Health Promotion and Wellness Program for Adults With Disabling Conditions

January 18, 2022 updated by: Matthew Plow, Case Western Reserve University

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

26 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SystemCHANGE Group Lifestyle counseling
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.
Behavioral: SystemCHANGE Group Lifestyle counseling
Active Comparator: Phone Lifestyle Counseling
Participants will receive pamphlets that contain information on healthy eating, physical activity, sleep, and symptom management, and will be followed-up with telephone calls.
Behavioral: Phone Lifestyle Counseling

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
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.
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 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
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 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
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).
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
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).
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
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).
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
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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Case Western Reserve University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)
American Heart Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matthew A Plow, PhD, Case Western Reserve University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 07-14-16 / 03-14-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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