1. The HELP Prevent Diabetes D&I Story David Goff, MD, PhD Dean and Professor Colorado School of Public Health Design Strategies CRISP D&I Training Workshop 2013 www.ucdenver.edu/implementation

2. Diabetes Prevention Diabetes is a major public health problem –25.8 million people in US Pre-diabetes is common and a risk factor for developing diabetes –79 million people in US –10% conversion rate per year Lifestyle interventions show efficacy to prevent diabetes in people with pre-diabetes –Highly trained interventionists –Individual mode of intervention delivery –Highly selected participants –~60% reduction in risk www.ucdenver.edu/implementation2

3. Healthy Living Partnerships (HELP) to Prevent Diabetes Project overview: –Background: Translation of diabetes prevention into the community a challenge. –Goal: Testing community delivery of group-based behavioral lifestyle change strategy versus usual care –Population setting and context: Overweight or obese community residents with pre-diabetes, intervention delivered via community diabetes care center (DCC) and community health workers –Audience / stakeholders involved: DCC Community Advisory Board, focus groups of patients with pre- diabetes www.ucdenver.edu/implementation3

4. Developing Partnerships Diabetes Care Center with Certified Diabetes Educators –Intervention hosting and delivery, CHW selection, training, and support Community Health Workers (CHWs) –Intervention delivery and monitoring & supporting adherence Community organizations –Supporting and participating in intervention –Examples: YMCA, Lowes Foods, Fleet Feet Participants –Group member support responsibility and individual responsibility www.ucdenver.edu/implementation4

5. Agenda Setting Focus on effectiveness and subsequent dissemination Keep research team far in background Train the trainers to train the trainers Develop and use enduring materials Monitor costs including participant costs Complete separation of research assessment visits from intervention visits www.ucdenver.edu/implementation5

6. Selecting the Population/Setting for Implementation Simple eligibility goals –No OGTT, fasting glucose only –Few exclusions Community-based recruitment (mailings & a phone bank, clinic referrals) Community-based ADA certified DCC with ADA Certified Diabetes Educators (CDEs) Recruitment of CHWs from pool of patients with diabetes who had completed diabetes education Concept that successful participants could become future CHWs www.ucdenver.edu/implementation6

7. Selecting your Framework The research team could not train all the CHWs who would need training in the US. We might be able to establish a training center to train (and provide technical assistance to) CDEs to add diabetes prevention to their scope of practice. There are over 3000 ADA recognized diabetes education programs in the US, making wide dissemination practical. www.ucdenver.edu/implementation7

8. Developing the Intervention Focus groups Testing on the initial CHWs in training Enduring materials (DVDs and web- based) Process monitoring tools, including on web www.ucdenver.edu/implementation8

9. Body Weight: 24 months 9 Baseline to 12 month change: LWL: -7.1 kg EUC: -1.5 kg p<0.001 Baseline to 24 month change: LWL: -5.34 kg EUC: -1.16 kg p<0.001 Katula JA, at al. Am J Prev Med. 2013 Apr;44(4 Suppl 4):S324-32. doi: 10.1016/j. PubMed PMID: 23498294.

10. Fasting Blood Glucose: 24 months 10 Baseline to 12 month change: LWL: -4.2 mg/dl EUC: -0.3 mg/dl p = 0.002 Baseline to 24 month change: LWL: -2.2 mg/dl EUC: 2.1 mg/dl p = 0.002 Katula JA, at al. Am J Prev Med. 2013 Apr;44(4 Suppl 4):S324-32. doi: 10.1016/j. PubMed PMID: 23498294.

11. Lessons Learned 1.Focus on proven efficacy 2.Think about dissemination first 3.Monitor implementation with an eye on dissemination 4.Be cautious regarding mid-course “improvements” and “adjustments” that you remember dissemination www.ucdenver.edu/implementation11

12. References 1.Lawlor MS, Blackwell CS, Isom SP, Katula JA, Vitolins MZ, Morgan TM, Goff DC Jr. Cost of a group translation of the Diabetes Prevention Program: Healthy Living Partnerships to Prevent Diabetes. Am J Prev Med. 2013 Apr;44(4 Suppl 4):S381-9. doi: 10.1016/j.amepre.2012.12.016. PubMed PMID: 23498303. 2.Katula JA, Vitolins MZ, Morgan TM, Lawlor MS, Blackwell CS, Isom SP, Pedley CF, Goff DC Jr. The Healthy Living Partnerships to Prevent Diabetes study: 2-year outcomes of a randomized controlled trial. Am J Prev Med. 2013 Apr;44(4 Suppl 4):S324-32. doi: 10.1016/j.amepre.2012.12.015. PubMed PMID: 23498294; PubMed Central PMCID: PMC3731757. 3.Rosenberger Hale E, Goff DC, Isom S, Blackwell C, Whitt-Glover MC, Katula JA. Relationship of weekly activity minutes to metabolic syndrome in prediabetes: the healthy living partnerships to prevent diabetes. J Phys Act Health. 2013 Jul;10(5):690-8. Epub 2012 Oct 4. PubMed PMID: 23036940; PubMed Central PMCID: PMC3765007. 4.Katula JA, Blackwell CS, Rosenberger EL, Goff DC Jr; Healthy Living Partnerships to Prevent Diabetes Research Team. Translating diabetes prevention programs: implications for dissemination and policy. N C Med J. 2011 Sep-Oct;72(5):405-8. PubMed PMID: 22416527. 5.Katula JA, Vitolins MZ, Rosenberger EL, Blackwell CS, Morgan TM, Lawlor MS, Goff DC Jr. One-year results of a community-based translation of the Diabetes Prevention Program: Healthy-Living Partnerships to Prevent Diabetes (HELP PD) Project. Diabetes Care. 2011 Jul;34(7):1451-7. doi: 10.2337/dc10-2115. Epub 2011 May 18. Erratum in: Diabetes Care. 2012 Feb;35(2):455. PubMed PMID: 21593290; PubMed Central PMCID: PMC3120203. 6.Blackwell CS, Foster KA, Isom S, Katula JA, Vitolins MZ, Rosenberger EL, Goff DC Jr. Healthy Living Partnerships to Prevent Diabetes: recruitment and baseline characteristics. Contemp Clin Trials. 2011 Jan;32(1):40-9. doi: 10.1016/j.cct.2010.10.006. Epub 2010 Oct 23. PubMed PMID: 20974289; PubMed Central PMCID: PMC3005835. 7.Katula JA, Vitolins MZ, Rosenberger EL, Blackwell C, Espeland MA, Lawlor MS, Rejeski WJ, Goff DC. Healthy Living Partnerships to Prevent Diabetes (HELP PD): design and methods. Contemp Clin Trials. 2010 Jan;31(1):71-81. doi: 10.1016/j.cct.2009.09.002. Epub 2009 Sep 13. PubMed PMID: 19758580; PubMed Central PMCID: PMC2818212. www.ucdenver.edu/implementation12