Effects of an abbreviated obesity intervention supported by mobile technology: The ENGAGED randomized clinical trial.
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ABSTRACT: Objective
To determine the effects on weight loss of three abbreviated behavioral weight loss interventions with and without coaching and mobile technology.Methods
A randomized controlled efficacy study of three 6-month weight loss treatments was conducted in 96 adults with obesity: 1) self-guided (SELF), 2) standard (STND), or 3) technology-supported (TECH). STND and TECH received eight in-person group treatment sessions. SELF and STND used paper diaries to self-monitor diet, activity, and weight; TECH used a smartphone application with social networking features and wireless accelerometer.Results
Weight loss was greater for TECH and STND than SELF at 6 months (-5.7?kg [95% confidence interval: -7.2 to -4.1] vs. -2.7?kg [95% confidence interval: -5.1 to -0.3], P?ConclusionsAbbreviated behavioral counseling can produce clinically meaningful weight loss regardless of whether self-monitoring is performed on paper or smartphone, but long-term superiority over standard of care self-guided treatment is challenging to maintain.
SUBMITTER: Spring B
PROVIDER: S-EPMC5487285 | biostudies-literature | 2017 Jul
REPOSITORIES: biostudies-literature
Publications
Effects of an abbreviated obesity intervention supported by mobile technology: The ENGAGED randomized clinical trial.
Spring Bonnie B Pellegrini Christine A CA Pfammatter Angela A Duncan Jennifer M JM Pictor Alex A McFadden H Gene HG Siddique Juned J Hedeker Donald D
Obesity (Silver Spring, Md.) 20170511 7
<h4>Objective</h4>To determine the effects on weight loss of three abbreviated behavioral weight loss interventions with and without coaching and mobile technology.<h4>Methods</h4>A randomized controlled efficacy study of three 6-month weight loss treatments was conducted in 96 adults with obesity: 1) self-guided (SELF), 2) standard (STND), or 3) technology-supported (TECH). STND and TECH received eight in-person group treatment sessions. SELF and STND used paper diaries to self-monitor diet, ac ...[more]
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Project description:BackgroundThis paper describes the research protocol for a randomized controlled trial of a multimodal mobile sleep intervention for heavy-drinking young adults. Young adults report the highest rates of heavy, risky alcohol consumption and are a priority population for alcohol prevention and intervention efforts. Alcohol strategies that leverage other health concerns and use technology may offer an innovative solution. Poor sleep is common among young adults and is a risk factor for developing an alcohol use disorder. Moreover, young adults are interested in information to help them sleep better, and behavioral sleep interventions address alcohol use as a standard practice.ObjectiveThe primary aim of this study is to assess the effectiveness of a 2-week multimodal mobile sleep intervention for reducing drinks consumed per week among heavy-drinking young adults. We will explore the effects on alcohol-related consequences, assessing quantitative and qualitative sleep characteristics as secondary aims. The study's goals are to identify the optimal combination of sleep intervention components for improving drinking outcomes, the feasibility and acceptability of these components, and the potential mechanisms by which these components may promote alcohol behavior change.MethodsYoung adults (aged 18-25 years) who report recent heavy drinking will be randomly assigned to one of three conditions: mobile sleep hygiene advice (n=30), mobile sleep hygiene advice and sleep and alcohol diary self-monitoring (n=30), or mobile sleep hygiene advice, sleep and alcohol diary self-monitoring, and sleep and alcohol data feedback (n=60). For the feedback component, participants will complete two web-based sessions with a health coach during which they will receive summaries of their sleep and alcohol data, and the potential association between them along with brief advice tailored to their data. All participants will wear sleep and alcohol biosensors daily for 2 weeks for objective assessments of these outcomes.ResultsThe study was funded by the National Institutes of Health in May 2018. Recruitment began in December 2018 and will be concluded in Spring 2021. As of February 4, 2021, we have enrolled 110 participants.ConclusionsUltimately, this research could result in an efficacious, low-cost intervention with broad population reach through the use of technology. In addition, this intervention may substantially impact public health by reducing alcohol use disorder risk at a crucial developmental stage.Trial registrationClinicalTrials.gov NCT03658954; https://clinicaltrials.gov/ct2/show/NCT03658954.International registered report identifier (irrid)DERR1-10.2196/26557.
