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Plenary lecture at the PSEM Prediabetes Congress, 21 March 2012.
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Diabetes Prevention:Translating the DPP Results to Address the NNHeS Challenge
Iris Thiele Isip Tan MD, MSc, FPCP, FPSEMClinical Associate Professor, UP College of Medicine
Department of Medicine, Philippine General Hospital
http://www.sxc.hu/photo/1253865
21 March 2012
Wednesday, March 21, 12
Wednesday, March 21, 12
US Model
The DPP Lifestyle Change Program
National Diabetes Prevention Program
DPP Lifestyle Balance
Diabetes Prevention Program (DPP)
Diabetes Prevention Program Outcomes Study
Wednesday, March 21, 12
Diabetes Prevention ProgramTrial Design
Diabetes Prevention Program Research Group NEJM 2002;346:393-403
P: 3234 with IFG or IGT
I: Lifestyle modification vs Metformin vs placebo
O: Incidence of diabetes over follow-up
M: Randomized controlled trial
Wednesday, March 21, 12
DPP Protocol:Intensive Lifestyle Modification
16-lesson curriculum covering diet, exercise and behavior modification taught one-on-one for 1st 24 weeks
Diabetes Prevention Program Research Group. NEJM 2002;346:393-403
Wednesday, March 21, 12
>7% weight loss: healthy, low-calorie, low-fat diet
Diabetes Prevention Program Research Group. NEJM 2002;346:393-403
Wednesday, March 21, 12
Moderate intensity physical activityi.e. brisk walking >150 min/week
Diabetes Prevention Program Research Group. NEJM 2002;346:393-403
Wednesday, March 21, 12
Diabetes Prevention Program Research Group. NEJM 2002;346:393-403
Wednesday, March 21, 12
DPP ResultsReduction in Incidence of Diabetes (vs placebo)
Lifestyle Modification⬇ 58% (95% CI 48-66%)
Metformin⬇ 31% (95% CI 17-43%)
Diabetes Prevention Program Research Group NEJM 2002;346:393-403 p.
Wednesday, March 21, 12
DPP Results
Diabetes Prevention Program Research Group NEJM 2002;346:393-403 p.
To prevent one case of diabetes during a period of 3 yearsNNT (lifestyle): 6.9 [95% CI 5.4-9.5]
NNT (Metformin): 13.9 [95% CI 8.7-33.9]
Wednesday, March 21, 12
Bridge Phase1-2 week drug wash-outUnmasked to treatment assignments Group-administered version of Lifestyle Balance for all
Wednesday, March 21, 12
DPP Outcomes StudyTrial Design
P: 2766 of DPP subjects
I: Lifestyle modification vs Metformin vs placebo
O: Incidence of diabetes over follow-up
Intention-to-treat
Diabetes Prevention Program Research Group Lancet 2009;374(9702):1677-86
Wednesday, March 21, 12
DPPOS protocolIntensive lifestyle group offered 2 group classes (each comprising 4 sessions every year)
Metformin group continued Metformin 850 mg bid unless already with diabetes (HbA1c >7%)
Wednesday, March 21, 12
Cumulative incidence of diabetes during three study phases
Diabetes Prevention Program Research Group Lancet 2009;374(9702):1677-86
Wednesday, March 21, 12
Cumulative incidence of diabetes remained lowest in lifestyle group
1 2 3 4 5 6 7 8 9 10Years since DPP randomization
Diabetes Prevention Program Research Group Lancet 2009;374(9702):1677-86
Wednesday, March 21, 12
US Model
The DPP Lifestyle Change Program
National Diabetes Prevention Program
DPP Lifestyle Balance
Diabetes Prevention Program (DPP)
Diabetes Prevention Program Outcomes Study
✔
Wednesday, March 21, 12
Lifestyle Balancehttp://www.bsc.gwu.edu/dpp/manuals.htmlvdoc
Wednesday, March 21, 12
Lifestyle Balancehttp://www.bsc.gwu.edu/dpp/manuals.htmlvdoc
Overview of strategies to achieve goalsProfessional resourcesOptional materials for participants464 pages!
