CONSORT-EHEALTH Checklist V1.6.2 Report

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT "Methods: Fifty obese women were randomized to a 6-month intervention that included daily text messages for self-monitoring tailored behavioral goals (e.g., no sugary drinks, 10,000 steps per day) along with brief feedback and tips using a full automated-system or an education control arm. Weight was measured at baseline and 6 months. Adherence was defined as the proportion of text messages received in response to self-monitoring prompts. " 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT "Methods: Fifty obese women were randomized to a 6-month intervention that included daily text messages for self-monitoring tailored behavioral goals (e.g., no sugary drinks, 10,000 steps per day) along with brief feedback and tips using a full automated-system or an education control arm. Weight was measured at baseline and 6 months. Adherence was defined as the proportion of text messages received in response to self-monitoring prompts. " 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT "Weight was objectively measured at baseline and 6 months. " 1b-iv) RESULTS section in abstract must contain use data "Results: The average daily text messaging adherence rate was 49.0% ± 27.9%; 84.6% self-monitored behavioral goals ≥2 days per week. Almost 70% strongly agreed that daily texting was easy and helpful and 76.2% felt the frequency of texting was appropriate. At 6 months, the intervention arm lost 1.27±6.51kg, and the control arm gained 1.14±2.53kg [mean difference: -2.41kg (-5.22, 0.39); p= 0.09]. There was a trend towards greater text messaging adherence being associated with greater percent weight loss (r = -.363; p=.08). " 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials "Conclusion: Given the increasing penetration of mobile devices, text messaging may be a useful self-monitoring tool for weight control, particularly among populations most in need of intervention. " INTRODUCTION 2a-i) Problem and the type of system/solution "Text messaging has become ubiquitous,[12] particularly among racial/ethnic minority groups. [13] Recent studies show that racial/ethnic minorities are more likely than Whites to own mobile phones. [13] The high familiarity with, and penetration of mobile technologies makes text messaging an ideal intervention platform among these populations. This is notable because we have few interventions that produce clinically meaningful weight loss outcomes among racial/ethnic minority populations,[14-16] those with the highest rates of obesity. Black women, in particular, have alarmingly high rates of obesity as compared to other gender and racial/ethnic groups; 59% of Black women are obese as compared to 36% in the general U.S. population. [17] However, little is known about the use of text messaging for self-monitoring weight control behaviors in this population. " 2a-ii) Scientific background, rationale: What is known about the (type of) system "In contrast, electronic health (eHealth) self-monitoring approaches include features (e.g. prompts, real-time data collection, data driven feedback, asynchronous communication) that may decrease participant burden and increase adherence. [6] Indeed, evidence does show that electronic selfmonitoring either via web or mobile devices produces greater adherence over traditional paper and pencil methods,[4, 7, 8] and improves attitudes towards self-monitoring behaviors. [9] Text messaging shows promise as an alternative eHealth self-monitoring approach[10] and offers several advantages compared to other eHealth modalities (e.g., web, interactive voice response). Data can be entered quickly on nearly all mobile phone platforms, making it portable, proximal to actual behaviors, and more accessible for providing tailored feedback. [11] Additionally, text messaging has been conventionally limited to 160 characters (approximately 15-20 words) per message, limiting the detail and cognitive load that is required. Thus, text messaging may be a viable and sustainable self-monitoring modality. " METHODS 3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio "The purpose of this pilot study was to evaluate the feasibility of daily text messaging for self-monitoring behavioral goals for weight loss among predominantly obese Black women. Our secondary aim was to evaluate the effects of the intervention on weight change, relative to an education control arm. " 3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons n/a We did not have any changes. 3b-i) Bug fixes, Downtimes, Content Changes no we do not have documented reports on this. 4a) CONSORT: Eligibility criteria for participants ""We recruited women, aged 25-50, with body mass index (BMI) greater than or equal to 25 kg/m2. Other inclusion criteria were: willingness to come to all study assessments over 6 months, use of a personal cell phone to send and receive up to five texts per day for 6 months without compensation for text messages, and to be randomized into either treatment arm. Exclusion criteria included pregnancy or planned pregnancy within the next 6 months and a history of myocardial infarction or stroke within the past 2 years. "" 4a-i) Computer / Internet literacy no we do not have reports on this. 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: "Interested participants visited a study website to complete initial eligibility screening that assessed self-reported age, gender, height, weight and race. Eligible participants were then invited to an in-person enrollment event. Ineligible participants were directed to a website where they could access publicly available weight-loss information. At the enrollment events, study staff obtained informed consent, and collected baseline anthropometric and survey measures. "