The Diabetes Prevention Program Outcomes Study Diabetes Prevention Program Lifestyle Balance By Mary Hoskin MS, RD on behalf of The DPPOS Research Group
Today s Topics What was the DPP/DPPOS? What do we know from the DPP/DPPOS? What was the DPP/DPPOS Lifestyle Balance? What were the Keys to Success?
DPP Primary Goals To prevent or slow the development of type 2 diabetes in persons with impaired glucose tolerance (IGT) Prevention of diabetes complications such as kidney, eye and nerve problems, and heart disease DPPOS Primary Goals Continue to evaluate the effects of active interventions Microvascular and microvascular events
Diabetes Prevention Program Clinics....................
Study Timeline
Study Interventions Eligible participants Randomized Standard lifestyle recommendations Intensive Metformin Placebo Lifestyle (n = 1079) (n = 1073) (n = 1082)
Diabetes Prevention Program 3,234 Participants at risk for diabetes (Impaired glucose tolerance) Age 25 and older All ethnic groups Male and Female Overweight (BMI >24) Diabetes assessed by OGTT and FBG
DPP Screening and Recruitment Number of DPP participants Step 1 screening Step 2 OGTT Step 3 start run-in Step 3 end run-in Step 4 randomization 158,177 30,985 4,719 4,080 3,819* *3,234 in 3- arm study (585 in troglitazone arm)
Retention and Adherence 99.6% of the study cohort alive at end of DPP 93% completed DPP 93% of DPP annual visits completed 86% joined DPPOS ~90% of DPPOS cohort active in a given year Trivial permanent loss to follow-up Those who miss visits for 1 year, usually recaptured next year High rate of procedure completion (>98%) at all visits
Intervention Medications: Metformin- 850 mg per day escalating after 4 weeks to 850 mg twice per day Placebo- Metformin placebo adjusted in parallel with active drugs
Lifestyle Intervention An intensive program with the following specific goals: > 7% loss of body weight and maintenance of weight loss Dietary fat goal -- <25% of calories from fat Calorie intake goal -- 1200-1800 kcal/day > 150 minutes per week of physical activity
DPPOS Treatment Protocols (Sept 2002 to present) Original Placebo group HELP classes four times a year Original Metformin group HELP classes four times a year Metformin 850 mg twice daily Original Lifestyle group HELP classes four times a year BOOST lifestyle classes twice a year
Preventing Diabetes: What Do We Know from the DPP and DPPOS?
Cumulative incidence (%) 40 30 20 10 0 Percent developing diabetes Placebo (n=1082) All participants Metformin (n=1073, p<0.001 vs. Placebo) Lifestyle (n=1079, p<0.001 vs. Met, p<0.001 vs. Plac ) Metformin Lifestyle (n=1079, (n=1073, p<0.001 vs. Metformin, Plac) Placebo (n=1082) p<0.001 vs. Placebo) Risk reduction 31% by metformin 58% by lifestyle DPP Incidence of Diabetes 0 1 2 3 4 Years from randomization
Effect of Treatment on Incidence of Diabetes in the DPP Placebo Metformin Life-style Incidence of diabetes 11.0% 7.8% 4.8% (percent per year) Reduction in incidence ---- 31% 58% compared with placebo Number needed to treat ---- 13.9 6.9 to prevent 1 case in 3 yrs
DPP/DPPOS Incidence of Diabetes Knowler et al. Lancet. 2009; 374:1677-1686 (Figure 3)
DPP/DPPOS Incidence of Diabetes Knowler et al. Lancet. 2009; 374:1677-1686 (Figure 3)
DPP vs. DPPOS Diabetes Rates Crude Rate per 100 PYR 12 10 8 6 4 2 0 DPP (n=3234) Placebo Metformin Lifestyle DPPOS (n=1994) Knowler et al. Lancet. 2009; 374:1677-1686 (Figure 4)
Diabetes Development in DPPOS Original Lifestyle participants continue to develop diabetes at the lower rate they developed diabetes during DPP. Original Placebo and Metformin participants have lowered their rate of diabetes development to a similar rate as the Lifestyle group.
