Dataset Information

A Tailored Web- and Text-Based Intervention to Increase Physical Activity for Latino Men: Protocol for a Randomized Controlled Feasibility Trial.

ABSTRACT:

Background

Latino men in the United States report low physical activity (PA) levels and related health conditions (eg, diabetes and obesity). Engaging in regular PA can reduce the risk of chronic diseases and yield many health benefits; however, there is a paucity of interventions developed exclusively for Latino men.

Objective

To address the need for culturally relevant PA interventions, this study aims to develop and evaluate Hombres Saludables, a 6-month theory-based, tailored web- and text message-based PA intervention in Spanish for Latino men. This protocol paper describes the study design, intervention, and evaluation methods for Hombres Saludables.

Methods

Latino men aged 18-65 years were randomized to either the individually tailored PA internet intervention arm or the nutrition and wellness internet control arm. The PA intervention included 2 check-in phone calls; automated SMS text messages; a pedometer; a 6-month gym membership; access to a private Facebook group; and an interactive website with PA tracking, goal setting, and individually tailored PA content. The primary outcomes were feasibility, acceptability, and efficacy (minutes per week of total moderate-to-vigorous PA assessed via the ActiGraph GT3X+ accelerometer worn at the waist and 7-day physical activity recall at baseline and 6 months). Secondary outcomes examined potential moderators (eg, demographics, acculturation, and environmental variables) and mediators (eg, self-efficacy and cognitive and behavioral processes of change) of treatment effects at 6 months post randomization.

Results

This study was funded in September 2016. Initial institutional review board approval was received in February 2017, and focus groups and intervention development were conducted from April 2017 to January 2018. Recruitment for the clinical trial was carried out from February 2018 to July 2019. Baseline data collection was carried out from February 2018 to October 2019, with a total of 43 participants randomized. Follow-up data were collected through April 2020. Data cleaning and analysis are ongoing.

Conclusions

We developed and tested protocols for a highly accessible, culturally and linguistically relevant, theory-driven PA intervention for Latino men. Hombres Saludables used an innovative, interactive, web- and text message-based intervention for improving PA among Latino men, an underserved population at risk of low PA and related chronic disease. If the intervention demonstrates feasibility, acceptability, and preliminary efficacy, we will refine and evaluate it in a larger randomized control trial.

Trial registration

Clinicaltrials.gov: NCT03196570; https://clinicaltrials.gov/ct2/show/NCT03196570.

International registered report identifier (irrid)

DERR1-10.2196/23690.

SUBMITTER: Gans KM

PROVIDER: S-EPMC7880809 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A Tailored Web- and Text-Based Intervention to Increase Physical Activity for Latino Men: Protocol for a Randomized Controlled Feasibility Trial.

Gans Kim M KM Dulin Akilah A Palomo Vanessa V Benitez Tanya T Dunsiger Shira S Dionne Laura L Champion Gregory G Edgar Rachelle R Marcus Bess B

JMIR research protocols 20210129 1

<h4>Background</h4>Latino men in the United States report low physical activity (PA) levels and related health conditions (eg, diabetes and obesity). Engaging in regular PA can reduce the risk of chronic diseases and yield many health benefits; however, there is a paucity of interventions developed exclusively for Latino men.<h4>Objective</h4>To address the need for culturally relevant PA interventions, this study aims to develop and evaluate Hombres Saludables, a 6-month theory-based, tailored ...[more]

PMID: 33512327

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Project description:IntroductionLatino men experience disproportionately high rates of diseases related to low physical activity, yet they are poorly represented in physical activity intervention trials. Efforts to promote physical activity in Latina women show promising results, yet such interventions are yet to be extended to Latino men. This study tested a computer expert system‒tailored, text messaging-supported physical activity intervention for underactive Spanish-speaking Latino men compared with a control group matched for contact time. Potential predictors of intervention success were also explored.Study designRandomized trial. Participants were randomized to receive a Tailored Physical Activity Intervention (Intervention) or a Wellness Control (Control). Data were collected in 2015-2017 and analyzed in 2018-2019.Setting/participantsInsufficiently active Latino men (n=46).InterventionIntervention participants received a baseline counseling session and then, individually tailored print materials and text messages on a tapered schedule for 6 months. Control participants received printed wellness materials and text messages on the same schedule.Main outcome measuresPrimary outcome was a change in weekly moderate to vigorous physical activity from baseline to 6 months measured by accelerometers. Self-reported moderate to vigorous physical activity measured by the 7-day Physical Activity Recall Interview was a secondary outcome.ResultsFor Intervention participants, median accelerometer-measured moderate to vigorous physical activity increased from 10.0 minutes/week at baseline to 57.5 minutes/week at 6 months, whereas for Control participants, it increased from 21.0 minutes/week at baseline to 23.0 minutes/week at 6 months (p<0.05). Similar results were found for self-reported moderate to vigorous physical activity. At 6 months, 47% of Intervention participants met national guidelines of 150 minutes/week versus 25% of Control participants (p=0.15, not significant).ConclusionsFindings suggest that an individually tailored intervention can successfully increase moderate to vigorous physical activity in underactive Latino men. Such technology-supported interventions have the potential for broad dissemination.Trial registrationThis study is registered at www.clinicaltrials.gov NCT02512419.

