions per week for the duration of the study. The exercise sessions will incorporate aerobic exercise and resistance training. Participants will also be encouraged to exercise at home. Body weight will be monitored monthly.
Follow-up evaluations for all participants will occur at Months 6 and 18, during which most of the screening procedures will be repeated. The Month 6 follow-up will include two study visits, and the Month 18 follow-up will include three study visits. Group 2 participants will be offered dietary counseling at the end of the study.
- Conditions
- Osteoarthritis
- Being tested
- Diet, Exercise
- Keywords
- Arthritis, Arthritis, Degenerative, Knee Health, Obesity, Overweight, Osteoarthritis, Weight Loss, Diet, Exercise, Knee Pain
- Medical subject headings
- Osteoarthritis, Arthritis, Obesity, Overweight, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietBehavioural
The prescribed diet will include traditional healthy food and up to two meal replacement supplements. Initially, the diet will be set to result in an overall loss of 800 to 1000 calories per day.
ExerciseBehavioural
The program will consist of 60-minute exercise sessions per week for the duration of the study. The exercise sessions will incorporate aerobic exercise and resistance training. Participants will also be encouraged to exercise at home.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants will follow an exercise regimen Receives: Behavioral: Exercise |
| 2 | Active comparator | Participants will follow a calorie-restricted diet Receives: Behavioral: Diet |
| 3 | Active comparator | Participants will follow a calorie-restricted diet and an exercise regimen Receives: Behavioral: Diet; Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory biomarkers
Measured: Measured at 0, 6, and 18 months (analyzed at 18 months)
Knee joint loads
Measured: Measured at 0, 6, and 18 months
Secondary outcomes (6)
Bone marrow lesions
Measured: Measured at 0 and 18 months (analyzed at 18 months)
Articular cartilage
Measured: Measured at 0 and 18 months (analyzed at 18 months)
Function
Measured: Measured at 0, 6, and 18 months
Pain
Measured: Measured at 0, 6, and 18 months
Mobility
Measured: Measured at 0, 6, and 18 months
Change in quadriceps' strength and disease progression as a function of knee alignment
Measured: Measured at 0, 6, and 18 months (analyzed at 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 454 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), General Nutrition Center, Inc
- Responsible party
- Sponsor
- Investigators
- Stephen P. Messier, PhD, Principal investigator, Wake Forest University, Department of Health and Exercise Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381290
- Sponsor's protocol ID
- R01AR052528
- Other IDs
- R01AR052528, 1R01AR052528-01A2
- Status last verified
- Sep 2011
- First submitted
- 25 Sep 2006
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Focht BC, Rejeski WJ, Ambrosius WT, Katula JA, Messier SP. Exercise, self-efficacy, and mobility performance in overweight and obese older adults with knee osteoarthritis. Arthritis Rheum. 2005 Oct 15;53(5):659-65. doi: 10.1002/art.21466.
PubMed 16208674Messier SP, Gutekunst DJ, Davis C, DeVita P. Weight loss reduces knee-joint loads in overweight and obese older adults with knee osteoarthritis. Arthritis Rheum. 2005 Jul;52(7):2026-32. doi: 10.1002/art.21139.
PubMed 15986358Messier SP, Loeser RF, Miller GD, Morgan TM, Rejeski WJ, Sevick MA, Ettinger WH Jr, Pahor M, Williamson JD. Exercise and dietary weight loss in overweight and obese older adults with knee osteoarthritis: the Arthritis, Diet, and Activity Promotion Trial. Arthritis Rheum. 2004 May;50(5):1501-10. doi: 10.1002/art.20256.
PubMed 15146420Welhaven HD, Welfley AH, Bothner B, Messier SP, Loeser RF, June RK. The metabolome of male and female individuals with knee osteoarthritis is influenced by 18-months of weight loss intervention: the IDEA trial. BMC Musculoskelet Disord. 2024 Dec 20;25(1):1057. doi: 10.1186/s12891-024-08166-7.
