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Text Message Behavioral Intervention for Teens on Eating, Physical Activity and Social Wellbeing (TEXTBITES): Protocol for a Randomized Controlled Trial.

ABSTRACT: 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.

SUBMITTER: Partridge SR

PROVIDER: S-EPMC7055806 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Text Message Behavioral Intervention for Teens on Eating, Physical Activity and Social Wellbeing (TEXTBITES): Protocol for a Randomized Controlled Trial.

Partridge Stephanie R SR Raeside Rebecca R Singleton Anna C AC Hyun Karice K Latham Zoe Z Grunseit Alicia A Steinbeck Katharine K Chow Clara C Redfern Julie J

JMIR research protocols 20200218 2

<h4>Background</h4>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.<h4>Objective</h4>This study aims to investigate whether a two-way text message program, with optional telephone health counseling, improves body mass index (BMI) z scor ...[more]

PMID: 32130194

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Project description:BACKGROUND:Heavy 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/DESIGN:We 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. DISCUSSION:This 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 REGISTRATION:Clinicaltrials.gov NCT01688245.

Project description:Interventions to support people with hypertension in attending clinics and taking their medication have potential to improve outcomes, but delivery on a wide scale and at low cost is challenging. Some trials evaluating clinical interventions using short message service (SMS) text-messaging systems have shown important outcomes, although evidence is limited. We have developed a novel SMS system integrated with clinical care for use by people with hypertension in a low-resource setting. We aim to test the efficacy of the system in improving blood pressure control and treatment adherence compared to usual care.The SMS Text-message Adherence suppoRt trial (StAR) is a pragmatic individually randomised three-arm parallel group trial in adults treated for hypertension at a single primary care centre in Cape Town, South Africa. The intervention is a structured programme of clinic appointment, medication pick-up reminders, medication adherence support and hypertension-related education delivered remotely using an automated system with either informational or interactive SMS text-messages. Usual care is supplemented by infrequent non-hypertension related SMS text-messages. Participants are 1:1:1 individually randomised, to usual care or to one of the two active interventions using minimisation to dynamically adjust for gender, age, baseline systolic blood pressure, years with hypertension, and previous clinic attendance. The primary outcome is the change in mean systolic blood pressure at 12-month follow-up from baseline measured with research staff blinded to trial allocation. Secondary outcomes include the proportion of patients with 80% or more of days medication available, proportion of participants achieving a systolic blood pressure less than 140 mmHg and a diastolic blood pressure less than 90 mmHg, hospital admissions, health status, retention in clinical care, satisfaction with treatment and care, and patient related quality of life. Anonymised demographic data are collected on non-participants.The StAR trial uses a novel, low cost system based on widely available mobile phone technology to deliver the SMS-based intervention, manage communication with patients, and measure clinically relevant outcomes. The results will inform implementation and wider use of mobile phone based interventions for health care delivery in a low-resource setting.NCT02019823.

Project description:BACKGROUND:Ensuring treatment adherence is important for the internal validity of clinical trials. In intervention studies where touch points decrease over time, there is even more of an adherence challenge. Trials with multiple cohorts offer an opportunity to innovate on ways to increase treatment adherence without compromising the integrity of the study design, and previous cohorts can serve as historical controls. Electronically delivered nudges offer low-cost opportunities to increase treatment adherence. OBJECTIVE:This study aimed to evaluate the effectiveness of electronic messages (e-messages) on treatment adherence to the last cohort of a parent weight loss intervention during the second half of a year-long trial, when intervention checkpoint frequency decreases. Treatment adherence is measured by intervention class attendance and adherence to the intervention diet. METHODS:All participants in the last cohort (cohort 5, n=128) of a large randomized weight loss study were offered an e-message intervention to improve participant adherence during the last 6 months of a 1-year weight loss program. Overall, 3 to 4 electronic weekly messages asked participants about intervention diet adherence. A propensity score model was estimated using 97 participants who opted to receive e-messages and 31 who declined in cohort 5 and used to pair match cohort 5 e-message participants to a historical control group from cohorts 1 to 4. Moreover, 88 participants had complete data, yielding 176 participants in the final analyses. After matching, intervention and matched control groups were compared on (1) proportion of class attendance between the 6 and 12 month study endpoints, (2) diet adherence, as measured by total carbohydrate grams for low-carbohydrate (LC) and total fat grams for low-fat (LF) diets at 12 months, and (3) weight change from 6 to 12 months. The dose-response relationship between the proportion of text messages responded to and the 3 outcomes was also investigated. RESULTS:Compared with matched controls, receiving e-messages had no effect on (1) treatment adherence; class attendance after 6 months +4.6% (95% CI -4.43 to 13.68, P=.31), (2) adherence; LC -2.5 g carbohydrate, 95% CI -29.9 to 24.8, P=.85; LF +6.2 g fat, 95% CI -4.1 to 17.0, P=.26); or on (3) the secondary outcome of weight change in the last 6 months; +0.3 kg (95% CI -1.0 to 1.5, P=.68). There was a positive significant response correlation between the percentage of messages to which participants responded and class attendance (r=.45, P<.001). CONCLUSIONS:Although this e-message intervention did not improve treatment adherence, future studies can learn from this pilot and may incorporate more variety in the prompts and more interaction to promote more effective user engagement. Uniquely, this study demonstrated the potential for innovating within a multicohort trial using propensity score-matched historical control subjects. TRIAL REGISTRATION:ClinicalTrials.gov NCT01826591; https://clinicaltrials.gov/ct2/show/NCT01826591. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR2-10.1016/j.cct.2016.12.021.