Wednesday, March 21, 12
The DPP manual and materials are made available to the public subject to the following Creative commons License: Creative Commons - Attribution-NonCommercial-ShareAlike 3.0. Accordingly, the manuals may be downloaded, duplicated, transmitted and otherwise distributed for educational or research purposes only, provided proper credits are given to the DPP Research Group. (Note that some of the materials may have incorrect formatting while undergoing revisions.) Use of any of the DPP Lifestyle materials herein for commercial purposes is strictly forbidden without the permission or license of the University of Pittsburgh.
Copyright 1996; 2011University of Pittsburgh
Wednesday, March 21, 12
Key Aspects of DPP Lifestyle ProtocolClearly defined weight loss and physical activity goals
Diabetes Prevention Program Research Group. Diabetes Care 2002;25:2165-71
Wednesday, March 21, 12
Physical Activity Goal
Aerobic dance, bicycle riding, skating and swimmingMin of 3x/week (at least 10 min per session)Maximum of 75 min of strength training can be applied toward goalImportance of lifestyle activities discussed; cannot be applied toward goal
Diabetes Prevention Program Research Group. Diabetes Care 2002;25:2165-71
Wednesday, March 21, 12
High CV risk: exercise tolerance testSedentary: increase activity in 30-min increments over 5 weeks Active at baseline: not required to add further exercise (same 150-min weekly goal)
Participants can be more active than minimum goal in absence of medical contraindications
Wednesday, March 21, 12
Key Aspects of DPP Lifestyle Protocol
Diabetes Prevention Program Research Group. Diabetes Care 2002;25:2165-71
Individual case managers or “lifestyle
coaches”
Wednesday, March 21, 12
Key Aspects of DPP Lifestyle Protocol
Diabetes Prevention Program Research Group. Diabetes Care 2002;25:2165-71
Intensive ongoing
intervention
Initial core curriculum to achieve standardization of intervention
Wednesday, March 21, 12
DPP 16-session core curriculum
1 - Welcome to the Lifestyle Balance Program2 - Be a Fat Detective3 - Three Ways to Eat Less Fat4 - Healthy Eating
5 - Move Those Muscles6 - Being Active: A Way of Life7 - Tip the Calorie Balance8 - Take Charge of What’s Around You
Diabetes Prevention Program Research Group. Diabetes Care 2002;25:2165-71
Wednesday, March 21, 12
Self-monitoring fat and/or calorie intake
Diabetes Prevention Program Research Group. Diabetes Care 2002;25:2165-71
Daily for first 24 wks of the studyGiven food scale & measuring cups/spoons
Wednesday, March 21, 12
Self-monitoring physical activity
Diabetes Prevention Program Research Group. Diabetes Care 2002;25:2165-71
Daily for first 24 wks of the study
Wednesday, March 21, 12
DPP 16-session core curriculum
9 - Problem Solving10 - The Four Keys to Healthy Eating Out11 - Talk back to Negative Thoughts12 - The Slippery Slope of Lifestyle Change
13 - Jump Start Your Activity Plan14 - Make Social Cues Work for You15 - You Can Manage Stress16 - Ways to Stay Motivated
Diabetes Prevention Program Research Group. Diabetes Care 2002;25:2165-71
Wednesday, March 21, 12
Key Aspects of DPP Lifestyle Protocol
Diabetes Prevention Program Research Group. Diabetes Care 2002;25:2165-71
Intensive ongoing
intervention
Supervised exercise sessions offered at least 2 times/week throughout the trial
Wednesday, March 21, 12
Key Aspects of DPP Lifestyle Protocol
Diabetes Prevention Program Research Group. Diabetes Care 2002;25:2165-71
Intensive ongoing
intervention
Flexible maintenance program supplemental group classes, motivational campaigns and restart opportunities
Wednesday, March 21, 12
DPP After Core CurriculumMotivation
1 - Give Yourself Credit for Your Success2 - How Do Successful Weight Losers Do It?3 - A Tough Day, A Better Day4 - What If the Scale Doesn’t Budge
5 - If You Believe You Can’t Lose Weight6 - The Fight Against Flab7 - DPP Lifestyle Progress Summary8 - Decision Balance
http://www.bsc.gwu.edu/dpp/manuals.htmlvdoc