PubMed 39707277Munugoda IP, Beavers DP, Wirth W, Aitken DA, Loeser RF, Miller GD, Lyles M, Carr JJ, Guermazi A, Hunter DJ, Messier SP, Eckstein F. The effect of weight loss on the progression of meniscal extrusion and size in knee osteoarthritis: a post-hoc analysis of the Intensive Diet and Exercise for Arthritis (IDEA) trial. Osteoarthritis Cartilage. 2020 Apr;28(4):410-417. doi: 10.1016/j.joca.2020.01.006. Epub 2020 Jan 31.
PubMed 32014493Messier SP, Resnik AE, Beavers DP, Mihalko SL, Miller GD, Nicklas BJ, deVita P, Hunter DJ, Lyles MF, Eckstein F, Guermazi A, Loeser RF. Intentional Weight Loss in Overweight and Obese Patients With Knee Osteoarthritis: Is More Better? Arthritis Care Res (Hoboken). 2018 Nov;70(11):1569-1575. doi: 10.1002/acr.23608.
PubMed 29911741Mihalko SL, Cox P, Beavers DP, Miller GD, Nicklas BJ, Lyles M, Hunter DJ, Eckstein F, Guermazi A, Loeser RF, DeVita P, Messier SP. Effect of intensive diet and exercise on self-efficacy in overweight and obese adults with knee osteoarthritis: The IDEA randomized clinical trial. Transl Behav Med. 2019 Mar 1;9(2):227-235. doi: 10.1093/tbm/iby037.
PubMed 29635402Loeser RF, Beavers DP, Bay-Jensen AC, Karsdal MA, Nicklas BJ, Guermazi A, Hunter DJ, Messier SP. Effects of dietary weight loss with and without exercise on interstitial matrix turnover and tissue inflammation biomarkers in adults with knee osteoarthritis: the Intensive Diet and Exercise for Arthritis trial (IDEA). Osteoarthritis Cartilage. 2017 Nov;25(11):1822-1828. doi: 10.1016/j.joca.2017.07.015. Epub 2017 Jul 27.
PubMed 28756278Beavers KM, Beavers DP, Newman JJ, Anderson AM, Loeser RF Jr, Nicklas BJ, Lyles MF, Miller GD, Mihalko SL, Messier SP. Effects of total and regional fat loss on plasma CRP and IL-6 in overweight and obese, older adults with knee osteoarthritis. Osteoarthritis Cartilage. 2015 Feb;23(2):249-56. doi: 10.1016/j.joca.2014.11.005. Epub 2014 Nov 13.
PubMed 25450847Messier SP, Beavers DP, Loeser RF, Carr JJ, Khajanchi S, Legault C, Nicklas BJ, Hunter DJ, Devita P. Knee joint loading in knee osteoarthritis: influence of abdominal and thigh fat. Med Sci Sports Exerc. 2014 Sep;46(9):1677-83. doi: 10.1249/MSS.0000000000000293.
PubMed 25133996Beavers DP, Beavers KM, Loeser RF, Walton NR, Lyles MF, Nicklas BJ, Shapses SA, Newman JJ, Messier SP. The independent and combined effects of intensive weight loss and exercise training on bone mineral density in overweight and obese older adults with osteoarthritis. Osteoarthritis Cartilage. 2014 Jun;22(6):726-33. doi: 10.1016/j.joca.2014.04.002. Epub 2014 Apr 15.
PubMed 24742955Messier SP, Mihalko SL, Legault C, Miller GD, Nicklas BJ, DeVita P, Beavers DP, Hunter DJ, Lyles MF, Eckstein F, Williamson JD, Carr JJ, Guermazi A, Loeser RF. Effects of intensive diet and exercise on knee joint loads, inflammation, and clinical outcomes among overweight and obese adults with knee osteoarthritis: the IDEA randomized clinical trial. JAMA. 2013 Sep 25;310(12):1263-73. doi: 10.1001/jama.2013.277669.