Project description:IntroductionThe prevalence of smoking among Somali Muslim male immigrants residing in Minnesota is estimated at 44%, however smoking reduction is common during the month of Ramadan. This study evaluated the feasibility and impact of a religiously tailored text message intervention delivered during Ramadan to encourage smoking reduction among Somali Muslim men who smoke.MethodsFifty Somali men were recruited. Participants received two text messages per day starting 1 week prior to and throughout the month of Ramadan. Approximately half were religiously tailored and half were about the risks of smoking and benefits of quitting. Smoking behavior was assessed at baseline, and at weeks 4 (end of Ramadan), 8, and 16. Outcomes included feasibility, acceptability, and preliminary impact of the text message intervention on smoking reduction and bioverified abstinence.ResultsThe average age was 41 years. Average time to first cigarette was 1.8 hours at baseline, and 46% of participants smoked menthol cigarettes. Eighteen of 50 participants selected English and 32 selected Somali text messages. Subjects significantly reduced self-reported cigarettes per day (CPD) from 12.4 CPD at baseline to 5.8 CPD at week 16 (p < 0.001). Seven subjects reported quitting at week 16, five completed CO testing, confirming self-reported abstinence. The majority of participants found the cultural and religious references encouraging at the end of the week 16 survey.ConclusionsReligiously tailored text messages to decrease smoking are feasible and acceptable to Somali Muslim men who smoke during Ramadan. This intervention for addressing smoking disparities is worthy of further study.ImplicationsRecruitment of Somali Muslim men who smoke is feasible and supports the idea that further studies targeting smoking during Ramadan are practical. Ramadan presents a window of opportunity upon which to build smoking cessation interventions for smokers who identify as Muslim. These preliminary findings suggest that text messaging is a feasible and acceptable intervention strategy, and that religious tailoring was well received. Such an approach may offer potential for addressing smoking disparities among Somali Muslim male smokers.Trial registrationClinicalTrial.gov: NCT03379142.

Project description:IntroductionPhysical activity is an integral part of healthy ageing, yet the majority of older adults 65+ years are not sufficiently active. Web-based physical activity interventions hold much promise to reach older adults. Preliminary evidence suggests that web-based interventions with tailored advice and Fitbits may be well suited for older adults.Methods and analysisThis study aims to test the effectiveness of 'Active for Life', a 12-week computer-tailored web-based physical activity intervention using Fitbits for older adults. We will recruit 300 participants who will be randomly assigned to one of three trial arms: (1) web-based physical activity intervention with tailored advice only, (2) web-based physical activity intervention with tailored advice and Fitbit or (3) a wait-list control. The primary outcome, objective moderate to vigorous physical activity (MVPA) and secondary outcomes of objective sedentary behaviour, objective sleep, quality of life, social support, physical function and satisfaction with life will be assessed at baseline and week 12. The secondary outcomes of self-reported physical activity, sitting time and sleep will be assessed at baseline, week 6, 12 and 24. Website usability and participant satisfaction will be assessed at week 12 and website usage and intervention fidelity will be assessed from week 1 to 24. Intention-to-treat linear mixed model analyses will be used to test for group (tailoring only, tailoring +Fitbit, control) differences on changes in the main outcome, MVPA and secondary outcomes. Generalised linear models will be used to compare intervention groups (tailoring only, tailoring +Fitbit) on website usability, participant satisfaction, website usage and intervention fidelity.Ethics and disseminationThe study has received ethics approval from the Central Queensland University Human Research Ethics Committee (H16/12-321). Study outcomes will be disseminated through peer-reviewed publications and academic conferences and used to inform improvements and dissemination of a tailored, web-based physical activity intervention for adults 65+ years.Trial registration numberAustralian and New Zealand Clinical Trials Registry Number: ACTRN12618000646246.

