Text Message Intervention for Teens with Type 1 Diabetes Preserves HbA1c: Results of a Randomized Controlled Trial.
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SUBMITTER: McGill DE
PROVIDER: S-EPMC7196367 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BACKGROUND:Obesity is among the most significant health challenges facing today's adolescents. Weight gain during adolescence is related to cardiovascular disease, type 2 diabetes, and some cancers in later life. Presently, adolescents living in Australia have limited access to age-appropriate obesity prevention services. OBJECTIVE:This study aims to investigate whether a two-way text message program, with optional telephone health counseling, improves body mass index (BMI) z score and lifestyle outcomes in adolescents who are overweight. METHODS:This study will be a single-blind randomized controlled trial (N=150) comparing a two-way text message intervention, with optional telephone health counseling, to usual care in adolescents (13-18 years old, inclusive) who are overweight (recruited from a pediatric weight management clinic and the broader community in Sydney, Australia). The intervention group will receive a six-month text message program, which consists of two-way, semipersonalized, lifestyle-focused text messages (four messages/week) in addition to usual care. The control group will be assigned to receive usual care. The study also includes a follow-up at 12-months. The primary outcome is a change in BMI z score at six months. Secondary outcomes are changes in waist-to-height ratio, diet, physical and sedentary activity levels, sleep quality, quality of life, self-esteem, self-efficacy, social support, and eating disorder and depression symptoms. Also, we will examine acceptability, utility, and engagement with the program through a study-specific process evaluation questionnaire, semi-structured telephone interviews, and an analysis of health counselor communication logs. The analyses will be performed by the intention-to-treat principle to assess differences between intervention and control groups. RESULTS:The study opened for recruitment in December 2019. Data collection is expected to be completed by December 2021, and the results for the primary outcome are expected to be published in early 2022. CONCLUSIONS:This study will test the effectiveness of an interactive two-way text message program compared to usual care in improving BMI z score and lifestyle outcomes in adolescents with overweight. This interactive, innovative, and scalable project also aims to inform future practice and community initiatives to promote obesity prevention behaviors for adolescents. TRIAL REGISTRATION:Australia New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619000389101; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377158&isReview=true. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/16481.
| S-EPMC7055806 | biostudies-literature
Project description:To our knowledge, no studies have evaluated whether weight loss can be promoted in overweight adults through the use of an intervention that is largely based on daily SMS (Short Message Service: text) and MMS (Multimedia Message Service: small picture) messages transmitted via mobile phones.This paper describes the development and evaluation of a text message-based intervention designed to help individuals lose or maintain weight over 4 months.The study was a randomized controlled trial, with participants being exposed to one of the following two conditions, lasting 16 weeks: (1) receipt of monthly printed materials about weight control; (2) an intervention that included personalized SMS and MMS messages sent two to five times daily, printed materials, and brief monthly phone calls from a health counselor. The primary outcome was weight at the end of the intervention. A mixed-model repeated-measures analysis compared the effect of the intervention group to the comparison group on weight status over the 4-month intervention period. Analysis of covariance (ANCOVA) models examined weight change between baseline and 4 months after adjusting for baseline weight, sex, and age.A total of 75 overweight men and women were randomized into one of the two groups, and 65 signed the consent form, completed the baseline questionnaire, and were included in the analysis. At the end of 4 months, the intervention group (n = 33) lost more weight than the comparison group (-1.97 kg difference, 95% CI -0.34 to -3.60 kg, P = .02) after adjusting for sex and age. Intervention participants' adjusted average weight loss was 2.88 kg (3.16%). At the end of the study, 22 of 24 (92%) intervention participants stated that they would recommend the intervention for weight control to friends and family.Text messages might prove to be a productive channel of communication to promote behaviors that support weight loss in overweight adults.
