Counselor Surveillance of Digital Self-Monitoring Data: A Pilot Randomized Controlled Trial.
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ABSTRACT: Objective
This pilot study tested counselor access to participants' digital self-monitoring (SM) data as a means of improving long-term lifestyle modification (LM) outcomes.Methods
After 12 weeks of weight-loss treatment, participants (N = 77) were randomized to LM or LM+SHARE for weeks 13 to 52. All participants received monthly phone calls and weekly text messages from weeks 13 to 52 and were instructed to engage in daily digital SM of weight, eating, and exercise. In LM+SHARE, but not LM, counselors had access to SM device data. Assessments were conducted as weeks 0, 13, 26, and 52.Results
Retention, engagement, and treatment satisfaction were excellent. LM+SHARE participants, compared with LM, had more frequent SM of weight and eating. Weight loss continued at a similar rate in both conditions from weeks 13 to 26. From weeks 26 to 52, those in LM regained approximately 2 kg, whereas those in LM+SHARE maintained weight loss, a significant difference. Nonetheless, total weight loss did not significantly differ by condition. Engagement in dietary SM mediated the effect of condition on weight.Conclusions
Counselor access to SM data is feasible and acceptable. Additional research is warranted to determine whether it can meaningfully improve outcomes.
SUBMITTER: Butryn ML
PROVIDER: S-EPMC8628117 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveWeight control programs that incorporate group sessions produce greater weight losses, but this has not been explored in the context of online programs. Further, counselor-crafted self-monitoring feedback is a core element of lifestyle interventions, although pre-scripted, modular feedback which does not require detailed counselor review may adequately promote weight loss. The current study explored the weight losses achieved in an online program that included facilitated group sessions, as well as outcomes when counselor-crafted self-monitoring feedback was provided.MethodsA 2 × 2 pilot factorial randomized participants (90% women) with overweight/obesity (N = 73) to facilitated group sessions (yes/no) and type of feedback (counselor-crafted/pre-scripted, modular) within a 16-week online behavioral weight control program. Weight change outcomes were collected digitally. Treatment engagement and intervention delivery time were also tracked.ResultsIndividuals offered weekly facilitated online group sessions lost more weight (-5.3% ± 4.9%) than those receiving the same digital program without group sessions (-3.1% ± 4.0%; p = 0.04). Those receiving group sessions also demonstrated significantly greater treatment engagement. Individuals receiving pre-scripted, modular feedback lost significantly more weight (-5.3% ± 4.8%) than those receiving the more traditional counselor-crafted feedback (-3.1% ± 4.1%; p = 0.04), but treatment engagement did not differ between conditions. However, interventionist time required to provide feedback was markedly lower for pre-scripted than counselor-crafted feedback (1.4 vs. 3.5 h per participant over 16 weeks, respectively, p = 0.01).ConclusionsIncorporating weekly facilitated online group sessions significantly increased weight losses achieved in a digital lifestyle program. Further, pre-scripted, modular feedback required significantly less staff time than counselor-crafted feedback without diminishing weight losses. Thus, group sessions and pre-scripted feedback warrant consideration when designing digital lifestyle programs.
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Project description:IntroductionAutomated text messaging programs show promise for e-cigarette cessation. Adding live text counseling could make them more engaging. We developed Quit the Vape (QTV), an automated e-cigarette cessation text messaging program, designed to be delivered as stand-alone or with counselor-delivered messages (QTV-C), and evaluated the acceptability and preliminary efficacy of QTV and QTV-C.MethodsBetween May and August 2021, we recruited 58 e-cigarette users, aged 20-43 years, 53.5% male, 63.8% non-Hispanic White, from an ongoing cohort study in the United States. Inclusion criteria were: using nicotine-containing e-cigarettes on ≥4 days per month; smartphone ownership; and not receiving tobacco cessation treatment. Motivation to quit did not impact eligibility. Participants were randomized to QTV (n=20), QTV-C (n=19), or control (link to e-cigarette cessation website, n=19). At end-of-treatment, we assessed program engagement and satisfaction, and self-reported quitting behaviors (e.g. point prevalence abstinence, PPA).ResultsAt baseline, average past-month e-cigarette use was 26.8 days (SD=6.2). At follow-up at 4 weeks, among QTV and QTV-C participants, ≥85% replied to ≥1 message, ≥35% set a quit date, and ≤15% opted out. More QTV and QTV-C participants (55.6%) versus control (17.7%) reported program satisfaction (p=0.034). QTV-C participants (vs QTV and control) trended more favorably on 7-day e-cigarette PPA [27.8% (95% CI: 11.5-53.3) vs 11.1% (95% CI: 2.6-37.0) and 5.9% (95% CI: 0.7-34.5)] and quit attempts [66.7% (95% CI: 41.6-84.9) vs 50.0% (95% CI: 27.4-72.6) and 52.9% (95% CI: 29.2-75.5)].ConclusionsAdding live text counseling to an automated text messaging program is acceptable and shows promise for e-cigarette cessation. A larger trial is warranted to assess its efficacy.
