A Mobile Health Lifestyle Program for Prevention of Weight Gain in Young Adults (TXT2BFiT): Nine-Month Outcomes of a Randomized Controlled Trial

BACKGROUND: The unprecedented rise in obesity among young adults, who have limited interaction with health services, has not been successfully abated. OBJECTIVE: The objective of this study was to assess the maintenance outcomes of a 12-week mHealth intervention on prevention of weight gain in young adults and lifestyle behaviors at 9 months from baseline. METHODS: A two-arm, parallel, randomized controlled trial (RCT) with subjects allocated to intervention or control 1:1 was conducted in a community setting in Greater Sydney, Australia. From November 2012 to July 2014, 18- to 35-year-old overweight individuals with a body mass index (BMI) of 25-31.99 kg/m2 and those with a BMI ≥ 23 kg/m2 and a self-reported weight gain of ≥ 2 kg in the past 12 months were recruited. A 12-week mHealth program "TXT2BFiT" was administered to the intervention arm. This included 5 coaching calls, 96 text messages, 12 emails, apps, and downloadable resources from the study website. Lifestyle behaviors addressed were intake of fruits, vegetables, sugar-sweetened beverages (SSBs), take-out meals, and physical activity. The control group received 1 phone call to introduce them to study procedures and 4 text messages over 12 weeks. After 12 weeks, the intervention arm received 2 further coaching calls, 6 text messages, and 6 emails with continued access to the study website during 6-month follow-up. Control arm received no further contact. The primary outcome was weight change (kg) with weight measured at baseline and at 12 weeks and self-report at baseline, 12 weeks, and 9 months. Secondary outcomes were change in physical activity (metabolic equivalent of task, MET-mins) and categories of intake for fruits, vegetables, SSBs, and take-out meals. These were assessed via Web-based surveys. RESULTS: Two hundred and fifty young adults enrolled in the RCT. Intervention participants weighed less at 12 weeks compared with controls (model β=-3.7, 95% CI -6.1 to -1.3) and after 9 months (model β=- 4.3, 95% CI - 6.9 to - 1.8). No differences in physical activity were found but all diet behaviors showed that the intervention group, compared with controls at 9 months, had greater odds of meeting recommendations for fruits (OR 3.83, 95% CI 2.10-6.99); for vegetables (OR 2.42, 95% CI 1.32-4.44); for SSB (OR 3.11, 95% CI 1.47-6.59); and for take-out meals (OR 1.88, 95% CI 1.07-3.30). CONCLUSIONS: Delivery of an mHealth intervention for prevention of weight gain resulted in modest weight loss at 12 weeks with further loss at 9 months in 18- to 35-year-olds. Although there was no evidence of change in physical activity, improvements in dietary behaviors occurred, and were maintained at 9 months. Owing to its scalable potential for widespread adoption, replication trials should be conducted in diverse populations of overweight young adults. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12612000924853; (Archived by WebCite at http://www.webcitation.org/6i6iRag55)

Effectiveness of a mHealth Lifestyle Program With Telephone Support (TXT2BFiT) to Prevent Unhealthy Weight Gain in Young Adults: Randomized Controlled Trial

BACKGROUND: Weight gained in young adulthood often persists throughout later life with associated chronic disease risk. Despite this, current population prevention strategies are not specifically designed for young adults. OBJECTIVE: We designed and assessed the efficacy of an mHealth prevention program, TXT2BFiT, in preventing excess weight gain and improving dietary and physical activity behaviors in young adults at increased risk of obesity and unhealthy lifestyle choices. METHODS: A two-arm, parallel-group randomized controlled trial was conducted. Subjects and analyzing researchers were blinded. A total of 250 18- to 35-year-olds with a high risk of weight gain, a body mass index (BMI) of 23.0 to 24.9 kg/m(2) with at least 2 kg of weight gain in the previous 12 months, or a BMI of 25.0 to 31.9 kg/m(2) were randomized to the intervention or control group. In the 12-week intervention period, the intervention group received 8 text messages weekly based on the transtheoretical model of behavior change, 1 email weekly, 5 personalized coaching calls, a diet booklet, and access to resources and mobile phone apps on a website. Control group participants received only 4 text messages and printed dietary and physical activity guidelines. Measured body weight and height were collected at baseline and at 12 weeks. Outcomes were assessed via online surveys at baseline and at 12 weeks, including self-reported weight and dietary and physical activity measures. RESULTS: A total of 214 participants—110 intervention and 104 control—completed the 12-week intervention period. A total of 10 participants out of 250 (4.0%)—10 intervention and 0 control—dropped out, and 26 participants (10.4%)—5 intervention and 21 control—did not complete postintervention online surveys. Adherence to coaching calls and delivery of text messages was over 90%. At 12 weeks, the intervention group were 2.2 kg (95% CI 0.8-3.6) lighter than controls (P=.005). Intervention participants consumed more vegetables (P=.009), fewer sugary soft drinks (P=.002), and fewer energy-dense takeout meals (P=.001) compared to controls. They also increased their total physical activity by 252.5 MET-minutes (95% CI 1.2-503.8, P=.05) and total physical activity by 1.3 days (95% CI 0.5-2.2, P=.003) compared to controls. CONCLUSIONS: The TXT2BFiT low-intensity intervention was successful in preventing weight gain with modest weight loss and improvement in lifestyle behaviors among overweight young adults. The short-term success of the 12-week intervention period shows potential. Maintenance of the behavior change will be monitored at 9 months. TRIAL REGISTRATION: Trial Registration: The Australian New Zealand Clinical Trials Registry ACTRN12612000924853; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000924853 (Archived by WebCite at http://www.webcitation.org/6Z6w9LlS9)

