Knee OsteoarthritisADAPTNCT00979043
The Arthritis, Diet, and Activity Promotion Trial
A study testing Dietary Weight-loss and Exercise in people with Knee Osteoarthritis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The primary purpose of this study was to determine the effect of dietary weight-loss, exercise training, or a combination of both on physical function in overweight and obese adults with knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Dietary 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
- 318 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1997to Dec 2000
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years.
- BMI ≥ 28 kg/m2.
- Knee pain on most days of the month.
- Sedentary lifestyle pattern (<20 min exercise per week for last 6 months)
- Self-reported difficulty with at least one of the following: walking 1/4 mile, climbing stairs, kneeling, bending, stooping, shopping, lifting, self-care.
- Radiographic evidence of grade 1-3 knee osteoarthritis.
Who cannot join
- Serious medical condition that precludes safe participation in exercise such as heart disease (angina, congestive heart failure), severe hypertension, COPD, renal or liver disease, insulin-dependent diabetes.
- Mini-mental state exam score <24.
- Inability to walks without a cane.
- Reported alcohol consumption >14 drinks/week.
- Inability to complete protocol.
- ST segment depression.
- Participation in another research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
The primary purpose of this study was to determine the effect of dietary weight-loss, exercise training, or a combination of both on physical function in overweight and obese adults with knee osteoarthritis (OA). In secondary analyses, the effect of weight-loss and/or exercise on OA progression, self-reported pain and inflammation were examined. In post-trial analyses, the effect of dietary weight-loss on total mortality was determined.
- Conditions
- Knee Osteoarthritis
- Being tested
- Dietary Weight-loss, Exercise
- Keywords
- knee osteoarthritis, weight-loss, exercise, obesity, physical function, total mortality
- Medical subject headings
- Osteoarthritis, Knee, Weight Loss, Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Weight-lossBehavioural
The goal of the dietary weight-loss intervention was to produce and maintain a mean weight-loss of 5% initial body weight during the 18-month intervention, using dietary counseling and behavior modification.
ExerciseBehavioural
Participants participated in resistance training (15 minutes) and aerobic exercise (30 minutes) 3d/week for 18-months. The first 4-months of the exercise training were facility-based. After 4-months, participants were allowed to transition to a home-based intervention if they chose to.
| Study group | Role | What they receive |
|---|---|---|
| Dietary weight-loss | Active comparator | The goal of the dietary weight-loss intervention was to produce and maintain a mean weight-loss of 5% initial body weight during the 18-month intervention, using dietary counseling and behavior modification. Receives: Behavioral: Dietary Weight-loss |
| Exercise | Active comparator | Participants participated in resistance training (15 minutes) and aerobic exercise (30 minutes) 3d/week for 18-months. The first 4-months of the exercise training were facility-based. After 4-months, participants were allowed to transition to a home-based intervention if they chose to. Receives: Behavioral: Exercise |
| Dietary weight-loss & exercise | Active comparator | Participants received both the dietary weight-loss and exercise interventions for 18-months Receives: Behavioral: Dietary Weight-loss; Behavioral: Exercise |
| Health lifestyle control | No intervention | The healthy-lifestyle control served as the usual care comparison group. For 3 months, participants met monthly with a health educator to discuss topics such as osteoarthritis, obesity, and exercise. Regular phone contact was maintained during months 4-18. |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-reported physical function (WOMAC scale)
Measured: baseline, 6-months, 18-months
Secondary outcomes (7)
6-minute walking distance
Measured: baseline, 6-months, 18-months
timed stair climbing
Measured: baseline, 6-months, 18-months
weight-loss
Measured: baseline, 6-months, 18-months
self-reported pain
Measured: baseline, 6-months, 18-months
progression of knee osteoarthritis, measured radiographically
Measured: baseline, 6-months, 18-months
chronic inflammation, measured according to CRP, IL-6, IL-6 soluble receptor, TNF-alpha, TNF alpha receptors 1 and 2
Measured: baseline and 18-months
total mortality
Measured: 7-9 yrs post-trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startNov 1997
- Primary completionDec 2000
- Study completionDec 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Stephen P Messier, PhD, Principal investigator, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979043
- Sponsor's protocol ID
- IRB00003799
- Other IDs
- P60AG010484-07
- Acronym
- ADAPT
- Status last verified
- Jul 2018
- First submitted
- 16 Sep 2009
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Messier 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 15146420Nicklas BJ, Ambrosius W, Messier SP, Miller GD, Penninx BW, Loeser RF, Palla S, Bleecker E, Pahor M. Diet-induced weight loss, exercise, and chronic inflammation in older, obese adults: a randomized controlled clinical trial. Am J Clin Nutr. 2004 Apr;79(4):544-51. doi: 10.1093/ajcn/79.4.544.
PubMed 15051595Miller GD, Nicklas BJ, Davis CC, Ambrosius WT, Loeser RF, Messier SP. Is serum leptin related to physical function and is it modifiable through weight loss and exercise in older adults with knee osteoarthritis? Int J Obes Relat Metab Disord. 2004 Nov;28(11):1383-90. doi: 10.1038/sj.ijo.0802737.
PubMed 15278105Chua SD Jr, Messier SP, Legault C, Lenz ME, Thonar EJ, Loeser RF. Effect of an exercise and dietary intervention on serum biomarkers in overweight and obese adults with osteoarthritis of the knee. Osteoarthritis Cartilage. 2008 Sep;16(9):1047-53. doi: 10.1016/j.joca.2008.02.002. Epub 2008 Mar 24.
