Fit and Strong! Plus Comparative Effectiveness Trial

Study Overview
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Brief Summary
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This randomized controlled trial is comparing outcomes of customary Fit and Strong!, to Fit and Strong! Plus, an enhanced version of the program that incorporates weight management. We hypothesize that Fit and Strong! Plus participants will show improved diet behaviors at 2, 6, 12, and 18 months that will be accompanied by a significant 5% weight loss at 6 months and maintained to 18 months, compared to participants in customary Fit and Strong!.

Official Title
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Comparative Effectiveness of Customary Fit and Strong! vs. Fit and Strong Plus!

Conditions
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Osteoarthritis, Overweight and Obesity

Intervention / Treatment
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* Behavioral: Fit and Strong!
* Behavioral: Fit and Strong! Plus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of symptoms of lower extremity osteoarthritis Age 60 or older Not currently participating in a regular physical activity program BMI 25-50 Able to attend Fit and Strong! classes Exclusion Criteria: Score of 3 or greater on Mental Status Questionnaire Recent hip or knee surgery Recent steroid injection into hip or knee Diagnosis of rheumatoid arthritis Uncontrolled diabetes Unspecified health conditions that may interfere with exercise

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fit and Strong!<br> | Behavioral: Fit and Strong!<br>* Fit and Strong! is a group exercise and self-management program that meets for 90 minutes, 3 days per week, for 8 weeks. Each 90 minute session consists of 60 minutes of multi-component physical activity (stretching/flexibility exercises, low-impact aerobics, and strength/resistance exercise) and 30 minutes of health education delivered from a structured curriculum. The health education topics build self-efficacy for managing arthritis through physical activity.<br>|
| Experimental: Fit and Strong! Plus<br> | Behavioral: Fit and Strong! Plus<br>* The intervention consists of the traditional Fit and Strong! intervention (see previous description), but the health education component has been revised to focus on diet and weight management in addition to physical activity and arthritis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet change | As measured by a Food Frequency Questionnaire | Baseline, 6, 12, and 18 months | 
| 5% weight loss | Change in weight | Baseline, 6, 12, and 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity participation | Minutes spent engaging in physical activity | Baseline, 2, 6, 12, and 18 months | 
| Lower extremity pain | Measured by the WOMAC | Baseline, 2, 6, 12, and 18 months | 
| Lower extremity stiffness | Measured by the WOMAC | Baseline, 2, 6, 12, and 18 months | 
| Lower extremity physical function | Measured by the WOMAC | Baseline, 2, 6, 12, and 18 months | 
| Lower extremity muscle strength | Measured by a Sit-Stand test | Baseline, 2, 6, 12, and 18 months | 
| Physical endurance | Measured by the 6-minute Distance Walk | Baseline, 2, 6, 12, and 18 months |