Scientific Foundation of the Wellsteps Turnkey Solution

Scientific Foundation of the WellSteps Turnkey Solution

Summary 1) The Coronary Health Improvement Program (CHIP) behavior change program demonstrated efficacy in several research settings. 2) A scientific evaluation framework was used to translate research findings from research to real life. 3) CHIP strengths and weaknesses were identified. These results were used to design the WellSteps turnkey behavior change solution.

Introduction The single biggest causal factor in today’s most common chronic diseases is individual health behavior. Cohort and case control studies have shown that between 70 and 91 percent of the several common chronic diseases are related to lifestyle behaviors such as poor nutrition, sedentary living, and tobacco.1-3 Lifestyle change programs can improve physical activity participation, healthy eating, and tobacco avoidance. It has been suggested that the adoption and maintenance of healthy behaviors will have a larger impact on reducing morbidity and mortality than any other single strategy or breakthrough.4

1) The Coronary Health Improvement Program In 2000, the Coronary Health Improvement Program (CHIP) was introduced in Rockford, IL. The CHIP program is a community lifestyle change intervention aimed at adults.5,6 The purpose of CHIP is to reduce chronic disease incidence and to improve the overall health of the public by providing a lifestyle change program within the community setting. The program highlights the importance of making better lifestyle choices for preventing, arresting, and reversing many common Western diseases and teaches participants how to implement these choices through a change in diet, physical activity, and smoking. Early evaluations of the CHIP program using one-group pre-test/post-test analysis showed that participants were able to significantly reduce blood pressure, body weight, and total and low density lipoprotein (LDL) cholesterol within four weeks.5,7

Since the first CHIP program in 2000, the program has been delivered in communities,8,9 clinics,10 churches,11 and worksites.12 Later, a video version of the CHIP intervention was also developed and evaluated.13 The video program was able to produce findings comparable to the programs that were conducted with a live health educator. To date, 15 different CHIP studies have been completed including several randomized clinical trials.5-19 The CHIP program has been delivered to ethnically diverse groups of adults living in a variety of community settings and has showed consistent evidence of effectiveness. For example, African Americans showed improvements similar to Caucasians.11 The intervention produced significant weight loss among participants in each study, with those weighing the most at baseline showing the greatest weight reductions.15,17 Participants from rural environments demonstrated changes similar to those from urban settings.14 The CHIP program has also produced improvements in sleep quality,16 depression,17 and perceived health.18 Taken collectively, this evidence shows a consistent pattern of effectiveness across a variety of participants, in different settings, and with a variety of program delivery methods. In sum, the materials, books, and presentations included in CHIP have been able to improve nutrition and physical activity behavior and significantly reduce blood pressure, cholesterol and glucose at 6 weeks, 6 months, 12-months and after 2 years.7-10

Developed and facilitated exclusively by Dr. Hans Diehl, the CHIP program focuses on markedly reducing coronary risk factor levels through the adoption of better health habits and appropriate lifestyle changes. It is a community-based program conducted either by Dr. Diehl as a “live” program, or through a DVD video set with trained facilitators. The program is either conducted over a period of four weeks during which participants meet 4 days a week for two hours, or over a period of eight weeks during which participants meet twice a week for two hours. The curriculum topics cover modern medicine and health myths, atherosclerosis, coronary risk factors, obesity, dietary fiber, dietary fat, diabetes, hypertension, cholesterol, exercise, osteoporosis, cancer, lifestyle and health, the Optimal Diet,5 behavioral change, and “self-worth.”

Participants in both the live and video-based sessions received workbooks that contained assignments with learning objectives for each topic that closely followed the discussion topics in session. These assignments were designed to facilitate the understanding and integration of the concepts and information presented. In addition, dietitians and medical professionals spoke to the groups weekly about the prevention, arrest and reversibility of chronic diseases. Participants were given access to scheduled shopping tours at local supermarkets and cooking demonstrations conducted by a dietitian.