Wednesday, March 21, 12
Individualization through a
“tool box” of adherence strategies
Key Aspects of DPP Lifestyle Protocol
Diabetes Prevention Program Research Group. Diabetes Care 2002;25:2165-71
Wednesday, March 21, 12
http://www.flickr.com/photos/pasukaru76/4005076313/
Wednesday, March 21, 12
http://www.sxc.hu/photo/337742
Wednesday, March 21, 12
Materials and strategies that addressed the needs of an ethnically diverse population
Key Aspects of DPP Lifestyle Protocol
Diabetes Prevention Program Research Group. Diabetes Care 2002;25:2165-71
Wednesday, March 21, 12
Materials and strategies that addressed the needs of an ethnically diverse population
Key Aspects of DPP Lifestyle Protocol
Diabetes Prevention Program Research Group. Diabetes Care 2002;25:2165-71
Wednesday, March 21, 12
Materials and strategies that addressed the needs of an ethnically diverse population
Key Aspects of DPP Lifestyle Protocol
Diabetes Prevention Program Research Group. Diabetes Care 2002;25:2165-71
Wednesday, March 21, 12
Key aspects
DPP Lifestyle ProtocolAn extensive local and national network of training, feedback and clinical support
Diabetes Prevention Program Research Group. Diabetes Care 2002;25:2165-71
Wednesday, March 21, 12
Case Manager aka “Lifestyle Coach”
4-step Training Required reading
Manual of operations, participant notebook, manual for contacts after Core, book chapters and journal articlesVideotapes from previous lifestyle training programs
Observation of centrally trained personnelAudio taped practice session and lifestyle resource core review
http://www.bsc.gwu.edu/dpp/manuals.htmlvdoc
Wednesday, March 21, 12
Group Lifestyle BalanceTM Materialshttp://www.diabetesprevention.pitt.edu/glbmaterials.aspx
Diabetes Prevention Program Research Group. Diabetes Care 2002;25:2165-71
Wednesday, March 21, 12
US Model
The DPP Lifestyle Change Program
National Diabetes Prevention Program
DPP Lifestyle Balance
Diabetes Prevention Program (DPP)
Diabetes Prevention Program Outcomes Study
✔
✔
Wednesday, March 21, 12
Challenges to the Translation of Prevention Programs in the CommunityDavid Marrero, PhD
Screening is NOT routinely done to identify the patients most at risk for diabetes. Diabetes Prevention Summit
July 12, 2011Washington DC, USA
www.joslin.org/docs/Summit_executive_summary_8.11.11.pdf
Wednesday, March 21, 12
Challenges to the Translation of Prevention Programs in the CommunityDavid Marrero, PhD
There do NOT currently exist enough facilities in the US to adequately serve people where they to be identified as at-risk.
Diabetes Prevention SummitJuly 12, 2011
Washington DC, USA
www.joslin.org/docs/Summit_executive_summary_8.11.11.pdf
Wednesday, March 21, 12
Challenges to the Translation of Prevention Programs in the CommunityDavid Marrero, PhD
The source of funding is an ever-present challenge.
Diabetes Prevention SummitJuly 12, 2011
Washington DC, USA
www.joslin.org/docs/Summit_executive_summary_8.11.11.pdf
Wednesday, March 21, 12
Challenges to the Translation of Prevention Programs in the CommunityDavid Marrero, PhD
Our overall culture and environment does not support healthy lifestyle choices. Diabetes Prevention Summit
July 12, 2011Washington DC, USA
www.joslin.org/docs/Summit_executive_summary_8.11.11.pdf
Wednesday, March 21, 12
From the presentation of Dr. Ronald T. Ackermannwww.allhealth.org/.../Ackermannpresentation--doc-1824.ppt
Population-based Diabetes Prevention
Wednesday, March 21, 12
From the presentation of Dr. Ronald T. Ackermannwww.allhealth.org/.../Ackermannpresentation--doc-1824.ppt
Partnered Approach for Prevention
Wednesday, March 21, 12
From the presentation of Dr. Ronald T. Ackermannwww.allhealth.org/.../Ackermannpresentation--doc-1824.ppt
Group Delivery of DPP
Wednesday, March 21, 12
From the presentation of Dr. Ronald T. Ackermannwww.allhealth.org/.../Ackermannpresentation--doc-1824.ppt
Group Delivery of DPP
Wednesday, March 21, 12
Translating the DPP into the CommunityThe DEPLOY Pilot Study (YMCA)
