NCT00365404

Brief Summary

The purpose of the study was to implement well-developed guidelines for arthritis management beyond acute medical management to independent community living by modifying existing weight management and physical activity promotion programs for people with disabling arthritis. Our hypotheses were:

  1. 1.Existing individual, health care system, and community strategies to promote physical activity and weight management can effectively be modified and expanded to include those with debilitating joint diseases.
  2. 2.People with inflammatory joint disease can have healthy physical activity levels and weight at home and in the community.
  3. 3.The effect of these interventions will be higher quality of life, lower depression rates, modest pain levels, and functional independence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
465

participants targeted

Target at P75+ for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Oct 2003

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed
Last Updated

November 26, 2015

Status Verified

July 1, 2006

First QC Date

August 16, 2006

Last Update Submit

November 25, 2015

Conditions

Keywords

Behavioral changeWeight managementPhysical activity

Outcome Measures

Primary Outcomes (2)

  • Normal body mass index is normal

  • At least four days of 20 minutes exercise in past seven

Secondary Outcomes (7)

  • Weight loss of five pounds

  • Increased exercise days by 2

  • Improved quality of life (including reduced pain) as measured with the AIMS-2

  • Improved dietary characteristics as measured with the Block FFQ

  • Increased physical activity as measured with the Physical ACtivity History

  • +2 more secondary outcomes

Interventions

Eligibility Criteria

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

You may qualify if:

  • Adult men and women
  • A medical visit at one of six Park Nicollet Health System sites from November 2003 through June 2004.
  • ICD-9 visit code of 714.0, 715.90 or 715.95 through 715.97
  • Patient's clinician provided written consent to invite participation
  • Patients had previously consented to be contacted for research purposes.

You may not qualify if:

  • The patient was unaware of a medical diagnosis of arthritis.
  • They did not report having a medical provider they could call with arthritis-related questions
  • Arthritis-related problems for less than nine months duration for rheumatoid arthritis, less than three months for osteoarthritis.
  • Scheduled for surgery.
  • History of lower extremity joint replacement.
  • Less than daily arthritis pain or problems.
  • History of chest pain or medically restricted activity.
  • Unable to participate for 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Park Nicollet Institute

Saint Louis Park, Minnesota, 55416, United States

Location

MeSH Terms

Conditions

Arthritis, RheumatoidOsteoarthritisMotor Activity

Interventions

Diet

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Barbara L Braun, PhD

    HealthPartners Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 16, 2006

First Posted

August 17, 2006

Study Start

October 1, 2003

Study Completion

February 1, 2006

Last Updated

November 26, 2015

Record last verified: 2006-07

Locations