| S-EPMC7954653 | biostudies-literature
Project description:BACKGROUND:The principal aim of this study was to investigate whether a caregiver-inclusive assistive technology intervention improved older care recipients' functional autonomy and decreased the perceived burden of their family caregivers compared to customary care. METHODS:The study was a single-blind, mixed-methods, randomized controlled trial with baseline data collection and follow-ups at 6-, 22-, and 58-weeks after baseline evaluation, which was prospectively registered ( ClinicalTrials.gov Identifier: NCT01640470. Registered 11/21/2011). Dyads comprising a care recipient and family caregiver were randomly assigned to either a caregiver-inclusive experimental group (N?=?44) or a customary-care comparison group (N?=?46). Eligible care recipients were aged ?55 years and had one or more limitations with mobility or daily activities, and family caregivers provided at least four hours per week of assistance. Outcome measures were administered to both groups at baseline and at the three follow-up time points. The data collectors were blinded regarding participants' intervention group. The primary outcome measures were the Functional Autonomy Measurement System to assess care recipients' functional performance, and the Caregiver Assistive Technology Outcome Measure to assess caregivers' burden. Qualitative interviews examined participants' perceptions of the caregiver-inclusive and customary care interventions. RESULTS:The experimental intervention addressed significantly more dyad-identified problematic activities, but caregiver involvement was evident in both groups and outcomes were not significantly different over time. In both groups, care recipients' functional autonomy declined significantly (P?<?.01), and caregivers' activity-specific and overall burden decreased significantly (P?<?.01). CONCLUSIONS:Given the unintended congruence between the caregiver-inclusive and customary care interventions, the overall findings lend support for the provision of assistive technology to reduce caregiver burden.
| S-EPMC5907288 | biostudies-literature
Project description:ImportanceThe Mobile Health Technology for Improved Screening and Optimized Integrated Care in Atrial Fibrillation (mAFA-II) trial is a prospective cluster randomized trial that found a significant reduction in the composite clinical outcome of stroke or thromboembolism, all-cause death, and rehospitalization among patients with atrial fibrillation (AF) who used a mobile health (mHealth) technology that implemented the Atrial Fibrillation Better Care (ABC) pathway (ie, A, anticoagulation/avoid stroke; B, better symptom control; and C, cardiovascular disease and comorbidity management) compared with those receiving usual care. Multimorbidity (defined as ≥2 chronic long-term conditions) is common in older patients with AF, but the impact of integrated or holistic care (based on the ABC pathway) on clinical outcomes in this population is uncertain.ObjectiveTo evaluate whether implementation of the integrated ABC pathway, supported by mHealth technology, would reduce AF-related adverse events in patients with multimorbidity.Design, setting, and participantsThis prespecified ancillary analysis of data from the extended follow-up of the mAFA II trial was conducted between June 2018 and April 2021. Adult patients with AF were included in the analysis if they had at least 2 comorbidities. Participants were enrolled across 40 centers in China.InterventionIntegrated care supported by mHealth technology (mAFA intervention) vs usual care.Main outcomes and measuresThe main outcome was the composite outcome of stroke or thromboembolism, all-cause death, and rehospitalization. Cox proportional hazard modeling was performed for adverse outcomes after adjusting for cluster effect and baseline risk factors.ResultsOf 1890 patients, 833 (mean [SD] age, 72.0 [12.0] years; 278 [33.4%] women) with multimorbidity were allocated to the intervention group (ABC pathway), with a mean (SD) follow-up of 419 (257) days, and 1057 patients (mean [SD] age, 72.8 [13.0] years; 443 [41.9%] women) with multimorbidity were allocated to usual care, with a mean (SD) follow-up of 457 (154) days. Compared with usual care, the composite outcome of stroke or thromboembolism, all-cause death, and rehospitalization was significantly reduced in the intervention group (hazard ratio [HR], 0.37; 95% CI, 0.26-0.53; P < .001), as were rehospitalizations alone (HR, 0.42; 95% CI, 0.27-0.64; P < .001). For the C criterion of the ABC pathway, rates of acute coronary syndrome, heart failure, and uncontrolled blood pressure during follow-up were lower in the intervention group than the usual care group (27 patients [3.2%] vs 145 patients [13.7%]; HR, 0.29; 95% CI, 0.19-0.45; P < .001). Subgroup analyses by age, prior stroke, and sex demonstrated consistently lower HRs for the primary composite outcome and rehospitalization for patients with AF allocated to the intervention group compared with patients receiving usual care.Conclusions and relevanceIn this study, mHealth technology-based integrated care that facilitated the implementation of the ABC pathway reduced meaningful clinical adverse events in older patients with AF and multimorbidity vs usual care.Trial registrationWHO International Clinical Trials Registry Platform (ICTRP) Registration number: ChiCTR-OOC-17014138.