In the live settings, Dr. Diehl was available to answer questions regarding the presentations, workbook assignments, and the program, with assistance of program staff. Participants were encouraged to follow pre-set dietary and exercise goals. The dietary goal involved adopting a more plant-food based diet that emphasized largely unrefined “food- as-grown.” These recommended foods were usually high in unrefined complex carbohydrates and included grains, legumes, fresh fruits and vegetables. A whole-food diet that is low in fat, animal protein, cholesterol, sugar, and salt, and high in fiber, antioxidants and micronutrients, is in contrast to the typical Western diet. Participants were encouraged to eat some nuts and were introduced to the idea of topping cereal with ground flax seed. At the same time, program participants were encouraged to progressively implement a 30- min/day exercise program of walking and general fitness. At the completion of the program, participants were encouraged to join the CHIP Alumni Organization for a cost of $35 per year. Membership benefits included a monthly newsletter with news of health promoting community events such as healthy dinners, walking groups, and support group meetings. The alumni are encouraged to attend special lectures on healthy living and relapse prevention.

The primary objectives of the CHIP program were to improve participants’ cognitive understanding of the importance of healthy lifestyles, improve nutrition and physical activity behavior, and to reduce the risk factors associated with diabetes, hypertension, cardiovascular disease, and cancer. The CHIP intervention follows a framework for behavior change that includes elements from social cognitive theory20 and social support.21 As participants worked though the program they gained awareness, motivation, skills, and learned how community, cultural, and environmental factors can either encourage or discourage healthy behaviors.

2) Use of the RE-AIM Translation Framework to Evaluate CHIP In order to better evaluate the potential of the CHIP program to reach a broader population using a different delivery channel, the RE-AIM framework was utilized. This framework has been used to evaluate a variety of behavior change interventions.22-24 RE-AIM is a systematic way to evaluate health behavior interventions in two important ways: 1) to determine the potential an intervention may have to be used in a larger public health arena sometimes referred to as translational potential and 2) to evaluate existing public health interventions to determine if they were able get maximum reach by satisfying each of five different dimensions.25

This proposal describes how both applications of the RE-AIM framework have and will be applied. The RE-AIM framework was used to determine the translational potential of the CHIP and later in the evaluation section of this proposal, the RE-AIM framework will be included as the analysis methodology for evaluating the WellSteps program.26

Glasgow et al.25 proposed that the translatability and public health impact of behavior change interventions are best evaluated by examining five different dimensions: Reach-How much of the target population does the intervention reach? Effectiveness-Is the intervention effective? Adoption-Is there organizational support for the intervention? Implementation-Can the intervention be implemented correctly in different settings? Maintenance-Is the intervention sustainable long-term?

Another advantage of the RE-AIM framework is its inclusion of both individual and organizational factors that my impact the program’s translational potential. Evaluating both individual and organizational factors reduces the risk of proceeding with the creation of a public health intervention that may produce little or no improvements in reach. The following table shows the specific questions that were asked within each dimension as it relates to the CHIP program. To better understand how the CHIP program may be applied in a direct-to-consumer model, program cost was added as an additional dimension.

Table 1. RE-AIM Assessment of the CHIP Program Dimension Questions Reach (Individual Level) What percent of the population knew about CHIP? What percentage of the total target population actually participated in CHIP? Did the participants reflect the targeted population? Where there unanticipated barriers to participation? Effectiveness (Individual Level) Did the CHIP program improve health behaviors and lower health risks? Did the CHIP program cause any unwanted side effects? Did CHIP participants improve quality of life (QOL)? Did CHIP participants receive adequate value for the cost of program registration? Adoption (Organizational Level) What other organizations have been able to implement CHIP? Will organizations having underserved or high-risk populations use it? Does program help these organizations address its primary mission? Implementatio (Organizational level) n How well were the different CHIP programs implemented? Can individuals besides Dr. Diehl implement the program? Is there fidelity across the different CHIP programs? Maintenance (Individual and Organizational Level) Does the program produce lasting effects at individual level? Can organizations sustain the program over time? Are those persons and settings that show maintenance those most in need? Cost (Individual Level) Did CHIP participants receive adequate value for the cost of program registration? Was program cost a barrier to participation? Is there an ideal program cost that is sustainable? The strengths of the CHIP program are the efficacy and implementation. Many of the sessions were delivered live in a lecture hall by Dr. Hans Diehl. He is a charismatic, intelligent, and caring instructor. He is endearing to his participants. Each participant gets a comprehensive participant workbook that is used in each lecture. The teaching materials are grounded in behavior change theory. Each lecture has been video taped and many participants watch just the videos. Some cohorts watch videos with a trained group facilitator. The program has been offered in a variety of settings, in groups of different sizes and typically cost between $100 and $300 per person depending on the setting. The program has been promoted heavily through church groups especially through the Seventh Day Adventists. The program has received some limited support from community groups and corporations.

