Multiple large scale randomized controlled trials have shown that in people with impaired glucose tolerance, 40-60% of Type 2 diabetes cases can be prevented with lifestyles interventions that emphasize diet, exercise and weight loss. Despite the strong evidence base supporting preventability, the incidence of diabetes continues to increase. VA MOVE! does not specifically target those with pre-diabetes. Most veterans referred to VA MOVE! who do not already have a diagnosis of diabetes do not know if they are pre-diabetic. With a few exceptions, lifestyle modification interventions that target individuals with pre-diabetes and follow the Diabetes Prevention Program (DPP) curriculum are not available to Veterans with pre-diabetes in the VA. This project builds on two concurrent projects, the VA Diabetes Prevention clinical demonstration project funded by our partners at VA National Center for Health Promotion and Disease Prevention (NCP) and the QUERI funded RRP titled: VA Diabetes Prevention: Epidemiology of Pre-Diabetes and Implementation Pilot.
The overarching goal of this proposal is to provide our clinical partner, NCP, with evidence to guide future implementation of diabetes prevention strategies in the VA.
The specific aims of this study are to:
1. Test an implementation strategy and identify barriers and facilitators to implementation of the VA-DPP demonstration project at three VA medical centers using a mixed methods approach that is informed by the Consolidated Framework for Implementation Research (CFIR) and Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) frameworks.
2. Test for mediation of intervention effect on weight loss by constructs that are addressed differently in VA MOVE! and VA-DPP including group cohesion, intervention intensity, outcome expectations, goal awareness and commitment, and self-regulation skills.
3. Conduct cost-effectiveness and budget impact analyses of implementing the VA-DPP broadly in the VA from the perspective of the health system.
This was a Hybrid Type 3 mixed methods implementation evaluation project. Veterans referred to the VA MOVE! program at three VA medical centers were screened for the VA-DPP clinical demonstration project between August 2012 and January 2014. Veterans who had a HbA1c of 5.7-6.4 or a fasting plasma glucose of 100-125ml, lived within 60 minutes of the VAMC, and met additional inclusion criteria were assigned to the VA-DPP or MOVE! program using a systematic sampling approach. Participants were invited to complete surveys at baseline and 12 months. Medical records data were used to evaluate participation, health outcomes and conduct a cost effectiveness analyses. Qualitative data were elicited through interviews with a subset of participants. Additionally, staff interviews pre- and post-implementation were conducted and coded using the CFIR and RE-AIM implementation framework to inform implementation and to guide development of implementation strategies for future dissemination.
A total of 1850 patients were screened and/or attended a MOVE! orientation session at one of three VAMCs and were assessed for eligibility. Among these, 387 individuals met all eligibility criteria; 273 were assigned to the VA-DPP program and 114 were assigned to MOVE! program.
Among the 273 participants assigned to VA-DPP, 36% (n=98) explicitly declined to participate. However, our weight analyses at 6 and 12 months included all VA-DPP assigned participants consistent with an intent-to-treat (ITT) analytic approach. One patient who did not have a baseline weight assessment was excluded, leaving a final analytic weight sample of 386 participants (VA-DPP n=273, MOVE! n=113). For HbA1c outcomes assessment, patients were excluded who did not have a baseline HbA1c or FPG within six months of enrollment (n=6) and participants who did not complete a follow-up HbA1c test (n=71), leaving a final analytic HgA1c sample of 310 participants (VA-DPP n=210, MOVE! n=100).
Participants were mostly middle-aged with an average HbA1c of 6.0% and co-morbid hypertension. All baseline characteristics were comparable between study arms except for race/ethnicity. MOVE! program participants had a higher percentage of Hispanics and lower proportions of African Americans and Caucasians (p = 0.04). Participants were representative of the VHA population (overweight/obese males) and also reflected the racial/ethnic diversity at the three VAMCs included in this trial.