| S-EPMC2729073 | biostudies-literature
Project description:BackgroundAmong adolescents with type 1 diabetes, some experience great difficulties with treatment adherence, putting them at high risk of complications. We assessed the effect of text messaging (Short Messaging Service [SMS]) on glycemic control.MethodsA two-arm open label randomized controlled trial enrolled adolescents with type 1 diabetes aged 12-21 years with baseline HbA1c ≥ 69 mmol/mol (8.5%). The intervention group received daily SMS reminders at self-selected times about insulin injections while the control group received standard of care. The patients allocated to the control group were not aware of the intervention.Results92 patients were randomized, 45 in the SMS arm and 47 in the control arm. After 6 months, median HbA1c level was significantly lower in the intervention arm: 73 mmol/mol (8.8%) in the SMS arm and 83 mmol/mol (9.7%) in the control arm in the intent-to-treat analysis (P = 0.03) but no longer in the per protocol analysis (P = 0.65). When we consider the proportions of patients whose HbA1c level decreased by at least 1% between baseline and 6 months, we find a significant difference among patients whose baseline HbA1c was ≥ 80 mmol/mol (9.5%) (n = 56): 60% in the SMS arm and 30.6% in the control arm had lowered their HbA1c level (P = 0.03) in the intent-to-treat analysis but not in the per-protocol analysis (P = 0.50). Patients in the SMS arm reported high satisfaction with the intervention.ConclusionsWhile there is a trend to lower HbA1c in the intervention group, no firm conclusions can yet be drawn. Further studies are needed to address methodological issues as we believe these interventions can support behavior change among adolescents with poorly controlled type 1 diabetes. ClinicalTrials.gov identifier: NCT02230137.
| S-EPMC7959392 | biostudies-literature
Project description:ObjectiveTo evaluate the feasibility of a randomized controlled pilot study with lifestyle-promoting text messages as a treatment for hypertension in primary care.DesignRandomized controlled pilot trial.SettingThree primary health care centers in southern Sweden.SubjectsSixty patients aged 40-80 years with hypertension were included.Main outcome measuresFeasibility of the pilot study, i.e. recruitment rate, dropout rate and eligibility criteria. Secondary outcomes were change in blood pressure and other cardiovascular risk factors.MethodsThirty participants were randomized to the intervention group with four lifestyle-promoting text messages sent every week for six months. The control group received usual care. The baseline and follow-up visits for all 60 patients included measurements of blood pressure, anthropometrics, blood tests and a self-reported questionnaire.ResultsAll feasibility criteria (recruitment rate (≥55%), dropout rate (≤15%) and eligibility (60 eligible patients during the four-month inclusion period) for the pilot study were fulfilled. This means that a larger study with a similar design may be conducted. After six months, there were no significant improvements in cardiovascular risk factors. However, we found favorable trends for all secondary outcomes in the intervention group as compared to the control group.ConclusionLifestyle modification in patients with hypertension is important to reduce cardiovascular risk. However, primary healthcare has limited resources to work with modifying lifestyle habits. This is the first pilot study to test the feasibility of text message-based lifestyle intervention in patients with hypertension in Swedish primary healthcare. Whether significant improvement in cardiovascular risk factors may be achieved in a larger study population remains to be evaluated. Key points This pilot randomized controlled trial (RCT) is the first study to evaluate the feasibility of text message-based lifestyle advice to patients with hypertension in Swedish primary healthcare. •All feasibility criteria for the pilot study were fulfilled. This outcome means that a larger study with a similar design may be conducted. •The study was not powered to find significant changes in cardiovascular risk factors. Nevertheless, after six months we found favorable trends for all secondary outcomes in the intervention group compared to control. •If a future larger study can show significant results, this intervention could serve as a useful tool in everyday primary healthcare.
| S-EPMC7470149 | biostudies-literature
Project description:AimsTo evaluate the effectiveness of a combined internet and text message intervention for smoking cessation compared with an internet intervention alone. The text message intervention was optimized for engagement in an earlier multiphase optimization (MOST) screening phase.DesignA parallel, two-group, individually randomized clinical trial (RCT) was conducted in a MOST confirming phase. Recruitment spanned December 2018 to March 2019. Follow-up was conducted at 3 and 9 months, beginning March 2019 and ending January 2020.SettingUnited States: a digital study conducted among new registrants on a free tobacco cessation website.ParticipantsEligible individuals were 618 adult current smokers in the United States, age 18 years or older who signed up for text messages during website registration (67.2% female, 70.4% white).InterventionsThe treatment arm (WEB+TXT; n = 311) received access to the website and text messaging. The control arm (WEB; n = 307) received access to the website alone.MeasurementsThe primary outcome was self-reported 30-day point prevalence abstinence (ppa) at 9 months post-randomization analyzed under intent to treat (ITT), counting non-responders as smoking. Secondary outcomes included 3-month measures of 30-day ppa, intervention engagement and intervention satisfaction.FindingsAbstinence rates at 9 months were 23.1% among WEB+TXT and 23.2% among WEB (OR = 1.00, 95% CI = 0.69-1.45; P = 0.99). WEB+TXT increased engagement with 5 of 6 interactive features (standardized mean difference (SMD) = 0.26-0.47, all P < 0.001) and repeat website visits (48.7% vs 38.9%, SMD = 0.14, P = 0.02). Satisfaction metrics favored WEB+TXT (satisfied: 96.3% vs 90.5%, SMD = 0.17, P = 0.008; recommend to friend: 95.9% vs 90.1%, SMD = 0.16, P = 0.028).ConclusionsA randomized controlled trial found no evidence that a combined internet and text message intervention for smoking cessation compared with an internet intervention alone increased 9-month abstinence rates among adult current smokers in the United States, despite evidence of higher levels of intervention engagement and satisfaction at 3 months.
