Lifestyle Risk ReductionNCT05554705
Lifestyle Intervention for Rheumatoid Arthritis
A study testing Intensive Lifestyle intervention in people with Lifestyle Risk Reduction and Rheumatoid Arthritis, run by Blue Cross Blue Shield of Vermont at 1 site in United States.
Trial summary
The main purpose of this study is to assess whether adding a multifaceted lifestyle intervention to the standard best practice of care can be more effective than standard best practices alone for treating Rheumatoid Arthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lifestyle Risk Reduction, Rheumatoid Arthritis
- What is being tested?
- Intensive Lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2023to 2 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BCBSVT members who also carry the prescription benefit with BCBSVT (due to the need for tracking prescription costs).
- BCBSVT membership for minimum of 12 months prior to start of study (due to the need for tracking prescription costs before and after intervention).
- Age 18 or older
- Medical diagnosis of RA
Who cannot join
- Pregnancy
- Currently taking warfarin (since fluctuating amounts of green leafy vegetable intake can adversely affect INR levels and because we will be asking participants to increase the amount of green leafy vegetables they consume)
- Malignancy currently undergoing treatment (with further planned treatment at the time of enrollment) since patients undergoing cancer treatment often need to stop RA medications in order to improve immune function, and thus could be a confounder.
- Food allergy (including reactions such as hives, wheezing, difficulty breathing, fainting, or anaphylaxis)
Trial locations and contacts
1 site in 1 country.
United States1 site
Blue Cross Blue Shield of Vermont
Berlin Corners, Vermont, 05602
About this study
Official title: A Lifestyle Intervention for Rheumatoid Arthritis: Effect of an Intensive Therapeutic Lifestyle Change Program on Inflammatory Markers and Clinical Outcomes
The main purpose of this study is to assess whether adding a multifaceted lifestyle intervention to the standard best practice of care can be more effective than standard best practices alone for treating Rheumatoid Arthritis.
Read the detailed description
The main purpose of this study is to assess whether adding a multifaceted lifestyle intervention to the standard best practice of care can be more effective than standard best practices alone for treating Rheumatoid Arthritis. If a lifestyle intervention is effective, we expect to see improvement in functional status and decreased health care costs to the study participant and the insurer.
- Conditions
- Lifestyle Risk Reduction, Rheumatoid Arthritis
- Being tested
- Intensive Lifestyle intervention
- Medical subject headings
- Risk Reduction Behavior, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Lifestyle interventionBehavioural
12 week therapeutic lifestyle change program
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | standard of care + lifestyle intervention Receives: Behavioral: Intensive Lifestyle intervention |
| control | No intervention | no intervention (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HAQ-2 score
The HAQ-II is a validated and reliable tool used frequently by rheumatologists evaluating patients with RA (Wolfe et al, 2004). It is an indicator of quality of life as well as functional status. It is also a predictor of premature mortality.
Measured: Up to 24 months
Change in serum C-Reactive Protein
CRP is a reliable marker of acute and chronic inflammation (Sproston and Ashworth, 2018).
Measured: Up to 24 months
Secondary outcomes (10)
Change in dosage of RA-related medications
Dosage of Medications Taken Specifically for Rheumatoid Arthritis
Measured: Up to 24 months
Change in the number of medications required to treat RA
Number of Medications Taken Specifically for Rheumatoid Arthritis
Measured: Up to 24 months
Change in RA-related costs for the study participant
Out of Pocket costs related to Rheumatoid Arthritis Care
Measured: Up to 24 months
Change in RA-related costs to the insurer
Costs for care of Rheumatoid Arthritis paid by insurer
Measured: Up to 24 months
Change in serum LDL cholesterol
Elevated Low Density Lipoprotein is strongly associated with heart disease
Measured: Up to 24 months
Change in serum total cholesterol
Elevated total cholesterol is associated with heart disease
Measured: Up to 24 months
Change in serum HbA1c
Hemoglobin HbA1c is used to assess glucose control in diabetics
Measured: Up to 24 months
Change in blood pressure
Blood pressure change
Measured: Up to 24 months
Change in BMI
Body Mass Index change
Measured: Up to 24 months
Change in weight
Weight change
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start2 Jan 2023
- Primary completion2 Jan 2023
- Study completion2 Jan 2023
Why it stopped: Lost necessary staff support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lifestyle Risk ReductionStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blue Cross Blue Shield of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keri LeCompte, PharmD, Principal investigator, Blue Cross Blue Shield of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554705
- Sponsor's protocol ID
- 22-08-629-1275
- Status last verified
- Aug 2023
- First submitted
- 17 Sep 2022
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Lifestyle Intervention for Rheumatoid Arthritis: Effect of an Intensive Therapeutic Lifestyle Change Program on Inflammatory Markers and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT05554705
- Acronym / sponsor ID
- 22-08-629-1275
- Conditions
- Lifestyle Risk Reduction, Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lost necessary staff support
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Blue Cross Blue Shield of VermontUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 2 Jan 2023 (actual)
- Study completion
- 2 Jan 2023 (actual)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to assess whether adding a multifaceted lifestyle intervention to the standard best practice of care can be more effective than standard best practices alone for treating Rheumatoid Arthritis.