Ackermann R et al. Am J Prev Med 2008;35(4):357-363
P: 92 with DM RF & random CBG 110-199 mg/dL
I: Brief counseling vs DPP-group intervention
O: Group differences in wt, chol, BP, HbA1c
M: Clustered randomized trial
Wednesday, March 21, 12
DEPLOY Pilot Study
Body weightIntervention: ⬇6% (95% CI 4.7, 7.3)
Control: ⬇2% (95% CI 0.6, 3.3)p<0.001
The YMCA: promising channel for wide-scale dissemination for low-cost approach
Ackermann R et al. Am J Prev Med 2008;35(4):357-363
Wednesday, March 21, 12
Healthy-Living Partnerships To Prevent Diabetes (HELP PD) Project
Community health workers (volunteers with well-controlled T2DM) Katula JA et al. Diabetes Care 2011;34(7):1451-7
P: 301 overweight/obese with FBS 95-125 mg/dL
I: Enhanced usual care vs DPP-group intervention
O: Mean FPG over 12 mos ff-up adjusted for baseline glucose
M: Randomized controlled trial
Wednesday, March 21, 12
HELP-PD Project
Intervention vs controlBlood glucose-4.3 vs -0.4 mg/dL, p<0.001Weight-7.1 vs -1.4 kg, p<0.001 Insulin-6.5 vs 2.7 uU/mL, p<0.001HOMA-1.9 vs -0.8, p<0.001
Katula JA et al. Diabetes Care 2011;34(7):1451-7
Wednesday, March 21, 12
Centers for Disease Control & Prevention (CDC)
National Diabetes Prevention Program
Public-private partnership of community organizations, private insurers, employers, health care organizations and government agencies
http://www.cdc.gov/diabetes/prevention/
Wednesday, March 21, 12
National Diabetes Prevention ProgramCOMPONENTS
Training: Increase WorkforceTrain the workforce that can implement the program cost e!ectively.
Recognition Program: sure Quality
Implement a recognition program that will:
a program registry.
Intervention Sites: Deliver Program
Health Marketing: Support Program
UptakeIncrease referrals to
prevention program.
http://www.cdc.gov/diabetes/prevention/
* Inagural partners: YMCA, USA and UnitedHealth Group
Wednesday, March 21, 12
Diabetes Training & Technical Assistance Center (DTTAC)http://www.cdc.gov/diabetes/prevention/dttac.htm
Master trainers will provide a fee-based, 2- day, face-to-face training for lifestyle coachesCurriculum adapted from the original DPP research materials for group deliveryOnline learning community at DTTAC website
Training: Increase WorkforceTrain the workforce that can implement the program cost e!ectively.
http://www.cdc.gov/diabetes/prevention/
Wednesday, March 21, 12
Diabetes Prevention Recognition Program (DPRP)http://www.cdc.gov/diabetes/prevention/recognition/index.htm
Organizations interested in offering the curriculum apply for recognitionWhy apply for recognition?
Assure potential participants of qualityMore likely to get health care provider referralsCDC offers technical assistance
Insurance companies more likely to reimburse recognized programs
Recognition Program: sure Quality
Implement a recognition program that will:
a program registry.
Wednesday, March 21, 12
National Diabetes Prevention ProgramCOMPONENTS
Training: Increase WorkforceTrain the workforce that can implement the program cost e!ectively.
Recognition Program: sure Quality
Implement a recognition program that will:
a program registry.
Intervention Sites: Deliver Program
Health Marketing: Support Program
UptakeIncrease referrals to
prevention program.
http://www.cdc.gov/diabetes/prevention/
* Inagural partners: YMCA, USA and UnitedHealth Group
Wednesday, March 21, 12
Download the free toolkit at http://ndep.nih.gov/publications
Copier-ready Game Plan Tools for Patients1. Small Steps. Big Rewards. Your GAME PLAN for Preventing Type 2 Diabetes2. Who Is at Risk for Type 2 Diabetes and Pre-diabetes?3. Walking ... A Step in the Right Direction4. Food and Activity Tracker
Wednesday, March 21, 12
US Model
The DPP Lifestyle Change Program
National Diabetes Prevention Program
DPP Lifestyle Balance
Diabetes Prevention Program (DPP)
Diabetes Prevention Program Outcomes Study
✔
✔
✔Wednesday, March 21, 12
!ank Y"http://www.endocrine-witch.net
Wednesday, March 21, 12