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Project description:BackgroundDigital interventions provided through smartphones or the internet that are guided by a coach have been proposed as promising solutions to support the self-management of chronic conditions. However, digital intervention for poststroke self-management is limited; we developed the interactive Self-Management Augmented by Rehabilitation Technologies (iSMART) intervention to address this gap.ObjectiveThis study aimed to examine the feasibility and initial effects of the iSMART intervention to improve self-management self-efficacy in people with stroke.MethodsA parallel, 2-arm, nonblinded, randomized controlled trial of 12-week duration was conducted. A total of 24 participants with mild-to-moderate chronic stroke were randomized to receive either the iSMART intervention or a manual of stroke rehabilitation (attention control). iSMART was a coach-guided, technology-supported self-management intervention designed to support people managing chronic conditions and maintaining active participation in daily life after stroke. Feasibility measures included retention and engagement rates in the iSMART group. For both the iSMART intervention and active control groups, we used the Feasibility of Intervention Measure, Acceptability of Intervention Measure, and Intervention Appropriateness Measure to assess the feasibility, acceptability, and appropriateness, respectively. Health measures included the Participation Strategies Self-Efficacy Scale and the Patient-Reported Outcomes Measurement Information System's Self-Efficacy for Managing Chronic Conditions.ResultsThe retention rate was 82% (9/11), and the engagement (SMS text message response) rate was 78% for the iSMART group. Mean scores of the Feasibility of Intervention Measure, Acceptability of Intervention Measure, and Intervention Appropriateness Measure were 4.11 (SD 0.61), 4.44 (SD 0.73), and 4.36 (SD 0.70), respectively, which exceeded our benchmark (4 out of 5), suggesting high feasibility, acceptability, and appropriateness of iSMART. The iSMART group showed moderate-to-large effects in improving self-efficacy in managing emotions (r=0.494), symptoms (r=0.514), daily activities (r=0.593), and treatments and medications (r=0.870), but the control group showed negligible-to-small effects in decreasing self-efficacy in managing emotions (r=0.252), symptoms (r=0.262), daily activities (r=0.136), and treatments and medications (r=0.049). In addition, the iSMART group showed moderate-to-large effects of increasing the use of participation strategies for management in the home (r=0.554), work (r=0.633), community (r=0.673), and communication activities (r=0.476). In contrast, the control group showed small-to-large effects of decreasing the use of participation strategies for management in the home (r=0.567), work (r=0.342, community (r=0.215), and communication activities (r=0.379).ConclusionsOur findings support the idea that iSMART was feasible to improve poststroke self-management self-efficacy. Our results also support using a low-cost solution, such as SMS text messaging, to supplement traditional therapeutic patient education interventions. Further evaluation with a larger sample of participants is still needed.Trial registrationClinicalTrials.gov 202004137; https://clinicaltrials.gov/study/NCT04743037?id=202004137&rank=1.
| S-EPMC10912984 | biostudies-literature
Project description:BackgroundThis study aimed to assess the effects of digital storytelling on the self-management behavior of adolescents with type 1 diabetes (TID).MethodsIn this pilot randomized controlled clinical trial, 60 adolescents with TID were randomly allocated into two parallel groups: intervention (training with digital storytelling method, n = 33) or control (training with a conventional method, n = 33). The primary outcome was assessing the Self-Management behavior of adolescents with TID (SMOD-A) at baseline and three months after the intervention.ResultsThe results revealed that digital storytelling could significantly improve self-management behaviors amongst adolescents with TID (P = 0.005). In contrast, in the control group, no significant changes were observed (P > 0.05). Furthermore, the mean score of Collaboration with Parents subscale was significantly higher in the digital storytelling group than in the control group after the intervention (p = 0.022). The results also showed that the level of Collaboration With Parents' subscale scores had a meaningful reverse relationship with the adolescent age after digital storytelling (p = 0.048). Repeated measures ANOVAs showed that there were significant main effects of time and group on collaboration with parents(p = 0.002) and goal subscales (p = 0.035). With respect to HbA1c levels, significant changes were not observed in any of the groups (P > 0.05).ConclusionsDigital storytelling is practicable and a potentially beneficial training modality for adolescents with TID.Trial registrationThis trial was respectively registered.Clinicaltrialsgov Identifier: IRCT20191220045828N1 . Date of registration: Oct 29. 2020.
