Project description:Valid, reliable behavioral data and contextually meaningful interventions are necessary for improved health outcomes. Ecological Momentary Assessment and Intervention (EMAI), which collects data as behaviors occur to deliver real-time interventions, may be more accurate and reliable than retrospective methods. The rapid expansion of mobile technologies in low-and-middle-income countries allows for unprecedented remote data collection and intervention opportunities. However, no previous studies have trialed EMAI in sub-Saharan Africa. We assessed EMAI acceptability and feasibility, including participant retention and response rate, in a prospective, parallel group, randomized pilot trial in Rakai, Uganda comparing behavioral outcomes among adults submitting ecological momentary assessments (EMA) versus EMAI. After training, participants submitted EMA data on five nutrition and health risk behaviors over a 90-day period using a smartphone-based application utilizing prompt-based, participant-initiated, and geospatial coordinate data collection, with study coordinator support and incentives for >50% completion. Included behaviors and associated EMAI-arm intervention messages were selected to pilot a range of EMAI applications. Acceptability was measured on questionnaires. We estimated the association between high response rate and participant characteristics and conducted thematic analysis characterizing participant experiences. Study completion was 48/50 participants. Median prompt response rate was 66.5% (IQR: 60.0%-78.6%). Prior smartphone app use at baseline (aPR 3.76, 95%CI: 1.16-12.17, p = 0.03) and being in the intervention arm (aPR 2.55, 95% CI: 1.01-6.44, p = 0.05) were significantly associated with the top response rate quartile (response to >78.6% of prompts). All participants submitted self-initiated reports, covering all behaviors of interest, including potentially sensitive behaviors. Inconsistent phone charging was the most reported feasibility challenge. In this pilot, EMAI was acceptable and feasible. Response rates were good; additional strategies to improve compliance should be investigated. EMAI using mobile technologies may support improved behavioral data collection and intervention approaches in low and middle-income settings. This approach should be tested in larger studies.

Project description:ObjectiveTo determine the feasibility and acceptability of an mHealth, home-based exercise intervention among stage II-III colorectal cancer (CRC) survivors within 5-years post-resection and adjuvant therapy.MethodsThis pilot randomized controlled trial of a 12-week mHealth, home-based exercise intervention, randomly assigned CRC survivors to a high-intensity interval training (HIIT) or moderate-intensity continuous exercise (MICE) prescription. The following assessments were carried out at baseline and end-of-study (EOS): handgrip strength, short physical performance battery (SPPB), PROMIS physical function, neuropathy total symptom score-6 (NTSS-6), Utah early neuropathy scale (UENS), cardiopulmonary exercise testing, anthropometrics, and body composition via BOD POD, modified Godin leisure-time activity questionnaire. Feasibility, as defined by number of completed prescribed workouts and rate of adherence to individualized heart rate (HR) training zones, was evaluated at EOS. Acceptability was assessed by open-ended surveys at EOS. Descriptive statistics were generated for participant characteristics and assessment data.ResultsSeven participants were included in this pilot study (MICE: n = 5, HIIT: n = 2). Median age was 39 years (1st quartile: 36, 3rd quartile: 50). BMI was 27.4 kg/m2 (1st quartile: 24.5, 3rd quartile: 29.7). Most participants had stage III CRC (71%, n = 5). We observed an 88.6% workout completion rate, 100% retention rate, no adverse events, and qualitative data indicating improved quality of life and positive feedback related to ease of use, accountability, motivation, and autonomy. Mean adherence to HR training zones was 95.7% in MICE, and 28.9% for the high-intensity intervals and 51.0% for the active recovery intervals in HIIT; qualitative results revealed that participants wanted to do more/work-out harder.ConclusionAn mHealth, home-based delivered exercise intervention, including a HIIT prescription, among stage II-III CRC survivors' post-resection and adjuvant therapy was tolerable and showed trends towards acceptability.

