Pasos Hacia La Salud: a randomized controlled trial of an internet-delivered physical activity intervention for Latinas.
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SUBMITTER: Marcus BH
PROVIDER: S-EPMC4884436 | biostudies-literature | 2016 May
REPOSITORIES: biostudies-literature
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Pasos Hacia La Salud: a randomized controlled trial of an internet-delivered physical activity intervention for Latinas.
Marcus Bess H BH Hartman Sheri J SJ Larsen Britta A BA Pekmezi Dori D Dunsiger Shira I SI Linke Sarah S Marquez Becky B Gans Kim M KM Bock Beth C BC Mendoza-Vasconez Andrea S AS Noble Madison L ML Rojas Carlos C
The international journal of behavioral nutrition and physical activity 20160528
<h4>Background</h4>Internet access has grown markedly in Latinos during the past decade. However, there have been no Internet-based physical activity interventions designed for Latinos, despite large disparities in lifestyle-related conditions, such as obesity and diabetes, particularly in Latina women. The current study tested the efficacy of a 6-month culturally adapted, individually tailored, Spanish-language Internet-based physical activity intervention.<h4>Methods</h4>Inactive Latinas (N = ...[more]
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Project description:BackgroundLatinas are at increased risk for many lifestyle-related chronic diseases and are one of the least physically active populations in the US Innovative strategies are needed to help Latinas achieve the health benefits associated with physical activity (PA). This manuscript describes the study protocol of the Pasos Hacia La Salud II Study, which builds upon our previous research to test an enhanced individually-tailored, text-message and website-delivered, Spanish-language intervention (enhanced intervention), in comparison to the original web-based Pasos Hacia La Salud Intervention (original intervention).MethodsSedentary Latinas between the ages of 18-65 will be recruited and will complete an orientation and baseline assessments. Participants will be subsequently randomized to the original intervention, or the Enhanced Intervention, which has greater targeting of theoretical constructs such as self-efficacy, enjoyment, and social support, and which uses text messages and more dynamic and refined website features to encourage increased website use. Using a linear mixed effects regression model, we will simultaneously estimate the intervention effects on mean accelerometer-measured hours/week of moderate-to-vigorous PA (MVPA) at 6, 12, 18, and 24 months, with a subject-specific intercept (intent-to-treat sample). Change in self-reported MVPA, measured via the 7-day Physical Activity Recall, will be assessed as a secondary outcome using a similar model. We will investigate potential mediators of the intervention effect using a multiple mediation approach, and potential moderators by evaluating potential interactions. As an exploratory outcome, we will study the differences (among both study arms) in cost, in US dollars, per minute increases in weekly mean MVPA.DiscussionThe original Pasos PA intervention showed efficacy in helping Latinas increase PA; we expect the Enhanced Intervention to help a larger proportion of participants to increase and maintain their PA long term. This web- and text-based enhanced intervention could have great reach and dissemination potential, which could be capitalized on in the future to help to advance health equity. Adaptations made in response to the COVID-19 pandemic are also described in this manuscript.Trial registrationClinical Trial Number: NCT03491592 . First posted April 9, 2018.
