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

ABSTRACT: Over 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.We 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.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.ClinicalTrials.gov Identifier: NCT01776034.

SUBMITTER: Plow M

PROVIDER: S-EPMC3663646 | biostudies-literature | 2013 May

REPOSITORIES: biostudies-literature

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

Plow Matthew M Moore Shirley M SM Kirwan John P JP Frost Fredrick F Katzan Irene I Jaeger Sue S Alberts Jay J

Trials 20130507

<h4>Background</h4>Over 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 ...[more]

PMID: 23782741

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Project description:BackgroundHealth behavior and weight management interventions for cancer survivors have the potential to prevent future cancer recurrence and improve long-term health; however, their translation can be limited if the intervention is complex and involves high participant burden. Mobile health (mHealth) offers a delivery modality to integrate interventions into daily life routines.ObjectiveThe objective of this study was to evaluate the effects of a one-group trial with a pre-post evaluation design on engagement (use and acceptability), physiological (weight), behavioral (diet and physical activity), and other secondary outcomes.MethodsThe 10-week intervention consisted of mHealth components (self-monitoring of selected diet behaviors via daily text messages, wireless devices to automatically track weight and steps) and 4 motivational interviewing-based technology-assisted phone sessions with a nonprofessionally trained counselor. Participants were overweight breast cancer survivors who had completed treatment and owned a smartphone. Weight was measured objectively; diet and physical activity were measured with brief self-reported questionnaires.ResultsTen women participated; they had a mean age of 59 years (SD 6), 50% belonged to a racial or ethnic minority group, 50% had some college or less, and 40% reported using Medicaid health insurance. Engagement was high: out of 70 days in total, the mean number of days recording steps via the wristband pedometer was 64 (SD 7), recording a weight via the scale was 45 (SD 24), and responding to text messages was 60 (SD 13); 100% of participants completed all 4 calls with the counselor. Most (90%) were very likely to participate again and recommend the program to others. Mean weight in pounds decreased (182.5 to 179.1, mean change -3.38 [SD 7.67]), fruit and vegetable daily servings increased (2.89 to 4.42, mean change 1.53 [SD 2.82]), and self-reported moderate physical activity increased in metabolic equivalent of task (MET) minutes per week (2791 to 3336, mean change 545 [SD 1694]).ConclusionsFindings support the conduct of a fully powered trial to evaluate the efficacy of mHealth as a feasible intervention modality for breast cancer survivors. Future research should employ accelerometer-based physical activity assessment and consider development of an all-in-one app to integrate devices, messaging, and educational content and other mHealth approaches to support behavioral counselors conducting weight management interventions.Trial registrationClinicalTrials.gov NCT02387671; https://clinicaltrials.gov/ct2/show/NCT02387671 (Archived by WebCite at http://www.webcitation.org/6hGEuttbZ).

Project description:Background:Several studies have reported that using the Wii™ Balance Board can provide added value regarding balance (re-)training in neurological diseases. However, for the large group of mobile older stroke survivors, there is no evidence regarding the feasibility of an unsupervised Wii™ Balance Board training in the home setting. The aim of this study was to investigate the feasibility of a home-based Wii™ balance training for these patients and to identify methodological challenges for randomised controlled trials in the future. Methods:We conducted a pilot randomised controlled trial with two intervention arms in participants' homes. Mobile stroke survivors (aged 60 years or above; 12 weeks after discharge from hospital) received a 6-week (once per week) supervised balance training at the study centre, followed by a 6-week (three times per week) unsupervised balance training at home. We used the Nintendo Wii™ Balance Board for one intervention arm and conventional balance exercises for the other intervention arm. Feasibility was assessed by recruiting rates, appropriateness of assessments regarding sensitivity to changes and acceptance of the intervention by the participants. Results:In two German hospital stroke units, 349 stroke survivors were screened over a period of 6 months, 91 were eligible and 52 were interested. Twelve weeks after discharge, 14 participants agreed and 11 completed the intervention (7 men and 4 women, mean age 74 years). The Berg Balance Scale and Dynamic Gait Index showed ceiling effects already at baseline measure. The participants in both intervention arms evaluated the unsupervised training positively and feasible for self-application. No falls or injuries occurred over the intervention period, while the required scope of the exercises could largely be achieved. Conclusions:In this pilot study, the recruitment of participants and the chosen assessments were not satisfactory due to selection bias and corresponding ceiling effects. However, the two home-based balance interventions proved feasible for mobile older stroke survivors with low functional limitations. Trial registration:ClinicalTrials.gov, NCT02251470. Registered 29 September 2014.