| S-EPMC8693229 | biostudies-literature
Project description:ObjectiveTo determine the effect on weight of two mobile technology-based (mHealth) behavioral weight loss interventions in young adults.MethodsRandomized, controlled comparative effectiveness trial in 18- to 35-year-olds with BMI ≥ 25 kg/m(2) (overweight/obese), with participants randomized to 24 months of mHealth intervention delivered by interactive smartphone application on a cell phone (CP); personal coaching enhanced by smartphone self-monitoring (PC); or Control.ResultsThe 365 randomized participants had mean baseline BMI of 35 kg/m(2) . Final weight was measured in 86% of participants. CP was not superior to Control at any measurement point. PC participants lost significantly more weight than Controls at 6 months (net effect -1.92 kg [CI -3.17, -0.67], P = 0.003), but not at 12 and 24 months.ConclusionsDespite high intervention engagement and study retention, the inclusion of behavioral principles and tools in both interventions, and weight loss in all treatment groups, CP did not lead to weight loss, and PC did not lead to sustained weight loss relative to Control. Although mHealth solutions offer broad dissemination and scalability, the CITY results sound a cautionary note concerning intervention delivery by mobile applications. Effective intervention may require the efficiency of mobile technology, the social support and human interaction of personal coaching, and an adaptive approach to intervention design.
| S-EPMC4636032 | biostudies-literature
Project description:BACKGROUND:Home-based noninvasive ventilation has proven cost-effective. But, adherence to therapy still constitutes a common clinical problem. We hypothesized that a behavioral intervention supported by a mobile health (mHealth) app could enhance patient self-efficacy. It is widely accepted that mHealth-supported services can enhance productive interactions among the stakeholders involved in home-based respiratory therapies. OBJECTIVE:This study aimed to measure changes in self-efficacy in patients with chronic respiratory failure due to diverse etiologies during a 3-month follow-up period after the intervention. Ancillary objectives were assessment of usability and acceptability of the mobile app as well as its potential contribution to collaborative work among stakeholders. METHODS:A single-blind, single-center, randomized controlled trial was conducted between February 2019 and June 2019 with 67 adult patients with chronic respiratory failure undergoing home-based noninvasive ventilation. In the intervention group, a psychologist delivered a face-to-face motivational intervention. Follow-up was supported by a mobile app that allowed patients to report the number of hours of daily noninvasive ventilation use and problems with the therapy. Advice was automatically delivered by the mobile app in case of a reported problem. The control group received usual care. The primary outcome was the change in the Self Efficacy in Sleep Apnea questionnaire score. Secondary outcomes included app usability, app acceptability, continuity of care, person-centered care, and ventilatory parameters. RESULTS:Self-efficacy was not significantly different in the intervention group after the intervention (before: mean 3.4, SD 0.6; after: mean 3.4, SD 0.5, P=.51). No changes were observed in adherence to therapy nor quality of life. Overall, the mHealth tool had a good usability score (mean 78 points) and high acceptance rate (mean score of 7.5/10 on a Likert scale). It was considered user-friendly (mean score of 8.2/10 on a Likert scale) and easy to use without assistance (mean score of 8.5/10 on a Likert scale). Patients also scored the perception of continuity of care and person-centered care as high. CONCLUSIONS:The integrated care intervention supported by the mobile app did not improve patient self-management. However, the high acceptance of the mobile app might indicate potential for enhanced communication among stakeholders. The study identified key elements required for mHealth tools to provide effective support to collaborative work and personalized care. TRIAL REGISTRATION:ClinicalTrials.gov NCT03932175; https://clinicaltrials.gov/ct2/show/NCT03932175.
