Clinical trial NCT03180008: Fit and Strong! Plus Comparative Effectiveness Trial
Official title: Comparative Effectiveness of Customary Fit and Strong! vs. Fit and Strong Plus!
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Overweight and Obesity
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-06-07
Enrollment: 413
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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!.


Eligibility criteria: 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

Primary outcomes:
measure: Dietary Intake
timeFrame: 2, 6, 12, and 18 months
measure: Body Weight
timeFrame: 2, 6, 12, and 18 months
Secondary outcomes:
measure: Physical Activity Engagement
timeFrame: 2, 6, 12, and 18 months
measure: Lower Extremity Pain
timeFrame: Baseline, 2, 6, 12, and 18 months
measure: Lower Extremity Stiffness
timeFrame: Baseline, 2, 6, 12, and 18 months
measure: Lower Extremity Physical Function
timeFrame: Baseline, 2, 6, 12, and 18 months
measure: Lower Extremity Muscle Strength
timeFrame: Baseline, 2, 6, 12, and 18 months
measure: Physical Endurance
timeFrame: Baseline, 2, 6, 12, and 18 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Susan Hughes, DSW
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith-Ray RL, Fitzgibbon ML, Tussing-Humphreys L, Schiffer L, Shah A, Huber GM, Braunschweig C, Campbell RT, Hughes SL. Fit and Strong! Plus: design of a comparative effectiveness evaluation of a weight management program for older adults with osteoarthritis. Contemp Clin Trials. 2014 Mar;37(2):178-88. doi: 10.1016/j.cct.2013.11.014. Epub 2013 Dec 5.
citation: Mears M, Tussing-Humphreys L, Cerwinske L, Tangney C, Hughes SL, Fitzgibbons M, Gomez-Perez S. Associations between Alternate Healthy Eating Index-2010, Body Composition, Osteoarthritis Severity, and Interleukin-6 in Older Overweight and Obese African American Females with Self-Reported Osteoarthritis. Nutrients. 2018 Dec 22;11(1):26. doi: 10.3390/nu11010026.
citation: Fitzgibbon ML, Tussing-Humphreys L, Schiffer L, Smith-Ray R, Demott AD, Martinez M, Berbaum ML, Huber GM, Hughes SL. FIT & STRONG! PLUS: DESCRIPTIVE DEMOGRAPHIC AND RISK CHARACTERISTICS IN A COMPARATIVE EFFECTIVENESS TRIAL FOR OLDER AFRICAN-AMERICAN ADULTS WITH OSTEOARTHRITIS. J Aging Res Clin Pract. 2018;7(1):9-16. doi: 10.14283/jarcp.2018.3.
citation: Hughes SL, Tussing-Humphreys L, Schiffer L, Smith-Ray R, Marquez DX, DeMott AD, Berbaum ML, Fitzgibbon ML. Fit & Strong! Plus Trial Outcomes for Obese Older Adults with Osteoarthritis. Gerontologist. 2020 Apr 2;60(3):558-570. doi: 10.1093/geront/gny146.
citation: Fitzgibbon ML, Tussing-Humphreys L, Schiffer L, Smith-Ray R, Marquez DX, DeMott AD, Berbaum ML, Hughes SL. Fit and Strong! Plus: Twelve and eighteen month follow-up results for a comparative effectiveness trial among overweight/obese older adults with osteoarthritis. Prev Med. 2020 Dec;141:106267. doi: 10.1016/j.ypmed.2020.106267. Epub 2020 Oct 3.