Project description:BackgroundDiet and exercise may be associated with quality of life and survival in men with prostate cancer.ObjectiveThis study aimed to determine the feasibility and acceptability of a remotely delivered web-based behavioral intervention among men with prostate cancer.MethodsWe conducted a multi-site 4-arm pilot randomized controlled trial of a 3-month intervention (TrueNTH Community of Wellness). Eligibility included self-reported prostate cancer diagnosis, having a personal device that connected to the internet, age ≥18 years, and ability to read English and receive text messages and emails. Men receiving chemotherapy or radiation, or those who reported contraindications to exercise, could participate with physician clearance. Participants were randomized (1:1:1:1) to additive intervention levels: website; website and personalized diet and exercise prescription; website, personalized prescription, Fitbit, and text messages; and website, personalized prescription, Fitbit, text messages, and 2 30-minute phone calls-one with an exercise trainer and one with a registered dietician. Primary outcomes were feasibility (accrual and attrition) and acceptability (survey data and website use). We described self-reported diet and exercise behavior at the time of enrollment, 3 months, and 6 months as secondary outcomes.ResultsIn total, 202 men consented and were randomized between August 2017 and September 2018 (level 1: 49, level 2: 51, level 3: 50, level 4: 52). A total of 160 men completed the onboarding process and were exposed to their randomly assigned intervention (38, 38, 42, and 42 in levels 1, 2, 3, and 4, respectively). The follow-up rate was 82.7% (167/202) at 3 months and 77.2% (156/202) at 6 months. Participants had a median age of 70 years and were primarily White and college educated. Website visit frequency over the 3-month intervention period increased across levels (median: 2, 9, 11, and 16 visits for levels 1, 2, 3, and 4, respectively). Most were satisfied or very satisfied with the intervention (20/39, 51%; 27/42, 64%; 23/44, 52%; and 27/42, 64% for levels 1, 2, 3, and 4, respectively). The percentage of men who reported being very satisfied was highest among level 4 participants (10/42, 24% vs 4/39, 10%; 5/42, 12%; and 5/44, 11% for levels 1, 2, and 3, respectively). Dissatisfaction was highest in level 1 (5/39, 13% vs 1/42, 2%; 3/44, 7%; and 2/42, 5% for levels 2, 3, and 4, respectively). We observed small improvements in diet and physical activity at 3 months among men in level 4 versus those in level 1.ConclusionsA web-based, remotely delivered, tailored behavioral intervention for men with prostate cancer is feasible. Future studies are warranted to increase the effect of the intervention on patient behavior while maintaining sustainability and scalability as well as to design and implement interventions for more diverse populations.Trial registrationClinicalTrials.gov NCT03406013; http://clinicaltrials.gov/ct2/show/NCT03406013.

Project description:BackgroundPhysical literacy (PL), given as a multidimensional construct, is considered a person's capacity and commitment to a physically active lifestyle. We investigated the effect of a holistic physical exercise training on PL among physically inactive adults.MethodsA non-randomised controlled study was conducted. Thirty-one physically inactive adults in the intervention group (IG; 81% females, 44 ± 16 years) participated in a holistic physical exercise training intervention once weekly for 15 weeks. A matched, non-exercising control group (CG) consisted of 30 physically inactive adults (80% female, 45 ± 11 years). PL, compliance and sociodemographic parameters were measured. PL was evaluated by a questionnaire, covering five domains: physical activity behaviour, attitude towards a physically active lifestyle, exercise motivation, knowledge and self-confidence/self-efficacy. Data were analysed using ANCOVA models, adjusted for age, gender and BMI at baseline.ResultsAt post-training intervention, the IG showed significant improvements in PL (p = 0.001) and in the domains physical activity behaviour (p = 0.02) and exercise self-confidence/self-efficacy (p = 0.001), with no changes overserved for the CG regarding PL and those domains. No intervention effect were found for the other three domains, i.e. attitude, knowledge and motivation. Additionally, for the IG baseline BMI was identified to be positively correlated with physical exercise-induced improvements in PL (β = 0.51, p = 0.01).ConclusionsThe results from this study are very useful for further public health activities, which aim at helping physically inactive adults to adopt a physically active lifestyle as well as for the development of further PL intervention strategies. This pilot-study was a first attempt to measure PL in inactive adults. Yet, a validated measurement tool is still not available. Further research is necessary to determine the psychometric properties for this PL questionnaire.Trial registrationGerman Clinical Trials Register (DRKS), DRKS00013991 , date of registration: 09.02.2018, retrospectively registered.

