A Method to Deliver Automated and Tailored Intervention Content: 24-month Clinical Trial.

BACKGROUND: The use of digital technologies and software allows for new opportunities to communicate and engage with research participants over time. When software is coupled with automation, we can engage with research participants in a reliable and affordable manner. Research Electronic Data Capture (REDCap), a browser-based software, has the capability to send automated text messages. This feature can be used to automate delivery of tailored intervention content to research participants in interventions, offering the potential to reduce costs and improve accessibility and scalability. OBJECTIVE: This study aimed to describe the development and use of 2 REDCap databases to deliver automated intervention content and communication to index participants and their partners (dyads) in a 2-arm, 24-month weight management trial, Partner2Lose. METHODS: Partner2Lose randomized individuals with overweight or obesity and cohabitating with a partner to a weight management intervention alone or with their partner. Two databases were developed to correspond to 2 study phases: one for weight loss initiation and one for weight loss maintenance and reminders. The weight loss initiation database was programmed to send participants (in both arms) and their partners (partner-assisted arm) tailored text messages during months 1-6 of the intervention to reinforce class content and support goal achievement. The weight maintenance and reminder database was programmed to send maintenance-related text messages to each participant (both arms) and their partners (partner-assisted arm) during months 7-18. It was also programmed to send text messages to all participants and partners over the course of the 24-month trial to remind them of group classes, dietary recall and physical activity tracking for assessments, and measurement visits. All text messages were delivered via Twilio and were unidirectional. RESULTS: Five cohorts, comprising 231 couples, were consented and randomized in the Partner2Lose trial. The databases will send 53,518 automated, tailored text messages during the trial, significantly reducing the need for staff to send and manage intervention content over 24 months. The cost of text messaging will be approximately US $450. Thus far, there is a 0.004% known error rate in text message delivery. CONCLUSIONS: Our trial automated the delivery of tailored intervention content and communication using REDCap. The approach described provides a framework that can be used in future behavioral health interventions to create an accessible, reliable, and affordable method for intervention delivery and engagement that requires minimal trial-specific resources and personnel time. TRIAL REGISTRATION: ClinicalTrials.gov NCT03801174; https://clinicaltrials.gov/ct2/show/NCT03801174?term=NCT03801174.

Translation of exercise testing to exercise prescription using the talk test.

Traditionally defined in terms of %maximal heart rate (%HRmax) or %maximal metabolic equivalents, the process of exercise prescription is still difficult and individually imprecise. An alternative, and simpler, method is to define exercise intensity in terms of the Talk Test, which may be a surrogate for ventilatory threshold and more consistent with contemporary recommendations for index training intensity in well-trained and athletic individuals. This study was designed to determine how much of a reduction in the absolute exercise intensity from those observed during incremental exercise testing was necessary to allow for comfortable speech during exercise training. Fourteen well-trained (5-7 h·wk(-1)) individuals performed 2 incremental exercise tests (to evaluate reproducibility) and 3 steady-state training bouts (40 minutes), based on the stage before the last positive (LP) stage of the Talk Test (LP-1), the LP stage, and the equivocal (EQ) stage. The LP-1 and LP runs resulted in %HRmax and rating of perceived exertion (RPE) values within the recommended range for exercise training, the EQ run in an unacceptably high %HRmax and RPE. Most subjects could still speak comfortably during the LP-1 and LP stages, and no subject could speak comfortably during the EQ stage. The HR (r = 0.84), RPE (r = 0.81), and Talk Test (r = 0.71) responses during paired incremental tests were well correlated. The results of this test suggest that the absolute exercise intensity during the LP-1 and LP stages of incremental exercise tests with the Talk Test may produce steady-state exercise responses appropriate for training in well-trained and athletic individuals and that the reproducibility of the Talk Test is satisfactory.

Protocol for Partner2Lose: A randomized controlled trial to evaluate partner involvement on long-term weight loss.

BACKGROUND: Behavioral interventions produce clinically significant weight reduction, with many participants regaining weight subsequently. Most interventions focus on an individual, but dietary and physical activity behaviors occur with, or are influenced by, domestic partners. According to interdependence theory, couples who approach behavior change as a problem to be tackled together versus independently are more likely to utilize communal coping processes to promote behavior change. We utilized interdependence theory to develop a partner-assisted intervention to increase long-term weight loss. METHODS: Community-dwelling individuals (index participants) cohabitating with a partner with 1) overweight and at least one obesity-related comorbidity or 2) obesity are randomized to participate in a standard weight management program alone or with their partner. The weight management program involves biweekly, in-person, group sessions focusing on weight loss for six months, followed by three group sessions and nine telephone calls focusing on weight loss maintenance for twelve months. In the partner-assisted arm, partners participate in half of the group sessions and telephone calls. Couples receive training in principles of cognitive behavioral therapy for couples, including sharing thoughts and feelings and joint problem solving, to increase communal coping. The primary outcome is participant weight loss at 24 months, with caloric intake and moderate-intensity physical activity as secondary outcomes. Partner weight and caloric intake will also be analyzed. Mediation analyses will examine the role of interdependence variables and social support. DISCUSSION: This trial will provide knowledge about effective ways to promote long-term weight loss and the role of interdependence constructs in weight loss. Clinical trials identifier: NCT03801174.