Diabetes Risk Reduction in DPPOS Delay in diabetes onset after 10 years follow-up: 4 years for Lifestyle 2 years for Metformin The lower rate of diabetes development for lifestyle and metformin during DPP means: Original Lifestyle participants have a 34% lower risk of diabetes compared to Placebo Original Metformin participants have a 18% lower risk of diabetes compared to Placebo
Study Population Caucasian 1768 African-American 645 Hispanic-American 508 Asian-American & Pacific Islander 142 American Indian 171 Total 3234 African American 20% Hispanic 16% Caucasian 55% Asian 4% American Indian 5%
DPP Diabetes Incidence Rates by Ethnicity Lifestyle Metformin Placebo Cases/100 person-yr 12 8 4 0 Caucasian (n=1768) African American (n=645) Hispanic (n=508) American Indian (n=171) Asian (n=142)
Study Population Age Distribution > 60 20% 25-44 31% 45-59 49%
DPP Diabetes Incidence Rates by Age Cases/100 person-yr 12 8 4 Lifestyle Metformin Placebo 0 25-44 (n=1000) 45-59 (n=1586) > 60 (n=648) Age (years)
Percent with Diabetes by Treatment Group at 10-years 52% of Placebo participants have diabetes 47% of Metformin participants have diabetes 42% of Lifestyle participants have diabetes
Hazard Rate for Developing Diabetes As A Function of Weight Change From Baseline Hazard rate per 100/yr 0 5 10 15 20 Intensive Lifestyle Group Average Risk -15-10 -5 0 +5 Hamman Diabetes Care 2006 Mean weight change from baseline (kg)
What Contributed to Prevention? Weight loss was the most important predictor of diabetes risk For every 2.2 pounds of weight loss, diabetes risk was reduced 16% Self reported improvements in diet and physical activity that did not result in weight loss did not result in lower diabetes risk Weight loss predicted by lower dietary fat and physical activity More fasting glucoses normalized in ILS group
What Contributed to Prevention? (cont.) Persons reporting the lowest % of calories from fat had a greater decrease in risk of diabetes for every kilogram of weight loss For every 5% reduction in percent fat during follow-up, diabetes incidence was reduced by 25% Reduction of >90% for those meeting both goals Success higher in older individuals, higher initial body weight and lower physical activity The effect of weight loss on the risk of diabetes was not modified by age, sex, ethnicity, physical activity
Weight Change Over Time Overall Knowler et al. Lancet. 2009; 374:1677-1686 (Figure 2)
DPP Changes in Leisure Physical Activity MET-hours/week 8 6 4 2 Lifestyle Metformin Placebo 0 0 1 2 3 4 Years from Randomization
Physical Activity in the DPP Those not meeting the weight loss goal, but achieving the physical activity goal had 44% lower diabetes incidence Increased physical activity was not associated with initial weight loss, but was significantly related to long term weight loss Exercise is more strongly associated with maintenance of weight loss than with initial weight loss Physical activity does not always decrease with age The most active age group in the DPP was aged 60 and over Physical Activity in Individuals at Risk for Diabetes: Diabetes Prevention Program. Medicine and Science in Sports and Exercise.
