NCT02835326

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
227

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 18, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

5.5 years

First QC Date

July 13, 2016

Last Update Submit

October 10, 2022

Conditions

Osteoarthritis

Keywords

Older AdultsWeight LossExerciseKnee pain

Outcome Measures

Primary Outcomes (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)

    baseline up to 2 years

Secondary Outcomes (8)

  • Anthropometric Battery

    baseline up to 2 years

  • Functional Battery and Limitations

    baseline up to 2 years

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    baseline up to two years

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

    baseline up to two years

  • Dietary intake

    baseline up to two years

  • +3 more secondary outcomes

Study Arms (2)

Exercise and Dietary Weight Loss

EXPERIMENTAL

For 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.

Behavioral: Exercise and Dietary Weight Loss

Walk with Ease

ACTIVE COMPARATOR

The 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

Behavioral: Walk with Ease

Interventions

Exercise and Dietary Weight LossBEHAVIORAL

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.

Exercise and Dietary Weight Loss
Walk with EaseBEHAVIORAL

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.

Walk with Ease

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • 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.

    PMID: 35283261DERIVED

MeSH Terms

Conditions

OsteoarthritisWeight LossMotor Activity

Interventions

ExerciseWalkingmethyl hydroxyethyl cellulose

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaLocomotion

Study Officials

  • Brian Focht, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chair, Associate Professor

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 18, 2016

Study Start

October 1, 2016

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

October 12, 2022

Record last verified: 2022-10

Locations

US(1)