| S-EPMC9341151 | biostudies-literature
Project description:There is evidence that physical activity (PA) can attenuate the influence of the fat mass- and obesity-associated (FTO) genotype on the risk to develop obesity. However, whether providing personalized information on FTO genotype leads to changes in PA is unknown.The purpose of this study was to determine if disclosing FTO risk had an impact on change in PA following a 6-month intervention.The single nucleotide polymorphism (SNP) rs9939609 in the FTO gene was genotyped in 1279 participants of the Food4Me study, a four-arm, Web-based randomized controlled trial (RCT) in 7 European countries on the effects of personalized advice on nutrition and PA. PA was measured objectively using a TracmorD accelerometer and was self-reported using the Baecke questionnaire at baseline and 6 months. Differences in baseline PA variables between risk (AA and AT genotypes) and nonrisk (TT genotype) carriers were tested using multiple linear regression. Impact of FTO risk disclosure on PA change at 6 months was assessed among participants with inadequate PA, by including an interaction term in the model: disclosure (yes/no) × FTO risk (yes/no).At baseline, data on PA were available for 874 and 405 participants with the risk and nonrisk FTO genotypes, respectively. There were no significant differences in objectively measured or self-reported baseline PA between risk and nonrisk carriers. A total of 807 (72.05%) of the participants out of 1120 in the personalized groups were encouraged to increase PA at baseline. Knowledge of FTO risk had no impact on PA in either risk or nonrisk carriers after the 6-month intervention. Attrition was higher in nonrisk participants for whom genotype was disclosed (P=.01) compared with their at-risk counterparts.No association between baseline PA and FTO risk genotype was observed. There was no added benefit of disclosing FTO risk on changes in PA in this personalized intervention. Further RCT studies are warranted to confirm whether disclosure of nonrisk genetic test results has adverse effects on engagement in behavior change.ClinicalTrials.gov NCT01530139; http://clinicaltrials.gov/show/NCT01530139 (Archived by WebCite at: http://www.webcitation.org/6XII1QwHz).
| S-EPMC4761101 | biostudies-literature
Project description:BackgroundIn the U.S., Latinos report particularly high levels of inactivity and related chronic illnesses and are in need of intervention. Thus, the purpose of the current study was to culturally and linguistically adapt an empirically supported, individually tailored physical activity print intervention for Latinos and then conduct an RCT of the modified program.DesignAn RCT was conducted.Setting/participantsThe sample included 93 overweight/obese (80%) Latinas with low income and acculturation.InterventionData were collected in 2007-2008 and analyzed by intent-to-treat in 2009. Participants were randomly assigned to either (1) a culturally and linguistically adapted physical activity intervention (Seamos Activas) or (2) a wellness contact control condition.Main outcome measuresSelf-report physical activity, as measured pre- and post-intervention (6 months, 87% retention) by the 7-Day Physical Activity Recall.ResultsModerate-intensity (or greater) physical activity increased from an average of 16.56 minutes/week (SD=25.76) at baseline to 147.27 (SD=241.55) at 6 months in the intervention arm (n=45), and from 11.88 minutes/week (SD=21.99) to 96.79 (SD=118.49) in the wellness contact control arm (n=48). No between-group differences were seen in overall physical activity. Intervention participants reported significantly greater increases in cognitive (F[1, 91]=9.53, p=0.003) and behavioral processes of change (F[1, 91]=8.37, p=0.005) and available physical activity supplies and equipment at home (F[1, 91]=4.17, p=0.04) than control participants.ConclusionsResults supported the hypothesized feasibility, acceptability, and preliminary efficacy of individually tailored physical activity print interventions among Latinas. Although more research is needed to corroborate these findings, such high-reach, low-cost approaches have great potential to positively affect public health.Trial registrationNCT00724165.
