Dataset Information

Study protocol of a randomized controlled trial to improve cancer prevention behaviors in adolescents and adults using a web-based intervention supplemented with SMS.

ABSTRACT:

Background

The overall number of cancer cases is increasing and, therefore, strengthening cancer prevention has become a priority. The institutions responsible for its control establish guidelines for primary prevention. These include recommendations, such as: not smoking, following a healthy diet, doing daily physical exercise or avoiding overweight. Adolescence is a period of adoption and/or consolidation of health behaviors, and both school- and family-based interventions have proven effective to improve them. Furthermore, online and mobile phone educational interventions are encouraging. Consequently, the main aim of this study is to assess the efficacy of an intervention in which these requirements (school, family, the Internet and SMS) are combined to prevent behavioral cancer risk.

Methods

This protocol describes the design and implementation of a complex online program that includes a randomized controlled trial put into practice in two countries: Spain and Mexico. Adolescents and adults of their environment (relatives and teachers) who voluntarily participate will be randomly assigned to the experimental group or to the control group once they have completed the online pre-test. The experimental group members will have free access to a tailor-made and interactive website (http://www.alertagrumete.com). During the academic year, this website will be periodically updated with different school and leisure activities related to the avoidance of risk behaviors. To encourage participation, the program includes a competition that gives rewards to the winners. SMS are also sent to students to stimulate the adoption of healthy behaviors and as a reminder of participation. Finished the intervention, an online post-test is performed in both groups and the impact on the risk behaviors is therefore assessed.

Discussion

The program is pioneer, since it combines many components which have already proven effective in previous researches. Moreover, it aims to compare efficacy in two countries with different socio-economic levels to find out if these approaches are equally effective in countries with a lower income level. However, the vertiginous evolution of the Internet and mobile phones may make this tool less attractive for adolescents, who may prefer social networks and other mobile phone applications which are nowadays massively used by their peers.

Trial registration

ISRCTN27988779.

SUBMITTER: Lana A

PROVIDER: S-EPMC3637581 | biostudies-literature | 2013 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Study protocol of a randomized controlled trial to improve cancer prevention behaviors in adolescents and adults using a web-based intervention supplemented with SMS.

Lana Alberto A del Valle Maria Olivo MO López Santiago S Faya-Ornia Goretti G López Maria Luisa ML

BMC public health 20130417

<h4>Background</h4>The overall number of cancer cases is increasing and, therefore, strengthening cancer prevention has become a priority. The institutions responsible for its control establish guidelines for primary prevention. These include recommendations, such as: not smoking, following a healthy diet, doing daily physical exercise or avoiding overweight. Adolescence is a period of adoption and/or consolidation of health behaviors, and both school- and family-based interventions have proven ...[more]

PMID: 23594381

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Project description:BackgroundPredictive theoretical models suggest that health knowledge works in conjunction with motivation and behavioral skills to influence adolescents' obesogenic behavior. However, most of the existing adolescent interventions target these variables in isolation. Furthermore, health literacy (HL), a precursor to health knowledge, is necessary for translating health knowledge into behavior and is negatively related to adolescents' obesity status. However, HL has not been included in obesity interventions targeting adolescents.ObjectiveThis study aims to pilot the feasibility of a 2-armed web-based obesity prevention intervention in school settings and assess the preliminary effectiveness of adding an HL module to an obesity prevention intervention for adolescents.MethodsThis web-based pilot feasibility study will take place in the Northeastern United States. Participants will be adolescents (aged 13-16 years) attending school, and recruitment will be conducted through flyers to parents and adolescents in participating classes or advisory groups at the school. The intervention includes 2 arms: an experimental arm that will receive an HL module and 3 obesity prevention modules and a comparison arm that will receive a vaping module and 3 obesity prevention modules. A blinded randomized procedure will be used to allocate classrooms and advisory groups to the experimental and comparison arms. The intervention will be fully web-based. Participants will complete measures of their HL and obesogenic behavior-related health knowledge, motivation, and behaviors at 3 time points (baseline, 1 month after the intervention, and 3 months after the intervention) via web-based surveys. The primary outcomes will be the measures of study feasibility (recruitment, retention, completion, and treatment fidelity rates). Secondary outcomes will be preliminary efficacy, as measured by logistic and linear regressions and calculation of effect sizes. Descriptive statistics will be calculated for all measures at each time point.ResultsThis study was approved by the City University of New York Institutional Review Board in August 2020. As of June 2022, the web-based intervention design is complete and ready for use. Recruitment, data collection, and intervention implementation are scheduled to begin in September 2022. These results are expected to be published in 2023.ConclusionsThis study's feasibility findings will inform changes to the intervention content and randomized controlled trial design. The study's efficacy findings will inform the sample size for the full-scale randomized controlled trial and the preliminary utility of the intervention.Trial registrationClinicalTrials.gov NCT04252677; https://clinicaltrials.gov/ct2/show/NCT04252677.International registered report identifier (irrid)PRR1-10.2196/40191.