The CHIP program does have some serious limitations in its translational potential. Without Dr. Diehl, the future of CHIP is not good. He is CHIP’s greatest asset and liability. Without Dr. Diehl, the CHIP program would likely cease to exist. The program is time intensive, requiring almost 40 hours for completion. In communities where CHIP has been conducted live, it has required external funding. Without a self-sustaining financial model, its reach is limited. Some may find the program’s strict counsel to avoid all dairy foods and maintain a low fat diet hard to sustain. Outside of some church groups, organizational support is limited.

Using RE-AIM scoring methodologies and procedures suggested by Glasgow et al.27 and Estabrooks et al.28 CHIP program strengths and weaknesses were rated on each of the five dimensions. Figure 1 shows the resulting ratings that were determined for each of Glasgow’s basic dimensions.

Figure 1. RE-AIM Dimensional Ratings for the CHIP Program

The CHIP program scored high in efficacy. Most of the translational weaknesses demonstrated by the program are in the maintenance dimension.

The RE-AIM model does consider cost as a sub-component of adoption, but it will be treated as a separate factor in this proposal. When designing direct-to-consumer campaigns, cost is a critical factor. Individuals are typically more cautious and prudent when spending their own money than they are spending, “the companies” money or when participating in a program that is funded with subsidies or community donations.

The results from the RE-AIM evaluation of CHIP were used to develop the WellSteps behavior change program. WellSteps is a program that helps adults adopt and maintain healthy behaviors. It consists of a series of behavior change campaigns offered over a period of 12 months. Individuals who participate learn how to adopt and maintain a variety of healthy behaviors. Currently, nearly 400,000 adults and over 4,500 worksites in the U.S are using materials employed in the WellSteps program.

3) Concurrent Behavior Change Interventions During the same time that the research on the CHIP program was being conducted, a wellness program at Washoe County School District in Reno, Nevada utilized the web to deliver simple behavior change campaigns to 8,000 school district employees.29 Employees were invited to participate in up to eight behavior change campaigns over a 12-month period. The scalability of the web was used to deliver these campaigns to a large numbers of adults at a small cost. Participants in the behavior change campaigns were given small incentives as they completed each program. Participation and compliance with program components was tracked and aggregate reports are created. Aldana and colleagues29 published findings that showed that for every dollar the school district spent on wellness programming, they saved nearly 16 dollars in reduced employee absenteeism.29 Behavioral and risk improvements from program participation have yet to be reported. The most notable aspect of this program was the feasibility of delivering behavior change programs to large audiences at a low cost using the Internet and printed material. This success demonstrated that behavior change applications delivered through the web might be able to overcome some of the inherent translation weaknesses of the CHIP program and expand the reach of behavior change programs.