Project description:Background: Electronic communication is used in various populations to achieve health goals, but evidence in stroke is lacking. We pilot tested the feasibility and potential effectiveness of a novel personalised electronic self-management intervention to support person-centred goal attainment and secondary prevention after stroke.Methods: A phase I, prospective, randomised controlled pilot trial (1:1 allocation) with assessor blinding, intention-to-treat analysis, and a process evaluation. Community-based survivors of stroke were recruited from participants in the Australian Stroke Clinical Registry (AuSCR) who had indicated their willingness to be contacted for research studies. Inclusion criteria include 1-2?years following hospital admission for stroke and living within 50 km of Monash University (Melbourne). Person-centred goals were set with facilitation by a clinician using a standardised template. The intervention group received electronic support messages aligned to their goals over 4 weeks. The control group received only 2-3 electronic administrative messages. Primary outcomes were study retention, goal attainment (assessed using Goal Attainment Scaling method) and satisfaction. Secondary outcomes were self-management (Health Education Impact Questionnaire: 8 domains), quality of life, mood and acceptability.Results: Of 340 invitations sent from AuSCR, 73 responded, 68 were eligible and 57 (84%) completed the baseline assessment. At the goal-setting stage, 54/68 (79%) were randomised (median 16?months after stroke): 25 to intervention (median age 69?years; 40% female) and 29 to control (median age 68?years; 38% female). Forty-five (83%) participants completed the outcome follow-up assessment. At follow-up, goal attainment (mean GAS-T score ? 50) in the intervention group was achieved for goals related to function, participation and environment (control: environment only). Most intervention participants provided positive feedback and reported that the iVERVE messages were easy to understand (92%) and assisted them in achieving their goals (77%). We found preliminary evidence of non-significant improvements between the groups for most self-management domains (e.g. social integration and support: ? coefficient 0.34; 95% CI -?0.14 to 0.83) and several quality-of-life domains in favour of the intervention group.Conclusion: These findings support the need for further randomised effectiveness trials of the iVERVE program to be tested in people with new stroke.Trial registration: ANZCTR, ACTRN12618001519246 . Registered on 11 September 2018-retrospectively registered.

Project description:BackgroundMinorities have an increased incidence of early-onset, obesity-related cerebrovascular disease. Unfortunately, effective weight management in this vulnerable population has significant barriers.ObjectiveOur objective was to determine the feasibility and preliminary treatment effects of a smartphone-based weight loss intervention versus food journals to monitor dietary patterns in minority stroke patients.MethodsSwipe out Stroke was a pilot prospective randomized controlled trial with open blinded end point. Minority stroke patients and their caregivers were screened for participation using cluster enrollment. We used adaptive randomization for assignment to a behavior intervention with (1) smartphone-based self-monitoring or (2) food journal self-monitoring. The smartphone group used Lose it! to record meals and communicate with us. Reminder messages (first 30 days), weekly summaries plus reminder messages on missed days (days 31-90), and weekly summaries only (days 91-180) were sent via push notifications. The food journal group used paper diaries. Both groups received 4 in-person visits (baseline and 30, 90, and 180 days), culturally competent counseling, and educational materials. The primary outcome was reduced total body weight.ResultsWe enrolled 36 stroke patients (n=23, 64% African American; n=13, 36% Hispanic), 17 in the smartphone group, and 19 in the food journal group. Mean age was 54 (SD 9) years; mean body mass index was 35.7 (SD 5.7) kg/m2; education, employment status, and family history of stroke or obesity did not differ between the groups. Baseline rates of depression (Patient Health Questionnaire-9 [PHQ-9] score median 5.5, IQR 3.0-9.5), cognitive impairment (Montreal Cognitive Assessment score median 23.5, IQR 21-26), and inability to ambulate (5/36, 14% with modified Rankin Scale score 3) were similar. In total, 25 (69%) stroke survivors completed Swipe out Stroke (13/17 in the smartphone group, 12/19 in the food journal group); 1 participant in the smartphone group died. Median weight change at 180 days was 5.7 lb (IQR -2.4 to 8.0) in the smartphone group versus 6.4 lb (IQR -2.2 to 12.5; P=.77) in the food journal group. Depression was significantly lower at 30 days in the smartphone group than in the food journal group (PHQ-9 score 2 vs 8; P=.03). Clinically relevant depression rates remained in the zero to minimal range for the smartphone group compared with mild to moderate range in the food journal group at day 90 (PHQ-9 score 3.5 vs 4.5; P=.39) and day 180 (PHQ-9 score 3 vs 6; P=.12).ConclusionsIn a population of obese minority stroke survivors, the use of a smartphone did not lead to a significant difference in weight change compared with keeping a food journal. The presence of baseline depression (19/36, 53%) was a confounding variable, which improved with app engagement. Future studies that include treatment of poststroke depression may positively influence intervention efficacy.Trial registrationClinicalTrials.gov NCT02531074; https://www.clinicaltrials.gov/ct2/show/NCT02531074.

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

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

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