Project description:Interventions to support people with hypertension in attending clinics and taking their medication have potential to improve outcomes, but delivery on a wide scale and at low cost is challenging. Some trials evaluating clinical interventions using short message service (SMS) text-messaging systems have shown important outcomes, although evidence is limited. We have developed a novel SMS system integrated with clinical care for use by people with hypertension in a low-resource setting. We aim to test the efficacy of the system in improving blood pressure control and treatment adherence compared to usual care.The SMS Text-message Adherence suppoRt trial (StAR) is a pragmatic individually randomised three-arm parallel group trial in adults treated for hypertension at a single primary care centre in Cape Town, South Africa. The intervention is a structured programme of clinic appointment, medication pick-up reminders, medication adherence support and hypertension-related education delivered remotely using an automated system with either informational or interactive SMS text-messages. Usual care is supplemented by infrequent non-hypertension related SMS text-messages. Participants are 1:1:1 individually randomised, to usual care or to one of the two active interventions using minimisation to dynamically adjust for gender, age, baseline systolic blood pressure, years with hypertension, and previous clinic attendance. The primary outcome is the change in mean systolic blood pressure at 12-month follow-up from baseline measured with research staff blinded to trial allocation. Secondary outcomes include the proportion of patients with 80% or more of days medication available, proportion of participants achieving a systolic blood pressure less than 140 mmHg and a diastolic blood pressure less than 90 mmHg, hospital admissions, health status, retention in clinical care, satisfaction with treatment and care, and patient related quality of life. Anonymised demographic data are collected on non-participants.The StAR trial uses a novel, low cost system based on widely available mobile phone technology to deliver the SMS-based intervention, manage communication with patients, and measure clinically relevant outcomes. The results will inform implementation and wider use of mobile phone based interventions for health care delivery in a low-resource setting.NCT02019823.

Project description:BackgroundRisky sexual behaviors of adolescents in Mexico are a public health problem; 33.4 % of adolescent girls and 14.7 % of boys report not having used any protection at their first intercourse. The fertility rate is 77 births/1000 girls aged 15-19 years. The infrequent contact of adolescents with health services and the limited extent of school sex and reproductive health education require the support of innovative strategies. The objective of this paper is to present the design of an internet-based educational strategy to prevent risky sexual behaviors in Mexican adolescents.MethodsA field trial with intervention and comparison group and with ex-ante and ex-post measurements will be conducted in two public secondary schools. Adolescents between 14 and 15 years of age will participate. The intervention will be conducted in one school and the second school will serve as a comparison group where the investigators will observe the usual sex education provided by the school. The intervention will be delivered using an internet web page that includes four educational sessions provided during a 4 week period. Follow-up will last 3 months. Information on the study variables will be obtained through an Internet-based self-applied questionnaire and collected on three occasions: 1) when the adolescents enter the study (baseline), 2) once the intervention is completed (at 1 month) and 3) after 3 months of follow-up (at the fourth month). There will be three outcome variables: 1) knowledge in regard to sexually transmitted infections, 2) attitudes regarding condom use, and 3) self-efficacy toward consistent condom use. The generalized linear model will be used to assess changes in each outcome variable controlling for baseline measures and for study covariates.DiscussionThe design and evaluation of an Internet-based educational strategy to prevent risky sexual behaviors in Mexican adolescents is important in order to provide a new, large-scale, easily implemented preventive tool.Trial registrationThe study was registered at the ClinicalTrials.gov ID: NCT02686736 .

