Health Promotion and Wellness Program for Adults With Disabling Conditions

NCT01776034 | Completed

• 1 other identifier: 07-14-16 / 03-14-24
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke; Multiple Sclerosis; Rheumatoid Arthritis

Keywords

Self Care; Exercise; Weight management

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in body weight.

  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 Outcomes (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).

• 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).

Study Arms (2)

SystemCHANGE Group Lifestyle counseling

EXPERIMENTAL

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

Phone Lifestyle Counseling

ACTIVE COMPARATOR

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

Interventions

SystemCHANGE Group Lifestyle counseling BEHAVIORAL

SystemCHANGE Group Lifestyle counseling

Phone Lifestyle Counseling BEHAVIORAL

Phone Lifestyle Counseling

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician-confirmed diagnosis of stroke (\> 6 weeks)
• Body mass index between 23 to 45 kg/m2
• Age 30 to 75 years

You may not qualify if:

• 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
• 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)
• Physician-confirmed diagnosis of multiple sclerosis or rheumatoid arthritis

Sponsors & Collaborators

• Case Western Reserve University: lead
• American Heart Association: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• 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.

  PMID: 23782741 DERIVED

MeSH Terms

Conditions

Stroke; Multiple Sclerosis; Arthritis, Rheumatoid; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Matthew A Plow, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: January 25, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)