--- title: "Automated diabetes prev program: design and RCT protocol. | Sutter Health" description: "Randomized trial will provide rigorous evidence regarding the efficacy of this Internet-based program in preventing progression to diabetes." url: "https://www.sutterhealth.org/research/publications/automated-diabetes-prevention-program-1055312824" --- 1. [Home](https://www.sutterhealth.org/) / 2. [Research](https://www.sutterhealth.org/research) / 3. [Research publications](https://www.sutterhealth.org/research/publications) / 4. Automated diabetes prev program: design and RCT protocol. # A fully automated diabetes prevention program, Alive-PD: program design and randomized controlled trial protocol. Block G, Azar KM, Block TJ, Romanelli RJ, Carpenter H, Hopkins D, Palaniappan L, & Block CH. _JMIR Res Protoc. 2015 Jan 21;4(1):e3. doi: 10.2196/resprot.4046._ 2015-01-21 ## 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. [PubMed abstract](http://www.ncbi.nlm.nih.gov/pubmed/25608692) ![Kristen M J Azar, RN, MSN, MPH](https://dyn.mktgcdn.com/p/rFmyR1kiX8JzE5-XNwup0gVC1GRaVTlH7oSDlG0Tr5A/fit=crop,gravity=auto,dpr=2,width=188,height=250,quality=100) Kristen M J Azar, RN, MSN, MPH Principal investigator [View profile](https://www.sutterhealth.org/research/investigators/kristen-m-j-azar-rn-msn-mph-1049680985) ## Research topics - [Diabetes, Insulin Resistance and Metabolic Syndrome](https://www.sutterhealth.org/research-search-results?query=%22%5C%22Diabetes%2C+Insulin+Resistance+and+Metabolic+Syndrome%5C%22%22) - [Disease Management](https://www.sutterhealth.org/research-search-results?query=%22%5C%22Disease+Management%5C%22%22) - [Health Services](https://www.sutterhealth.org/research-search-results?query=%22%5C%22Health+Services%5C%22%22) - [Prevention and Health Maintenance](https://www.sutterhealth.org/research-search-results?query=%22%5C%22Prevention+and+Health+Maintenance%5C%22%22) ## Related publications [View all publications](https://www.sutterhealth.org/research-search-results?verticalKey=research_publication) - Publication ### [A Latino Patient-Centered, Evidence-Based Approach to Diabetes Prevention.](https://www.sutterhealth.org/research/publications/latino-pt-centered-evidence-based-approach-to-dm-prevention-1055312326) Rosas LG, Lv N, Lewis MA, Venditti EM, Zavella P, Luna V, Ma J. J Am Board Fam Med. 31(3):364-374. doi: 10.3122/jabfm.2018.03.170280. 2018 May 01 - Publication ### [Evaluation of a culturally-adapted lifestyle intervention to treat elevated cardiometabolic risk of Latino adults in primary care (Vida Sana): a randomized controlled trial.](https://www.sutterhealth.org/research/publications/eval-outpt-diabetes-prev-prog-latino-adults-1055312475) Rosas LG, Lv N, Xiao L, Lewis M, Zavella P, Kramer MK, Luna V, Ma J. Contemp Clin Trials. pii: S1551-7144(16)30029-5. doi: 10.1016/j.cct.2016.03.003. \[Epub ahead of print\] 2016 Mar 16 - Publication ### [Virtual small groups for weight management: an innovative delivery mechanism for evidence-based lifestyle interventions among obese men.](https://www.sutterhealth.org/research/publications/virtual-small-groups-weight-mgmt-in-obese-men-1055312966) Azar KM, Aurora M, Wang EJ, Muzaffar A, Pressman A, Palaniappan LP. Transl Behav Med. 5(1):37-44. doi: 10.1007/s13142-014-0296-6. 2015 Mar 01 - Publication ### [Why do we observe a limited impact of primary care access measures on clinical quality indicators?](https://www.sutterhealth.org/research/publications/impact-of-primary-care-access-on-clinical-quality-1055312662) Chung S, Panattoni L, Hung D, Johns N, Trujillo L, Tai-Seale M. J Ambul Care Manage. 37(2):155-63. doi: 10.1097/JAC.0000000000000026. 2014 Apr 01 - Publication ### [Racial difference in diabetes preventive care.](https://www.sutterhealth.org/research/publications/racial-difference-in-diabetes-preventive-care-1055312866) Pu J, Chewning B. Res Social Adm Pharm. 9(6):790-6. doi: 10.1016/j.sapharm.2012.11.005. Epub 2012 Dec 13. 2013 Nov 01 [View all publications](https://www.sutterhealth.org/research-search-results?verticalKey=research_publication) ```json {"@context":"https://schema.org","@type":"MedicalOrganization","name":"Sutter Health","@id":"https://www.sutterhealth.org/#medicalorganization","url":"https://www.sutterhealth.org","logo":"https://www.sutterhealth.org/static/images/sutter-health-logo.svg","address":{"@type":"PostalAddress","streetAddress":"2200 River Plaza Drive","addressLocality":"Sacramento","addressRegion":"CA","postalCode":"95833","addressCountry":"US"},"areaServed":{"@type":"AdministrativeArea","name":"California"},"sameAs":["https://www.facebook.com/SutterHealth","https://www.instagram.com/sutterhealth/","https://x.com/SutterHealth","https://www.youtube.com/sutterhealth","https://www.linkedin.com/company/sutter-health","https://en.wikipedia.org/wiki/Sutter_Health"]} ``` ```json {"@context":"https://schema.org","@type":"BreadcrumbList","@id":"https://www.sutterhealth.org/research/publications/automated-diabetes-prevention-program-1055312824#breadcrumblist","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https://www.sutterhealth.org/"},{"@type":"ListItem","position":2,"name":"Research","item":"https://www.sutterhealth.org/research"},{"@type":"ListItem","position":3,"name":"Research publications","item":"https://www.sutterhealth.org/research/publications"},{"@type":"ListItem","position":4,"name":"Automated diabetes prev program: design and RCT protocol."}]} ``` ```json {"@context":"https://schema.org","@type":"MedicalScholarlyArticle","@id":"https://www.sutterhealth.org/research/publications/automated-diabetes-prevention-program-1055312824#medicalscholarlyarticle","name":"A fully automated diabetes prevention program, Alive-PD: program design and randomized controlled trial protocol.","headline":"Automated diabetes prev program: design and RCT 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. 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