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OsteoarthritisCLIP-OANCT02835326

Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients

A study testing Exercise and Dietary Weight Loss and Walk with Ease in people with Osteoarthritis, run by Ohio State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Collaborative Lifestyle Intervention Program in Knee OsteoArthritis Patients (CLIP-OA) compares a novel community-based exercise and dietary weight loss program to the Arthritis Foundation's Walk with Ease intervention on improved mobility in knee osteoarthritis (OA) patients. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Osteoarthritis
What is being tested?
Exercise and Dietary Weight Loss and Walk with Ease
Could I receive a placebo?
No, everyone receives an active treatment
How many people
227 participants
Where
1 siteUnited States
Study dates
Oct 2016to Apr 2022
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 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Diagnosed with knee OA: physician documented radiographic tibiofemoral OA of one or both knees
  • Overweight or Obese: BMI >25 and <40
  • Knee Pain and Risk for Mobility Disability: self-reported difficulty walking ¼ mile, climbing stairs, lifting or carrying groceries, or performing other household activities due to knee pain
  • Sedentary: sedentary lifestyle defined as currently participating < 20 minutes of weekly structured moderate intensity exercise occurring in bouts >10 min
  • Health Status: all participants must be free of severe heart or systemic disease that would make moderate intensity exercise participation unsafe
  • Age: > 50 years of age
Show all 9Show fewer
  • Stability of Residence: does not plan to move out of the Columbus metropolitan area for the duration of the study
  • Consents: willing to give an informed consent and sign a HIPPA authorization form; (9) Physician Consent: treating rheumatologist and primary care physician provide medical consent for participation
  • Agreeableness: willing to accept randomization and complete all assessment and intervention procedures

Who cannot join

  • Health Status: any serious medical condition that precludes safe participation in an exercise program
  • Study Staff Judgment: Inability to complete the study protocol, in the opinion of the study staff, due to frailty, illness, or other reasons

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Ohio State University

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: The Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients: CLIP-OA

The Collaborative Lifestyle Intervention Program in Knee OsteoArthritis Patients (CLIP-OA) compares a novel community-based exercise and dietary weight loss program to the Arthritis Foundation's Walk with Ease intervention on improved mobility in knee osteoarthritis (OA) patients.

Read the detailed description

Knee OA is a chronic, progressive, degenerative disease that affects over 20 million Americans, and is cited as the primary cause for activity restriction and physical disability in older adults. The joint damage and symptoms (i.e., pain, stiffness, and fatigue) accompanying symptomatic knee OA result in activity restriction, muscle atrophy, reduced quality of life and difficulty in performance of functional tasks.

Despite the well-established benefits of the Arthritis Foundation's (AF) exercise programs, recent evidence suggests that lifestyle interventions combining Exercise and Dietary Weight Loss (EX+DWL) results in superior improvements in key clinical outcomes in older, overweight or obese knee OA patients.

Primary Aim: To compare the effects of a novel community-based EX+DWL program to AF's Walk with Ease (WWE) EX intervention on improved mobility in knee osteoarthritis (OA) patients.

Secondary Aim: To compare the cost effectiveness and effects of the EX+DWL and WWE interventions on weight loss, pain, and quality of life.

Conditions
Osteoarthritis
Being tested
Exercise and Dietary Weight Loss, Walk with Ease
Keywords
Older Adults, Weight Loss, Exercise, Knee pain
Medical subject headings
Osteoarthritis, Weight Loss, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise and Dietary Weight LossBehavioural

    The EX+DWL intervention consists of group and individual exercise sessions, as well as, nutritional and dietary counseling. Bimonthly phone calls are made in the final year of the study to aid in maintenance of the program.

  • Walk with EaseBehavioural

    The WWE 6 week program consists of health education lectures on arthritis self-management, a walking exercise portion, and at- home strength exercises. Participants will complete two consecutive WWE programs. Monthly and bimonthly phone calls are made to participants in months 4-12 and 12-24, respectively, to aid in maintenance of the program.

