StrokeNCT01776034
Health Promotion and Wellness Program for Adults With Disabling Conditions
A study testing SystemCHANGE Group Lifestyle counseling and Phone Lifestyle Counseling in people with Stroke and Multiple Sclerosis, run by Case Western Reserve University at 1 site in United States.
Trial summary
The objective of this study is to conduct a randomized controlled pilot study to examine the efficacy, feasibility and safety of the SystemCHANGE™(SC) health promotion and wellness program in adults with disabling conditions. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Stroke, Multiple Sclerosis, Rheumatoid Arthritis
- What is being tested?
- SystemCHANGE Group Lifestyle counseling and Phone Lifestyle Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Dec 2016
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician-confirmed diagnosis of stroke (> 6 weeks)
- Body mass index between 23 to 45 kg/m2
- Age 30 to 75 years
- Physician-confirmed diagnosis of multiple sclerosis or rheumatoid arthritis
- Body mass index between 23 to 45 kg/m2
Who cannot join
- Pregnant or plans to become pregnant in the next 6 months
- Current participation in a face-to-face weight management program
- Uncontrolled diabetes (hospitalization within the prior 6 months)
- Serious mental illness
- Thyroid and adrenal gland diseases
- Inability to walk 3 meters with or without a cane or walker
Show all 26Show fewer
- Severe cardiopulmonary disease that limits engagement in physical activity (e.g., myocardial infarction, congestive heart failure, coronary artery bypass grafting or valve replacement during the past three months, serious cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, and pulmonary embolus) or abnormal blood pressure or heart rate response after the 6-Minute Walking Test (e.g., a drop in systolic blood pressure of >10mmHg from baseline)
- Severe cognitive deficits (Screening questioanire called the Short Orientation Memory-Concentration < 12)
- Currently taking oral corticosteroids, antipsychotic (except for depression medication), or medications specifically for weight loss
- 3 or more falls in the past month
- Bulimia
- Unable to speak English over the phone
- Able to eat independently and is not on a special diet because of difficulty in swallowing
- Unstable weight (gained or lost >10lbs in the last two months)
- Pregnant or plans to become pregnant in the next 6 months
- Current participation in a face-to-face weight management program
- Uncontrolled diabetes (hospitalization within the prior 6 months)
- Serious mental illness
- Inability to walk 3 meters with or without a cane or walker
- Severe cardiopulmonary disease that limits engagement in physical activity
- Severe cognitive deficits (Short Orientation Memory-Concentration < 12)
- Currently taking oral corticosteroids, antipsychotic (except for depression medication), or medications specifically for weight loss
- 3 or more falls in the past month
- Bulimia
- Unable to speak English
- Uncontrolled thyroid or adrenal disease (change in type and dosage of medication within the prior 3 months)
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University
Cleveland, Ohio, 44106
About this study
Official title: Examining the Efficacy of a SystemCHANGE™ Weight Management Intervention in Stroke Survivors and Persons With Chronic Inflammatory Autoimmune/Immune-mediated Diseases
The objective of this study is to conduct a randomized controlled pilot study to examine the efficacy, feasibility and safety of the SystemCHANGE™(SC) health promotion and wellness program in adults with disabling conditions. Particularly, the study will focus on developing a program of research on adapting and testing SC weight management interventions in overweight and obese stroke survivors and persons with chronic inflammatory autoimmune/immune-mediated diseases, specifically those with multiple sclerosis (MS) and rheumatoid arthritis (RA).
Read the detailed description
Individuals with disabling conditions, such as stroke, multiple sclerosis, or rheumatoid arthritis, face many barriers to engaging in physical activity, healthy nutritional habits, and good sleep hygiene. This leads to weight gain, de-conditioning, and declines in upper- and lower- extremity function, which makes it even more difficult to engage in healthy behaviors, thereby perpetuating a cycle of functional decline. Developing an effective weight management intervention may be a strategy for disrupting this disabling cycle and reducing the impact of the disease. Fostering a positive social environment may help adults with disabling conditions overcome barriers to engaging in healthy behaviors. SystemCHANGE (SC) is a new behavior change program that uses approaches consistent with social ecological theories and process improvement techniques (i.e. changing the dynamics of a system or group) to increase social support in lifestyle behaviors that promote energy balance. SC focuses on redesigning the social environment using a series of trial-and-error "experiments", which is in contrast to cognitive-behavioral interventions that focus on changing a person's viewpoint of a situation and increasing motivation. In a SC intervention, individuals are taught a set of skills to assist them in incorporating habitual lifestyle behaviors into their daily systems so they succeed despite wavering motivation. The rationale for developing a weight management intervention for these patients is to slow disability progression and prevent secondary conditions.
