Clinical trial NCT01776034: Health Promotion and Wellness Program for Adults With Disabling Conditions
Official title: Examining the Efficacy of a SystemCHANGE™ Weight Management Intervention in Stroke Survivors and Persons With Chronic Inflammatory Autoimmune/Immune-mediated Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Multiple Sclerosis
Rheumatoid Arthritis
Keywords: Self Care
Exercise
Weight management
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: National Institutes of Health (NIH)
First posted: 2013-01-25
Enrollment: 66
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility 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)

Primary outcomes:
measure: Changes from baseline in body weight.
timeFrame: 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:
measure: Changes from baseline in cardiovascular risk biomarkers.
timeFrame: 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: Changes from baseline in Walking Test.
timeFrame: 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: Changes from baseline in 1-minute sit to stand test
timeFrame: 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: Changes from baseline Physical Activity
timeFrame: 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: Changes from baseline Self-efficacy for weight management
timeFrame: 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: Changes from baseline social support for physical activity from family
timeFrame: 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: Changes from baseline in emotional well-being
timeFrame: 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 outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Matthew A Plow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.