| S-EPMC7186864 | biostudies-literature
Project description:BackgroundLeading causes of unintentional child injury such as poisoning and falls are preventable, and the majority occur in the home. Numerous home safety interventions have been developed and tested to increase safety behaviors; however, no smart phone-based applications (apps) have been developed and evaluated for this purpose. The objective of this study was to evaluate whether a mobile technology-based health behavior change intervention, the Make Safe Happen® app, was an effective tool to increase safety knowledge and safety actions/behaviors for the prevention of child unintentional injuries in and around the home.MethodsData were collected in pretest and posttest online surveys from an existing nationwide population-based survey panel. Intervention subjects were randomized to organically (participant-driven) use the Make Safe Happen® app for 1 week, which provided home safety information and the ability to purchase safety products, while control participants were assigned to download and use an app about a topic other than home safety. The primary outcomes of safety knowledge and home safety actions were assessed by using linear mixed model regressions with intention-to-treat analyses.ResultsA total of 5032 participants were randomized to either the intervention (n = 4182) or control (n = 850) group, with 2055 intervention participants downloading and entering their participant IDs into the Make Safe Happen® app. The online posttest survey was completed by 770 intervention and 283 control subjects. Mean knowledge parent safety score increased at a greater rate for intervention than control subjects (p < 0.0001), and at posttest was significantly higher for intervention than control subjects (p < 0.0001). The percentage of intervention subjects who reported doing all one-time and repeated safety actions significantly increased from pretest to posttest (p < 0.0001 and p = 0.0001, respectively), but there was no change among the control subjects (p = 0.1041 and p = 0.9755, respectively). At posttest, this percentage was larger for intervention than control subjects only for repeated safety actions (p = 0.0340).ConclusionsThe mobile application significantly improved safety knowledge and safety actions for participants using the Make Safe Happen® app, although loss to follow-up was a limitation. The results of this study indicate the usefulness of widespread distribution and use of the Make Safe Happen® app. Trial registration number NCT02751203 ; Registered April 26, 2016.
| S-EPMC8485517 | biostudies-literature
Project description:BackgroundEmerging evidence indicates the effectiveness of internet-based mobile-supported stress management interventions (iSMIs) in highly stressed employees. It is yet unclear, however, whether iSMIs are also effective without a preselection process in a universal prevention approach, which more closely resembles routine occupational health care. Moreover, evidence for whom iSMIs might be suitable and for whom not is scarce.ObjectiveThe aim of this study was to evaluate the iSMI GET.ON Stress in a universal prevention approach without baseline inclusion criteria and to examine the moderators of the intervention effects.MethodsA total of 396 employees were randomly assigned to the intervention group or the 6-month waiting list control group. The iSMI consisted of 7 sessions and 1 booster session and offered no therapeutic guidance. Self-report data were assessed at baseline, 7 weeks, and at 6 months following randomization. The primary outcome was perceived stress. Several a priori defined moderators were explored as potential effect modifiers.ResultsParticipants in the intervention group reported significantly lower perceived stress at posttreatment (d=0.71, 95% CI 0.51-0.91) and at 6-month follow-up (d=0.61, 95% CI 0.41-0.81) compared to those in the waiting list control group. Significant differences with medium-to-large effect sizes were found for all mental health and most work-related outcomes. Resilience (at 7 weeks, P=.04; at 6 months, P=.01), agreeableness (at 7 weeks, P=.01), psychological strain (at 6 months, P=.04), and self-regulation (at 6 months, P=.04) moderated the intervention effects.ConclusionsThis study indicates that iSMIs can be effective in a broad range of employees with no need for preselection to achieve substantial effects. The subgroups that might not profit had extreme values on the respective measures and represented only a very small proportion of the investigated sample, thereby indicating the broad applicability of GET.ON Stress.Trial registrationGerman Clinical Trials Register DRKS00005699; https://www.drks.de/DRKS00005699.