Participation rates were higher in the VA-DPP program over the 12 months. In the first 6 months, 88.3% of VA-DPP participants and 84% of MOVE! participants completed at least one session of their respective program and 55.0% and 42.4%, respectively, completed at least 4 sessions.
Based on adjusted outcomes within groups, participants in the VA-DPP had statistically significant weight loss at 6 and 12 months but MOVE! program participants did not. There were significant differences in predicted weight change between arms at 6 months (MOVE! -1.9 kg vs. VA-DPP -4.1kg, p<0.001) but not at 12 months (MOVE! -2.0 vs. VA-DPP -3.4kg, p=0.16). After controlling for covariates, HbA1c at 12 months did not show significant changes from baseline, and no difference was found in the predicted HbA1c change at 12 months by study arm (MOVE! 0.06 vs. VA-DPP -0.02, p=0.34).
The quality of coaching, reflected by fidelity ratings for coach characteristics, was rated highly for both programs. However, VA-DPP had higher fidelity ratings for four domains of program delivery. Thus, though session leaders for both programs tended to come "prepared and organized," the programs differed in many other ways, e.g., more "positive relationships among the group members" in VA-DPP than MOVE!. Additionally, VA-DPP participants reported higher satisfaction for six of eight items related to their program. Together, these differences may partially explain weight loss differences, and perhaps more importantly the higher rates of continued engagement of VA-DPP participants. Multi-faceted strategies are needed to successfully reach targeted patients and to implement and maintain the DPP in a clinical setting.
Implementation of the VA-DPP demonstration program has the potential to significantly improve health outcomes for Veterans by delaying or preventing the onset of Type 2 diabetes. The research component of the VA-DPP contributed to our knowledge about the incidence of pre-diabetes in Veterans, their attitudes and beliefs about diet, exercise and weight loss, and understanding how different programs may impact weight loss.
Preliminary VA-DPP data provided important and relevant information to NCP who updated MOVE! group visit guidance to align more closely with the DPP's curriculum for all Veterans, not just those with pre-diabetes.
This work, along with other projects, also helped lead to our newly funded MOVE! LEAP project as part of our new PRoVE QUERI program.
- Moin T, Damschroder LJ, AuYoung M, Maciejewski ML, Havens K, Ertl K, Vasti E, Weinreb JE, Steinle NI, Billington CJ, Hughes M, Makki F, Youles B, Holleman RG, Kim HM, Kinsinger LS, Richardson CR. Results From a Trial of an Online Diabetes Prevention Program Intervention. American journal of preventive medicine. 2018 Nov 1; 55(5):583-591.
- Janney CA, Greenberg JM, Moin T, Kim HM, Holleman RG, Hughes M, Damschroder LJ, Richardson CR, Young AS, Steinle N. Does mental health influence weight loss in adults with prediabetes? Findings from the VA Diabetes Prevention Program. General hospital psychiatry. 2018 Jul 1; 53:32-37.
- Damschroder LJ, Reardon CM, AuYoung M, Moin T, Datta SK, Sparks JB, Maciejewski ML, Steinle NI, Weinreb JE, Hughes M, Pinault LF, Xiang XM, Billington C, Richardson CR. Implementation findings from a hybrid III implementation-effectiveness trial of the Diabetes Prevention Program (DPP) in the Veterans Health Administration (VHA). Implementation science : IS. 2017 Jul 26; 12(1):94.
- AuYoung M, Damschroder LJ, Kinsinger L, Moin T, Richardson CR. Practical partnered research to improve weight loss among overweight/obese veterans: lessons from the trenches. BMC medical research methodology. 2017 Mar 29; 17(1):50.
- Moin T, Damschroder LJ, AuYoung M, Maciejewski ML, Datta SK, Weinreb JE, Steinle NI, Billington C, Hughes M, Makki F, Holleman RG, Kim HM, Jeffreys AS, Kinsinger LS, Burns JA, Richardson CR. Diabetes Prevention Program Translation in the Veterans Health Administration. American journal of preventive medicine. 2017 Jul 1; 53(1):70-77.
