The research community is making strides in designing effective digital health interventions. Still, we face critical barriers related to the amount of time it takes to secure funding and then to design, test, and evaluate evidence-based interventions. Moreover, once interventions have been evaluated, they cannot compete with industry on important success factors such as dissemination capability and user interface.

Failure to address these issues risks creating new, much more pervasive divides between those who can easily access their health information and those whose access is constrained.

Center faculty members and postdoctoral students conduct basic research, clinical trials and implementation studies, all designed to develop strategies that can improve the health of people and populations. Together, we study a wide range of health conditions that disproportionately affect medically vulnerable populations. In so doing, we represent the vast expertise of interested faculty and the interdisciplinary ethos of Duke University.

Studies

**Currently Recruiting**

Charge

Charge is a 12-month experimental trial among adults with obesity to determine which stand-alone text messaging intervention components produce a meaningful contribution to 6-month weight change. All participants will receive a core 6-month weight loss texting intervention (based on our iOTA approach) that includes tailored behavior change goals, interactive self-monitoring, automated feedback, and skills training. We will use a full factorial design to randomize participants to experimental conditions that reflect the texting intervention components: motivational messaging, texting frequency, reminders, feedback type and comparison unit.  We aim to enroll 448 adults and will be recruiting participants soon. For more information please visit http://www.chargestudy.com/

Balance

Balance is a 5-year randomized controlled pragmatic effectiveness trial, funded by the NIH.  Balance builds on the design and findings of Shape and Track to test a pragmatic intervention for weight maintenance within primary care in safety net clinics throughout central North Carolina. Balance randomizes adults who are overweight or have obesity and who are current patients at local Piedmont Health Services community health centers to: 1) a tailored weight gain prevention intervention, using customized behavior change goals delivered via our digital health platform; daily self-weighing on a network-connected scale; and responsive coaching from Registered Dietitians; or 2) a standard weight gain prevention intervention, consistent with current care.  All intervention components and materials are provided in Spanish or English. Recruitment for the study began in early 2017, with a target of enrolling 442 total patients. Stay tuned for findings in the near future!

**Active studies – recruitment has closed**

DASH Cloud

Thank you for your interest in the DASH Cloud Study – we are no longer recruiting for this study but please see the currently recruiting section above for other studies for which we are recruiting.

The goal of DASH Cloud is to test whether diet tracking smartphone apps can help improve eating habits and diet quality among women who are at risk for or have high blood pressure.  We enrolled approximately 50 women in this study. Participants are asked to use a mobile app on their smartphone to track their diet every day for 3 months. Expect to see results in 2018.

GoalTracker

GoalTracker is a randomized controlled trial led by doctoral student Shelley L. Patel that is currently underway. The study examines optimal ways to self-monitor behavior for weight loss using technology. Participants are adults ages 21-65 with overweight or obesity. All participants receive a 3-month behavioral weight loss intervention. Expect to see results in 2018.

Track

Track is a randomized controlled trial being tested now. It is designed as a higher intensity weight loss treatment option for community health centers. We’re using iOTA, asking patients to self-monitor and offering them multiple ways to do that (text messaging or automated phone) each week. Each intervention participant is assigned his or her own personal health coach. We’ve also added a new piece of technology: a network scale with instructions to weigh every day. This is based on the groundbreaking work of Dori Steinberg, Ph.D., R.D., one of our team members.

Expect to see results published in 2017.

**Past studies**

The Sino-US Cooperation in Weight Loss

The rapid gains in China’s economic development during the past two decades have been accompanied by similar gains in the population’s waistline. Over 25% of Chinese adult women and more than a third of men are overweight or obese; rates are highest in urban areas such as Beijing. Working closely with researchers at Peking University and faculty at Duke Medicine, we adapted iOTA and ran a pilot study in Beijing.  In 2010, we recruited 123 overweight/obese Chinese adults to either receive a 6-month mobile phone-assisted lifestyle intervention for weight loss or a usual care control.

See publications here.

 Shape Plan

We ran a pilot study among 50 women in the Raleigh-Durham area to test the effect of daily self-monitoring of behaviors via SMS on weight. The daily text messages focused on tracking tailored behavioral goals (i.e., no sugary drinks, 10,000 steps per day) along with brief feedback and tips. After six months, the study showed that 26 obese women who used daily texting as part of the Shape Plan weight-loss intervention lost nearly 3 pounds, while another 24 who followed traditional methods gained 2.5 pounds.

See publications here.

The Shape Program

“Maintain, Don’t Gain”

Black women have the highest rates of obesity, but many traditional weight loss studies show smaller weight losses for Black women than for whites. We, and others, have been searching for more effective treatment options. We think we’ve found one in weight gain prevention. Shape was a weight gain prevention trial conducted among 194 Black women in NC community health centers. Shape used iOTA, delivered by automated calls, and enhanced with monthly called with a health coach. Study findings were supportive of our “maintain, don’t gain” obesity treatment approach. We suspect that this “maintain, don’t gain” approach has value beyond Black women. For those who are having difficulty losing weight, or for those who are uninterested in weight loss, weight gain prevention should be the fundamental clinical priority. Shape shows how you can get there.

See publications here.

Be Fit, Be Well

Few evidence-based weight loss treatment options exist for medically vulnerable patients in the primary care setting. We conducted a 2-arm, 24-month randomized effectiveness trial in 3 Boston community health centers (from 2008- 2011). Participants were 365 obese patients receiving hypertension treatment (71.2% black, 13.1% Hispanic, 68.5% female). We randomized participants to usual care or a behavioral intervention that promoted weight loss and hypertension self-management using digital health. The intervention included tailored behavior change goals, self-monitoring, and skills training, available via a website or interactive voice response; 18 telephone counseling calls; primary care provider endorsement; 12 optional group support sessions; and links with community resources.

See publications here.

Step Up, Trim Down

Self-monitoring is an effective weight loss tool, but it is a difficult and time-consuming task. The goal of this pilot study was to test a simpler self-monitoring method for weight loss. The theory was this: if we worked with people to find 4 concrete behaviors to change (e.g., no sugary drinks, no fried food, walk 10,000 steps) that would create an energy deficit, and give them a simple website to track their changes, they’d actually self-monitor more, and therefore lose weight. This was how we started work on what ultimately became the Interactive Obesity Treatment Approach (iOTA).

See publications here.