NCT01977872

Brief Summary

JointADventure: A worksite activity-diet intervention for chronic knee pain is a randomized controlled trial evaluation of a physical activity and nutritional worksite intervention to decrease symptoms and disability associated with knee osteoarthritis (OA), a major public health problem and a leading cause of work disability and work absenteeism/presenteeism in the US workforce. The overarching goal of this project is to find an effective and sustainable intervention strategy that can assist large populations of persons with or at risk for knee OA to attain and maintain healthy dietary and physical activity behaviors. This project has to potential to have a tremendous impact on improving symptoms and quality of life of persons with chronic knee pain and decreasing the functional limitation, work absenteeism/presenteeism, and soaring healthcare utilization associated with knee OA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

June 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

Enrollment Period

2 years

First QC Date

October 31, 2013

Last Update Submit

December 29, 2014

Conditions

Keywords

ArthritisPhysical ActivityDiet

Outcome Measures

Primary Outcomes (3)

  • change in accelerometer counts/day

    Baseline, 3, 6 and 12 months

  • change in kilocalorie intake

    Baseline, 3, 6 and 12 months

  • percent change in body weight

    Baseline, 3, 6 and 12 months

Secondary Outcomes (2)

  • 20 meter walk

    Baseline, 3, 6 and 12 months

  • chair stand test

    Baseline, 3, 6 and 12 months

Other Outcomes (1)

  • Quality of Life

    Baseline, 3 months, 6 months, 12 months

Study Arms (2)

A worksite activity-diet intervention

EXPERIMENTAL

A 12 month intensive program that includes individual sessions, interactive group sessions and online activities.

Behavioral: A worksite activity-diet intervention

Motiva Program

NO INTERVENTION

The Motiva Program is the internal corporate wellness program offered to all BCBSIL employees.

Interventions

A worksite activity-diet intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BCBSIL employee
  • Must be able to ambulate household distances (50 ft)
  • Must be able to read and speak English
  • Pain, aching, stiffness in or around one or both knees on most days for at least one month during the past 12 months
  • BMI of \>25, but \<40

You may not qualify if:

  • Primary diagnosis of fibromyalgia
  • Any co-morbidity that is more functionally limiting than the knee symptoms (e.g. spinal stenosis, peripheral vascular disease or residual effects of stroke)
  • Comorbid condition (based on medication review) that contraindicates a physical activity or dietary intervention
  • Total joint replacement surgery within 1 year or plans for total joint replacement in the next 12 months
  • Plans to relocate away from the Chicago-land area in the next 12 months
  • Being on a special diet that is inconsistent with the DASH diet
  • Concurrent involvement in a weight loss program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Blue Cross Blue Shield of Illinois

Chicago, Illinois, 60601, United States

Location

Northwestern University Feinberg School of Medicine Department of Preventive Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Osteoarthritis, KneeArthritisMotor Activity

Condition Hierarchy (Ancestors)

OsteoarthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Preventive Medicine, Medicine, and Physical Medicine & Rehabilitation

Study Record Dates

First Submitted

October 31, 2013

First Posted

November 7, 2013

Study Start

June 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations