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Protocol for an experimental study design to evaluate computer-enabled intervention to prevent and manage metabolic syndrome.

ABSTRACT: The rising prevalence of overweight and obesity has a direct correlation with increasing prevalence of hypertension, dyslipidaemia, type 2 diabetes, metabolic syndrome (MetS) and cardiovascular diseases. Most of the previous studies have been cross-sectional in nature and have looked at the prevalence of metabolic syndrome. Despite the clinical and public health importance of this phenomenon, not enough work has been carried out so far to study and remedy this situation. The objectives of the proposed study is to develop an innovative user-centred informatics platform that will facilitate delivery of a multifactorial intervention after taking into account user sociodemographics, health behaviour, prior disease state and knowledge attitudes and practices.The objective of the proposed study is to develop an innovative user-centred informatics platform that will facilitate delivery of a multifactorial intervention after taking into account users' sociodemographics, health behaviour, prior disease state and knowledge, attitudes and behaviour.A randomised two-group repeated-measures clinical trial design will be used, on 750 subjects from urban, rural and slum areas, in an Indian setting. The study participants will be randomly assigned to either the intervention (computer-based MetS Program, CBMP) or control (printed educational material, PEM) group. Both the groups will undergo screening, learning and evaluation assessments at the time of the visit and at follow-up visits 30, 60 and 90 days after the first visit.The outcomes expected in the intervention group include improvement in Mets-related knowledge, adherence to self-care practices, better quality of life and increased satisfaction with medical care.The study has been approved by the Institutional Review Board of Asian Institute of Public Health (IRB#621). The proposed study will also help us assess the usefulness and challenges of technology to disseminate health education among diverse users. Findings will be disseminated through peer-reviewed publications and national and international conference presentations to various stakeholders and local community health leaders. The ClinicalTrials.gov Identifier is NCT01713465.

SUBMITTER: Joshi A

PROVIDER: S-EPMC3612782 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature

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Protocol for an experimental study design to evaluate computer-enabled intervention to prevent and manage metabolic syndrome.

Joshi Ashish A Mehta Shruti S Talati Kandarp K Grover Ashoo A

BMJ open 20130301 3

<h4>Introduction</h4>The rising prevalence of overweight and obesity has a direct correlation with increasing prevalence of hypertension, dyslipidaemia, type 2 diabetes, metabolic syndrome (MetS) and cardiovascular diseases. Most of the previous studies have been cross-sectional in nature and have looked at the prevalence of metabolic syndrome. Despite the clinical and public health importance of this phenomenon, not enough work has been carried out so far to study and remedy this situation. The ...[more]

PMID: 23454666

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Project description:BACKGROUND:Binge-drinking in adolescents is a highly prevalent healthcare problem that associates physical and mental health complications with community implications. This paper describes the design, implementation and evaluation of the first web-based computer tailored intervention aimed at the prevention of binge drinking in Spanish adolescents. METHODS:The Alerta Alcohol program is based on the I-Change Model. First, feedback from focus and Delphi groups are used for cultural adaptation and to obtain further information on the items to be included on the program. A pilot study is then conducted to assess feasibility and to identify strengths and weaknesses. Second, a Cluster Randomized Controlled Trial is conducted to test the effectiveness of Alerta Alcohol in students aged 16 to 18 years. The study is performed in 16 high schools from Andalusia (southern Spain), which are randomized either to the experimental or the control condition (EC and CC). The EC receives the Alerta Alcohol intervention, which consists of four sessions at school (baseline questionnaire, two sessions in three scenarios: at home, celebrations, and public places, and a final evaluation). The adolescents are provided with answers related to their views of each scenario; this information is used to provide highly specific feedback regarding their knowledge, risk perception, self-esteem, attitude, social influence, and self-efficacy. In addition, two booster sessions are given at home to reinforce the previous messages. The CC just completes the baseline and the final evaluation questionnaires and then they are allowed to receive the intervention as well (as a waiting list). Evaluation takes place after four months. The primary endpoint is binge drinking within 30 days prior to the evaluation and alcohol use in the previous week. It is expected that Alerta Alcohol reduce the prevalence of binge drinking by 10%. Follow up analyses are carried out to determine the differences in effectiveness according to the compliance of the program (quality of the implementation). DISCUSSION:The results are expected to be applicable and may incorporate improvements in the practice of the Healthcare and Education Systems. If the program proves to be effective, regional and eventual national implementation should be considered. TRIAL REGISTRATION:Trial registration number (ClinicalTrials.gov): NCT03288896 . This study was retrospectively registered on 19/09/2017.

Project description:Alcohol and cannabis are the most commonly used substances among adolescents in the U.S. The consequences related to using both substances together are significantly higher relative to use of either substance alone. Teens' propensity to engage in risky driving behaviors (e.g., speeding, rapid lane changes, and texting) and their relative inexperience with the timing and duration of cannabis' effects puts them at heightened risk for experiencing harms related to driving under the influence. Use of alcohol and cannabis peak at age 16, the legal age teens may apply for a provisional driver's license in some states. Targeting novice teen drivers prior to licensure is thus an ideal time for prevention efforts focused on reducing alcohol and/or cannabis initiation, use, and impaired driving. The current study proposes to evaluate the efficacy of webCHAT among 15.5 to 17-year-old adolescents (n = 150) recruited at driver education programs. WebCHAT is a single session online intervention that aims to prevent alcohol and cannabis use and risky driving behaviors. We will recruit adolescents enrolled in driver education programs, and stratify based on whether they used cannabis and/or alcohol in the past 3 months (60% screening negative and 40% screening positive). All participants will receive usual driver education and half will also receive webCHAT. We will test whether webCHAT in addition to usual driver education reduces alcohol and/or cannabis initiation or use and reduces risky driving attitudes and behaviors (intent to drive after drinking/using, riding as a passenger with someone who drank/used) compared to teens in usual driver education over a 6-month period. We will also explore whether variables such as beliefs and perceived norms serve as explanatory mechanisms for our outcomes. The study has the potential to promote public welfare by decreasing adolescent initiation and use of cannabis and alcohol and reducing risky driving behaviors that can have substantial monetary, personal, and social costs. The study recruits adolescents who are at risk for substance use as well as those who are not and it is delivered remotely during a teachable moment when adolescents receive driver education. Trial registration This study was registered with ClinicalTrials.gov on July 13, 2021 (NCT04959461). https://clinicaltrials.gov/ct2/show/NCT04959461.

Project description:BACKGROUND:To increase cardiovascular disease prevention efforts, worksite interventions can promote healthy food choices, facilitate health education, increase physical activity and provide social support. This pioneer study will measure the effectiveness of a cafeteria and a behavioral intervention on cardio-metabolic risk in a worksite in Nepal. METHODS:The Nepal Pioneer Worksite Intervention Study is a two-step intervention study conducted in Dhulikhel Hospital in eastern Nepal. In the first step, we will assess the effectiveness of a 6-month cafeteria intervention on cardio-metabolic risk using a pre-post design. In the second step, we will conduct a 6-month, open-masked, two-arm randomized trial by allocating half of the participants to an individual behavioral intervention based on the 'diabetes prevention program' for the prevention of cardio-metabolic risk. We will recruit 366 full time employees with elevated blood pressure, fasting blood sugar, or glycosylated haemoglobin (HbA1c). At baseline, we will measure their demographic variables, lifestyle factors, anthropometry, fasting blood sugar, HbA1c,and lipid profiles. We will measure cardio-metabolic outcomes at 6?months, 12?months, and 18?months. At 12?months, we will compare the proportion of participants who have attained two or more cardio-metabolic risk factor reduction goals (HbA1c decrease ?0.5%; systolic blood pressure decrease ?5?mmHg; or triglycerides decrease ?10?mg/dL) during the cafeteria intervention period and the control period using generalized estimating equations. At 18?months, we will compare the proportion from the 'cafeteria only arm' to the 'cafeteria and behavior arm' for the same outcome using a chi-square test. DISCUSSION:This pioneer study will estimate the effect of environmental-level changes on lowering cardio-metabolic risks; and added benefit of an individual-level dietary intervention. If the study demonstrates a significant effect, a scaled up approach could produce an important reduction in cardiovascular disease burden through environmental and individual level prevention programs in Nepal and similar worksites worldwide. TRIAL REGISTRATION:The trial was retrospectively registered on clincaltrials.gov (Identification Member: NCT03447340 ; Date of Registration: February 27, 2018).

Project description:BackgroundThe regular practice of mindfulness has been shown to provide benefits for mental well-being and prevent depression relapse. Technology-mediated interventions can facilitate the uptake and sustained practice of mindfulness, yet the evaluation of interactive systems, such as brain-computer interfaces, has been little explored.ObjectiveThe objective of this paper is to present an interactive mindfulness-based technology to improve mental well-being in people who have experienced depression. The system, Anima, is a brain-computer interface that augments mandala coloring by providing a generative color palette based on the unfolding mindfulness states during the practice. In addition, this paper outlines a multiple-baseline, single-case experimental design methodology to evaluate training effectiveness.MethodsAdult participants who have experienced depression in the past, have finished treatment within the last year, and can provide informed consent will be able to be recruited. The Anima system, consisting of 2 tablets and a nonintrusive mental activity headband, will be delivered to participants to use during the study. Measures include state and trait mindfulness, depression symptoms, mental well-being, and user experience, and these measures will be taken throughout the baseline, intervention, and monitoring phases. The data collection will take place in the form of a questionnaire before and after each mandala-coloring session and a semistructured interview every 2 weeks. Trial results will be analyzed using structured visual analysis, supplemented with statistical analysis appropriate to single-case methodology.ResultsStudy results will offer new insights into the deployment and evaluation of novel interactive brain-computer interfaces for mindfulness training in the context of mental health. Moreover, findings will validate the effectiveness of this training protocol to improve the mental well-being of people who have had depression. Participants will be recruited locally through the National Health Service.ConclusionsEvidence will assist in the design and evaluation of brain-computer interfaces and mindfulness technologies for mental well-being and the necessary services to support people who have experienced depression.International registered report identifier (irrid)PRR1-10.2196/20819.

Project description:BackgroundCorrection professionals are a highly stressed workforce with heightened risks for depression, suicide, obesity, cardiovascular disease, and injury. These professionals, largely hidden from view, have received little study concerning means to improve their safety, health, and well-being. In other settings, mindfulness has resulted in lowered stress, along with other benefits. We hypothesized that a program that promoted mindfulness combined with more typical health and safety components could uniquely benefit corrections professionals.ObjectiveThis project will assess a novel scalable, self-administered program to enhance the mindfulness, safety, and health of a vulnerable worker group.MethodsIn partnership with the Oregon Department of Corrections, we are conducting a prospective quasi-experimental trial of a safety, health, and mindfulness program among 100 corrections professionals from 2 institutions. Survey and physiologic data will be collected at enrollment, upon weekly program completion (3 months), and at 9 months after enrollment. Primary outcome behaviors promoted by the program are being mindful, healthier eating, more physical activity, and greater restorative sleep. Secondary downstream benefits are anticipated in stress level, mood, positive feelings about the organization, vascular health, and cellular aging, along with job performance, injuries, and economic costs. Participants will meet in-person or in a Zoom-type meeting as 3- to 5-member coworker groups during their usual work hours for 30-minute sessions once a week for 12 weeks. The program uses self-guided web-based learning modules that include brief mindfulness practice, and it is accessible by smartphone, tablet, or laptop. Daily mindfulness practice is encouraged between sessions, which is facilitated by the study website and group format. The modules' structure emphasizes prerequisite knowledge, peer support, skill practice, self-monitoring, and enhancing self-efficacy for change. The program continues through self-directed use of the Headspace app following the 12 weekly sessions.ResultsParticipants are being enrolled, and the intervention is ready to launch.ConclusionsAlthough mindfulness training has gained traction for worker well-being, its usual format requires a skilled trainer, an initial retreat, and weekly 2-hour meetings for several weeks. The content is limited to mindfulness without safety or health promotion aspects. The need for skilled trainers and time commitment limits the scalability of the usual mindfulness interventions. The planned program is an innovative combination of technology, e-learning, and a group format to add mindfulness to a safety and health curriculum. If acceptable and effective, the format would facilitate its widespread use.Trial registrationClinicalTrials.gov NCT05608889; https://classic.clinicaltrials.gov/ct2/show/NCT05608889.International registered report identifier (irrid)PRR1-10.2196/45535.