| S-EPMC9293135 | biostudies-literature
Project description:IntroductionAs a high symptom burden chronic condition, endometriosis is associated with diminished quality of life (QoL) and psychological distress. The EndoSMS text message intervention was developed to inform and support individuals living with endometriosis. The primary aim of this study is to assess the acceptability, feasibility and preliminary efficacy of EndoSMS, to improve endometriosis-specific QoL and reduce psychological distress in a randomised controlled trial, compared with care as usual. We will additionally assess the impact of EndoSMS on self-efficacy for managing endometriosis.MethodologyA two-arm parallel pilot randomised controlled trial with waitlist control was conducted. Baseline assessments included QoL, psychological distress, self-efficacy, demographic and medical variables. Following baseline survey completion, participants were randomised to either the Intervention (EndoSMS: 3-months of text messaging) or Control condition. At 3-month follow-up, all participants completed an online survey reassessing outcomes, and Intervention participants provided quantitative and qualitative user feedback on EndoSMS.ResultsData collection commenced on 18 November 2021 and was completed on 30 March 2022. Descriptive statistics will be used to analyse feasibility and acceptability of the intervention. Preliminary efficacy analyses will be conducted using linear mixed models for QoL, psychological distress and self-efficacy outcomes. Subgroup analyses will also be conducted for typically underserved populations (e.g., rural/regional).ConclusionThis pilot will provide acceptability, feasibility and preliminary efficacy evidence for the impact of a supportive text messaging program for endometriosis. It will contribute to understanding how to optimally support individuals in living with and managing their endometriosis.Trial registrationAustralian New Zealand Clinical Trials Registry.
| S-EPMC9989515 | biostudies-literature
Project description:BackgroundMobile technology offers the potential to deliver health-related interventions to individuals who would not otherwise present for in-person treatment. Text messaging (short message service, SMS), being the most ubiquitous form of mobile communication, is a promising method for reaching the most individuals.ObjectiveThe goal of the present study was to evaluate the feasibility and preliminary efficacy of a smoking cessation intervention program delivered through text messaging.MethodsAdult participants (N=60, age range 18-52 years) took part in a single individual smoking cessation counseling session, and were then randomly assigned to receive either daily non-smoking related text messages (control condition) or the TXT-2-Quit (TXT) intervention. TXT consisted of automated smoking cessation messages tailored to individual's stage of smoking cessation, specialized messages provided on-demand based on user requests for additional support, and a peer-to-peer social support network. Generalized estimating equation analysis was used to assess the primary outcome (7-day point-prevalence abstinence) using a 2 (treatment groups)×3 (time points) repeated measures design across three time points: 8 weeks, 3 months, and 6 months.ResultsSmoking cessation results showed an overall significant group difference in 7-day point prevalence abstinence across all follow-up time points. Individuals given the TXT intervention, with higher odds of 7-day point prevalence abstinence for the TXT group compared to the Mojo group (OR=4.52, 95% CI=1.24, 16.53). However, individual comparisons at each time point did not show significant between-group differences, likely due to reduced statistical power. Intervention feasibility was greatly improved by switching from traditional face-to-face recruitment methods (4.7% yield) to an online/remote strategy (41.7% yield).ConclusionsAlthough this study was designed to develop and provide initial testing of the TXT-2-Quit system, these initial findings provide promising evidence that a text-based intervention can be successfully implemented with a diverse group of adult smokers.Trial registrationClinicalTrials.gov: NCT01166464; http://clinicaltrials.gov/ct2/show/NCT01166464 (Archived by WebCite at http://www.webcitation.org/6IOE8XdE0).