Project description:BACKGROUND:Smoking in pregnancy is a public health problem. Self-help smoking cessation support can help pregnant women to stop smoking, but the effects of delivering this kind of support via SMS text message are not known. A previous randomised controlled trial (RCT) demonstrated the feasibility and acceptability of providing such support to pregnant smokers using an automated, tailored text message intervention called MiQuit. This larger RCT will estimate key parameters for and will test the feasibility of delivering a major trial run within the United Kingdom National Health Service settings aimed at providing definitive evidence on the utility of MiQuit for helping pregnant smokers to stop. METHODS/DESIGN:This will be a multi-centre, parallel group RCT. Participants are being identified in 16 English antenatal care settings and must be >16 years old, pregnant, <25 weeks gestation, smoke >1 daily cigarette, have smoked >5 daily cigarettes before pregnancy, and able to understand texts in English. After consenting and the collection of baseline data, participants are randomised to control or intervention groups in a 1:1 ratio; randomisation is stratified by trial site and gestation and employs computer-generated pseudo-random code using random permuted blocks of randomly varying size, and held on a secure server. All participants receive a National Health Service (NHS) leaflet aimed at helping them to stop smoking. Intervention group women also receive the 12-week MiQuit programme of tailored, supportive, interactive text message, self-help cessation support. Women are followed up by telephone 4 weeks after randomisation and at 36 weeks gestation. The study aims to recruit 400 women, and with this sample we will be able to estimate trial centres' recruitment rates to within +/-1% (margin of error?=?half width of 95% confidence interval); individual trial groups' ascertainment of rates for smoking outcomes between 4 weeks after randomisation until approximately 36 weeks gestation to within +/-4%, and across both groups, the combined cessation rate at 36 weeks +/-3%. DISCUSSION:Pilot trial completion will provide data to facilitate planning for a definitive trial investigating whether MiQuit works for smoking cessation in pregnancy. TRIAL REGISTRATION:ClinicalTrials.gov NCT02043509 Registered 14 January 2014.

Project description:Sleep and physical activity are two health behaviors associated with improved smoking cessation outcomes. Text message-based interventions have previously been used to promote physical activity and smoking cessation; however, this type of intervention has not targeted sleep habits. This study examined the effectiveness of a text message-based active control intervention in improving sleep and physical activity habits among a U.S. national sample of young adult smokers participating in a smoking cessation intervention.This study was a secondary analysis of data from the Stop My Smoking USA randomized controlled trial. Baseline and 3-month follow-up data were collected from 116 young adult smokers (mean age 21.8 years, SD?=?2.1) who were randomized at a 2:1 ratio to receive a 6-week text messaging program focused on either smoking cessation (n?=?72), or improving sleep and physical activity (n?=?44). Three main outcomes were assessed: 1) sleep quantity (on work/school nights, and non-work/non-school nights), 2) sleep quality, and 3) physical activity at follow-up. Multivariable linear regression analysis was used to quantify the differences in these outcomes between the groups. To identify possible effect modification by baseline sleep and physical activity, the sample was stratified by indicators defined for both of these variables.At follow-up, sleep quantity and quality were similar for participants in the smoking cessation and sleep/activity groups when assessed among the total sample and those sleeping ?6 hours/night at baseline. Among short sleepers (<6 hours/night at baseline), sleep quantity on work/school nights improved for those receiving sleep/activity messages compared to those receiving smoking cessation messages, after adjusting for covariates (^? = 1.373, 95% CI [0.262, 2.484]; p?=?0.02). Physical activity at follow-up was similar for the two groups, when examined among the total sample and when stratified by baseline activity level.This study provides preliminary evidence that a text message-based intervention may be a promising approach for improving sleep quantity among young adult smokers who are short sleepers and interested in quitting smoking. Similar programs should be further explored as a novel approach for improving sleep habits among individuals with insufficient sleep.ClinicalTrials.gov NCT01516632.

Dataset Information

Text Message Behavioral Intervention for Teens on Eating, Physical Activity and Social Wellbeing (TEXTBITES): Protocol for a Randomized Controlled Trial.

Publications

Text Message Behavioral Intervention for Teens on Eating, Physical Activity and Social Wellbeing (TEXTBITES): Protocol for a Randomized Controlled Trial.

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