- Conditions
- Stroke, Multiple Sclerosis, Rheumatoid Arthritis
- Being tested
- SystemCHANGE Group Lifestyle counseling, Phone Lifestyle Counseling
- Keywords
- Self Care, Exercise, Weight management
- Medical subject headings
- Stroke, Multiple Sclerosis, Arthritis, Rheumatoid, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SystemCHANGE Group Lifestyle counselingBehavioural
Phone Lifestyle CounselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| SystemCHANGE Group Lifestyle counseling | Experimental | The SystemCHANGE™ intervention will be delivered over a six-month period involving 12 face-to-face group sessions (1.5 to 2 hours each) held weekly for three months, followed by three monthly "booster calls." Intervention groups include ~10 to 15 patients, and friends and family members are encouraged to attend. Intervention sessions consist of 30-min to 60-min of behavior change activities and 60-min focused on healthy behaviors. Receives: Behavioral: SystemCHANGE Group Lifestyle counseling |
| Phone Lifestyle Counseling | Active comparator | Participants will receive pamphlets that contain information on healthy eating, physical activity, sleep, and symptom management, and will be followed-up with telephone calls. Receives: Behavioral: Phone Lifestyle Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in body weight.
A digital scale will be used to measure Body weight.
Measured: Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).
Secondary outcomes (7)
Changes from baseline in cardiovascular risk biomarkers.
The Alere Cholestech LDX 1 Analyzer will be used to measure Triglycerides levels.
Measured: Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).
Changes from baseline in Walking Test.
A Six Minute Walking Test will be administered using standardized instructions and verbal cues
Measured: Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).
Changes from baseline in 1-minute sit to stand test
A 1-minute sit to stand test will be administered using standardized instructions and verbal cues
Measured: Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).
Changes from baseline Physical Activity
Physical Activity and Disability Survey-Revised will be administered to assess physical function. Higher scores on the Physical Activity and Disability Survey-Revised indicates increased physical activity levels. Score range: Not applicable.
Measured: Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).
Changes from baseline Self-efficacy for weight management
Weight Efficacy Lifestyle Questionnaire-Short Form (WEL-SF) will be administered. A higher score on the weight efficacy lifestyle questionnaire indicates more confidence to engage in a healthy behavior (possible score range for self-efficacy weight is 1 to 10)
Measured: Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).
Changes from baseline social support for physical activity from family
Social Support for Exercise Behavior scales will be administered. A higher score on social support scales indicates greater social support from family to engage in physical activity (possible score range is 1 to 5).
Measured: Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).
Changes from baseline in emotional well-being
Quality of Life in Neurological Disorders (Neuro-Qol) positive affect \& wellbeing questionnaires will be administered. Higher scores on Quality of Life in Neurological Disorders (Neuro-Qol) positive affect and well-being indicates a greater life satisfaction (possible score range 9 to 45).
Measured: Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Matthew Plow, Case Western Reserve University
- Investigators
- Matthew A Plow, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776034
- Sponsor's protocol ID
- 07-14-16 / 03-14-24
- Status last verified
- Jan 2022
- First submitted
- 23 Jan 2013
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Plow M, Moore SM, Kirwan JP, Frost F, Katzan I, Jaeger S, Alberts J. Randomized controlled pilot study of a SystemCHANGE weight management intervention in stroke survivors: rationale and protocol. Trials. 2013 May 7;14:130. doi: 10.1186/1745-6215-14-130.
PubMed 23782741
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Efficacy of a SystemCHANGE™ Weight Management Intervention in Stroke Survivors and Persons With Chronic Inflammatory Autoimmune/Immune-mediated Diseases
- ClinicalTrials.gov ID
- NCT01776034
- Acronym / sponsor ID
- 07-14-16 / 03-14-24
- Conditions
- Stroke, Multiple Sclerosis, Rheumatoid Arthritis
- Keywords
- Self Care, Exercise, Weight management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- American Heart Association, National Institutes of Health (NIH)
- Study start
- Jan 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Jan 2013 (estimated)
- 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 objective of this study is to conduct a randomized controlled pilot study to examine the efficacy, feasibility and safety of the SystemCHANGE™(SC) health promotion and wellness program in adults with disabling conditions. Particularly, the study will focus on developing a program of research on adapting and testing SC weight management interventions in overweight and obese stroke survivors and persons with chronic inflammatory autoimmune/immune-mediated diseases, specifically those with multiple sclerosis (MS) and rheumatoid arthritis (RA).