Project description:BackgroundAdolescent depression carries a high burden of disease worldwide, but access to care for this population is limited. Prevention is one solution to curtail the negative consequences of adolescent depression. Internet interventions to prevent adolescent depression can overcome barriers to access, but few studies examine long-term outcomes.ObjectiveThis study compares CATCH-IT (Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training), an internet-based intervention, to a general health education active control for depression onset at 12 and 24 months in adolescents presenting to primary care settings.MethodsA 2-site randomized trial, blinded to the principal investigators and assessors, was conducted comparing Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training to health education to prevent depressive episodes in 369 adolescents (193 youths were randomly assigned to Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training and 176 to health education) with subthreshold depressive symptoms or prior depressive episodes. Participants were recruited from primary care settings in the United States. The primary outcome was the occurrence of a depressive episode, determined by the Depression Symptom Rating. The secondary outcome was functioning, measured by the Global Assessment Scale.ResultsIn intention-to-treat analyses, the adjusted hazard ratio favoring Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training for first depressive episode was not statistically significant at 12 months (hazard ratio 0.77, 95% CI 0.42-1.40, P=.39) and 24 months (hazard ratio 0.87, 95% CI 0.52-1.47, P=.61). Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training provided preventive benefit for first depressive episode for those with mild hopelessness or at least moderate paternal monitoring at baseline. Global Assessment Scale scores improved comparably in both groups (intention-to-treat).ConclusionsA technology-based intervention for adolescent depression prevention implemented in primary care did not have additional benefit at 12 or 24 months. Further research is necessary to determine whether internet interventions have long-term benefit.Trial registrationClinicalTrials.gov NCT01893749; http://clinicaltrials.gov/ct2/show/NCT01893749.

Project description:BackgroundTwo strategies of the US Ending the HIV Epidemic initiative are early diagnosis of infections via widespread testing and prevention of new infections using pre-exposure prophylaxis (PrEP). These strategies are particularly important for adolescents and young adults (AYAs) who are disproportionately affected by HIV, particularly if they identify as Black and/or lesbian, gay, bisexual, transgender, queer or questioning, and others (LGBTQ+). This study will develop and test an interactive life-simulation game in which players can enact real-life behaviors and receive their HIV risk profile to improve HIV testing and PrEP access among AYAs aged 13-24 years in Washington, DC.ObjectiveThis mixed methods study aims to determine the acceptability of an interactive, enhanced life-simulation game prototype among AYAs, conduct a pilot test of the gaming intervention among a small cohort of AYAs to ensure game usability and acceptability, and evaluate the efficacy of the game in a randomized controlled study with AYAs at risk for HIV in Washington, DC.MethodsThis research protocol will be conducted in 3 phases. A formative phase will involve surveys and focus groups (n=64) with AYAs living in the DC area. These focus groups will allow researchers to understand youth preferences for game enhancement. The second phase will consist of a pilot test (n=10) of the gaming intervention. This pilot test will allow researchers to modify the game based on formative results and test the planned recruitment and data collection strategy with intended end users. The third phase will consist of a randomized controlled study among 300 AYAs to examine the efficacy of the life-simulation game compared with app-based HIV educational materials on HIV and PrEP in changing HIV testing, knowledge, risk behaviors, and PrEP access. Participants will have unlimited access to either the life-simulation game or the educational app for 3 months from the time of enrollment. Study assessments will occur at enrollment and at 1, 3, and 6 months post enrollment via e-surveys. At 6 months, a subset of intervention participants (n=25) will participate in in-depth exit interviews regarding their experience being in the study.ResultsInstitutional review board approval was received on February 5, 2020. This project is currently recruiting participants for the formative phase.ConclusionsThis interactive life-simulation intervention aims to increase HIV testing and PrEP access among AYAs in the DC area. In this intervention, players can enact real-life behaviors and receive their HIV risk profile to promote HIV testing and PrEP seeking. Such an intervention has great potential to improve knowledge of HIV and PrEP among AYAs, increase motivation and self-efficacy related to HIV testing and PrEP use, and decrease individual and structural barriers that often preclude engagement in HIV prevention services.Trial registrationClinicalTrials.gov NCT04917575; https://clinicaltrials.gov/ct2/show/NCT04917575.International registered report identifier (irrid)PRR1-10.2196/29792.