Project description:BACKGROUND:Effective, evidence-based interventions to prevent childhood tuberculosis (TB) in high TB/HIV-burden, resource-limited settings are urgently needed. There is limited implementation of evidence-based contact management strategies, including isoniazid preventive therapy (IPT), for child contacts of TB cases in Lesotho. METHODS/DESIGN:This mixed-methods implementation science study utilizes a two-arm cluster-randomized trial design with randomization at the health facility level. The study aims to evaluate the effectiveness and acceptability of a combination community-based intervention (CBI) versus standard of care (SOC) for the management of child TB contacts. The study includes three phases: (I) exploratory phase; (II) intervention implementation and testing phase; (III) post-intervention explanatory phase. Healthcare provider interviews to inform intervention refinement (phase I) were completed in December 2015. In phase II, 10 health facilities were randomized to deliver the CBI or SOC, with stratification by facility type (i.e., hospital vs. health center). CBI holistically addresses the complex provider-related, patient-related, and caregiver-related barriers to prevention of childhood TB through nurse training and mentorship; health education for caregivers and patients by village health workers; adherence support using text messaging and village health workers; and multidisciplinary team meetings, where programmatic data are reviewed and challenges and solutions are discussed. SOC sites follow country guidelines for child TB contact management. Routine TB program data will be abstracted for all adult TB cases newly registered during the study period and their child contacts from TB registers and cards. The anticipated sample size is 1080 child contacts. Primary outcomes are yield (number) of child contacts, including children?<?5 years of age and HIV-positive children?<?15 years of age; IPT initiation; and IPT completion. Secondary outcomes include HIV testing; yield of active prevalent TB among child contacts; and acceptability and utilization of CBI components. Intervention implementation began in February 2016 and is ongoing. Post-intervention interviews with healthcare providers and caregivers (phase III) commenced in February 2017. DISCUSSION:The PREVENT study tests the effectiveness and acceptability of a novel combination CBI for child TB contact management in Lesotho. If effective, CBI will have important implications for addressing childhood TB in Lesotho and elsewhere. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02662829 . Registered on 15 January 2016.

Project description:IntroductionThe rising prevalence of stroke and stroke-related disability witnessed globally over the past decades may cause an overwhelming demand for rehabilitation services. This situation is of concern for low-income and middle-income countries like India where the resources for rehabilitation are often limited. Recently, a smartphone-enabled carer-supported educational intervention for management of physical disabilities following stroke was developed in India. It was found to be feasible and acceptable, but evidence of effectiveness is lacking. Hence, as a step forward, this study intends to evaluate clinical effectiveness of the intervention through a randomised controlled trial.MethodsThe objective of the study is to evaluate whether the 'Care for Stroke' intervention is clinically and cost-effective for the reduction of dependency in activities of daily living among stroke survivors in an Indian setting. This study is designed as a randomised controlled trial comparing people who received the intervention to those receiving standard care. The trial will be pragmatic and outcome assessor-blinded. The primary outcome for the study is dependency in daily living measured by the Modified Rankin Scale (MRS). A total of 266 adult stroke survivors who fulfil the eligibility criteria will be randomised to receive either 'Care for Stroke' intervention or standard treatment and will be followed up for 6?weeks. The main analyses will compare participants allocated to the 'Care for Stroke' intervention versus those allocated to the standard treatment group on an 'intention-to-treat' basis, irrespective of whether the participants received the treatment allocated or not. The dichotomised MRS scores (0-3 and 4-6) in both the groups will be used to calculate the effect estimates with a measure of precision (95% CI) and presented in the results of the trial.Ethics and disseminationThe Indian Institute of Public Health-Hyderabad/Public Health Foundation of India - Independent Institutional Ethics Committee and the Ethics Committee of the London School of HygieneandTropical Medicine. Dissemination will be through peer-reviewed publications.Trial registration numberClinical Trial Registry of India CTRI/2017/07/009014.

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Protocol for an experimental study design to evaluate computer-enabled intervention to prevent and manage metabolic syndrome.

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Protocol for an experimental study design to evaluate computer-enabled intervention to prevent and manage metabolic syndrome.

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