Fit and Strong! Plus Comparative Effectiveness Trial

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

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!.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Overweight and Obesity
• Intervention / Treatment: Behavioral: Fit and Strong!; Behavioral: Fit and Strong! Plus

• Study Type: Interventional
• Enrollment (Actual): 413
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60608
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fit and Strong!; Fit & Strong! is evidence-based group exercise and self-management program. Classes meet for 90 minutes and include 60 minutes of physical activity (stretching/flexibility, low impact aerobics, and lower-extremity strength training) and 30 minutes of health education that follows a structured, scripted curriculum that centers on physical activity and osteoarthritis and incorporates self-efficacy, social support, and self-regulation. Classes are held 3 days per week for 8 weeks (24 sessions total).	Behavioral: Fit and Strong!; 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.
Experimental: Fit and Strong! Plus; Fit & Strong! Plus differs from Fit & Strong! only in that the 30 minutes of health education, while retaining the core physical activity and osteoarthritis components, has weight and diet-related topics added to the curriculum.	Behavioral: Fit and Strong! Plus; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary Intake	The Healthy Eating Index 2010 (HEI-2010) measures diet quality based on the Dietary Guidelines for Americans. HEI-2010 total scores range from 0 to 100 points, with a higher score signifying superior diet quality.	2, 6, 12, and 18 months
Body Weight	A change in body weight (kilograms) measured using a calibrated digital scale (Tanita).	2, 6, 12, and 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity Engagement	A change in Physical activity was assessed using the Physical Activity Scale for the Elderly (PASE). Scored on a scale of 0 - 400, a higher score indicates greater PA.	2, 6, 12, and 18 months
Lower Extremity Pain	A change in Osteoarthritis "lower extremity pain" symptoms were measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC). The WOMAC is a self-report instrument that has been well-validated and used widely with individuals with osteoarthritis. Pain (5 items) was rated on a Likert scale ranging from 0 (none) to four. Higher scores indicate more severe osteoarthritis symptoms, scores range from 0-20.	Baseline, 2, 6, 12, and 18 months
Lower Extremity Stiffness	A change in Osteoarthritis "lower extremity stiffness" symptoms were measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC). The WOMAC is a self-report instrument that has been well-validated and used widely with individuals with osteoarthritis. Stiffness (2 items) was rated on a Likert scale ranging from 0 (none) to four. Higher scores indicate more severe osteoarthritis symptoms, scores range from 0 to 8.	Baseline, 2, 6, 12, and 18 months
Lower Extremity Physical Function	A change in Osteoarthritis "lower extremity physical function" symptoms were measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC). The WOMAC is a self-report instrument that has been well-validated and used widely with individuals with osteoarthritis. Lower extremity physical function (17 items) was rated on a Likert scale ranging from 0 (none) to four. Higher scores indicate more severe osteoarthritis symptoms, scores range from 0 to 68.	Baseline, 2, 6, 12, and 18 months
Lower Extremity Muscle Strength	A change in Lower Extremity Muscle Strength was measured by a Sit-Stand test that measures the number of full stands from a seated position a participant can complete in 30 s with arms folded across the chest. A higher score reflects better performance.	Baseline, 2, 6, 12, and 18 months
Physical Endurance	A change in Physical Endurance was measured by the 6-minute Distance Walk, which is a self-paced timed test of the total distance a person can walk in six minutes. A higher score reflects better performance.	Baseline, 2, 6, 12, and 18 months

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Susan Hughes, DSW, University of Illinois at Chicago

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2012
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: June 6, 2017
• First Posted (Actual): June 7, 2017

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: 2012-0277 (Other Identifier: M D Anderson Cancer Center); 1R01AG039374 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No