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| Name | Class |
|---|---|
| American Heart Association | OTHER |
| National Institutes of Health (NIH) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SystemCHANGE Group Lifestyle counseling | Behavioral |
| ||
| Phone Lifestyle Counseling |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in body weight. | A digital scale will be used to measure Body weight. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in cardiovascular risk biomarkers. | The Alere Cholestech LDX 1 Analyzer will be used to measure Triglycerides levels. | 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. |
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Inclusion Criteria Stroke:
Exclusion Criteria Stroke:
Inclusion Criteria MS or RA:
Exclusion Criteria MS or RA:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew A Plow, PhD | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23782741 | Derived | 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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009103 | Multiple Sclerosis |
| D001172 | Arthritis, Rheumatoid |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Behavioral |
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A Six Minute Walking Test will be administered using standardized instructions and verbal cues |
| 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 | 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. | 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) | 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). | 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). | 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). |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001519 | Behavior |