Project description:BackgroundAdolescents and young adults (AYA) aged younger than 25 years have the highest rates of sexually transmitted infections (STIs) in the United States. Current STI prevention strategies for AYA rely primarily on individual approaches, leaving sexual partners with significant unmet sexual and reproductive health care and health education needs. Dyadic interventions may hold promise for harnessing the power of communal coping within relationship dynamics to enhance sexual decision making, communication, and behavior changes that reduce the future risk of STIs.ObjectiveThis paper describes the protocol and research methods of a dyad-based behavioral intervention that augments individual evidence-based interventions with joint health education counseling for heterosexual AYA dyads within a primary care setting. The trial aims to improve partner communication and collaborative sexual decision making and promote the adoption of sexual behaviors such as consistent condom use. The primary objective of this study is to assess the feasibility, acceptability, and effectiveness of a dyadic intervention targeted at preventing STIs in heterosexual couples in an urban setting.MethodsA total of 100 AYA (50 dyads) aged 16 to 25 years, engaged in heterosexual intercourse, who reside in the city and are willing to recruit their main sexual partner for the study will be recruited and randomized into 2 groups, an intervention arm and a control arm. Participants will be recruited from an AYA medicine clinic and by using social media (Facebook and Instagram). The index participant and partner will complete a single individual session separately (Sister to Sister or Focus on the Future) with a gender-matched health educator. Dyads will then be randomized to receive an additional joint debriefing session together to discuss relationship dynamics, condom negotiation, etc. Participants will separately complete a telephone interview 6 weeks postintervention to determine the feasibility, acceptability, and impact of the intervention on mutual sexual negotiation, consistency of condom use, and communal coping skills, etc.ResultsSo far, 25.4% (44/173) of eligible participants have been enrolled and randomized. Participants are mostly female (20/22, 91%), with at least a high school diploma (19/22, 86%), and 9 average lifetime sexual partners. Acceptability is high, with 98% (43/44) of participants expressing satisfaction with their study experience; 100% of dyads recruited were still together at 6-week follow-up.ConclusionsFindings from this study will add to the current literature on the approaches to STI prevention, and its success will inform its application in risk reduction counseling for youth who are most at risk.Trial registrationClinical Trials.gov NCT03275168; https://www.clinicaltrials.gov/ct2/history/NCT03275168.International registered report identifier (irrid)DERR1-10.2196/29389.

Project description:BackgroundMultiple chronic conditions (MCCs) are common among older adults and expensive to manage. Two-thirds of Medicare beneficiaries have multiple conditions (eg, diabetes and osteoarthritis) and account for more than 90% of Medicare spending. Patients with MCCs also experience lower quality of life and worse medical and psychiatric outcomes than patients without MCCs. In primary care settings, where MCCs are generally treated, care often focuses on laboratory results and medication management, and not quality of life, due in part to time constraints. eHealth systems, which have been shown to improve multiple outcomes, may be able to fill the gap, supplementing primary care and improving these patients' lives.ObjectiveThis study aims to assess the effects of ElderTree (ET), an eHealth intervention for older adults with MCCs, on quality of life and related measures.MethodsIn this unblinded study, 346 adults aged 65 years and older with at least 3 of 5 targeted high-risk chronic conditions (hypertension, hyperlipidemia, diabetes, osteoarthritis, and BMI ?30 kg/m2) were recruited from primary care clinics and randomized in a ratio of 1:1 to one of 2 conditions: usual care (UC) plus laptop computer, internet service, and ET or a control consisting of UC plus laptop and internet but no ET. Patients with ET have access for 12 months and will be followed up for an additional 6 months, for a total of 18 months. The primary outcomes of this study are the differences between the 2 groups with regard to measures of quality of life, psychological well-being, and loneliness. The secondary outcomes are between-group differences in laboratory scores, falls, symptom distress, medication adherence, and crisis and long-term health care use. We will also examine the mediators and moderators of the effects of ET. At baseline and months 6, 12, and 18, patients complete written surveys comprising validated scales selected for good psychometric properties with similar populations; laboratory data are collected from eHealth records; health care use and chronic conditions are collected from health records and patient surveys; and ET use data are collected continuously in system logs. We will use general linear models and linear mixed models to evaluate primary and secondary outcomes over time, with treatment condition as a between-subjects factor. Separate analyses will be conducted for outcomes that are noncontinuous or not correlated with other outcomes.ResultsRecruitment was conducted from January 2018 to December 2019, and 346 participants were recruited. The intervention period will end in June 2021.ConclusionsWith self-management and motivational strategies, health tracking, educational tools, and peer community and support, ET may help improve outcomes for patients coping with ongoing, complex MCCs. In addition, it may relieve some stress on the primary care system, with potential cost implications.Trial registrationClinicalTrials.gov NCT03387735; https://www.clinicaltrials.gov/ct2/show/NCT03387735.International registered report identifier (irrid)DERR1-10.2196/25175.

Dataset Information

Study protocol of a randomized controlled trial to improve cancer prevention behaviors in adolescents and adults using a web-based intervention supplemented with SMS.

Background

Methods

Discussion

Trial registration

Publications

Study protocol of a randomized controlled trial to improve cancer prevention behaviors in adolescents and adults using a web-based intervention supplemented with SMS.

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