Detailed description
The main purpose of this study is to assess whether adding a multifaceted lifestyle intervention to the standard best practice of care can be more effective than standard best practices alone for treating Rheumatoid Arthritis. If a lifestyle intervention is effective, we expect to see improvement in functional status and decreased health care costs to the study participant and the insurer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Behavioral: Intensive Lifestyle interventionstandard of care + lifestyle intervention |
| control | No intervention | –no intervention (control group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BCBSVT members who also carry the prescription benefit with BCBSVT (due to the need for tracking prescription costs).
- BCBSVT membership for minimum of 12 months prior to start of study (due to the need for tracking prescription costs before and after intervention).
- Age 18 or older
- Medical diagnosis of RA
Key exclusion criteria (4 listed)
- Pregnancy
- Currently taking warfarin (since fluctuating amounts of green leafy vegetable intake can adversely affect INR levels and because we will be asking participants to increase the amount of green leafy vegetables they consume)
- Malignancy currently undergoing treatment (with further planned treatment at the time of enrollment) since patients undergoing cancer treatment often need to stop RA medications in order to improve immune function, and thus could be a confounder.
- Food allergy (including reactions such as hives, wheezing, difficulty breathing, fainting, or anaphylaxis)
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 |
|---|---|---|
| Intensive Lifestyle intervention12 week therapeutic lifestyle change program | Behavioural | experimental |
Primary outcome
Change in HAQ-2 score
Time frame: Up to 24 months
The HAQ-II is a validated and reliable tool used frequently by rheumatologists evaluating patients with RA (Wolfe et al, 2004). It is an indicator of quality of life as well as functional status. It is also a predictor of premature mortality.
Change in serum C-Reactive Protein
Time frame: Up to 24 months
CRP is a reliable marker of acute and chronic inflammation (Sproston and Ashworth, 2018).
10 secondary outcomes
Change in dosage of RA-related medications
Time frame: Up to 24 months
Change in the number of medications required to treat RA
Time frame: Up to 24 months
Change in RA-related costs for the study participant
Time frame: Up to 24 months
Change in RA-related costs to the insurer
Time frame: Up to 24 months
Change in serum LDL cholesterol
Time frame: Up to 24 months
Change in serum total cholesterol
Time frame: Up to 24 months
Change in serum HbA1c
Time frame: Up to 24 months
Change in blood pressure
Time frame: Up to 24 months
Change in BMI
Time frame: Up to 24 months
Change in weight
Time frame: Up to 24 months
Results and safety
The study was stopped early (reason given: Lost necessary staff support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Lifestyle Risk Reduction
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Culinary And Lifestyle Medicine Education for Cancer Risk Reduction in Survivors of Breast Cancer
Breast Cancer
Active, not recruitingPhase 2
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
Risk Reduction, Breast Cancer
Recruiting
SMART GOALS for Youth With Prediabetes
PreDiabetes, Adolescent Obesity
RecruitingObservational study
Breast Cancer Risk Assessment in Night Shift Workers - Implementation of a Personalized Consultation
Breast Neoplasms Diagnosis
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.
Keri LeCompte, PharmD principal investigator
Blue Cross Blue Shield of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Lifestyle intervention in people with Lifestyle Risk Reduction and Rheumatoid Arthritis, run by Blue Cross Blue Shield of Vermont 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 4 Aug 2023. 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?
The study was stopped early (reason given: Lost necessary staff support). Results are not available in the source record.
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?
Change in HAQ-2 score (time frame: Up to 24 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?
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 4 Aug 2023.