Translating the DPP Results to Address the NNHeS Challenge

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

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21 March 2012

Wednesday, March 21, 12

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The DPP Lifestyle Change Program

National Diabetes Prevention Program

DPP Lifestyle Balance

Diabetes Prevention Program (DPP)

Diabetes Prevention Program Outcomes Study

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

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

>7% weight loss: healthy, low-calorie, low-fat diet

Moderate intensity physical activityi.e. brisk walking >150 min/week

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.

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]

Bridge Phase1-2 week drug wash-outUnmasked to treatment assignments Group-administered version of Lifestyle Balance for all

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

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%)

Cumulative incidence of diabetes during three study phases

Cumulative incidence of diabetes remained lowest in lifestyle group

1 2 3 4 5 6 7 8 9 10Years since DPP randomization

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Lifestyle Balancehttp://www.bsc.gwu.edu/dpp/manuals.htmlvdoc

Overview of strategies to achieve goalsProfessional resourcesOptional materials for participants464 pages!

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.

Key Aspects of DPP Lifestyle ProtocolClearly defined weight loss and physical activity goals

Diabetes Prevention Program Research Group. Diabetes Care 2002;25:2165-71

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

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

Key Aspects of DPP Lifestyle Protocol

Individual case managers or “lifestyle

coaches”

Intensive ongoing

intervention

Initial core curriculum to achieve standardization of intervention

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

Self-monitoring fat and/or calorie intake

Daily for first 24 wks of the studyGiven food scale & measuring cups/spoons

Self-monitoring physical activity

Daily for first 24 wks of the study

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

Intensive ongoing

intervention

Supervised exercise sessions offered at least 2 times/week throughout the trial

Intensive ongoing

intervention

Flexible maintenance program supplemental group classes, motivational campaigns and restart opportunities

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

Individualization through a

“tool box” of adherence strategies

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Materials and strategies that addressed the needs of an ethnically diverse population

Key aspects

DPP Lifestyle ProtocolAn extensive local and national network of training, feedback and clinical support

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

Group Lifestyle BalanceTM Materialshttp://www.diabetesprevention.pitt.edu/glbmaterials.aspx

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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

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

The source of funding is an ever-present challenge.

Diabetes Prevention SummitJuly 12, 2011

Washington DC, USA

Our overall culture and environment does not support healthy lifestyle choices. Diabetes Prevention Summit

July 12, 2011Washington DC, USA

From the presentation of Dr. Ronald T. Ackermannwww.allhealth.org/.../Ackermannpresentation--doc-1824.ppt

Population-based Diabetes Prevention

Partnered Approach for Prevention

Group Delivery of DPP

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

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

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

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

Centers for Disease Control & Prevention (CDC)

Public-private partnership of community organizations, private insurers, employers, health care organizations and government agencies

http://www.cdc.gov/diabetes/prevention/

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.

* Inagural partners: YMCA, USA and UnitedHealth Group

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

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

a program registry.

National Diabetes Prevention ProgramCOMPONENTS

a program registry.

Intervention Sites: Deliver Program

Health Marketing: Support Program

UptakeIncrease referrals to

prevention program.

* Inagural partners: YMCA, USA and UnitedHealth Group

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

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✔Wednesday, March 21, 12

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Translating the DPP Results to Address the NNHeS Challenge

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