Study groups in NCT02835326
Study groupRoleWhat they receive
Exercise and Dietary Weight LossExperimentalFor the first 6 months, participants will meet at a community center for 3 group-based sessions and 1 individual session each month. Sessions include a 45 minute exercise component and a 45 minute dietary weight loss component. Exercise will consist of progressive aerobic and strength training. The dietary component will focus on decreasing caloric intake, while being nutritionally safe. All diets will be monitored by a Registered Dietitian. During months 7-12, participants will meet for 1 group session and 1 individual session per month. The final 12-24 months, bimonthly phone calls are provided to the participants to aid in retention efforts.
Receives: Behavioral: Exercise and Dietary Weight Loss
Walk with EaseActive comparatorThe Arthritis Foundation's (AF) WWE is a self-management program for symptoms of arthritis (pain, fatigue, stiffness,etc.) through exercise. It is a 6 week program involving 3 sessions per week each lasting about 60 minutes. The WWE sessions are comprised of walking, stretching and strengthening exercises, and health education lectures. These group classes will be lead by an AF instructor. Each participant will complete 2 consecutive WWE classes for a total of 12 weeks in the program. During the final week of the program, participants will be trained and transitioin to the self-directed version of WWE for maintenance of exercise. To aid in retention efforts, phone contacts are provided to participants on a monthly basis from 4-12 months and bi-monthly from 12 to 24 months
Receives: Behavioral: Walk with Ease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mobility Disability

    This will be assessed using the 400 meter walk test (400MWT), which is the time to complete 400m as quickly as possible (without running)

    Measured: baseline up to 2 years

Secondary outcomes (8)

  1. Anthropometric Battery

    Body weight and height are used to calculate Body Mass Index (BMI). Body composition will be assessed using DEXA scans.

    Measured: baseline up to 2 years

  2. Functional Battery and Limitations

    Stair-climb time (SCT) is a functional performance measure that involves ascending and descending a flight of 5 stairs as quickly as possible. Limitations will be assessed using the Pepper Assessment Tool for Disability.

    Measured: baseline up to 2 years

  3. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Scale of 0 (none) to 4 (extreme) indicating the amount of difficulty they have experienced performing basic physical function tasks in the past 48 hours due to knee OA. The physical function subscale consists of 17 items that will be summed to produce a physical function score. Higher scores indicating poorer function

    Measured: baseline up to two years

  4. Rand Medical Outcomes Study 36-item Short Form Health Survey (SF-36)

    Health related quality of life survey consisting of mental and physical health with subscales of physical functioning, mental health, role-physical, role-emotional, bodily pain, general health, vitality, and social functioning

    Measured: baseline up to two years

  5. Dietary intake

    Dietary intake will be assessed by a registered dietician using the Daily food record measure. One weekend and 2 weekdays will be assessed.

    Measured: baseline up to two years

  6. Social Cognitive Process Measures

    Physical activity barriers self-efficacy scale, Satisfaction with function and appearance scale, Multiple exercise self-regulatory self-efficacy scale, the weight efficacy lifestyle questionnaire (WEL), goal commitment and goal difficulty, arthritis self-efficacy, and pain acceptance.

    Measured: baseline up to two years

  7. Change in physical activity

    Physical activity will be assessed using the Community Healthy Activities Model Program For Seniors (CHAMPS) and Lifecorder EX Accelerometer

    Measured: baseline up to two years

  8. Cost effectiveness

    The cost-effectiveness of the EX+DWL intervention compared to the WWE [program will be calculated as the ratio of additional cost per participant per increment of effectiveness. Effectiveness is based on improvement in the 400 MWT and the Quality of Well-being Scale- Self Administered (to calculate the Quality Adjusted Life Years).

    Measured: baseline up to two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionApr 2022
  4. Study completionApr 2022

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
227 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02835326
Sponsor's protocol ID
2015H0394
Other IDs
R01AG050725
Acronym
CLIP-OA
Status last verified
Oct 2022
First submitted
13 Jul 2016
Last updated
12 Oct 2022
Results posted
No
Data monitoring committee
No

Publications

  • Focht BC, Rejeski WJ, Hackshaw K, Ambrosius WT, Groessl E, Chaplow ZL, DeScenza VR, Bowman J, Fairman CM, Nesbit B, Dispennette K, Zhang X, Fowler M, Haynam M, Hohn S. The Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients (CLIP-OA) trial: Design and methods. Contemp Clin Trials. 2022 Apr;115:106730. doi: 10.1016/j.cct.2022.106730. Epub 2022 Mar 11.

    PubMed 35283261

Questions about this trial

What is this clinical trial studying?

A study testing Exercise and Dietary Weight Loss and Walk with Ease in people with Osteoarthritis, run by Ohio State 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 9 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 12 Oct 2022. 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?

Mobility Disability (time frame: baseline up to 2 years). 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 NCT02835326, which also lists 1 linked publication.

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 12 Oct 2022.

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