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Clinical Trials/NCT01776034
NCT01776034
Completed
Not Applicable

Examining the Efficacy of a SystemCHANGE™ Weight Management Intervention in Stroke Survivors and Persons With Chronic Inflammatory Autoimmune/Immune-mediated Diseases

Case Western Reserve University1 site in 1 country66 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Case Western Reserve University
Enrollment
66
Locations
1
Primary Endpoint
Changes from baseline in body weight.
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
December 2016
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Matthew Plow

Assistant Professor

Case Western Reserve University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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).)
  • Changes 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).)
  • Changes 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).)
  • Changes 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).)
  • Changes 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).)

Study Sites (1)

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