Detailed description
Individuals with disabling conditions, such as stroke, multiple sclerosis, or rheumatoid arthritis, face many barriers to engaging in physical activity, healthy nutritional habits, and good sleep hygiene. This leads to weight gain, de-conditioning, and declines in upper- and lower- extremity function, which makes it even more difficult to engage in healthy behaviors, thereby perpetuating a cycle of functional decline. Developing an effective weight management intervention may be a strategy for disrupting this disabling cycle and reducing the impact of the disease. Fostering a positive social environment may help adults with disabling conditions overcome barriers to engaging in healthy behaviors. SystemCHANGE (SC) is a new behavior change program that uses approaches consistent with social ecological theories and process improvement techniques (i.e. changing the dynamics of a system or group) to increase social support in lifestyle behaviors that promote energy balance. SC focuses on redesigning the social environment using a series of trial-and-error "experiments", which is in contrast to cognitive-behavioral interventions that focus on changing a person's viewpoint of a situation and increasing motivation. In a SC intervention, individuals are taught a set of skills to assist them in incorporating habitual lifestyle behaviors into their daily systems so they succeed despite wavering motivation. The rationale for developing a weight management intervention for these patients is to slow disability progression and prevent secondary conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SystemCHANGE Group Lifestyle counseling | Experimental | Behavioral: SystemCHANGE Group Lifestyle counselingThe SystemCHANGE™ intervention will be delivered over a six-month period involving 12 face-to-face group sessions (1.5 to 2 hours each) held weekly for three months, followed by three monthly "booster calls." Intervention groups include ~10 to 15 patients, and friends and family members are encouraged to attend. Intervention sessions consist of 30-min to 60-min of behavior change activities and 60-min focused on healthy behaviors. |
| Phone Lifestyle Counseling | Active comparator | Behavioral: Phone Lifestyle CounselingParticipants will receive pamphlets that contain information on healthy eating, physical activity, sleep, and symptom management, and will be followed-up with telephone calls. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Physician-confirmed diagnosis of stroke (> 6 weeks)
- Body mass index between 23 to 45 kg/m2
- Age 30 to 75 years
- Physician-confirmed diagnosis of multiple sclerosis or rheumatoid arthritis
- Body mass index between 23 to 45 kg/m2
Key exclusion criteria (26 listed)
- Pregnant or plans to become pregnant in the next 6 months
- Current participation in a face-to-face weight management program
- Uncontrolled diabetes (hospitalization within the prior 6 months)
- Serious mental illness
- Thyroid and adrenal gland diseases
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 |
|---|---|---|
| SystemCHANGE Group Lifestyle counseling | Behavioural | SystemCHANGE Group Lifestyle counseling |
| Phone Lifestyle Counseling | Behavioural | Phone Lifestyle Counseling |
Primary outcome
Changes from baseline in body weight.
Time frame: Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).
A digital scale will be used to measure Body weight.
7 secondary outcomes
Changes from baseline in cardiovascular risk biomarkers.
Time frame: Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).
Changes from baseline in Walking Test.
Time frame: Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).
Changes from baseline in 1-minute sit to stand test
Time frame: Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).
Changes from baseline Physical Activity
Time frame: Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).
Changes from baseline Self-efficacy for weight management
Time frame: Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).
Changes from baseline social support for physical activity from family
Time frame: Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).
Changes from baseline in emotional well-being
Time frame: Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Derived from this study: PubMed 23782741Plow M, Moore SM, Kirwan JP, Frost F, Katzan I, Jaeger S, Alberts J. Randomized controlled pilot study of a SystemCHANGE weight management intervention in stroke survivors: rationale and protocol. Trials. 2013 May 7;14:130. doi: 10.1186/1745-6215-14-130.
- 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.
Matthew A Plow, PhD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SystemCHANGE Group Lifestyle counseling and Phone Lifestyle Counseling in people with Stroke and Multiple Sclerosis, run by Case Western Reserve University 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 26 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 24 Jan 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes from baseline in body weight. (time frame: Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).). 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 NCT01776034, which also lists 1 linked publication.
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 24 Jan 2022.