| S-EPMC8734929 | biostudies-literature
Project description:BACKGROUND:Smoking cessation is a persistent leading public health challenge. Mobile health (mHealth) solutions are emerging to improve smoking cessation treatments. Previous approaches have proposed supporting cessation with tailored motivational messages. Some managed to provide short-term improvements in smoking cessation. Yet, these approaches were either static in terms of personalization or human-based nonscalable solutions. Additionally, long-term effects were neither presented nor assessed in combination with existing psychopharmacological therapies. OBJECTIVE:This study aimed to analyze the long-term efficacy of a mobile app supporting psychopharmacological therapy for smoking cessation and complementarily assess the involved innovative technology. METHODS:A 12-month, randomized, open-label, parallel-group trial comparing smoking cessation rates was performed at Virgen del Rocío University Hospital in Seville (Spain). Smokers were randomly allocated to a control group (CG) receiving usual care (psychopharmacological treatment, n=120) or an intervention group (IG) receiving psychopharmacological treatment and using a mobile app providing artificial intelligence-generated and tailored smoking cessation support messages (n=120). The secondary objectives were to analyze health-related quality of life and monitor healthy lifestyle and physical exercise habits. Safety was assessed according to the presence of adverse events related to the pharmacological therapy. Per-protocol and intention-to-treat analyses were performed. Incomplete data and multinomial regression analyses were performed to assess the variables influencing participant cessation probability. The technical solution was assessed according to the precision of the tailored motivational smoking cessation messages and user engagement. Cessation and no cessation subgroups were compared using t tests. A voluntary satisfaction questionnaire was administered at the end of the intervention to all participants who completed the trial. RESULTS:In the IG, abstinence was 2.75 times higher (adjusted OR 3.45, P=.01) in the per-protocol analysis and 2.15 times higher (adjusted OR 3.13, P=.002) in the intention-to-treat analysis. Lost data analysis and multinomial logistic models showed different patterns in participants who dropped out. Regarding safety, 14 of 120 (11.7%) IG participants and 13 of 120 (10.8%) CG participants had 19 and 23 adverse events, respectively (P=.84). None of the clinical secondary objective measures showed relevant differences between the groups. The system was able to learn and tailor messages for improved effectiveness in supporting smoking cessation but was unable to reduce the time between a message being sent and opened. In either case, there was no relevant difference between the cessation and no cessation subgroups. However, a significant difference was found in system engagement at 6 months (P=.04) but not in all subsequent months. High system appreciation was reported at the end of the study. CONCLUSIONS:The proposed mHealth solution complementing psychopharmacological therapy showed greater efficacy for achieving 1-year tobacco abstinence as compared with psychopharmacological therapy alone. It provides a basis for artificial intelligence-based future approaches. TRIAL REGISTRATION:ClinicalTrials.gov NCT03553173; https://clinicaltrials.gov/ct2/show/NCT03553173. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR2-10.2196/12464.