4) Translation of CHIP to WellSteps WellSteps will not be an exact copy of the CHIP intervention packaged for delivery to individuals. Rather, WellSteps will adopt selected components of CHIP and deliver behavior change campaigns in a way that addresses the CHIP translational weaknesses. Based on the RE-AIM ratings from CHIP, WellSteps will maintain high levels of efficacy and implementation while improving reach, adoption, and maintenance. It may be argued that deviation from the original intervention is a violation of the correct RE-AIM translation process since intervention fidelity is a sub-component of implementation. Treatment fidelity is important, yet without some variation of the intervention, the weaknesses of CHIP cannot be addressed and successful translation of the program may not be possible. The goal in this translation is to maintain as much intervention fidelity as possible while addressing the translational barriers.

Table 2. Programmatic Comparisons Between CHIP and WellSteps Program Similarities Aspects Unique to WellSteps Both programs: WellSteps: Use the same theoretical Makes additional use of tools from framework for behavior change social marketing theory programming Use video, printed, and electronic Uses behavior change programming that media is ongoing and tailored Cover the same health promotion Is funded by participants, not topics communities or churches Will be developed by behavior Is not constrained by community or change professionals geography Educate, motivate, and teach Does not depend any single individual behavior change tools and strategies Offer opportunities for follow-up Follows accepted national dietary support guidelines Conduct baseline and follow-up Does not require the same time evaluations commitment as CHIP Use qualified support staff Is scalable Has internal treatment fidelity (programs are delivered the same way every time) Is delivered via the web or paper pencil Uses incentives to encourage engagement