PubMed 24065013Chmelo E, Nicklas B, Davis C, Miller GD, Legault C, Messier S. Physical activity and physical function in older adults with knee osteoarthritis. J Phys Act Health. 2013 Aug;10(6):777-83. doi: 10.1123/jpah.10.6.777. Epub 2012 Oct 9.
PubMed 23307503Messier SP, Legault C, Mihalko S, Miller GD, Loeser RF, DeVita P, Lyles M, Eckstein F, Hunter DJ, Williamson JD, Nicklas BJ. The Intensive Diet and Exercise for Arthritis (IDEA) trial: design and rationale. BMC Musculoskelet Disord. 2009 Jul 28;10:93. doi: 10.1186/1471-2474-10-93.
PubMed 19638215
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Diet and Exercise for Arthritis
- ClinicalTrials.gov ID
- NCT00381290
- Acronym / sponsor ID
- R01AR052528
- Conditions
- Osteoarthritis
- Keywords
- Arthritis, Arthritis, Degenerative, Knee Health, Obesity, Overweight, Osteoarthritis, Weight Loss, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 454 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), General Nutrition Center, Inc
- Study start
- Oct 2006
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 27 Sep 2006 (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 compare the effects of a calorie-restricting diet, exercise, and a combination of both in reducing knee inflammation and compressive forces in obese and overweight adults with knee osteoarthritis (OA).
Detailed description
OA, the most common form of arthritis, occurs in about 21 million Americans. Of all the weight-bearing joints, the knee is most commonly affected by OA. Knee OA leads to physical changes to the entire joint structure, including cartilage, neighboring bone, and ligaments. Such structural changes to the knee alter joint function during movement, resulting in pain. The pain typically leads to less physical activity, leading to weight gain, followed by impaired physical function and disability.
Excessive body weight adds to the compressive forces on the knee joint and is a risk factor for OA. While there is no cure for OA, weight loss is the best nonpharmacologic way to slow OA progression. The amount of weight loss necessary to alter OA progression is unknown. The purpose of this study is to compare the effects of significant dietary restriction, exercise, and a combination of both in reducing knee inflammation and compressive forces in obese and overweight adults with knee OA. The study will also examine how diet and exercise affect everyday function and pain levels, as well as the extent of weight loss necessary for slowing OA disease progression.
This study will last 18 months. Four, 2-hour screening visits will include various questionnaires, physical exams, physical performance tests, x-rays, and blood and urine collection. Half of the participants will also undergo additional x-rays, magnetic resonance imaging (MRI), and a CT scan. Eligible participants will be randomly assigned to one of three intervention groups:
- Group 1 participants will follow a calorie-restricted diet
- Group 2 participants will follow an exercise regimen
- Group 3 participants will follow a calorie-restricted diet and an exercise regimen
Group 1 and 3 participants will aim to lose at least 10% of their body weight and drop to the next lower body mass index (BMI) class level; Group 2 participants will aim to maintain their weight. Group 1 and 3 participants will follow the prescribed diet, which will include traditional healthy food and up to two meal replacement supplements. Initially, the diet will be set to result in an overall loss of 800 to 1000 calories per day. Body weight will be monitored during weekly nutritional education and behavioral sessions. For the first 6 months, Group 1 and 3 participants will attend one individual session and three group sessions per month. During Months 7 through 18, participants will attend group sessions once every two weeks and individual sessions once every 3 months. Throughout the study, participants will record food and beverage intake in daily logs that will be collected monthly.
Group 2 and 3 participants will partake in three, 60-minute exercise sessions per week for the duration of the study. The exercise sessions will incorporate aerobic exercise and resistance training. Participants will also be encouraged to exercise at home. Body weight will be monitored monthly.
