Fit and Strong! Plus Comparative Effectiveness Trial
Comparative Effectiveness of Customary Fit and Strong! vs. Fit and Strong Plus!
2 other identifiers
interventional
413
1 country
1
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!.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2012
Longer than P75 for not_applicable
1 active site
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
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 30, 2017
CompletedFirst Posted
Study publicly available on registry
June 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2019
CompletedResults Posted
Study results publicly available
April 3, 2024
CompletedApril 19, 2024
April 1, 2024
5.2 years
May 30, 2017
April 28, 2022
April 17, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
Physical Activity Engagement
2, 6, 12, and 18 months
Lower Extremity Pain
Baseline, 2, 6, 12, and 18 months
Lower Extremity Stiffness
Baseline, 2, 6, 12, and 18 months
Lower Extremity Physical Function
Baseline, 2, 6, 12, and 18 months
Lower Extremity Muscle Strength
Baseline, 2, 6, 12, and 18 months
- +1 more secondary outcomes
Study Arms (2)
Fit and Strong!
ACTIVE COMPARATORFit \& 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).
Fit and Strong! Plus
EXPERIMENTALFit \& 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois at Chicago
Chicago, Illinois, 60608, United States
Related Publications (5)
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.
PMID: 24316240BACKGROUNDMears 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.
PMID: 30583501BACKGROUNDFitzgibbon 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.
PMID: 30167430BACKGROUNDHughes 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.
PMID: 30476065RESULTFitzgibbon 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.
PMID: 33022324DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Andrew DeMott, MPH
- Organization
- University of Illinois at Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Susan Hughes, DSW
University of Illinois at Chicago
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Director
Study Record Dates
First Submitted
May 30, 2017
First Posted
June 7, 2017
Study Start
December 1, 2012
Primary Completion
January 31, 2018
Study Completion
February 28, 2019
Last Updated
April 19, 2024
Results First Posted
April 3, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share