title: A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol.
abstract: BACKGROUND
  In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes.
  
  
  OBJECTIVE
  Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial.
  
  
  METHODS
  Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations.
  
  
  RESULTS
  A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline.
  
  
  CONCLUSIONS
  The randomized trial will provide rigorous evidence regarding the efficacy of this Web- and Internet-based program in reducing or preventing progression of glycemic markers and indirectly in preventing progression to diabetes.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01479062; http://clinicaltrials.gov/show/NCT01479062 (Archived by WebCite at http://www.webcitation.org/6U8ODy1vo).
authors.affiliation: NutritionQuest, Inc., Berkeley, CA, United States. gblock@berkeley.edu.
authors.forename: Gladys
authors.identifier: http://orcid.org/0000-0001-6722-930X
authors.initials: G
authors.lastname: Block
authors.forename: Kristen Mj
authors.identifier: http://orcid.org/0000-0002-5040-8595
authors.initials: KM
authors.lastname: Azar
authors.forename: Torin J
authors.identifier: http://orcid.org/0000-0001-5399-1950
authors.initials: TJ
authors.lastname: Block
authors.forename: Robert J
authors.identifier: http://orcid.org/0000-0001-6686-9962
authors.initials: RJ
authors.lastname: Romanelli
authors.forename: Heather
authors.identifier: http://orcid.org/0000-0002-4514-2438
authors.initials: H
authors.lastname: Carpenter
authors.forename: Donald
authors.identifier: http://orcid.org/0000-0003-3352-7485
authors.initials: D
authors.lastname: Hopkins
authors.forename: Latha
authors.identifier: http://orcid.org/0000-0002-1245-665X
authors.initials: L
authors.lastname: Palaniappan
authors.forename: Clifford H
authors.identifier: http://orcid.org/0000-0002-2400-8547
authors.initials: CH
authors.lastname: Block
keywords: blood glucose; diabetes; insulin resistance; internet; metabolic syndrome; obesity; physical activity; prediabetes; prevention; world wide web