Based on the finding that the CHIP program was effective when delivered in a video format, WellSteps will use monthly webinars transmitted with a live video image of the presenter and audience participation. In addition, several of the behavior change programs include pre-recorded videos. WellSteps participants are provided with behavior change materials, two national best sellers, a pedometer, and program incentives. As with CHIP, many different health topics are included in the 4-6 week campaigns. To date, there are 21 unique behavior change campaigns embedded in WellSteps. WellSteps does not include an Alumni group like CHIP because there really is no graduation, but it does include an online community that takes full advantage of new media including video conferencing, forums, discussion groups and blogs. The core WellSteps behavior change programs are available off line so those without access to the web can watch the same videos and participate in the same programs. Like CHIP, several WellSteps campaigns are taught by other health experts. References 1. Stampfer MJ, Hu FB, Manson JE, Rimm EB, Willett WC. Primary prevention of coronary heart disease in women through diet and lifestyle. N Engl J Med 2000 Jul 6;343(1):16–22. 2. Hu FB, Manson JE, Stampfer MJ, Colditz G, Liu S, Solomon CG, Willett WC. Diet, lifestyle, and the risk of type 2 diabetes mellitus in women. N Engl J Med 2001 Sep 13;345(11):790–7. 3. Platz EA, Willett WC, Colditz GA, Rimm EB, Spiegelman D, Giovannucci E. Proportion of colon cancer risk that might be preventable in a cohort of middle-aged US men. Cancer Causes Control 2000 Aug;11(7):579–88. 4.http://www.healthierus.gov/STEPS/summit/prevportfolio/Power_Of_Prevention.pdf 5. Diehl, HA. Coronary risk reduction through intensive community-based lifestyle intervention: the Coronary Health Improvement Project (CHIP) experience. Am J Cardiol. 1998;82:83T- 87T. 6. Englert HS, Diehl HA, Greenlaw RL. Rationale and design of the Rockford CHIP, a community- based coronary risk reduction program: results of a pilot phase. Prev Med. 2004 Apr;38(4):432-41. 7. Aldana SG, Greenlaw RL, Diehl HA, Salberg A, Merrill RM, Ohmine S, Thomas C. Effects of an intensive diet and physical activity modification program on the health risks of adults. Am Diet Assoc. 2005 Mar;105(3):371-81. 8. Merrill RM, Aldana SG. Cardiovascular risk reduction and factors influencing loss to follow-up in the coronary health improvement project. Med Sci Monit. 2008 Apr;14(4):PH17-25. 9. Merrill RM, Aldana SG, Greenlaw RL, Diehl HA, Salberg A, Englert H. Can newly acquired healthy behaviors persist? An analysis of health behavior decay. Prev Chronic Dis. 2008 Jan;5(1):A13. Epub 2007 Dec 15. 10. Aldana SG, Greenlaw RL, Diehl HA, Salberg A, Merrill RM, Ohmine S, Thomas C. The behavioral and clinical effects of therapeutic lifestyle change on middle-aged adults. Prev Chronic Dis. 2006 Jan;3(1):A05. Epub 2005 Dec 15. 11. Pilgrim Baptist Church, CHIP cohorts of 2004 and 2004, program completion data, Rockford, IL 12. Aldana SG, Greenlaw RL, Diehl HA, Salberg A, Merrill RM, Ohmine S. The effects of a worksite chronic disease prevention program. Occup Environ Med. 2005 Jun;47(6):558-64. 13. Aldana SG, Greenlaw RL, Diehl HA, Merrill RM, Salberg A, Englert H. A video-based lifestyle intervention and changes in coronary risk. Health Educ Res. 2008 Feb;23(1):115-24. Epub 2007 Mar 8. 14. CHIP internal analysis across communities. www.Chipusa.org 15. Merrill RM, Massey MT, Aldana SG, Greenlaw RL, Diehl HA, Salberg A. C-reactive protein levels according to physical activity and body weight for participants in the coronary health improvement project. Prev Med. 2008 May;46(5):425-30. Epub 2007 Dec 8. 16. Merrill RM, Aldana SG, Greenlaw RL, Diehl HA, Salberg A. The effects of an intensive lifestyle modification program on sleep and stress disorders. J Nutr Health Aging. 2007 May-Jun;11(3):242-8. 17. Merrill RM, Taylor P, Aldana SG. Coronary Health Improvement Project (CHIP) is associated with improved nutrient intake and decreased depression. Nutrition. 2008 Apr;24(4):314-21. 18. Merrill RM, Aldana SG. Improving Overall Health Status Through the CHIP Intervention. Am J Health Behav. 2009 Mar-Apr;33(2):135-46. 19. Aldana SG, Greenlaw R, Diehl HA, Englert H, Jackson R. Impact of the coronary health improvement project (CHIP) on several employee populations. J Occup Environ Med. 2002 Sep;44(9):831-9. 20. Bandura A. Self-efficacy: the exercise of control. New York: Freeman, 1997. 21. Cohen S, Underwood LG, Gottlieb BH. Social support measurement and intervention. New York: Oxford Univ. Press, 2000. 22. Lando, H.A., Valanis, B.G., Lichtenstein, E.L., et al. (2001). Promoting smoking abstinence in pregnant and postpartum patients: A comparison of 2 approaches. American Journal of Managed Care, 7, 685-693. 23. France, E.K., Glasgow, R.E., Marcus, A. (2001) Smoking cessation interventions among hospitalized patients: What have we learned? Preventive Medicine, 32(4):376-388. 24. Estabrooks, P.A., Dzewaltowski, D.A., Glasgow, R.E., Klesges, L.M. (2003) Reporting of Validity from School Health Promotion Studies Published in 12 Leading Journals, 1996- 2000. Journal of School Health, 73(1): 21-28. 25. Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. 26. Glasgow RE, Marcus AC, Bull SS. Disseminating effective cancer screening interventions. Cancer 2004;101:1239-1250 27. Glasgow, R.E., Toobert, D.J., Hampson, S.E., & Strycker, L.A. (2002). Implementation, generalization, and long-term results of the "Choosing Well" diabetes self-management intervention. Patient Education and Counseling, 48(2): 115-122. 28. Estabrooks, P.A., Bradshaw, M., Dzewaltowski, D.A., & Klesges, L. The Reach and Adoption of "Walk Kansas": Translating Research to Practice. Presented as part of the Society of Behavioral Medicine's 24th Annual Scientific Sessions, Salt Lake City, Utah, March, 2003. 29. Aldana SG, Merrill RM, Price K, Hardy A, Hager R. Financial impact of a comprehensive multisite workplace health promotion program. Prev Med. 2005 Feb;40(2):131-7.