| S-EPMC4114437 | biostudies-literature
Project description:BackgroundThe efficacy of antiretroviral therapy depends on patient adherence to a daily medication regimen, yet many patients fail to adhere at high enough rates to maintain health and reduce the risk of transmitting HIV. Given the explosive global growth of cellular-mobile phone use, text-messaging interventions to promote adherence are especially appropriate. This meta-analysis synthesized available text messaging interventions to promote antiretroviral therapy adherence in people living with HIV.MethodsWe performed Boolean searches of electronic databases, hand searches of recent year conference abstracts and reverse searches. Included studies (1) targeted antiretroviral therapy adherence in a sample of people living with HIV, (2) used a randomized-controlled trial design to examine a text messaging intervention, and (3) reported at least one adherence measurement or clinical outcome.ResultsEight studies, including 9 interventions, met inclusion criteria. Text-messaging interventions yielded significantly higher adherence than control conditions (OR = 1.39; 95% CI = 1.18, 1.64). Sensitivity analyses of intervention characteristics suggested that studies had larger effects when interventions (1) were sent less frequently than daily, (2) supported bidirectional communication, (3) included personalized message content, and (4) were matched to participants' antiretroviral therapy dosing schedule. Interventions were also associated with improved viral load and/or CD4+ count (k = 3; OR = 1.56; 95% CI = 1.11, 2.20).ConclusionsText-messaging can support antiretroviral therapy adherence. Researchers should consider the adoption of less frequent messaging interventions with content and timing that is individually tailored and designed to evoke a reply from the recipient. Future research is needed in order to determine how best to optimize efficacy.
| S-EPMC3914915 | biostudies-literature
Project description:The prevalence of cigarette smoking in young adults is higher among those with socioeconomic disadvantage than those without. Low treatment-seeking among young adult smokers is compounded by few efficacious smoking cessation interventions for this group, particularly socioeconomically-disadvantaged young adults (SDYA) who smoke cigarettes. The goal of this study was to test a tailored smoking-cessation intervention for SDYA. 343 SDYA aged 18-30 living in the U.S. (85% female) who smoke cigarettes with access to a smartphone and interest in quitting smoking in the next six months were recruited online in Spring 2020 and randomized to referral to online quit resources (usual care control; n = 171) or a 12-week tailored text message smoking-cessation program with a companion web-based intervention (n = 172). Intent to treat analyses examined associations between study condition, self-reported 30-day point prevalence abstinence (PPA), and confidence to quit smoking at 12 weeks, controlling for potential confounders. Intervention group participants had greater self-reported 30-day PPA at 12-weeks than controls (adjusted relative risk 3.93, 95% CI 2.14-7.24). Among those who continued smoking, the intervention increased confidence to quit (0.81 points, 95% confidence interval 0.08-1.53). Weekly engagement in the intervention predicted greater cessation. A tailored text message intervention for SDYA increased smoking abstinence and confidence to quit at the end-of-treatment. Findings may have been influenced by recruitment at the start of the COVID pandemic but suggest that text messaging is an acceptable and efficacious cessation strategy for SDYA smokers. Future studies should examine the impact on longer-term smoking-cessation and importance of intervention tailoring for SDYA.
| S-EPMC10186588 | biostudies-literature
Project description:BackgroundHeavy episodic (binge) drinking is common among young adults and can lead to injury and illness. Young adults who seek care in the Emergency Department (ED) may be disproportionately affected with binge drinking behavior, therefore provide an opportunity to reduce future risk through screening, brief intervention and referral to treatment (SBIRT). Mobile phone text messaging (SMS) is a common form of communication among young adults and has been shown to be effective at providing behavioral support to young adult drinkers after ED discharge. Efficacy of SMS programs to reduce binge drinking remains unknown.Methods/designWe will conduct a three parallel arm, randomized trial. A convenience sample of adults aged 18 to 25 years attending three EDs in Pittsburgh, PA and willing to participate in the study will be screened for hazardous alcohol consumption. Participants identified as hazardous drinkers will then be allocated to either 12 weeks of weekly SMS drinking assessments with feedback (SA+F), SMS drinking assessments without feedback (SA), or a control group. Randomization will be via an independent and remote computerized randomization and will be stratified by study site. The SA+F group will be asked to provide pre-weekend drinking intention as well as post-weekend consumption via SMS and will receive feedback messages focused on health consequences of alcohol consumption, personalized normative feedback, protective drinking strategies and goal setting. Follow-up data on alcohol use and injury related to alcohol will be collected through a password-protected website three, six and nine months later. The primary outcome for the study is binge drinking days (≥4 drinks for women; ≥5 drinks for men) during the previous month, and the main secondary outcome is the proportion of participants who report any injury related to alcohol in the prior three months.DiscussionThis study will test the hypothesis that a mobile phone text-messaging program will result in immediate and durable reductions in binge drinking among at-risk young adults. By testing an intervention group to an assessment-only and control group, we will be able to separate the effect of assessment reactivity. By collecting pre-weekend drinking intentions and post-weekend consumption data in the SA+F group, we will be able to better understand mechanism of change.Trial registrationClinicaltrials.gov NCT01688245.
| S-EPMC3652768 | biostudies-literature