Lifestyle Intervention Results Results: After Core Curriculum Weight Loss 6.6 kg (14.5 lb) % weight loss 7.0 % % at or above weight loss goal 49.7 % Physical Activity 224 minutes % at or above activity goal 74.4 % At weight goal after 2.8 years 37% At activity goal after 2.8 years 67% The DPP Research Group, NEJM 346:393-403, 2002
The DPP Research Group, NEJM 346:393-403, 2002 Change in Weight and Behavior Over Time Intensive Lifestyle Group Mean change at Variable Baseline Year 1 Year 2 Year 3 Weight (kg) 94.1-6.7-5.4-4.1 BMI (kg/m 2 ) 33.9-2.4-1.9-1.5 Met-hrs / Week (MAQ) 15.5 + 7.3 + 6.1 + 5.2 Met-hrs / Week (LoPAR) 67.1 + 8.5 + 8.1 + 8.3 Total kilocalories / day 2136.5-450.2 -- -- Total fat / day (grams) 83.0-30.4 -- -- % Calories from fat 34.1 % - 6.6 % -- --
PPAARGP12A s relation to diabetes Florez et al J Clin Endocrinol Metab 2007
Bridge Period between DPP and DPPOS LIFESTYLE participated less than other groups and gained slightly (+1.33 kg on avg) PLAC, MET, and TROG groups lost weight (about 2.3 kg on avg) High attenders (12 to 16 sessions) lost more than low attenders (except for LIFESTYLE) Conclusion simply repeating programs is not effective over time Venditti et al, 2008, Int J Obes; 32: 1537 1544
Additional Results Prevention or delay of diabetes within original lifestyle and metformin groups persists for 10 years Original lifestyle participants have a 34% risk reduction in diabetes compared to placebo Original metformin participants have a 18% risk reduction in diabetes compared to placebo
Additional Results (2) Lifestyle and metformin treatment resulted in improved blood pressure measurements All groups had decreased cholesterol and triglycerides Lifestyle presented the same or lower blood pressure and lipid levels over time as other groups despite lower use of medication
What Was the DPP/DPPOS Lifestyle Balance?
Role of the RD in the DPP/DPPOS As a part of the team of researchers Developed Protocol and Manuals of Operations Planned Lifestyle Interventions Implemented interventions, including lifestyle Evaluated the protocol implementation Assisted in translation efforts
RDs as Lifestyle Coaches Lifestyle coaches were usually dietitians Met with participants regularly Coordinated and monitored completion of curriculum Planned and implemented post core activities Case Managed followup care as needed and appropriate
RDs Role in Retention Tailored intervention for the needs, cultural and otherwise, of the participant Used counseling and rapport building skills to retain participants Assisted in group problem solving
RDs Participating in Central Management of the DPP/DPPOS Some Program Coordinators National planning and oversight committees Design and conduct of ancillary studies Participation in and leading writing groups for publications Quality Control planning and monitoring
Useful Resources The Diabetes Prevention Program Research Group. The Diabetes Prevention Program (DPP): Description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. Hoskin M, Begay S, Bolin P, Hermes J, Ingraham L, Killean T, Nelson J, Percy C, Scurlock N, Shovestull LE, Tomchee C, the Diabetes Prevention Program and Action for Health in Diabetes (Look AHEAD) research groups. Providing lifestyle interventions in American Indian communities. Obesity Management Journal 2005 Dec;1(6):251-5. Wylie-Rosette J, Delahanty L. An integral role of the dietitian: Implications of the Diabetes Prevention Program. J Am Diet Assoc. 2002 Aug;102(8):1065-8. Delahanty L, Begay S, Cooeyate N, Hoskin M, Isonaga M, Levy E, Mikami K, Ka julani Odom S, Szamos K The effectiveness of Lifestyle Intervention in the Diabetes Prevention Program: Application in Diverse Ethnic Groups On The Cutting Edge Winter 2002;23(6).
