Evidence map›Paper›PMID 23782741›Full record

Trial reportTrials2013

Randomized controlled pilot study of a SystemCHANGE™ weight management intervention in stroke survivors: rationale and protocol.

Matthew Plow, Shirley M Moore, John P Kirwan, Fredrick Frost, Irene Katzan, Sue Jaeger, Jay Alberts

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01776034 (Examining the Efficacy of a SystemCHANGE™ Weight Management Intervention in Stroke Survivors and Persons With Chronic Inflammatory Autoimmune/Immune-mediated Diseases), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01776034 nacompletednot on this map

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

TypeinterventionalSponsorCase Western Reserve UniversityRan2013 to 2016Enrolled66ConditionsStroke, Multiple Sclerosis, Rheumatoid ArthritisArmsSystemCHANGE Group Lifestyle counseling, Phone Lifestyle Counseling
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 1 country.

Matthew PlowDepartment of Biomedical Engineering, Physical Medicine and Rehabilitation, Cleveland Clinic Lerner Research Institute, 9500 Euclid Ave, ND-20, Cleveland, OH 44195, USA. plowm@ccf.org
Shirley M Moore
John P Kirwan
Fredrick Frost
Irene Katzan
Sue Jaeger
Jay Alberts
Cleveland Clinic · USCleveland Clinic Lerner College of Medicine · USCase Western Reserve University · USNeurological Surgery · US

Funding

Clinical and Translational Science Collaborative of ClevelandUL1TR000439 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI KONSTAN, MICHAEL W. · 2012 to 2016
$50.0M
NCATS NIH HHS UL1 TR000439
6 · The paper itself

Abstract

backgroundOver 65% of stroke survivors are either overweight or obese and have multiple cardiovascular risk factors. However, few studies have examined the effects of comprehensive lifestyle behavior interventions to promote weight loss and control cardiovascular risk factors in stroke survivors. Thus, the purpose of this study is to examine a novel behavior change approach--SystemCHANGE™--to promote weight loss and improve health and function in stroke survivors. SystemCHANGE™ focuses on redesigning the social environment to achieve a specific goal.

methodsWe will conduct a randomized controlled pilot study to examine the efficacy, feasibility, and safety of the SystemCHANGE™ weight management program in overweight and obese stroke survivors. The central hypothesis of the study is that the SystemCHANGE™ intervention will help overweight and obese stroke survivors lose 5% of their body weight, thereby improving health and function. Thirty-five stroke survivors will be randomized into either the 6-month SystemCHANGE™ intervention or a contact-control intervention. Outcome measures will be assessed at baseline and again at 3 and 6 months after the interventions. Body composition will be assessed using a Bod Pod. Patient-reported outcomes will be the Stroke Impact Scale and Reintegration to Normal Living Index. Objective outcomes will include the 6-Minute Walking Test and Rivermead Motor Assessment. DISCUSSION: This study will be the first randomized controlled trial to evaluate the efficacy and safety of a weight management intervention in stroke survivors using the SystemCHANGE™ approach. Furthermore, it will be the first empirically-examined comprehensive lifestyle intervention designed to target physical activity, nutrition, and sleep to promote weight loss in stroke survivors.

trial registrationClinicalTrials.gov Identifier: NCT01776034.

Indexed as

Health BehaviorResearch DesignRisk Reduction BehaviorStroke RehabilitationBody CompositionClinical ProtocolsComorbidityDietExercise TestFeasibility StudiesHealth Knowledge, Attitudes, PracticeHumansMotor ActivityNutritional StatusObesityOhio

Identifiers

PMID23782741
PMCPMC3663646
OpenAlexW2107310544

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.