'TXT2BFiT' a mobile phone-based healthy lifestyle program for preventing unhealthy weight gain in young adults: Study protocol for a randomized controlled trial

Background: Despite international efforts to arrest increasing rates of overweight and obesity, many population strategies have neglected young adults as a target group. Young adults are at high risk for unhealthy weight gain which tends to persist throughout adulthood with associated chronic disease health risks.Methods/design: TXT2BFiT is a nine month two-arm parallel-group randomized controlled trial aimed at improving weight management and weight-related dietary and physical activity behaviors among young adults. Participants are recruited via general practice (primary medical care) clinics in Sydney, New South Wales, Australia. All participants receive a mailed resource outlining national physical activity and dietary guidelines and access to the study website. Additional resources accessible to the intervention arm via the study website include Smartphone mobile applications, printable handouts, an interactive healthy weight tracker chart, and a community blog. The study consists of two phases: (1) Intensive phase (weeks 1 to 12): the control arm receives four short message service (SMS) text messages; the intervention arm receives eight SMS messages/week tailored to their baseline stage-of-change, one Email/week, and personalized coaching calls during weeks 0, 2, 5, 8, and 11; and (2) Maintenance phase (weeks 14 to 36): the intervention arm receives one SMS message/month, one Email/month and booster coaching calls during months 5 and 8. A sample of N = 354 (177 per arm) is required to detect differences in primary outcomes: body weight (kg) and body mass index (kg/m), and secondary outcomes: physical activity, sitting time, intake of specific foods, beverages and nutrients, stage-of-change, self-efficacy and participant well-being, at three and nine months. Program reach, costs, implementation and participant engagement will also be assessed.Discussion: This mobile phone based program addresses an important gap in obesity prevention efforts to date. The method of intervention delivery is via platforms that are highly accessible and appropriate for this population group. If effective, further translational research will be required to assess how this program might operate in the broader community.Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12612000924853. © 2013 Hebden et al.; licensee BioMed Central Ltd

Process evaluation of TXT2BFiT: A multi-component mHealth randomised controlled trial to prevent weight gain in young adults

Background: TXT2BFiT was one of the first few innovative mHealth programs designed for young adults (18-35 years) with demonstrated efficacy in weight management. However, research is lacking to understand intervention effectiveness, especially in complex, multi-component mHealth programs. This paper investigates participant perceptions of and engagement with the mHealth program components in the TXT2BFiT to understand program effects. Methods: Process evaluation data were collected continuously for the study duration. The TXT2BFiT program was a multi-component lifestyle program delivered intensively for 3-month followed by a 6-month maintenance phase. Program components included personalised coaching calls, text messages, emails, smartphone apps and website access. Process evaluation measures included frequency of use of components and frequency for number of components used (online survey data); dose delivered and engagement with program components (researcher logs and web platform reports); frequency, timing and difficulties experienced with program components (online survey data) and overall perceptions of program components (online survey data and semi-structured telephone interviews). Qualitative data analysis was performed using NVivo10. Results: Over 80% of participants completed post-intervention (3-months, intervention, n = 110, control n = 104) and follow-up surveys (9-months, intervention, n = 96, control n = 104). Thirty intervention participants completed semi-structured telephone interviews. Participants reported high use of coaching calls, text messages and emails and no issues in content delivery from these components. These components were described as helping them to achieve their goals. Website and app use and engagement was low for the duration of the program. Participants would prefer incorporation of the self-monitoring apps and website resources into one smartphone application that can be individualised by entry of their personal data. Conclusions: Our process evaluation has allowed a comprehensive understanding of use and preference for different program components. The high value placed on the coaching calls is consistent with a desire for personalisation of the mHealth program and even further tailoring of text messages and emails. The findings of this study will be used to revise TXT2BFiT for future users. Trial registration: The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12612000924853 )

Eliglustat protects from damage caused by Shiga toxin type 2 in human renal tubular epithelial cells