Follow-up evaluations for all participants will occur at Months 6 and 18, during which most of the screening procedures will be repeated. The Month 6 follow-up will include two study visits, and the Month 18 follow-up will include three study visits. Group 2 participants will be offered dietary counseling at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: ExerciseParticipants will follow an exercise regimen |
| 2 | Active comparator | Behavioral: DietParticipants will follow a calorie-restricted diet |
| 3 | Active comparator | Behavioral: Diet, Behavioral: ExerciseParticipants will follow a calorie-restricted diet and an exercise regimen |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Grade II to III radiographic tibiofemoral OA of one or both knees
- Body mass index (BMI) of 27 to 37
- Sedentary lifestyle, defined as not participating in more than 30 minutes of formal exercise per week within the 6 months prior to study entry
Key exclusion criteria (11 listed)
- Significant comorbidity that may pose a safety risk to the participant or otherwise interfere with the study. More information about this criterion can be found in the protocol.
- Previous acute knee injury
- Knee injection within 1 month of study entry
- Knee surgery within 6 months of study entry
- Knee OA other than tibiofemoral OA
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 |
|---|---|---|
| DietThe prescribed diet will include traditional healthy food and up to two meal replacement supplements. Initially, the diet will be set to result in an overall loss of 800 to 1000 calories per day. | Behavioural | 2, 3 |
| ExerciseThe program will consist of 60-minute exercise sessions per week for the duration of the study. The exercise sessions will incorporate aerobic exercise and resistance training. Participants will also be encouraged to exercise at home. | Behavioural | 1, 3 |
Primary outcome
Inflammatory biomarkers
Time frame: Measured at 0, 6, and 18 months (analyzed at 18 months)
Knee joint loads
Time frame: Measured at 0, 6, and 18 months
6 secondary outcomes
Bone marrow lesions
Time frame: Measured at 0 and 18 months (analyzed at 18 months)
Articular cartilage
Time frame: Measured at 0 and 18 months (analyzed at 18 months)
Function
Time frame: Measured at 0, 6, and 18 months
Pain
Time frame: Measured at 0, 6, and 18 months
Mobility
Time frame: Measured at 0, 6, and 18 months
Change in quadriceps' strength and disease progression as a function of knee alignment
Time frame: Measured at 0, 6, and 18 months (analyzed at 18 months)
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 6 Nov 2017.
- Background: PubMed 16208674Focht BC, Rejeski WJ, Ambrosius WT, Katula JA, Messier SP. Exercise, self-efficacy, and mobility performance in overweight and obese older adults with knee osteoarthritis. Arthritis Rheum. 2005 Oct 15;53(5):659-65. doi: 10.1002/art.21466.
- Background: PubMed 15986358Messier SP, Gutekunst DJ, Davis C, DeVita P. Weight loss reduces knee-joint loads in overweight and obese older adults with knee osteoarthritis. Arthritis Rheum. 2005 Jul;52(7):2026-32. doi: 10.1002/art.21139.
- Background: PubMed 15146420Messier SP, Loeser RF, Miller GD, Morgan TM, Rejeski WJ, Sevick MA, Ettinger WH Jr, Pahor M, Williamson JD. Exercise and dietary weight loss in overweight and obese older adults with knee osteoarthritis: the Arthritis, Diet, and Activity Promotion Trial. Arthritis Rheum. 2004 May;50(5):1501-10. doi: 10.1002/art.20256.
- Derived from this study: PubMed 39707277Welhaven HD, Welfley AH, Bothner B, Messier SP, Loeser RF, June RK. The metabolome of male and female individuals with knee osteoarthritis is influenced by 18-months of weight loss intervention: the IDEA trial. BMC Musculoskelet Disord. 2024 Dec 20;25(1):1057. doi: 10.1186/s12891-024-08166-7.
- Derived from this study: PubMed 32014493Munugoda IP, Beavers DP, Wirth W, Aitken DA, Loeser RF, Miller GD, Lyles M, Carr JJ, Guermazi A, Hunter DJ, Messier SP, Eckstein F. The effect of weight loss on the progression of meniscal extrusion and size in knee osteoarthritis: a post-hoc analysis of the Intensive Diet and Exercise for Arthritis (IDEA) trial. Osteoarthritis Cartilage. 2020 Apr;28(4):410-417. doi: 10.1016/j.joca.2020.01.006. Epub 2020 Jan 31.