| S-EPMC8941790 | biostudies-literature
Project description:BackgroundHeavy drinking (HD) is far more common among smokers compared with nonsmokers and interferes with successful smoking cessation. Alcohol-focused smoking cessation interventions delivered by counselors have shown promise, but digital versions of these interventions-which could have far greater population reach-have not yet been tested.ObjectiveThis pilot randomized controlled trial aimed to examine the feasibility, acceptability, and effect sizes of an automated digital smoking cessation program that specifically addresses HD using an interactive web-based intervention with an optional text messaging component.MethodsParticipants (83/119, 69.7% female; 98/119, 82.4% white; mean age 38.0 years) were daily smokers recruited on the web from a free automated digital smoking cessation program (BecomeAnEX.org, EX) who met the criteria for HD: women drinking 8+ drinks/week or 4+ drinks on any day and men drinking 15+ drinks/week or 5+ drinks on any day. Participants were randomized to receive EX with standard content (EX-S) or an EX with additional content specific to HD (EX-HD). Outcomes were assessed by web-based surveys at 1 and 6 months.ResultsParticipants reported high satisfaction with the website and the optional text messaging component. Total engagement with both EX-S and EX-HD was modest, with participants visiting the website a median of 2 times, and 52.9% of the participants enrolled to receive text messages. Participants in both the conditions showed substantial, significant reductions in drinking across 6 months of follow-up, with no condition effects observed. Although smoking outcomes tended to favor EX-HD, the condition effects were small and nonsignificant. A significantly smaller proportion of participants in EX-HD reported having a lapse back to smoking when drinking alcohol (7/58, 16%) compared with those in EX-S (18/61, 41%; χ21=6.2; P=.01).ConclusionsThis is the first trial to examine a digital smoking cessation program tailored to HD smokers. The results provide some initial evidence that delivering such a program is feasible and may reduce the risk of alcohol-involved smoking lapses. However, increasing engagement in this and other web-based interventions is a crucial challenge to address in future work.Trial registrationClinicalTrials.gov NCT03068611; https://clinicaltrials.gov/ct2/show/NCT03068611.
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Project description:Changes in gene expression were consistent with mechanism of action and show that clinical response to treatment with belimumab is associated with significant decrease in profibrotic genes and pathways. Additional study is needed to determine the role of belimumab in the treatment of dcSSc
2018-03-01 | GSE97248 | GEO
Project description:Few randomized controlled trials (RCTs) report interventions targeting improvement of frailty status as an outcome.This RCT enrolled 117 older adults (65-79?years of age) in Toufen, Taiwan who scored 3-6 on The Chinese Canadian Study of Health and Aging Clinical Frailty Scale Telephone Version and then score ?1 on the Cardiovascular Health Study Phenotypic Classification of Frailty (CHS_PCF). With a two by two factorial design, subjects were randomly assigned to interventions (Exercise and nutrition, EN, n?=?55 or problem solving therapy, PST, n?=?57) or controls (non-EN, n?=?62 or non-PST, n?=?60). Educational booklets were provided to all. EN group subjects received nutrition consultation and a thrice-weekly exercise-training program while PST group subjects received 6 sessions in 3?month. Subjects were followed at 3, 6, and 12?months. Primary outcome was improvement of the CHS_PCF by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline assessments. One hundred and one completed final assessments. Intention-to-treat analysis with the generalized estimating equation model was applied with adjustment for time and treatment-by-time interactions.Mean age was 71.4?±?3.7?years, with 59% females. Baseline characteristic were generally comparable between groups. EN group subjects had a higher improvement rate on the primary outcome than non-EN group subjects (45% vs 27%, adjusted p?=?0.008) at 3?months, but not 6 or 12?months. They also had more increase of serum 25(OH) vitamin D level (4.9?±?7.7 vs 1.2?±?5.4, p?=?0.006) and lower percentage of osteopenia (74% vs 89% p?=?0.042) at 12?months. PST group subjects had better improvement (2.7?±?6.1 vs 0.2?±?6.7, p?=?0.035, 6-month) and less deterioration (-3.5?±?9.7 vs -7.1?±?8.7, p?=?0.036, 12-month) of dominant leg extension power than non-PST subjects. Some secondary outcomes were also improved in control groups (non-EN or non-PST). No adverse effects were reported.The three-month EN intervention resulted in short-term (3-month) frailty status improvement and long-term effect on bone mineral density and serum vitamin D (12-month) among Taiwanese community-dwelling elders. The effect of PST was less pronounced.ClinicalTrials.gov: EC0970301
| S-EPMC3490887 | biostudies-other
Project description:ObjectivesTo evaluate the feasibility and acceptability of a behavioral intervention and explore its impact on depression symptom burden among older spousally-bereaved adults.MethodsParticipants were age ≥60 years, bereaved ≤8 months, and at high risk for depression. Participants were randomized to 12 weeks of digital monitoring of sleep, meals, and physical activity; digital monitoring plus health coaching; or enhanced usual care and followed for 9 months for new-episode depression.ResultsWe enrolled 57 participants, 85% of eligible adults and 38% of all adults screened. We observed high levels of adherence in both digital monitoring (90%) and health coaching (92%); 88% of participants were retained. In linear mixed-effects models, depression symptoms significantly decreased, but the interaction between time and intervention was not significant.ConclusionA behavioral intervention that uses both digital monitoring and motivational health coaching is feasible and acceptable to older bereaved adults.