Shigatoxin-producing Escherichia coli isresponsible for Hemolytic Uremic Syndrome (HUS), a cause of renal failure inchildren. We have previously shown that C-9 and Eliglustat (EG), inhibitors ofglucosylceramide  synthase andglobotriaosylceramide (Gb3), prevent the cytotoxic effects of Shiga toxin type2 (Stx2), in human cortical renal tubular epithelial cells (HRTEC) primarycultures and HK2 cell line. The aim of this work was to evaluate the efficacyof EG, elucidating EG treatments necessary to achieve total protection against Stx2in HRTEC and HK2. Cells were incubated with Stx2 (1 ng/ml, 24 and 72 h) andpre-incubated with or without EG (1-500 nM, 6 and 24 h), followed byco-incubation with same dilutions of EG and Stx2 (24 and 72 h). Total number ofcells stained with Hoechst was counted in microphotographs and compared withcell viability measured by neutral red uptake. Early and late apoptosis andnecrosis was evaluated by annexin V/propidium iodide staining. Tubulogenesis wasevaluated in HRTEC grown on matrigel. Treatment of cells with Stx2significantly decreased cell confluence and viability and the number of cellsattached (p<0.001). In HRTEC, Stx2 increased early and late apoptosis, andnecrosis compared to non-treated cells (p<0.01). Furthermore, Stx2 inhibitedcell aggregation and tubulogenesis on matrigel. HRTEC preincubated with EG (50nM, 24 h or 500 nM, 6 h) totally prevented Stx2 effects on HRTEC measured as cellcount, viability, apoptosis, necrosis and tubulogenesis (p<0.05). Preincubationof HK2 cells with EG (1 nM, 24 h or 10 nM, 6 h) totally prevented Stx2 effectson cell viability and confluence. EG alone did not produce cytotoxic effectsper se. In conclusion, EG protects human renal tubular epithelium against Stx2cytotoxicity being HRTEC more sensitive than HK2. Treatment with EG could be anovel substrate inhibition therapy to neutralize Stx2 action and prevent renal damagein patients with HUS.Fil: Sánchez, Diana Soledad. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Fisiología y Biofísica Bernardo Houssay. Universidad de Buenos Aires. Facultad de Medicina. Instituto de Fisiología y Biofísica Bernardo Houssay; ArgentinaFil: Fisher Sigel, L. K.. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Fisiología y Biofísica Bernardo Houssay. Universidad de Buenos Aires. Facultad de Medicina. Instituto de Fisiología y Biofísica Bernardo Houssay; ArgentinaFil: Balestracci, Alejandro. Gobierno de la Ciudad de Buenos Aires. Hospital General de Niños Pedro Elizalde (ex Casa Cuna); ArgentinaFil: Ibarra, Cristina Adriana. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Fisiología y Biofísica Bernardo Houssay. Universidad de Buenos Aires. Facultad de Medicina. Instituto de Fisiología y Biofísica Bernardo Houssay; ArgentinaFil: Amaral, María Marta. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Fisiología y Biofísica Bernardo Houssay. Universidad de Buenos Aires. Facultad de Medicina. Instituto de Fisiología y Biofísica Bernardo Houssay; ArgentinaFil: Silberstein, Claudia Marcela. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Fisiología y Biofísica Bernardo Houssay. Universidad de Buenos Aires. Facultad de Medicina. Instituto de Fisiología y Biofísica Bernardo Houssay; ArgentinaLXV Reunión Anual de la Sociedad Argentina de Investigación Clínica; LXVIII Reunión Anual de la Sociedad Argentina de Inmunología y Reunión Anual de la Asociación Argentina de FisiologíaArgentinaSociedad argentina de Investigación ClínicaSociedad Argentina de InmunologíaAsociación Argentina de Fisiologí

RhinAsthma Patient Perspective: A short daily asthma and rhinitis QoL assessment

Background The present study aimed to develop a short validated patient-completed questionnaire, the RhinAsthma Patient Perspective (RAPP), to assess the health-related quality of life (HRQoL) in patients with asthma and comorbid allergic rhinitis in clinical practice. Methods A provisional RAPP questionnaire was formed from candidate items identified through retrospective analysis of 333 RHINASTHMA questionnaires. This was then tested on 150 asthma patients with allergic rhinitis. Results Psychometric analyses identified eight items fitting a unidimensional model to form RAPP. Internal consistency (Cronbach's alpha coefficient > 0.8) and agreement with RHINASTHMA (r = -0.31, P = 0.0001) were excellent. Criterion, discriminant, and convergent validity were good. Reliability in 47 stable patients was very good (intra-class and concordance correlation coefficients were 0.90 and 0.89, respectively). Responsiveness in 103 patients with health improvement or deterioration was significantly associated with changes in Global Rating Scale (r = -0.4965, P < 0.01), Rhinitis Visual Analogue Scale (r = 0.5722, P < 0.01) and asthma control test (r = -0.6483, P < 0.01). Minimal clinical difference in the analyzed population was 2. Conclusion RhinAsthma Patient Perspective is a simple eight-question questionnaire with good measurement properties and sensitivity to health changes, which will provide a valid, reliable and standardized HRQoL measurement in patients with asthma and comorbid allergic rhinitis in clinical practice. \uc2\ua9 2012 John Wiley & Sons A/S