Diabetes Prevention and Weight Loss with a Fully Automated Behavioral Intervention by Email, Web, and Mobile Phone: A Randomized Controlled Trial Among Persons with Prediabetes.
BACKGROUND
One-third of US adults, 86 million people, have prediabetes. Two-thirds of adults are overweight or obese and at risk for diabetes. Effective and affordable interventions are needed that can reach these 86 million, and others at high risk, to reduce their progression to diagnosed diabetes.


OBJECTIVE
The aim was to evaluate the effectiveness of a fully automated algorithm-driven behavioral intervention for diabetes prevention, Alive-PD, delivered via the Web, Internet, mobile phone, and automated phone calls.


METHODS
Alive-PD provided tailored behavioral support for improvements in physical activity, eating habits, and factors such as weight loss, stress, and sleep. Weekly emails suggested small-step goals and linked to an individual Web page with tools for tracking, coaching, social support through virtual teams, competition, and health information. A mobile phone app and automated phone calls provided further support. The trial randomly assigned 339 persons to the Alive-PD intervention (n=163) or a 6-month wait-list usual-care control group (n=176). Participants were eligible if either fasting glucose or glycated hemoglobin A1c (HbA1c) was in the prediabetic range. Primary outcome measures were changes in fasting glucose and HbA1c at 6 months. Secondary outcome measures included clinic-measured changes in body weight, body mass index (BMI), waist circumference, triglyceride/high-density lipoprotein cholesterol (TG/HDL) ratio, and Framingham diabetes risk score. Analysis was by intention-to-treat.


RESULTS
Participants' mean age was 55 (SD 8.9) years, mean BMI was 31.2 (SD 4.4) kg/m(2), and 68.7% (233/339) were male. Mean fasting glucose was in the prediabetic range (mean 109.9, SD 8.4 mg/dL), whereas the mean HbA1c was 5.6% (SD 0.3), in the normal range. In intention-to-treat analyses, Alive-PD participants achieved significantly greater reductions than controls in fasting glucose (mean -7.36 mg/dL, 95% CI -7.85 to -6.87 vs mean -2.19, 95% CI -2.64 to -1.73, P<.001), HbA1c (mean -0.26%, 95% CI -0.27 to -0.24 vs mean -0.18%, 95% CI -0.19 to -0.16, P<.001), and body weight (mean -3.26 kg, 95% CI -3.26 to -3.25 vs mean -1.26 kg, 95% CI -1.27 to -1.26, P<.001). Reductions in BMI, waist circumference, and TG/HDL were also significantly greater in Alive-PD participants than in the control group. At 6 months, the Alive-PD group reduced their Framingham 8-year diabetes risk from 16% to 11%, significantly more than the control group (P<.001). Participation and retention was good; intervention participants interacted with the program a median of 17 (IQR 14) of 24 weeks and 71.1% (116/163) were still interacting with the program in month 6.


CONCLUSIONS
Alive-PD improved glycemic control, body weight, BMI, waist circumference, TG/HDL ratio, and diabetes risk. As a fully automated system, the program has high potential for scalability and could potentially reach many of the 86 million US adults who have prediabetes as well as other at-risk groups.


BACKGROUND
Clinicaltrials.gov NCT01479062; https://clinicaltrials.gov/ct2/show/NCT01479062 (Archived by WebCite at http://www.webcitation.org/6bt4V20NR).
Turnaround Health, a division of NutritionQuest, Berkeley, CA, United States. gblock@berkeley.edu.
Gladys
http://orcid.org/0000-0001-6722-930X
G
Block
Kristen Mj
http://orcid.org/0000-0002-5040-8595
KM
Azar
Robert J
http://orcid.org/0000-0001-6686-9962
RJ
Romanelli
Torin J
http://orcid.org/0000-0001-5399-1950
TJ
Block
Donald
http://orcid.org/0000-0003-3352-7485
D
Hopkins
Heather A
http://orcid.org/0000-0002-4514-2438
HA
Carpenter
Marina S
http://orcid.org/0000-0001-5288-3798
MS
Dolginsky
Mark L
http://orcid.org/0000-0003-4572-0629
ML
Hudes
Latha P
http://orcid.org/0000-0002-1245-665X
LP
Palaniappan
Clifford H
http://orcid.org/0000-0002-2400-8547
CH
Block
D000328:Adult; D001835:Body Weight; D040421:Cell Phone / Q000706:statistics & numerical data*; D003920:Diabetes Mellitus / Q000517:prevention & control*; D034742:Electronic Mail / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D020407:Internet / Q000706:statistics & numerical data*; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000517:prevention & control*; D011236:Prediabetic State / Q000517:prevention & control*; D012944:Social Support; D015431:Weight Loss / Q000502:physiology*
Internet; behavior change; intervention studies; nutrition; obesity; physical activity; prediabetes; prevention; smartphone; type 2 diabetes; weight loss