- Moin T, Damschroder LJ, Youles B, Makki F, Billington C, Yancy W, Maciejewski ML, Kinsinger LS, Weinreb JE, Steinle N, Richardson C. Implementation of a prediabetes identification algorithm for overweight and obese Veterans. Journal of rehabilitation research and development. 2016 Oct 1; 53(6):853-862.
- Damschroder LJ, Moin T, Datta SK, Reardon CM, Steinle N, Weinreb J, Billington CJ, Maciejewski ML, Yancy WS, Hughes M, Makki F, Richardson CR. Implementation and evaluation of the VA DPP clinical demonstration: protocol for a multi-site non-randomized hybrid effectiveness-implementation type III trial. Implementation science : IS. 2015 May 12; 10(1):68.
- Damschroder LJ. Diabetes Prevention Program (DPP) Translation in VA. [Cyberseminar]. 2017 Jan 5.
- AuYoung M, Damschroder LJ, Hughes ME, Youles B, Holleman R, Richardson CR. Who Decides? Self-Selected versus Assigned Goals for Weight Loss in a Veteran Population. Paper presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2016 Mar 31; Washington, DC.
- Moin T, AuYoung M, Richardson CR, Damschroder LJ. Enhancing Diabetes Prevention Program Translation through Partnership: Key Lessons & Opportunities in Diverse Care Settings. Paper presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2016 Mar 31; Washington, DC.
- AuYoung M, Reardon C, Sparks J, Richardson CR, Damschroder LJ. What's Your Type? A Qualitative Analysis of Weight Loss Success by Weight Loss Archetype. Poster session presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2016 Mar 30; Washington, DC.
- Moin T, Li J, Duru OK, Ettner S, Turk N, Chan C, Keckhafer A, Luchs R, Ho S, Mangione C. Results from next-d: Can a disease specific health plan reduce incident diabetes development among a national sample of working-age adults with pre-diabetes? Paper presented at: AcademyHealth Annual Research Meeting; 2015 Dec 14; Washington, DC.
- Moin T, Damschroder LJ, Makki F, Weinreb JE, Steinle N, Billington C, Yancy W, Maciejewski ML, Kinsinger LS, Richardson C. Implementing the Diabetes Prevention Program in the VA: Weight Outcomes from a Clinical Demonstration Project. Paper presented at: VA HSR&D / QUERI National Meeting; 2015 Jul 10; Philadelphia, PA.
- Moin T, Damschroder LJ, Makki F, Weinreb JE, Steinle N, Billington C, Yancy W, Maciejewski ML, Kinsinger LS, Richardson CR. Implementing the Diabetes Prevention Program in the VA: Weight Outcomes from a Clinical Demonstration Project. Paper presented at: AcademyHealth Annual Research Meeting; 2015 Jun 14; Minneapolis, MN.
- Kerr EA, Richardson CR. Health Care Resource Utilization: How do researchers and stakeholders partners together to reduce unnecessary care? Paper presented at: AcademyHealth Healthcare Resource Utilization Symposium; 2015 May 12; Washington, DC.
- Richardson CR. Essentials of Randomized Controlled Trial. Paper presented at: All India Institute for Medical Sciences Conference; 2014 Dec 4; New Delhi, India.
- Richardson CR. Introduction to Study Design. Paper presented at: All India Institute for Medical Sciences Conference; 2014 Dec 3; New Delhi, India.
- Damschroder LJ, Michie S, Richardson CR, Carroll J, Petrella R. Using Theory in Implementation Science. Paper presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2014 Apr 23; Philadelphia, PA.
- Richardson CR. Diabetes Prevention and Implementation Science. Paper presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2014 Apr 23; Philadelphia, PA.
Aging, Older Veterans' Health and Care, Diabetes and Related Disorders