PubMed 18359648
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Arthritis, Diet, and Activity Promotion Trial
- ClinicalTrials.gov ID
- NCT00979043
- Acronym / sponsor ID
- ADAPT / IRB00003799
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, weight-loss, exercise, obesity, physical function, total mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Nov 1997
- Primary completion
- Dec 2000 (actual)
- Study completion
- Dec 2000 (actual)
- First posted
- 17 Sep 2009 (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 primary purpose of this study was to determine the effect of dietary weight-loss, exercise training, or a combination of both on physical function in overweight and obese adults with knee osteoarthritis (OA). In secondary analyses, the effect of weight-loss and/or exercise on OA progression, self-reported pain and inflammation were examined. In post-trial analyses, the effect of dietary weight-loss on total mortality was determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dietary weight-loss | Active comparator | Behavioral: Dietary Weight-lossThe goal of the dietary weight-loss intervention was to produce and maintain a mean weight-loss of 5% initial body weight during the 18-month intervention, using dietary counseling and behavior modification. |
| Exercise | Active comparator | Behavioral: ExerciseParticipants participated in resistance training (15 minutes) and aerobic exercise (30 minutes) 3d/week for 18-months. The first 4-months of the exercise training were facility-based. After 4-months, participants were allowed to transition to a home-based intervention if they chose to. |
| Dietary weight-loss & exercise | Active comparator | Behavioral: Dietary Weight-loss, Behavioral: ExerciseParticipants received both the dietary weight-loss and exercise interventions for 18-months |
| Health lifestyle control | No intervention | –The healthy-lifestyle control served as the usual care comparison group. For 3 months, participants met monthly with a health educator to discuss topics such as osteoarthritis, obesity, and exercise. Regular phone contact was maintained during months 4-18. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 60 years.
- BMI ≥ 28 kg/m2.
- Knee pain on most days of the month.
- Sedentary lifestyle pattern (<20 min exercise per week for last 6 months)
- Self-reported difficulty with at least one of the following: walking 1/4 mile, climbing stairs, kneeling, bending, stooping, shopping, lifting, self-care.
Key exclusion criteria (7 listed)
- Serious medical condition that precludes safe participation in exercise such as heart disease (angina, congestive heart failure), severe hypertension, COPD, renal or liver disease, insulin-dependent diabetes.
- Mini-mental state exam score <24.
- Inability to walks without a cane.
- Reported alcohol consumption >14 drinks/week.
- Inability to complete protocol.
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 |
|---|---|---|
| Dietary Weight-lossThe goal of the dietary weight-loss intervention was to produce and maintain a mean weight-loss of 5% initial body weight during the 18-month intervention, using dietary counseling and behavior modification. | Behavioural | Dietary weight-loss, Dietary weight-loss & exercise |
| ExerciseParticipants participated in resistance training (15 minutes) and aerobic exercise (30 minutes) 3d/week for 18-months. The first 4-months of the exercise training were facility-based. After 4-months, participants were allowed to transition to a home-based intervention if they chose to. | Behavioural | Dietary weight-loss & exercise, Exercise |
Primary outcome
self-reported physical function (WOMAC scale)
Time frame: baseline, 6-months, 18-months
7 secondary outcomes
6-minute walking distance
Time frame: baseline, 6-months, 18-months
timed stair climbing
Time frame: baseline, 6-months, 18-months
weight-loss
Time frame: baseline, 6-months, 18-months
self-reported pain
Time frame: baseline, 6-months, 18-months
progression of knee osteoarthritis, measured radiographically
Time frame: baseline, 6-months, 18-months
chronic inflammation, measured according to CRP, IL-6, IL-6 soluble receptor, TNF-alpha, TNF alpha receptors 1 and 2
Time frame: baseline and 18-months
total mortality
Time frame: 7-9 yrs post-trial
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 14 Apr 2023.
- Results publication: 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.
- Results publication: PubMed 15051595Nicklas BJ, Ambrosius W, Messier SP, Miller GD, Penninx BW, Loeser RF, Palla S, Bleecker E, Pahor M. Diet-induced weight loss, exercise, and chronic inflammation in older, obese adults: a randomized controlled clinical trial. Am J Clin Nutr. 2004 Apr;79(4):544-51. doi: 10.1093/ajcn/79.4.544.
- Results publication: PubMed 15278105Miller GD, Nicklas BJ, Davis CC, Ambrosius WT, Loeser RF, Messier SP. Is serum leptin related to physical function and is it modifiable through weight loss and exercise in older adults with knee osteoarthritis? Int J Obes Relat Metab Disord. 2004 Nov;28(11):1383-90. doi: 10.1038/sj.ijo.0802737.
- Results publication: PubMed 18359648Chua SD Jr, Messier SP, Legault C, Lenz ME, Thonar EJ, Loeser RF. Effect of an exercise and dietary intervention on serum biomarkers in overweight and obese adults with osteoarthritis of the knee. Osteoarthritis Cartilage. 2008 Sep;16(9):1047-53. doi: 10.1016/j.joca.2008.02.002. Epub 2008 Mar 24.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Weight-loss and Exercise in people with Knee Osteoarthritis, run by Wake Forest University Health Sciences 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 6 inclusion and 7 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 14 Apr 2023. 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?
self-reported physical function (WOMAC scale) (time frame: baseline, 6-months, 18-months). 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 NCT00979043, which also lists 4 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 14 Apr 2023.