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Health Promotion and Wellness Program for Adults With Disabling Conditions

Primary Purpose

Stroke, Multiple Sclerosis, Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SystemCHANGE Group Lifestyle counseling
Phone Lifestyle Counseling
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring Self Care, Exercise, Weight management

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Case Western Reserve University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SystemCHANGE Group Lifestyle counseling

Phone Lifestyle Counseling

Arm Description

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.

Participants will receive pamphlets that contain information on healthy eating, physical activity, sleep, and symptom management, and will be followed-up with telephone calls.

Outcomes

Primary Outcome Measures

Changes from baseline in body weight.
A digital scale will be used to measure Body weight.

Secondary Outcome Measures

Changes from baseline in cardiovascular risk biomarkers.
The Alere Cholestech LDX 1 Analyzer will be used to measure Triglycerides levels.
Changes from baseline in Walking Test.
A Six Minute Walking Test will be administered using standardized instructions and verbal cues
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
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.
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)
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).
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).

Full Information

First Posted
January 23, 2013
Last Updated
January 18, 2022
Sponsor
Case Western Reserve University
Collaborators
American Heart Association, National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01776034
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University
Collaborators
American Heart Association, National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Multiple Sclerosis, Rheumatoid Arthritis
Keywords
Self Care, Exercise, Weight management

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SystemCHANGE Group Lifestyle counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Phone Lifestyle Counseling
Arm Type
Active Comparator
Arm Description
Participants will receive pamphlets that contain information on healthy eating, physical activity, sleep, and symptom management, and will be followed-up with telephone calls.
Intervention Type
Behavioral
Intervention Name(s)
SystemCHANGE Group Lifestyle counseling
Intervention Type
Behavioral
Intervention Name(s)
Phone Lifestyle Counseling
Primary Outcome Measure Information:
Title
Changes from baseline in body weight.
Description
A digital scale will be used to measure 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).
Secondary Outcome Measure Information:
Title
Changes from baseline in cardiovascular risk biomarkers.
Description
The Alere Cholestech LDX 1 Analyzer will be used to measure Triglycerides levels.
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).
Title
Changes from baseline in Walking Test.
Description
A Six Minute Walking Test will be administered using standardized instructions and verbal cues
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).
Title
Changes from baseline in 1-minute sit to stand test
Description
A 1-minute sit to stand test will be administered using standardized instructions and verbal cues
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).
Title
Changes from baseline Physical Activity
Description
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.
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).
Title
Changes from baseline Self-efficacy for weight management
Description
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)
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).
Title
Changes from baseline social support for physical activity from family
Description
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).
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).
Title
Changes from baseline in emotional well-being
Description
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).
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew A Plow, PhD
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23782741
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.
Results Reference
derived

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Health Promotion and Wellness Program for Adults With Disabling Conditions

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