DPP Lifestyle Intervention Structure 16 session core curriculum (over 24 weeks) Long-term maintenance program Supervised by a coach Access to lifestyle support staff Dietitian Behavior counselor Exercise specialist
The DPP Core Curriculum Education and training in eating and exercise methods and behavior modification skills Emphasis on: Self monitoring techniques Problem solving Individualizing programs Self esteem, empowerment, and social support Frequent contact with case manager and DPP support staff
DPP Post Core Program Self-monitoring and other behavioral strategies Monthly visits Must be seen in person at least every two months Supervised exercise sessions offered Periodic group classes and motivational campaigns Tool box strategies Provide exercise videotapes, pedometers Problem solving
In DPP behavioral guidance is integral to every session Let s think about the principles being used in each session
Session 1: Welcome to the Lifestyle Balance Program Build commitment Assign weight and exercise goals Review key aspects of relationship with interventionist Begin self-monitoring food intake (Keeping Track, Quick Track) Keeping Track
Session 2: Be a Fat Detective Begin self-monitoring weight Assign fat goal (25% calories): 33, 42, 50, or 55 grams/day Begin self-monitoring fat intake (Fat Counter) FAT
Daily Fat and Calorie Goals Weight (lbs) Fat Goal (grams) Calorie Goal 120-174 33 1,200 175-219 42 1,500 220-249 50 1,800 >250 55 2,000 Be a Fat and Calorie Detective
Session 3: Three Ways to Eat Less Fat Weigh and measure foods, estimate portions Practice three ways to eat less fat: Eat high-fat foods less often Eat them in smaller amounts Substitute lower-fat foods and cooking methods
Session 4: Healthy Eating Eat regular meals and eat slowly Follow the latest Food Pyramid (provided ethnic versions) Choose low-fat, low-calorie items from each Pyramid group
Session 5: Move Those Muscles Build to 150 minutes/week over five weeks Begin self-monitoring activity Introduce group activity sessions How to choose footwear
Session 6: Being Active: A Way of Life Ways to find time to be active, including short bouts Introduce lifestyle activity (e.g., climbing stairs) Review safety issues related to physical activity
Session 7: Tip the Calorie Balance Define energy balance If participant had little progress with weight loss, assign calorie goal, begin self-monitoring calories or following meal plan
Session 8: Take Charge of What s Around You Introduce cue control Identify problem cues and ways to avoid, change, or respond differently to them Identify helpful cues and ways to add them
Session 9: Problem Solving Describe problem in detail (include behavior chain) Brainstorm possible solutions Pick one to try Make a positive action plan Try it. Keep trying Problems can be solved.
Session 10: Four Keys to Healthy Eating Out Ways to manage eating out: Plan ahead Ask for what you want Be firm and friendly Take charge of what s around you Choose foods carefully
Session 11: Talk Back to Negative Thoughts Counter common patterns of self-defeating, negative thoughts with positive statements
Session 12: The Slippery Slope of Lifestyle Change Slips are normal Learn ways to recover from slips Review personal triggers, reactions, and how to get back on track
Session 13: Jump Start Your Activity Plan Add interest and variety Follow the FITT principle of aerobic fitness: frequency, intensity, time, type of activity Measure target heart rate and perceived level of exertion
Session 14: Make Social Cues Work for You Manage problem cues in social settings (e.g., being pressured to overeat) Add helpful cues (e.g., bring a low-fat item) Ask for support Plan ahead for social events
Session 15: You Can Manage Stress Ways to cope with stress: Take a brief time out to relax Say no. Seek support Solve problems. Plan ahead Talk back to negative thoughts Be physically active
Session 16: Ways to Stay Motivated Remember your purpose Recognize your successes Continue to self-monitor Add variety Set new goals and rewards Create friendly competition Seek support
DPP After Core Goals Maintain weight loss goals Maintain activity goals See participants in person every two months Most participants desired monthly contact Phone contact between visits Three group sessions per year Nutrition, activity, behavior
Motivational Campaigns in DPP (2-3 per year) Key features Make a commitment for 4-8 weeks Be part of a team Return to the basics Receive reward and recognition Goal driven, incentive based Group based
What were the Keys to Success? Lessons we are learning from the Diabetes Prevention Program and Outcomes Study
Keys to Success Clearly defined and achievable goals and expectations Case management approach Frequent contact Relationships- staff and family Intensive, ongoing intervention Individualization Materials and strategies that addressed the needs of an ethnically diverse population Keeping track Provide tools to achieve goals
Defined and Achievable Goals Individualized fat and calorie goals for weight loss Individual weight loss goal (7%) Physical Activity goal of 150 min per wk Time frame to meet stated goals Participant contracts
Case Management Consistent relationships Work with the participant as a team Hang in there- reinforcement Be supportive Utilize multidisciplinary approach
Health Coaching Model The health coaching model uses a team of health professionals to assist patients in making behavior changes to improve their health. An assigned health coach works with the patient and multi-disciplinary team to work collaboratively with the patient to create a health plan by helping them to identify barriers and establish goals to change health related behaviors.