Project description:BackgroundThis paper describes the systematic development of a text-driven and a video-driven web-based computer-tailored intervention aimed to prevent obesity among normal weight and overweight adults. We hypothesize that the video-driven intervention will be more effective and appealing for individuals with a low level of education.Methods and designThe Intervention Mapping protocol was used to develop the interventions, which have exactly the same educational content but differ in the format in which the information is delivered. One intervention is fully text-based, while in the other intervention in addition to text-based feedback, the core messages are provided by means of videos. The aim of the interventions is to prevent weight gain or achieve modest weight loss by making small changes in dietary intake or physical activity. The content of the interventions is based on the I-Change Model and self-regulation theories and includes behavior change methods such as consciousness raising, tailored feedback on behavior and cognitions, goal setting, action and coping planning, and evaluation of goal pursuit. The interventions consist of six sessions. In the first two sessions, participants will set weight and behavioral change goals and form plans for specific actions to achieve the desired goals. In the remaining four sessions, participants' will evaluate their progress toward achievement of the behavioral and weight goals. They will also receive personalized feedback on how to deal with difficulties they may encounter, including the opportunity to make coping plans and the possibility to learn from experiences of others. The efficacy and appreciation of the interventions will be examined by means of a three-group randomized controlled trial using a waiting list control group. Measurements will take place at baseline and six and twelve months after baseline. Primary outcome measures are body mass index, physical activity, and dietary intake.DiscussionThe present paper provides insight into how web-based computer-tailored obesity prevention interventions consisting of self-regulation concepts and text-driven and video-driven messages can be developed systematically. The evaluation of the interventions will provide insight into their efficacy and will result in recommendations for future web-based computer-tailored interventions and the additional value of using video tailoring.Trial registrationNTR3501.

Project description:Objective: Exercise interventions are underutilized in children with congenital heart disease (CHD) especially when the primary outcome is not peak oxygen uptake. Most of the studies are restricted to a low sample size and proximity of the patients to the study centers. Now eHealth approaches bear a promising but also challenging opportunity to transmit such intervention programs to participants, and check progress and compliance from remote. This study will aim to improve health-related physical fitness (HRPF) with a 24 weeks web-based exercise intervention. Methods and Design: The current study is planned as a randomized control trial (RCT) with a crossover design and the aim to improve functional outcome measures. It also estimates adherence and feasibility in patients with CHD in this web-based exercise/motor intervention over 24 weeks. Primary outcome will be the improvement of HRPF. Secondary outcomes are, functional and structural arterial stiffness measures and health-related quality of life. Thus, 70 children from 10 to 18 years with CHD of moderate and complex severity will be recruited and allocated randomly 1:1 in two study arms after baseline testing for their HRPF, arterial stiffness measures and health-related quality of life. For 24 weeks, participants in the intervention arm will receive three weekly exercise video clips of 20 min each. Every video clip comprises 20 child-oriented exercises which have to be executed for 30 s followed by a recovery period of 30 s. Each session will start with 3-4 warming-up exercises, followed by 10-12 strength and flexibility exercises, and ending with 3-4 min of cool down or stretching tasks. Continuous video clips will be streamed from a web-based e-Learning platform. The participant simply has to imitate the execution and follow some short advices. After each session, a brief online survey will be conducted to assess perceived exertion and feasibility. Discussion: The study will help to determine the efficacy and applicability of a web-based exercise intervention in children with CHD in regard to functional outcome measures. In addition, it will outline the effectiveness of remote monitoring, which provides a cost effective approach to reach patients with CHD that are low in prevalence and often do not live in close proximity to their tertiary center. Trial Registration: https://ClinicalTrials.gov Identifier: NCT03488797.

