1. AIRLIE Hypertension Study Automated Intervention to Reduce Lifestyle Impact on Emerging Hypertension

2. Investigative Team  Principal Investigator  Judith McCalla, PhD  Co-Investigators  Ali Ahmed, MD  Shawna Ehlers, PhD  Kevin Everett, PhD  Paula Rhode, PhD  Tracy Riley, PhD, RN  Consultants  Karina Davidson, PhD  Judy Ockene, PhD  Walter Ambrosius, PhD  Francois Lesperance, MD

3. Background: Hypertension (HTN) and Pre-HTN  HTN/high BP: >140/90 mm Hg or current Tx with anti-hypertensives  Affects ~50M or 1/4 th of all US adults  HTN: Independent risk factor for multiple CVD  High normal BP: Also independent risk factor  Pre-HTN: SBP 120-139/ DBP 80-89 mmHg  Significance: Healthy lifestyles could lower progression of pre-HTN to HTN

4. Significance of Pre-HTN  Incidence of HTN increases with age  New JNC-VII guidelines identify pre- hypertensive category  Adoption and maintenance of healthier lifestyle may reduce BP in pre- hypertensive persons and reduce incidence of HTN

5. Modifiable Risk Factors for HTN  Excess body weight  Reduced physical activity  Excess dietary sodium intake  Inadequate intake of fruits, vegetables, and potassium  Excess alcohol intake

6. Prevalence of Risk Factors for HTN  Overweight or obesity alone affects 122 million Americans  80% of Americans live sedentary lives w/o any regular physical activity  Over 75% do not consume > 5 servings of fruits and vegetables/day

7. Background Literature  Lifestyle Modification: Lower BP  Weight loss  Increased physical activity  Decreased alcohol consumption  Adherence to DASH (Dietary Approaches to Stop Hypertension  E.g., 1600 mg sodium DASH eating plan might be as effective as single drug therapy in lowering BP in some individuals

8. Multiple Risk Factors  Risk factors for HTN are often intertwined  Combination of multiple lifestyle modifications might be more effective than single lifestyle modification  However, multi-factor interventions may be complicated by low adherence

9. Objectives  Primary Aim  Test the efficacy of a patient-centered lifestyle intervention in reducing systolic BP in a sample of pre-hypertensive, overweight adults compared to usual care control at 6-months  Secondary Aims  Test the efficacy of a lifestyle intervention in reducing the onset of HTN in pre-hypertensive, overweight adults over an 18 month period  Reduce weight in lifestyle intervention group compared to usual care control

10. Design  Design – multi-site, parallel 2-arm RCT  Population  Overweight and slightly obese adults who meet JNC-VII guidelines for pre-hypertension  Innovation  Multi-factor behavioral intervention  Telephone expert system  Patient-centered

11. Inclusion Criteria  BMI: 25-35 Kg/m 2  BP: 120-139/80-89 mmHg  18-70 years of age  English/Spanish Speaking

12. Exclusion Criteria  Hx of HTN  CV diagnosis/event  severe psychiatric illness including MDD  Neuro-cognitive impairment  Pregnant/potential pregnancy  Alcohol/Drug dependency  Concurrent medications significantly impacting BP or experimental meds

13. Study Protocol  Recruitment  mass mailing  media announcements  community-based events  Prescreening  Prescreened for BP and BMI  Fact sheet provided  Scheduled for clinic screening

14. Study Protocol  Screening  Informed consent  Baseline Measures  Clinic BP  BMI/Body Fat Index  Waist Circumference  Co-morbidity Index

15. Study Protocol  Baseline Measures, continued  Lifestyle Inventory Block Food Frequency Questionnaire International Physical Activity Questionnaire Alcohol Consumption (> 14 drinks per week) Smoking Status (salivary cotinine)  Psychosocial Measures Prime MD SF-36 BDI

16. Randomization  Enrollment and Randomization  One week post screen  Off-site blocked randomization  Computer stratified randomization  Clinic  Race

17. Follow-up Assessment  Follow up  3 months abbreviated assessment  Only BP, weight, body fat analysis  6, 12, 18 month repeated assessment of baseline measures

18. Experimental and Control Groups  Usual Care Group Overview  One time meeting with behavioral coach  Review pamphlet regarding risk factors and encourage participant to follow it  Give refrigerator magnet as a reminder of the study  Tell participant of upcoming assessments

19. Experimental and Control Groups  Lifestyle Intervention Group Overview  Interactive Telephone Expert System  Patient-centered  Multi-factor behavioral

20. Experimental and Control Groups  Lifestyle Intervention Group Overview  Initial meeting with behavioral coach Discuss health assessment results Assist in selecting 3 components to work on either simultaneously or sequentially for next 6 months Introduce Interactive Telephone Expert System Remind participant of upcoming assessments Give refrigerator magnet as a reminder of the study

21. Design – Patient-Centered Lifestyle Intervention  Health Risk Assessment  Recommended Components  Physical Activity  Low Sodium Diet  DASH Diet (↑ fruits & veggies; ↓ fat & calories)  Stop Smoking  Reduce Alcohol Consumption  Stress Management  Participant Selection of 3 Components

22. Participant Contact during Study Month 0Community pre-screening; clinic screening; baseline assessment; randomization. Month 1Week 2 in-person telephone contact by case manager. Troubleshoot if necessary, schedule Month 3 appointment visit. Intervention Group Only: Home visit by case manager if participant has not yet accessed expert system. Month 2Week 5 study newsletter mailed to all participants. Month 3Month 3 appointment reminder call. Month 3 appointment and assessment. Schedule Month 6 appointment visit. Month 4Study newsletter mailed to all participants. Month 5In-person telephone contact by case manager. Month 6Month 6 appointment reminder call. Month 6 appointment and assessment. Schedule Month 12 appointment visit. Month 9Study newsletter mailed to all participants. Month 12Month 12 appointment reminder call. Month 12 appointment and assessment. Schedule Month 18 appointment visit. Month 18Month 18 appointment reminder call. Month 18 appointment and assessment.

23. Staff Training  Training  Expert Consultation Workshop at Airlie for all study related staff/investigators/site coordinators  Recruitment, consent, enrollment protocol  Data Collection  Blood pressure, waist circumference: Inter-rater reliability >.80  Database management

24. Staff Training  Manuals  Behavioral Coach  Participants  Data Collectors  Site Coordinators/Staff  Procedure

25. Design – Data Collection and Quality Control  Subject casebooks  Random checks of procedure completeness  Forms  Depression symptom monitoring  Follow-up of patients who haven ’ t accessed system > 1 week  Monthly site meetings  Quarterly inter-rater reliability site checks  Quarterly PI meetings  Annual and study end reports

26. Data Analysis  Power Analysis  N= 852/ group  90% Power  Assumptions  2-sided test at the 5% level  Difference of 1.7mmHg (PREMIER, 2003)  SD of 9.7mmHg (PREMIER, 2003)  20% attrition

27. Data Analysis  Primary Analysis  Mixed Model, adjust for baseline, unstructured covariance  Secondary Analysis 1  Generalized Estimating Equation, unstructured correlation  Secondary Analysis 2  Mixed Model, adjust for baseline, unstructured, time X treatment interaction

28. Organization  Clinical sites  Data Coordinating Center  University of Miami  DSMB Criteria and Development  Adverse event reporting guidelines  Termination policies

29. Time for Questions

30. AIRLIE Hypertension Study Automated Intervention to Reduce Lifestyle Impact on Emerging Hypertension