- Derived from this study: PubMed 29911741Messier SP, Resnik AE, Beavers DP, Mihalko SL, Miller GD, Nicklas BJ, deVita P, Hunter DJ, Lyles MF, Eckstein F, Guermazi A, Loeser RF. Intentional Weight Loss in Overweight and Obese Patients With Knee Osteoarthritis: Is More Better? Arthritis Care Res (Hoboken). 2018 Nov;70(11):1569-1575. doi: 10.1002/acr.23608.
- Derived from this study: PubMed 29635402Mihalko SL, Cox P, Beavers DP, Miller GD, Nicklas BJ, Lyles M, Hunter DJ, Eckstein F, Guermazi A, Loeser RF, DeVita P, Messier SP. Effect of intensive diet and exercise on self-efficacy in overweight and obese adults with knee osteoarthritis: The IDEA randomized clinical trial. Transl Behav Med. 2019 Mar 1;9(2):227-235. doi: 10.1093/tbm/iby037.
- Derived from this study: PubMed 28756278Loeser RF, Beavers DP, Bay-Jensen AC, Karsdal MA, Nicklas BJ, Guermazi A, Hunter DJ, Messier SP. Effects of dietary weight loss with and without exercise on interstitial matrix turnover and tissue inflammation biomarkers in adults with knee osteoarthritis: the Intensive Diet and Exercise for Arthritis trial (IDEA). Osteoarthritis Cartilage. 2017 Nov;25(11):1822-1828. doi: 10.1016/j.joca.2017.07.015. Epub 2017 Jul 27.
- Derived from this study: PubMed 25450847Beavers KM, Beavers DP, Newman JJ, Anderson AM, Loeser RF Jr, Nicklas BJ, Lyles MF, Miller GD, Mihalko SL, Messier SP. Effects of total and regional fat loss on plasma CRP and IL-6 in overweight and obese, older adults with knee osteoarthritis. Osteoarthritis Cartilage. 2015 Feb;23(2):249-56. doi: 10.1016/j.joca.2014.11.005. Epub 2014 Nov 13.
- Derived from this study: PubMed 25133996Messier SP, Beavers DP, Loeser RF, Carr JJ, Khajanchi S, Legault C, Nicklas BJ, Hunter DJ, Devita P. Knee joint loading in knee osteoarthritis: influence of abdominal and thigh fat. Med Sci Sports Exerc. 2014 Sep;46(9):1677-83. doi: 10.1249/MSS.0000000000000293.
- Derived from this study: PubMed 24742955Beavers DP, Beavers KM, Loeser RF, Walton NR, Lyles MF, Nicklas BJ, Shapses SA, Newman JJ, Messier SP. The independent and combined effects of intensive weight loss and exercise training on bone mineral density in overweight and obese older adults with osteoarthritis. Osteoarthritis Cartilage. 2014 Jun;22(6):726-33. doi: 10.1016/j.joca.2014.04.002. Epub 2014 Apr 15.
- Derived from this study: PubMed 24065013Messier SP, Mihalko SL, Legault C, Miller GD, Nicklas BJ, DeVita P, Beavers DP, Hunter DJ, Lyles MF, Eckstein F, Williamson JD, Carr JJ, Guermazi A, Loeser RF. Effects of intensive diet and exercise on knee joint loads, inflammation, and clinical outcomes among overweight and obese adults with knee osteoarthritis: the IDEA randomized clinical trial. JAMA. 2013 Sep 25;310(12):1263-73. doi: 10.1001/jama.2013.277669.
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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.
Stephen P. Messier, PhD principal investigator
Wake Forest University, Department of Health and Exercise Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and Exercise in people with Osteoarthritis, run by Wake Forest University 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 11 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 6 Nov 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.
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?
Inflammatory biomarkers (time frame: Measured at 0, 6, and 18 months (analyzed at 18 months)). The study lists 2 primary outcomes in all. 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 NCT00381290, which also lists 14 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 6 Nov 2017.