| S-EPMC2814545 | biostudies-literature
Project description:BackgroundThe internet's low cost and potential for high reach makes Web-based channels prime for delivering evidence-based physical activity (PA) interventions. Despite the well-studied success of internet-based PA interventions in primarily non-Hispanic white populations, evidence on Spanish-speaking Latinas' use of such interventions is lacking. The recent rise in technology use among Latinas in the United States, a population at heightened risk for low PA levels and related conditions, suggests that they may benefit from Web-based PA interventions tailored to their cultural and language preferences.ObjectiveThe goal of the research was to examine participant engagement with various features of an internet-based PA intervention for Latinas and explore how use of these features was differentially associated with adoption and maintenance of PA behavior change.MethodPasos Hacia la Salud tested a Spanish-language, culturally adapted, individually tailored, internet-based PA intervention versus a Spanish language, internet-based, Wellness Contact Control condition for underactive Latinas (N=205, mean age 39.2 [SD 10.5] years, 84% Mexican American). These analyses examined engagement with the website and explored how use was associated with adoption and maintenance of moderate to vigorous physical activity (MVPA) behavior.ResultsOverall, participants logged on to the website an average of 22 times (SD 28) over 12 months, with intervention participants logging on significantly more than controls (29 vs 14.7, P<.001). On average, participants spent more time on the website at months 1, 4, and 6 compared to all other months, with maximum use at month 4. Both log-ins and time spent on the website were significantly related to intervention success (achieving higher mean minutes of MVPA per week at follow-up: b=.48, SE 0.20, P=.02 for objectively measured MVPA and b=.74, SE 0.34, P=.03 for self-reported MVPA at 12 months, controlling for baseline). Furthermore, those meeting guidelines by the Centers for Disease Control and Prevention for PA at 12 months (≥150 minutes per week of MVPA) logged on significantly more than those not meeting guidelines (35 vs 20 over 12 months, P=.002). Among participants in the intervention arm, goal-setting features, personal PA reports, and PA tips were the most used portions of the website. Higher use of these features was associated with greater success in the program (significantly more minutes of self-reported MVPA at 12 months controlling for baseline). Specifically, one additional use of these features per month over 12 months translated into an additional 34 minutes per week of MVPA (goals feature), 12 minutes per week (PA tips), and 42 minutes per week (PA reports).ConclusionsThese results demonstrate that greater use of a tailored, Web-based PA intervention, particularly certain features on the site, was significantly related to increased PA levels in Latinas.Trial registrationClinicalTrials.gov NCT01834287; https://clinicaltrials.gov/ct2/show/NCT01834287.
| S-EPMC6685130 | biostudies-literature
Project description:BACKGROUND:Internet-delivered treatments for depressive symptoms have proved to be successful in high-income Western countries. There may be potential for implementing such treatments in low- and middle-income countries such as Colombia, where access to mental health services is limited. OBJECTIVE:The objective of this study was to assess the efficacy of a culturally adapted cognitive behavioral internet-delivered treatment for college students with depressive symptoms in Colombia. METHODS:This was a randomized controlled trial with a 3-month follow-up. The program comprised seven modules. A total of 214 Colombian college students were recruited. They were assessed and randomly assigned to either the treatment group (n=107) or a waiting list (WL) control group (n=107). Participants received weekly support from a trained supporter. The primary outcome was symptoms of depression, as measured by the Patient Health Questionnaire - 9, and the secondary outcomes were anxiety symptoms assessed by the Generalized Anxiety Disorder questionnaire - 7. Other measures, including satisfaction with treatment, were evaluated after 7 weeks. RESULTS:Research attrition and treatment dropouts were high in this study. On average, 7.6 sessions were completed per user. The mean time spent on the program was 3 hours and 18 min. The linear mixed model (LMM) showed significant effects after treatment (t197.54=-5.189; P<.001) for the treatment group, and these effects were maintained at the 3-month follow-up (t39.62=4.668; P<.001). Within-group results for the treatment group yielded a large effect size post treatment (d=1.44; P<.001), and this was maintained at the 3-month follow-up (d=1.81; P<.001). In addition, the LMM showed significant differences between the groups (t197.54=-5.189; P<.001). The results showed a large effect size between the groups (d=0.91; P<.001). In the treatment group, 76.0% (16/107) achieved a reliable change, compared with 32.0% (17/107) in the WL control group. The difference between groups was statistically significant (X22=10.5; P=.001). CONCLUSIONS:This study was the first contribution to investigating the potential impact of a culturally adapted internet-delivered treatment on depressive symptoms for college students as compared with a WL control group in South America. Future research should focus on identifying variables associated both with premature dropout and treatment withdrawal at follow-up. TRIAL REGISTRATION:ClinicalTrials.gov NCT03062215; https://clinicaltrials.gov/ct2/show/NCT03062215.