Project description:BACKGROUND:HIV epidemic among young men who have sex with men (YMSM) is characterized by strong racial disparities and concerns about the availability and access to culturally appropriate HIV prevention and care service delivery. Get Connected, a Web-based intervention that employs individual- and system-level tailoring technology to reduce barriers to HIV prevention care (eg, HIV or sexually transmitted infection [STI] testing, pre-exposure prophylaxis [PrEP]), was developed for YMSM (age 15-24 years). This protocol details the design and procedures of a 2-phase project that includes mystery shopping and a randomized controlled trial (RCT) to test the efficacy of Get Connected among YMSM in Philadelphia, Atlanta, and Houston. OBJECTIVE:The objective of mystery shopping is to examine the quality of HIV test counseling and PrEP-related referrals for YMSM within local HIV or STI testing sites. The objective of the RCT is to test the efficacy of Get Connected for increasing HIV-negative or HIV-unknown YMSM's successful uptake of HIV prevention services (eg, routine HIV or STI testing), PrEP awareness, and likelihood to start PrEP (PrEP willingness), compared with those in the control condition, over a 12-month period. METHODS:For Phase 1, we will create a master list of HIV and STI testing sites in each city. We will enroll and train 10-15 mystery shoppers per city; each testing site will be separately visited and assessed by 2 mystery shoppers. After each site visit, the mystery shoppers will complete a site evaluation to record their perceptions of various measures including lesbian, gay, bisexual, transgender, queer visibility and inclusivity, privacy and confidentiality, provider-patient interactions, and clinic environment. For Phase 2, we will enroll 480 YMSM for 12 months across the 3 iTech cities into a 2-arm prospective RCT. Participants randomized to the control condition are directed to the AIDSVu.org testing site locator. Participants randomized to the intervention condition will be granted access to a Web app with content tailored to their specific demographic characteristics (eg, age, race or ethnicity, location, and relationship status), HIV and STI risk behaviors (eg, HIV and STI testing history, substance use, communication with partners regarding status) and sociocultural context (eg, homelessness, incarceration). Study assessments will occur at enrollment and at 1, 3, 6, 9, and 12 months postenrollment. RESULTS:Get Connected research activities began in September 2016 and are ongoing. To date, institutional review board (IRB) submission is complete and IRB authorization agreements are pending at several other universities. CONCLUSIONS:The deployment of Get Connected through a mobile-optimized Web app seeks to optimize the intervention's acceptability, accessibility, availability, and long-term affordability among YMSM. TRIAL REGISTRATION:ClinicalTrials.gov (NCT03132415); https://clinicaltrials.gov/ct2/show/NCT03132415 (Archived by WebCite at http://www.webcitation.org/70j4gSFbZ). REGISTERED REPORT IDENTIFIER:RR1-10.2196/10444.

Project description:Background: There are at present no evidence-based interventions for marijuana use during pregnancy, despite it being by far the most commonly used illicit drug during pregnancy. Lack of treatment-seeking, combined with implementation challenges, has limited the extent to which at-risk women receive interventions of any kind. This study sought to evaluate the feasibility and acceptability of two high-reach technology-based interventions: electronic screening and brief intervention (e-SBI) and tailored text messaging, delivered either alone or in combination. Materials and Methods: In this exploratory feasibility trial, pregnant women seeking prenatal care services and scoring positive for marijuana use risk (n?=?45) were randomly assigned to e-SBI, text messaging, or e-SBI plus text messaging. We examined completion rates and acceptability ratings as a function of intervention condition and participant characteristics. Results: All participants assigned to receive the e-SBI (n?=?30) were able to complete it during the in-clinic baseline session. Participants assigned to text messaging (n?=?30) received a median of 24 text messages before giving birth; 6 of 30 (20%) chose to end text messages before giving birth. Acceptability ratings for the e-SBI were high, with most being above 4.4 on a 5-point scale (e.g., for ease of use, respectfulness, and helpfulness). Acceptability ratings for some aspects of the texting intervention were also high (e.g., for ease of understanding and respectfulness). Participants in the combined e-SBI plus texting condition chose to stop messages at a rate of 13.3% (2 of 15), versus 26.7% (4 of 15) in the texting-only condition (p?=?0.37). Conclusions: These two high-reach intervention elements showed strong feasibility and modest to high acceptability. Future efforts evaluating efficacy are warranted, and should specifically examine the possibility that combining text messaging with a brief intervention may promote retention.