| S-EPMC7483357 | biostudies-literature
Project description:Smoking is a health hazard. Current smoking cessation measures such as behavioral change counselling by trained professionals, nicotine replacement therapy and medications have limited success. Smoking intensity is assessed using a portable device to measure the smokers' exhaled breath carbon monoxide (eCO) level. A systematic review suggests the potential of serious gaming to increase smoking quit rate. However, the related studies were unable to explain and determine the effect gamification on smoking cessation. A handy personalized eCO measurement device linked to a smart-phone applications (app) has been developed (integrated STEADES-2 system). This novel system incorporates app-based video and print learning resources, authentication function and gamification using the eCO data as game element. Trained multidisciplinary healthcare professionals access the STEADES-2 data to monitor smoking status and support smokers via asynchronous virtual coaching. The pilot randomized controlled trial will enroll 20 smokers to use the STEADES-2 system (intervention group) and another 20 to the existing smoking cessation programme (control group) in primary care. The primary feasibility outcomes will include the recruitment response rate, the smokers' usability of the STEADES-2 system, their self eCO monitoring, frequencies of participation in the serious games and interactions with their virtual coaches. Their smoking literacy, utility and experience of the STEADES-2 system are other outcomes. Smokers in both groups will be compared on their cigarette abstinence as secondary outcome based on eCO levels and urine cotinine test (primary outcomes after 12 weeks). The results will be disseminated via conferences and publications.
| S-EPMC8330840 | biostudies-literature
Project description:BackgroundPoor self-management of heart failure (HF) contributes to devastating health consequences. Our innovative sensor-controlled digital game (SCDG) integrates data from sensors to trigger game rewards, progress, and feedback based on the real-time behaviors of individuals with HF.ObjectiveThe aim of this study is to compare daily weight monitoring and physical activity behavior adherence by older adults using an SCDG intervention versus a sensors-only intervention in a feasibility randomized controlled trial.MethodsEnglish-speaking adults with HF aged 55 years or older who owned a smartphone and could walk unassisted were recruited from Texas and Oklahoma from November 2019 to August 2020. Both groups were given activity trackers and smart weighing scales to track behaviors for 12 weeks. The feasibility outcomes of recruitment, retention, intervention engagement, and satisfaction were assessed. In addition to daily weight monitoring and physical activity adherence, the participants' knowledge, functional status, quality of life, self-reported HF behaviors, motivation to engage in behaviors, and HF-related hospitalization were also compared between the groups at baseline and at 6, 12, and 24 weeks.ResultsA total of 38 participants with HF-intervention group (IG; 19/38, 50%) and control group (CG; 19/38, 50%)-were enrolled in the study. Of the 38 participants, 18 (47%) were women, 18 (47%) were aged 65 years or older, 21 (55%) had been hospitalized with HF in the past 6 months, and 29 (76%) were White. Furthermore, of these 38 participants, 31 (82%)-IG (15/19, 79%) and CG (16/19, 84%)-had both weight monitoring and physical activity data at the end of 12 weeks, and 27 (71%)-IG (14/19, 74%) and CG (13/19, 68%)-participated in follow-up assessments at 24 weeks. For the IG participants who installed the SCDG app (15/19, 79%), the number of days each player opened the game app was strongly associated with the number of days the player engaged in weight monitoring (r=0.72; P=.04) and the number of days with physical activity step data (r=0.9; P<.001). The IG participants who completed the satisfaction survey (13/19, 68%) reported that the SCDG was easy to use. Trends of improvement in daily weight monitoring and physical activity in the IG, as well as within-group improvements in HF functional status, quality of life, knowledge, self-efficacy, and HF hospitalization in both groups, were observed in this feasibility trial.ConclusionsPlaying an SCDG on smartphones was feasible and acceptable for older adults with HF for motivating daily weight monitoring and physical activity. A larger efficacy trial of the SCDG intervention will be needed to validate trends of improvement in daily weight monitoring and physical activity behaviors.Trial registrationClinicalTrials.gov NCT03947983; https://clinicaltrials.gov/ct2/show/NCT03947983.
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