Project description:BackgroundDietary protein supplementation combined with resistance exercise (RE) may counteract declines in muscle strength, mass, and function (sarcopenia), but the role of whole foods rich in protein, such as milk, is less well understood. In the MIlkMAN study, we aimed to examine the feasibility and acceptability of milk+RE as an intervention for muscle function in community-dwelling older adults, and provide exploratory pilot data for future substantive research in population at risk of sarcopenia.MethodsIn a parallel groups design, 30 older adults (71.7±3.6 years; 12 women) were randomised into three groups: WM (whole milk 3.6% fat)+RE, SM (skimmed milk 0.3% fat)+RE, and C (isocaloric carbohydrate drink)+RE. RE was performed twice-weekly over 6 weeks in a community gym, followed by the consumption of 500 ml of milk (~20 g protein) or carbohydrate drink immediately after exercise and a further 500 ml at home within the following 4-5 hours. The feasibility and acceptability of the study was determined by calculating recruitment and attendance rates, compliance with the intervention, rating participants' experiences, and recording adverse health events.ResultsThe response rate was 49% (out of 400 invitations sent), and the recruitment rate was 73.2% (30 participants recruited out of 41 screened for eligibility). Twenty-nine participants completed the intervention-an attendance rate of 97.1%; 89.7% rated their experience as 'excellent'/very good'. Compliance with taking the drinks was 97.1% (WM), 98.3% (SM), and 95.0% (C); 93.1% rated their drink intake as 'easy'/'very easy' with no adverse effects. Collection of exploratory pilot data to inform future trials was successful. Mean change in grip strength, 5-chair rises, and gait speed were 0.9±3.4 kg, 1.8±2.2 s, 0.1±0.1 m/s, respectively with no differences between the groups.ConclusionsThis community-based milk+RE intervention was feasible and acceptable to older adults. The study successfully collected pilot data for future substantive research.

Project description:BackgroundTraditional mindfulness-based stress reduction programs are resource intensive for providers and time- and cost-intensive for participants, but the use of mobile technologies may be particularly convenient and cost-effective for populations that are busy, less affluent, or geographically distant from skilled providers. Women in southern Louisiana live in a vulnerable, disaster-prone region and are highly stressed, making a mobile program particularly suited to this population.ObjectiveThis study aimed to (1) assess the feasibility and acceptability of a mobile mindfulness app in real-world conditions in a pilot study of a community sample of women residing in southern Louisiana, (2) describe predictors of app usage, and (3) assess the effect of the app on secondary health outcomes.MethodsWomen were recruited from an oil spill study on health. A total of 236 women completed a baseline survey, were offered the mobile mindfulness program, and completed a follow-up survey. Subjects were asked to download and use the app for at least 30 days for 10 min. All study procedures were completed on the web. Primary outcomes were feasibility and acceptability of the app and characteristics of app utilization. Secondary outcomes included mindfulness, depression, perceived stress, sleep quality, physical activity, BMI, and healthy eating.ResultsOverall, 74.2% (236/318) of subjects completed the follow-up survey, and 13.5% (43/318) used the app. The main barrier to app usage was lack of time, cited by 37% (16/43) of users and 48.7% (94/193) of nonusers of the app. Women who chose to use the app were more highly educated (16/43, 63% had a college education vs 65/193, 33.7% of nonparticipants; P<.001), had higher incomes (23/43, 58% had incomes >US $50,000 per year vs 77/193, 43.0% of nonparticipants), and were employed (34/43, 79% vs 122/193, 63.2% of nonparticipants; P=.047). Those who engaged with the app did so at high levels, with 72% (31/43) of participants self-reporting the completion of some or all sessions and 74% (32/43) reporting high levels of satisfaction with the app. Participation with the app had a beneficial impact on depression (odds ratio [OR] 0.3, 95% CI 0.11-0.81), sleep quality (OR 0.1, 95% CI 0.02-0.96), sleep duration (OR 0.3, 95% CI 0.07-0.86), sleep latency (OR 0.3, 95% CI 0.11-0.81), and physical activity (2.8 95% CI 1.0-7.8), but mindfulness scores did not change from baseline to follow-up.ConclusionsThe Headspace mobile mindfulness app was easy and cost-effective to implement and acceptable to those who participated, but few women elected to try it. The unique characteristics of this southern Louisiana population suggest that more intense promotion of the benefits of mindfulness training is needed, perhaps in conjunction with some therapist or researcher support. Several short-term benefits of the app were identified, particularly for depression and sleep.