Project description:OBJECTIVES:To assess the feasibility and acceptability of a community pharmacy lifestyle intervention to improve physical activity and cardiovascular health of men with prostate cancer. To refine the intervention. DESIGN:Phase II feasibility study of a complex intervention. SETTING:Nine community pharmacies in the UK. INTERVENTION:Community pharmacy teams were trained to deliver a health assessment including fitness, strength and anthropometric measures. A computer algorithm generated a personalised lifestyle prescription for a home-based programme accompanied by supporting resources. The health assessment was repeated 12 weeks later and support phone calls were provided at weeks 1 and 6. PARTICIPANTS:116 men who completed treatment for prostate cancer. OUTCOME MEASURES:The feasibility and acceptability of the intervention and the delivery model were assessed by evaluating study processes (rate of participant recruitment, consent, retention and adverse events), by analysing delivery data and semi-structured interviews with participants and by focus groups with pharmacy teams. Physical activity (measured with accelerometry at baseline, 3 and 6?months) and patient reported outcomes (activation, dietary intake and quality of life) were evaluated. Change in physical activity was used to inform the sample size calculations for a future trial. RESULTS:Out of 403 invited men, 172 (43%) responded and 116 (29%) participated. Of these, 99 (85%) completed the intervention and 88 (76%) completed the 6-month follow-up (attrition 24%). Certain components of the intervention were feasible and acceptable (eg, community pharmacy delivery), while others were more challenging (eg, fitness assessment) and will be refined for future studies. By 3?months, moderate to vigorous physical activity increased on average by 34?min (95%?CI 6 to 62, p=0.018), but this was not sustained over 6?months. CONCLUSIONS:The community pharmacy intervention was feasible and acceptable. Results are encouraging and warrant a definitive trial to assess the effectiveness of the refined intervention.

Project description:BackgroundPregnant patients with overweight or obesity are at high risk for perinatal complications. Excess gestational weight gain (GWG) further exacerbates this risk. Mobile health (mHealth) lifestyle interventions that leverage technology to facilitate self-monitoring and provide just-in-time feedback may motivate behavior change to reduce excess GWG, reduce intervention costs, and increase scalability by improving access.ObjectiveThis study aimed to test the acceptability and feasibility of a pilot mHealth lifestyle intervention for pregnant patients with overweight or obesity to promote moderate intensity physical activity (PA), encourage guideline-concordant GWG, and inform the design of a larger pragmatic cluster randomized controlled trial.MethodsWe conducted a mixed methods acceptability and feasibility randomized controlled trial among pregnant patients with a prepregnancy BMI of 25 to 40 kg/m2. Patients with singletons at 8 to 15 weeks of gestation who were aged ≥21 years and had Wi-Fi access were recruited via email from 2 clinics within Kaiser Permanente Northern California and randomized to receive usual prenatal care or an mHealth lifestyle intervention. Participants in the intervention arm received wireless scales, access to an intervention website, activity trackers to receive automated feedback on weight gain and activity goals, and monthly calls from a lifestyle coach. Surveys and focus groups with intervention participants assessed intervention satisfaction and ways to improve the intervention. PA outcomes were self-assessed using the Pregnancy Physical Activity Questionnaire, and GWG was assessed using electronic health record data for both arms.ResultsOverall, 33 patients were randomly assigned to the intervention arm, and 35 patients were randomly assigned to the usual care arm. All participants in the intervention arm weighed themselves at least once a week, compared with 20% (7/35) of the participants in the usual care arm. Participants in the intervention arm wore the activity tracker 6.4 days per week and weighed themselves 5.3 times per week, and 88% (29/33) of them rated the program "good to excellent." Focus groups found that participants desired more nutrition-related support to help them manage GWG and would have preferred an app instead of a website. Participants in the intervention arm had a 23.46 metabolic equivalent of task hours greater change in total PA per week and a 247.2-minute greater change in moderate intensity PA per week in unadjusted models, but these effects were attenuated in adjusted models (change in total PA: 15.55 metabolic equivalent of task hours per week; change in moderate intensity PA: 199.6 minutes per week). We found no difference in total GWG (mean difference 1.14 kg) compared with usual care.ConclusionsThe pilot mHealth lifestyle intervention was feasible, highly acceptable, and promoted self-monitoring. Refined interventions are needed to effectively affect PA and GWG among pregnant patients with overweight or obesity.Trial registrationClinicalTrials.gov NCT03936283; https://clinicaltrials.gov/ct2/show/NCT03936283.

Dataset Information

A Tailored Web- and Text-Based Intervention to Increase Physical Activity for Latino Men: Protocol for a Randomized Controlled Feasibility Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

A Tailored Web- and Text-Based Intervention to Increase Physical Activity for Latino Men: Protocol for a Randomized Controlled Feasibility Trial.

Similar Datasets

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