OsteoarthritisNCT03180008

Fit and Strong! Plus Comparative Effectiveness Trial

A study testing Fit and Strong! and Fit and Strong! Plus in people with Osteoarthritis and Overweight and Obesity, run by University of Illinois Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Osteoarthritis, Overweight and Obesity
What is being tested?: Fit and Strong! and Fit and Strong! Plus
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 413 participants
Where: 1 siteUnited States
Study dates: Dec 2012to 28 Feb 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Illinois at Chicago
Chicago, Illinois, 60608

Other trials in United States

About this study

Official title: 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!.

Conditions: Osteoarthritis, Overweight and Obesity
Being tested: Fit and Strong!, Fit and Strong! Plus
Medical subject headings: Osteoarthritis, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fit and Strong!Behavioural
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.
Fit and Strong! PlusBehavioural
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.

Study groups in NCT03180008
Study group	Role	What they receive
Fit and Strong!	Active comparator	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). Receives: Behavioral: Fit and Strong!
Fit and Strong! Plus	Experimental	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. Receives: Behavioral: Fit and Strong! Plus

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2, 6, 12, and 18 months
Body Weight
A change in body weight (kilograms) measured using a calibrated digital scale (Tanita).
Measured: 2, 6, 12, and 18 months

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 2, 6, 12, and 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 201228 Feb 2019

First posted7 Jun 2017
Study startDec 2012
Primary completion31 Jan 2018
Study completion28 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 413 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03180008
Sponsor's protocol ID: 2012-0277
Other IDs: 1R01AG039374
Status last verified: Apr 2024
First submitted: 30 May 2017
Last updated: 19 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 24316240
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.
PubMed 30583501
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.
PubMed 30167430
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.
PubMed 30476065
Ocampo-Mota J, Padilla D, Karlinsey Skidmore B, Cardiel E, Khanna S, Pinto M, Marquez DX. Ojo 2-barriers and recommendations for the recruitment, retention, and implementation of remote physical activity interventions for older Latinos. Transl Behav Med. 2026 Jan 7;16(1):ibag066. doi: 10.1093/tbm/ibag066.
PubMed 42801273
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.
PubMed 33022324

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Effectiveness of Customary Fit and Strong! vs. Fit and Strong Plus!
ClinicalTrials.gov ID: NCT03180008
Acronym / sponsor ID: 2012-0277
Conditions: Osteoarthritis, Overweight and Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 413 participants (actual)
Lead sponsor: University of Illinois ChicagoUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: Dec 2012 (actual)
Primary completion: 31 Jan 2018 (actual)
Study completion: 28 Feb 2019 (actual)
First posted: 7 Jun 2017 (actual)
Results: Posted 3 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fit and Strong!	Active comparator	Behavioral: 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).
Fit and Strong! Plus	Experimental	Behavioral: Fit and Strong! PlusFit \& 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.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Fit and Strong!
Fit and Strong! PlusThe 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.	Behavioural	Fit and Strong! Plus

Primary outcome

Dietary Intake
Time frame: 2, 6, 12, and 18 months
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.
Body Weight
Time frame: 2, 6, 12, and 18 months
A change in body weight (kilograms) measured using a calibrated digital scale (Tanita).

6 secondary outcomes

Physical Activity Engagement
Time frame: 2, 6, 12, and 18 months
Lower Extremity Pain
Time frame: Baseline, 2, 6, 12, and 18 months
Lower Extremity Stiffness
Time frame: Baseline, 2, 6, 12, and 18 months
Lower Extremity Physical Function
Time frame: Baseline, 2, 6, 12, and 18 months
Lower Extremity Muscle Strength
Time frame: Baseline, 2, 6, 12, and 18 months
Physical Endurance
Time frame: Baseline, 2, 6, 12, and 18 months

Results and safety

Results posted to the registry on 3 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fit and Strong!	210	182
Fit and Strong! Plus	203	174

Primary outcome: Dietary Intake

Time frame: 2, 6, 12, and 18 months. Mean (Standard Error). Unit: score on a scale

Measure	Fit and Strong! n = 210	Fit and Strong! Plus n = 203
2-Month Follow-up	2.1 (0.7)	4.7 (0.7)
6-Month Follow-up	0.8 (0.7)	2.0 (0.7)
12-Month Follow-up	1.3 (0.7)	0.6 (0.7)
18-Month Follow-up	0.0 (0.7)	1.0 (0.7)

Population analysed: The number analyzed at each time point varies due to loss to follow-up.

Primary outcome: Body Weight

Time frame: 2, 6, 12, and 18 months. Mean (Standard Error). Unit: Kilograms

Measure	Fit and Strong! n = 210	Fit and Strong! Plus n = 203
2-Month Follow-up	-0.5 (0.2)	-2.0 (0.2)
6-Month Follow-up	-0.8 (0.3)	-2.0 (0.3)
12-Month Follow-up	-0.9 (0.3)	-1.7 (0.3)
18-Month Follow-up	-0.9 (0.3)	-1.3 (0.3)

Population analysed: The number analyzed at each time point varies due to loss to follow-up.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 18 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fit and Strong!	1 of 210 (0.5%)	1 of 210 (0.5%)	3 of 210
Fit and Strong! Plus	0 of 203 (0%)	4 of 203 (2%)	4 of 203

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24316240Smith-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.
Background: PubMed 30583501Mears 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.
Background: PubMed 30167430Fitzgibbon 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.
Results publication: PubMed 30476065Hughes 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.
Derived from this study: PubMed 42801273Ocampo-Mota J, Padilla D, Karlinsey Skidmore B, Cardiel E, Khanna S, Pinto M, Marquez DX. Ojo 2-barriers and recommendations for the recruitment, retention, and implementation of remote physical activity interventions for older Latinos. Transl Behav Med. 2026 Jan 7;16(1):ibag066. doi: 10.1093/tbm/ibag066.
Derived from this study: PubMed 33022324Fitzgibbon 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Susan Hughes, DSW principal investigator

University of Illinois Chicago

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fit and Strong! and Fit and Strong! Plus in people with Osteoarthritis and Overweight and Obesity, run by University of Illinois Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dietary Intake (time frame: 2, 6, 12, and 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03180008, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.