| S-EPMC7055858 | biostudies-literature
Project description:Objective. The main hypothesis, and the objective of the study, was to test if the participants allocated to the treatment group would show a larger reduction in depressive symptoms than those in the control group. Methods. This study was a randomized nine week trial of an Internet-administered treatment based on guided physical exercise for Major Depressive Disorder (MDD). A total of 48 participants with mild to moderate depression, diagnosed using the Structured Clinical Interview for DSM-IV Axis I Disorders, were randomized either to a treatment intervention or to a waiting-list control group. The main outcome measure for depression was the Beck Depression Inventory-II (BDI-II), and physical activity level was measured using the International Physical Activity Questionnaire (IPAQ). The treatment program consisted of nine text modules, and included therapist guidance on a weekly basis. Results. The results showed significant reductions of depressive symptoms in the treatment group compared to the control group, with a moderate between-group effect size (Cohen's d = 0.67; 95% confidence interval: 0.09-1.25). No difference was found between the groups with regards to increase of physical activity level. For the treatment group, the reduction in depressive symptoms persisted at six months follow-up. Conclusions. Physical activity as a treatment for depression can be delivered in the form of guided Internet-based self-help. Trial Registration. The trial was registered at ClinicalTrials.gov (NCT01573130).
| S-EPMC3792189 | biostudies-literature
Project description:School-based physical education is an important public health initiative as it has the potential to provide students with regular opportunities to participate in moderate-to-vigorous physical activity (MVPA). Unfortunately, in many physical education lessons students do not engage in sufficient MVPA to achieve health benefits. In this trial we will test the efficacy of a teacher professional development intervention, delivered partially via the Internet, on secondary school students' MVPA during physical education lessons. Teaching strategies covered in this training are designed to (i) maximize opportunities for students to be physically active during lessons and (ii) enhance students' autonomous motivation towards physical activity.A two-arm cluster randomized controlled trial with allocation at the school level (intervention vs. usual care control). Teachers and Year 8 students in government-funded secondary schools in low socio-economic areas of the Western Sydney region of Australia will be eligible to participate. During the main portion of the intervention (6 months), teachers will participate in two workshops and complete two implementation tasks at their school. Implementation tasks will involve video-based self-reflection via the project's Web 2.0 platform and an individualized feedback meeting with a project mentor. Each intervention school will also complete two group peer-mentoring sessions at their school (one per term) in which they will discuss implementation with members of their school physical education staff. In the booster period (3 months), teachers will complete a half-day workshop at their school, plus one online implementation task, and a group mentoring session at their school. Throughout the entire intervention period (main intervention plus booster period), teachers will have access to online resources. Data collection will include baseline, post-intervention (7-8 months after baseline) and maintenance phase (14-15 months after baseline) assessments. Research assistants blinded to group allocation will collect all data. The primary outcome will be the proportion of physical education lesson time that students spend in MVPA. Secondary outcomes will include leisure-time physical activity, subjective well-being, and motivation towards physical activity.The provision of an online training platform for teachers could help facilitate more widespread dissemination of evidence-based interventions compared with programs that rely exclusively on face-to-face training.Australia and New Zealand Clinical Trials Registry- ACTRN12614000184673 . Registration date: February 19, 2014.
| S-EPMC4704292 | biostudies-other
Project description:BackgroundAttention-deficit/hyperactivity disorder (ADHD) in adulthood, with an estimated prevalence of 2-3%, is associated with several challenges in daily life functioning. The availability of evidence-based psychological interventions for adults with ADHD is still poor. Interventions delivered over the Internet on smartphones or personal computers may help to increase the availability of effective psychological interventions. The primary aim of this randomized controlled trial is to examine the efficacy of a self-guided Internet-delivered intervention on severity levels of ADHD symptomatology and quality of life.MethodsWe aim to include 118 participants with a self-reported ADHD diagnosis in a randomized controlled trial with two arms: 1) self-guided Internet-delivered intervention for coping with ADHD (N = 59); 2) self-guided online psychoeducation (control group, N = 59). After 3 months, the control group will be given access to the intervention. The primary clinical outcomes are inattention and quality of life. Secondary clinical outcomes are hyperactivity, stress and depression. Measures will be obtained at three time points: before (baseline), immediately after (8 weeks) and 3 months after the intervention. Uptake, usage, adherence and satisfaction will be explored.DiscussionThis RCT will provide valuable information on the clinical effectiveness of an Internet-delivered intervention for adults with ADHD. This study is, to our knowledge, one of the first randomized control trials that investigates the effects of a self-guided Internet-delivered psychological intervention in a fairly large group of adults with ADHD.Trial registrationClinicalTrials.gov, Identifier NCT04726813, January 27, 2021.