Characteristics of a Health Coach and Participant Relationship Building Trust Facilitating Change Valuing Diversity Communication Gaining Commitment Problem Solving Revisiting and Adjusting Building on Success
Who Could be a Coach? Professionals were used in the DPP Paraprofessional helped support Implementation in American Indian communities have used both The coach needs to be supported by a team
Consistency Supportive Honest Believe in you Family Relationships
Frequent Contact Weekly Monthly Campaigns/Maintenance Most chose to come in more often
Intensive, Ongoing Intervention Continued self-monitoring and other behavioral strategies Frequent contact Group classes and motivational campaigns Tool box strategies
Individualization Goals individualized to starting weight and what makes them successfully lose weight Recipes and menus Interpersonal and individual needs like jobs, literacy and language Team approach they choose how
Targeting for Population Use local examples to reinforce points 3 ways to eat less fat Recipes and Foods Designed for use in many different ethnic groups Physical Activity
Strategies to Address Ethnic/Demographic Diversity Community personnel Materials adapted for ethnic/regional diversity Simplified self-monitoring tools Local centers choose/adapt supplemental classes
Tool Box: Problem Solving Dominates
What did DPP coaches do with most participants (for weight)? Top Approaches Used to Improve Weight Loss CORE POST- CORE Problem-Solving (review behavior chains/action plans) 77% 96% Review Self-Monitoring Skills 49% 76% Recommend Increased Activity 35% 76% Recommend Lower Fat/Cal Goal 24% 25% Schedule Extra Phone Call or Visit 18% 75% New Self-Monitoring Strategy 16% 47% Provide Healthy Recipes 14% 37% Motivational Strategy (No Cost) 13% 25% Motivational Strategy (Added Cost) 11% 52% Recommended Meal Plans 10% 40% Mailings; Recommend or Provide Slim Fast; Refer to Specialists; Involve Family; Provide Lower Fat/Cal Frozen Entrees, Taste Testings, Cookbooks/Utensils <10% 0-30%
What did DPP coaches do with most participants (for activity)? Top Approaches Used to Improve Physical Activity CORE POST- CORE Problem-Solving (review behavior chains/action plans) 74% 91% Coach Exercises With Participant 18% 48% Schedule Extra Phone Call or Visit 16% 64% Motivational Strategy (No Cost) 14% 24% Recommend Exercise Facility (No Cost) 10% 19% Refer to Exercise Specialist (No Cost) 10% 22% Make Plan to Find Exercise Partner 9% 24% Motivational Strategy (Added Cost) 8% 44% Loaned Item to Support PA 8% 18% Purchase Item to Support PA (Cost) 8% 26% Provide Trial Health Club Membership 6% 14% Gave Pedometer (Cost) 3% 41% Mailings, Register for Activity Events, Recommend New Self-Monitoring Tool, Involve Family <5% 0-30%
Motivational Interviewing in Health Care Guide Direct Follow Rollnick S, Mason P, Butler C. Motivational interviewing in health care: helping patients change behavior. Guilford Press, 2008.
Services-Research Continuum Identify problems and research questions Health Services Research Study Improve practice and standards of care
Implementation in our Communities YMCA Model Group Lifestyle Balance Model Small Steps Model Others Montana, Indian Health Service
Without the generous participation of the DPP/DPPOS participants, none of this information would be available.
Website for DPP lifestyle manuals, publications, and other information www.bsc.gwu.edu/dpp
SMALL STEPS BIG REWARDS
The risk is great.
The goals are important
The changes are modest.
The action steps are clear.
That doesn t make it easy for you, but the DPP demonstrated that it can be done. NIH Pub. No. 03-5335 Feb 2003
THANK YOU