BackgroundWeight 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.ObjectiveWe 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.MethodsA 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/m2 with at least 2 kg of weight gain in the previous 12 months, or a BMI of 25.0 to 31.9 kg/m2 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.ResultsA 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.ConclusionsThe 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 RegistrationTrial 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).
BackgroundThe unprecedented rise in obesity among young adults, who have limited interaction with health services, has not been successfully abated.ObjectiveThe 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.MethodsA 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. ResultsTwo 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).ConclusionsDelivery 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 RegistrationAustralian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12612000924853; (Archived by WebCite at http://www.webcitation.org/6i6iRag55)
BackgroundTXT2BFiT 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.MethodsProcess 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.ResultsOver 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.ConclusionsOur 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 registrationThe trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12612000924853).
BackgroundYounger adults are difficult to engage in preventive health, yet in Australia they are gaining more weight and increasing in waist circumference faster than middle-to-older adults. A further challenge to engaging 18- to 35-year-olds in interventions is the limited reporting of outcomes of recruitment strategies.ObjectiveThis paper describes the outcomes of strategies used to recruit young adults to a randomized controlled trial (RCT), healthy lifestyle mHealth program, TXT2BFiT, for prevention of weight gain. The progression from enquiry through eligibility check to randomization into the trial and the costs of recruitment strategies are reported. Factors associated with nonparticipation are explored.MethodsParticipants were recruited either via letters of invitation from general practitioners (GPs) or via electronic or print advertisements, including Facebook and Google—social media and advertising—university electronic newsletters, printed posters, mailbox drops, and newspapers. Participants recruited from GP invitation letters had an appointment booked with their GP for eligibility screening. Those recruited from other methods were sent an information pack to seek approval to participate from their own GP. The total number and source of enquiries were categorized according to eligibility and subsequent completion of steps to enrolment. Cost data and details of recruitment strategies were recorded.ResultsFrom 1181 enquiries in total from all strategies, 250 (21.17%) participants were randomized. A total of 5311 invitation letters were sent from 12 GP practices—16 participating GPs. A total of 131 patients enquired with 68 participants randomized (68/74 of those eligible, 92%). The other recruitment methods yielded the remaining 182 randomized participants. Enrolment from print media was 26% of enquiries, from electronic media was 20%, and from other methods was 3%. Across all strategies the average cost of recruitment was Australian Dollar (AUD) $139 per person. The least expensive modality was electronic (AUD $37), largely due to a free feature story on one university Web home page, despite Facebook advertising costing AUD $945 per enrolment. The most expensive was print media at AUD $213 and GP letters at AUD $145 per enrolment.ConclusionsThe research indicated that free electronic media was the most cost-effective strategy, with GP letters the least expensive of the paid strategies in comparison to the other strategies. This study is an important contribution for future research into efficacy, translation, and implementation of cost-effective programs for the prevention of weight gain in young adults. Procedural frameworks for recruitment protocols are required, along with systematic reporting of recruitment strategies to reduce unnecessary expenditure and allow for valuable public health prevention programs to go beyond the research setting.Trial RegistrationAustralian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12612000924853; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?...
Digital health applications (apps) have the potential to improve health behaviors and outcomes. We aimed to examine the effectiveness of a consumer web-based app linked to primary care electronic health records (EHRs). CONNECT was a multicenter randomized controlled trial involving patients with or at risk of cardiovascular disease (CVD) recruited from primary care (Clinical Trial registration ACTRN12613000715774). Intervention participants received an interactive app which was pre-populated and refreshed with EHR risk factor data, diagnoses and, medications. Interactive risk calculators, motivational messages and lifestyle goal tracking were also included. Control group received usual health care. Primary outcome was adherence to guideline-recommended medications (≥80% of days covered for blood pressure (BP) and statin medications). Secondary outcomes included attainment of risk factor targets and eHealth literacy. In total, 934 patients were recruited; mean age 67.6 (±8.1) years. At 12 months, the proportion with >80% days covered with recommended medicines was low overall and there was no difference between the groups (32.8% vs. 29.9%; relative risk [RR] 1.07 [95% CI, 0.88–1.20] p = 0.49). There was borderline improvement in the proportion meeting BP and LDL targets in intervention vs. control (17.1% vs. 12.1% RR 1.40 [95% CI, 0.97–2.03] p = 0.07). The intervention was associated with increased attainment of physical activity targets (87.0% intervention vs. 79.7% control, p = 0.02) and e-health literacy scores (72.6% intervention vs. 64.0% control, p = 0.02). In conclusion, a consumer app integrated with primary health care EHRs was not effective in increasing medication adherence. Borderline improvements in risk factors and modest behavior changes were observed.
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