Health Promotion and Wellness Program for Adults With Disabling Condit
Examining the Efficacy of a SystemCHANGE™ Weight Management Intervention in Stroke Survivors and Persons With Chronic Inflammatory Autoimmune/Immune-mediated Diseases
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- SystemCHANGE Group Lifestyle counseling
Compared with
- Phone Lifestyle Counseling
What it measured
Main measures
Changes from baseline in 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).
Other measures (7)
Changes from baseline in cardiovascular risk biomarkers.
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).
Blood or spinal fluid markersChanges from baseline in Walking Test.
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).
Walking and mobilityChanges from baseline in 1-minute sit to stand test
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
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).
Physical functionChanges from baseline Self-efficacy for weight management
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
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).
Physical functionChanges from baseline in emotional well-being
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).
Quality of life (reported by participants)
Who could take part
MS (type not specified) · 30 to 75
Show the full criteria
Inclusion criteria
Inclusion Criteria Stroke: * Physician-confirmed diagnosis of stroke (> 6 weeks) * Body mass index between 23 to 45 kg/m2 * Age 30 to 75 years Exclusion Criteria Stroke: * 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 * 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) Inclusion Criteria MS or RA: * Physician-confirmed diagnosis of multiple sclerosis or rheumatoid arthritis * Body mass index between 23 to 45 kg/m2 Exclusion Criteria MS or RA: * 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)
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
Papers
Loading reviews and guidelines…
History
Started
Jan 2013
Main results due
Dec 2016
Finished
Dec 2016