Project description:BackgroundThe transition from high school to college can exacerbate mental health problems in young adults yet barriers prevent seamless mental health care. Existing digital support tools show promise but are not yet designed to optimize engagement or implementation.ObjectiveThe goal of the research was to test acceptability and effects of an automated digital Mobile Support Tool for Mental Health (MoST-MH) for young adults transitioning to college.MethodsYouths aged 18 years and older with a current mental health diagnosis preparing to transition to college (n=52; 85% female [45/52], 91% White [48/52]) were recruited from a primary care (n=31) and a mental health clinic (n=21). Participants were randomized 2:1 to either receive MoST-MH (n=34) or enhanced Usual Care (eUC; n=18). MoST-MH included periodic text message and web-based check-ins of emotional health, stressors, negative impacts, and self-efficacy that informed tailored self-care support messages. Both eUC and MoST-MH participants received links to a library of psychoeducational videos and were asked to complete web-based versions of the Mental Health Self-Efficacy Scale (MHSES), College Counseling Center Assessment of Psychological Symptoms (CCAPS), and Client Service Receipt Inventory for Mental Health (C-SRI) monthly for 3 months and the Post-Study System Usability Scale (PSSUQ) at 3-months.ResultsMoST-MH participants were sent a median of 5 (range 3 to 10) text message check-in prompts over the 3-month study period and 100% were completed; participants were sent a median of 2 (range 1 to 8) web-based check-in prompts among which 78% (43/55) were completed. PSSUQ scores indicate high usability (mean score 2.0). Results from the completer analysis demonstrated reductions in mental health symptoms over time and significant between-group effects of MoST-MH compared to eUC on depressive symptom severity (d=0.36, 95% CI 0.08 to 0.64). No significant differences in mental health self-efficacy or mental health health care use were observed.ConclusionsIn this pilot trial, we found preliminary evidence that MoST-MH was engaged with at high rates and found to be highly usable and reduced depression symptoms relative to eUC among youth with mental health disorders transitioning to college. Findings were measured during the COVID-19 pandemic, and the study was not powered to detect differences in outcomes between groups; therefore, further testing is needed.Trial registrationClinicalTrials.gov NCT04560075; https://clinicaltrials.gov/ct2/show/NCT04560075.