| S-EPMC8632851 | biostudies-literature
Project description:BACKGROUND:Physical inactivity is high in Latinas, as are chronic health conditions. There is a need for physical activity (PA) interventions that are not only effective but have potential for cost-effective widespread dissemination. The purpose of this paper was to assess the costs and cost effectiveness of a Spanish-language print-based mail-delivered PA intervention that was linguistically and culturally adapted for Latinas. METHODS:Adult Latinas (N?=?266) were randomly assigned to receive mail-delivered individually tailored intervention materials or wellness information mailed on the same schedule (control). PA was assessed at baseline, six months (post-intervention) and 12 months (maintenance phase) using the 7-Day Physical Activity Recall Interview. Costs were calculated from a payer perspective, and included personnel time (wage, fringe, and overhead), materials, equipment, software, and postage costs. RESULTS:At six months, the PA intervention cost $29/person/month, compared to $15/person/month for wellness control. These costs fell to $17 and $9 at 12 months, respectively. Intervention participants increased their PA by an average of 72 min/week at six months and 94 min/week at 12 months, while wellness control participants increased their PA by an average of 30 min/week and 40 min/week, respectively. At six months, each minute increase in PA cost $0.18 in the intervention group compared to $0.23 in wellness control, which fell to $0.07 and $0.08 at 12 months, respectively. The incremental cost per increase in physical activity associated with the intervention was $0.15 at 6 months and $0.05 at 12 months. CONCLUSIONS:While the intervention was more costly than the wellness control, costs per minute of increase in PA were lower in the intervention. The print-based mail-delivered format has potential for broad, cost-effective dissemination, which could help address disparities in this at-risk population. TRIAL REGISTRATION:NCT01583140; Date of Registration: 03/06/2012; Funding Source of Trial: National Institute of Nursing Research (NINR); Name of Institutional Review Board: Brown University IRB; Date of Approval: 05/19/2009.
| S-EPMC4642691 | biostudies-literature
Project description:While the efficacy of therapist-guided internet-delivered cognitive behaviour therapy (iCBT) for anxiety and depression is well-established, a significant proportion of clients show little to no improvement with this approach. Given that motivational interviewing (MI) is found to enhance face-to-face treatment of anxiety, the current trial examined potential benefits of a brief online MI intervention prior to therapist-guided iCBT. Clients applying to transdiagnostic therapist-guided iCBT in routine care were randomly assigned to receive iCBT with (n = 231) or without (n = 249) the online MI pre-treatment. Clients rated motivation at screening and pre-iCBT and anxiety and depression at pre- and post-treatment and at 13- and 25-week follow-up after enrollment. Clients in the MI plus iCBT group made more motivational statements in their emails and were enrolled in the course for a greater number of days compared to clients who received iCBT only, but did not demonstrate higher motivation after completing the MI intervention or have higher course completion. Clients in both groups, at screening and pre-iCBT, reported high levels of motivation. No statistically significant group differences were found in the rate of primary symptom change over time, with both groups reporting large reductions in anxiety and depression pre- to post-treatment (Hedges' g range = 0.96-1.11). During follow-up, clients in the iCBT only group reported additional small reductions in anxiety, whereas clients in the MI plus iCBT group did not. The MI plus iCBT group also showed small increases in depression during follow-up, whereas improvement was sustained for the iCBT only group. It is concluded that online MI does not appear to enhance client outcomes when motivation at pre-treatment is high.
| S-EPMC8099490 | biostudies-literature