NCT00061490

Brief Summary

This study will evaluate whether a program of weight loss and exercise can help individuals with knee osteoarthritis (OA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2002

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

Study Start

First participant enrolled

September 1, 2002

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 29, 2003

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

September 26, 2017

Status Verified

September 1, 2017

Enrollment Period

3.6 years

First QC Date

May 28, 2003

Last Update Submit

September 22, 2017

Conditions

Osteoarthritis, Knee

Keywords

OsteoarthritisArthritisWeight Loss

Outcome Measures

Primary Outcomes (1)

  • Pain

    4 months and 16 months

Study Arms (2)

1

EXPERIMENTAL

16 weekly educational meetings

Behavioral: Behavioral weight control and lifestyle exercise

2

NO INTERVENTION

Wait list control

Interventions

Behavioral weight control and lifestyle exerciseBEHAVIORAL

16 weekly educational meetings vs. waitlist control

1

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Knee arthritis
  • Pain on \> 50 % of days in the month in one or both knees
  • Difficulty with activities of daily living due to knee pain
  • X-ray documenting knee OA within 1 year prior to study entry
  • lbs to 50 lbs overweight

You may not qualify if:

  • Significant cardiac, pulmonary, renal, or hepatic disease
  • Major psychiatric disease
  • ACR functional class IV
  • Structured exercise more than once per week for 20 minutes or longer during the 3 months prior to study entry
  • Anticipates moving from the area within 18 months of study entry
  • Anticipates undergoing knee surgery within 1 year of study entry
  • Weight loss of more than 5 kg (11 lbs) in 3 months prior to study entry
  • Anorexiant or other medications known to affect metabolism
  • Current or planned pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisArthritisWeight Loss

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Susan J. Bartlett, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2003

First Posted

May 29, 2003

Study Start

September 1, 2002

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

September 26, 2017

Record last verified: 2017-09

Locations

US(1)