Project description:BackgroundYouth homelessness is a substantial issue, and many youths experiencing homelessness have mental health issues as both a cause and consequence of homelessness. These youths face many barriers to receiving traditional mental health services, and as a result, only a few youths experiencing homelessness receive any form of mental health care.ObjectiveThis project aimed to develop and determine the feasibility and acceptability of engaging young adults (ie, individuals aged 18-24 years) experiencing homelessness in a remotely delivered mental health intervention. This intervention provided brief emotional support and coping skills, drawing from cognitive behavioral principles as an introduction into psychosocial support. The intervention was piloted in a homeless shelter network.MethodsA total of 35 young adults experiencing homelessness participated in a single-arm feasibility pilot trial. Participants received a mobile phone, a service and data plan, and 1 month of support from a coach consisting of up to 3 brief phone sessions, text messaging, and mobile mental health apps. We evaluated feasibility by looking at completion of sessions as well as the overall program and acceptability with satisfaction ratings. We also collected clinical symptoms at baseline and the end of the 1-month support period. We used validity items to identify participants who might be responding inappropriately and thus only report satisfaction ratings and clinical outcomes from valid responses.ResultsMost participants (20/35, 57%) completed all 3 of their phone sessions, with an average of 2.09 sessions (SD 1.22) completed by each participant. Participants sent an average of 15.06 text messages (SD 12.62) and received an average of 19.34 messages (SD 12.70). We found higher rates of satisfaction among the participants with valid responses, with 100% (23/23) of such participants indicating that they would recommend participation to someone else and 52% (12/23) reporting that they were very or extremely satisfied with their participation. We found very little change from pre- to posttreatment on measures of depression (d=0.27), post-traumatic stress disorder (d=0.17), and emotion regulation (d=0.10).ConclusionsThis study demonstrated that it was feasible to engage homeless young adults in mental health services in this technology-based intervention with high rates of satisfaction. We did not find changes in clinical outcomes; however, we had a small sample size and a brief intervention. Technology might be an important avenue to reach young adults experiencing homelessness, but additional work could explore proper interventions to deliver with such a platform.Trial registrationClinicalTrials.gov NCT03620682; https://clinicaltrials.gov/ct2/show/NCT03620682.

Project description:BackgroundPhysical inactivity and obesity are global public health challenges. Older adults are important to target for prevention and management of disease and chronic conditions. However, many individuals struggle with maintaining increased physical activity (PA) and improved diet. This feasibility study provides the foundation for the RESTART trial, a randomized controlled trial (RCT) to test a complex intervention to facilitate favourable lifestyle changes older adults can sustain. The primary objective of this study was to investigate study feasibility (recruitment, adherence, side-effects, and logistics) using an interdisciplinary approach.MethodsThis 1-year prospective mixed-method single-arm feasibility study was conducted in Tromsø, Norway, from September 2017. We invited by mail randomly selected participants from the seventh survey of the Tromsø Study (2015-2016) aged 55-75 years with sedentary lifestyle, obesity, and elevated cardiovascular risk. Participants attended a 6-month complex lifestyle intervention program, comprising instructor-led high-intensive exercise and nutritionist- and psychologist-led counselling, followed by a 6-month follow-up. All participants used a Polar activity tracker for daily activity monitoring during the intervention. Participants were interviewed three times throughout the study. Primary outcome was study feasibility measures.ResultsWe invited potential participants (n=75) by mail of which 27 % (n=20) agreed to participate. Telephone screening excluded four participants, and altogether 16 participants completed baseline screening. The intervention and test procedures of primary and secondary outcomes were feasible and acceptable for the participants. There were no exercise-induced injuries, indicating that the intervention program is safe. Participants experienced that the dietary and psychological counselling were delivered too early in the intervention and in too close proximity to the start of the exercise program. Minor logistic improvements were implemented throughout the intervention period.ConclusionThis study indicates that it is feasible to conduct a full-scale RCT of a multi-component randomized intervention trial, based on the model of the present study. No dropouts due to exercise-induced injury indicates that the exercises were safe. While minor improvements in logistics were implemented during the intervention, we will improve recruitment and adherence strategies, rearrange schedule of intervention contents (exercise, diet, and psychology), as well as improve the content of the dietary and behavioural counselling to maximize outcome effects in the RESTART protocol.Trial registrationClinicalTrials.gov Identifier: NCT03807323 Registered 16 January 2019 - retrospectively registered.

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Feasibility and Acceptability of a Mobile Health Exercise Intervention for Inactive Adults: 3-Arm Randomized Controlled Pilot Trial

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