| S-EPMC7215523 | biostudies-literature
Project description:BACKGROUND:The prevalence of nonalcoholic fatty liver disease (NAFLD) reaches up to 30% in the Asian adult population, with a higher prevalence in obese patients. Weight reduction is typically recommended for patients at high risk or diagnosed with NAFLD, but is a challenge to achieve. OBJECTIVE:We aimed to evaluate the effect of a lifestyle intervention with a mobile app on weight loss in NAFLD patients. METHODS:This prospective randomized controlled trial included 108 adults with NAFLD confirmed by steatosis on ultrasound and a body mass index ?23 kg/m2 who were recruited from a fatty liver outpatient clinic. The patients were randomly allocated to either a control group (n=53) receiving standard care, consisting of dietary and lifestyle advice by a trained nurse, or an intervention group (n=55) utilizing the Nutritionist Buddy (nBuddy) mobile app in addition to receiving dietary and lifestyle advice by a dietitian. Body weight, alanine aminotransferase (ALT), aspartate aminotransferase (AST), waist circumference, and blood pressure were measured at baseline, and then at 3 and 6 months. Intention-to-treat and per-protocol analyses were used for statistical comparisons. RESULTS:The intervention group had a 5-fold higher likelihood (relative risk 5.2, P=.003, 95% CI 1.8-15.4) of achieving ?5% weight loss compared to the control group at 6 months. The intervention group also showed greater reductions in weight (mean 3.2, SD 4.1 kg vs mean 0.5, SD 2.9 kg; P<.001), waist circumference (mean 2.9, SD 5.0 cm vs mean -0.7, SD 4.4 cm; P<.001), systolic blood pressure (mean 12.4, SD 14.8 mmHg vs mean 2.4, SD 12.4 mmHg; P=.003), diastolic blood pressure (mean 6.8, SD 8.9 mmHg vs mean -0.9, SD 10.0 mmHg; P=.001), ALT (mean 33.5, SD 40.4 IU/L vs mean 11.5, SD 35.2 IU/L; P=.004), and AST (mean 17.4, SD 27.5 U/L vs mean 7.4, SD 17.6 IU/L, P=.03) at 6 months. CONCLUSIONS:Lifestyle intervention enabled by a mobile app can be effective in improving anthropometric indices and liver enzymes in patients with NAFLD. This treatment modality has the potential to be extended to a larger population scale. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12617001001381; https://tinyurl.com/w9xnfmp.
| S-EPMC7186867 | biostudies-literature
Project description:BACKGROUND:New technologies, internet accessibility, social media, and increased smartphone ownership provide new opportunities for health researchers to communicate and engage target audiences. An innovative burn prevention intervention was developed using these channels. OBJECTIVE:The aim of this study was to evaluate the efficacy of Cool Runnings, an app-based intervention to increase knowledge of childhood burn risk (specifically hot beverage scalds) and correct burn first aid among mothers of young children. METHODS:This was a 2-group, parallel, single-blinded randomized controlled trial (RCT). Participants were women aged 18 years and above, living in Queensland, Australia, with at least 1 child aged 5-12 months at time of enrollment. The primary outcome measures were change in knowledge about risk of burns and correct burn first aid assessed via 2 methods: (1) overall score and (2) categorized as adequate (score=4) versus inadequate (score<4). Efficacy of gamification techniques was also assessed. RESULTS:In total, 498 participants were recruited via social media and enrolled. At the 6-month follow-up, 244 participants completed the posttest questionnaire. Attrition rates in both groups were similar. Participants who remained in the study did not differ from those lost to follow-up on any characteristics except education level. Although similar at baseline, intervention group participants achieved significantly greater improvement in overall knowledge posttest than control group participants on both primary outcome measures (overall knowledge intervention: mean [SD] of overall knowledge 2.68 [SD 1.00] for intervention vs 2.13 [SD 1.03] for control; 20.7% [25/121] adequate in intervention vs 7.3% [2/123] in control). Consequently, the number needed to treat was 7.46. Logistic regression showed participants exposed to the highest level of disadvantage had 7.3 times higher odds of improved overall knowledge scores than participants in other levels of disadvantage. There were also significant correlations between gamification techniques and knowledge change (P<.001). In addition, odds of knowledge improvement between baseline and 6-month follow-up was higher in participants with low-moderate app activity compared with no app activity (odds ratio [OR] 8.59, 95% CI 2.9-25.02) and much higher in participants with high app activity (OR 18.26, 95% CI 7.1-46.8). CONCLUSIONS:Despite substantial loss to follow-up, this RCT demonstrates the Cool Runnings app was an effective intervention for improving knowledge about risks of hot beverage scalds and burn first aid in mothers of young children. The benefits of combining gamification elements in the intervention were also highlighted. Given the low cost and large reach of smartphone apps to deliver content to and engage with targeted populations, the results from this RCT provide important information on how smartphone apps can be used for widespread injury prevention campaigns and public health campaigns generally. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12616000019404; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369745&showOriginal=true&isReview=true (Archived by WebCite at http://www.webcitation.org/72b1E8gTW).
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