1. Primary-Care Oriented Obesity Management: Readiness to change and weight reduction in urban medically underserved patients Kelley W. Carroll, MD Assistant Professor Family and Community Medicine University of Texas at Houston School of Medicine

2. Objectives 1. Participants will be able to understand the impact of obesity in different populations. 2. Participants will be able to understand the importance of obesity screening and treatment in the primary care setting. 3. Participants will be able to assess an obese patient’s readiness to change. 4. Participants will be able to develop group visits for management of obesity.

3. Obesity Epidemic

4. Obesity trends and gender Incidence of obesity in women is 35.5% Incidence of obesity in women is 35.5% Prevalence of obesity has stabilized for women over the past 10 years Prevalence of obesity has stabilized for women over the past 10 years Incident of obesity in men is 32.2% Incident of obesity in men is 32.2% Prevalence of obesity has stabilized for men over the past 5 years Prevalence of obesity has stabilized for men over the past 5 years Causes of stabilization unclear Causes of stabilization unclear Greater public awareness of dangers of obesity? Greater public awareness of dangers of obesity? Greater insurance coverage for bariatric surgery? Greater insurance coverage for bariatric surgery? Flegal et al. “Prevalence and Trends in Obesity Among US Adults, 1999-2008” JAMA. 2010. vol 303. No 3.

5. Obesity and ethnicity Adults with BMI > 30 Adults with BMI >40 AllWhitesBlacksHispanics 33.9%32.8%44.1%37.9% AllWhitesBlacksHispanics5.7%5.2%11.1%5.7% Flegal et al. “Prevalence and Trends in Obesity Among US Adults, 1999-2008” JAMA. 2010. vol 303. No 3. hildren with BMI>95%ile are highest in: Children with BMI>95%ile are highest in: Mexican boysMexican boys non-Hispanic black girlsnon-Hispanic black girls

6. Obesity and Socioeconomic status (SES)  Women of lower SES are 50% more likely to be obese.  There is no difference in men.  White adolescents from lower income families are more overweight than those from higher income families.  The difference is less certain in blacks and Hispanics. Obesity Prevalence among low-income, preschool-aged children – US 1998-2008. MMWR Weekly 2009. 58 (28). The Surgeon General's Call To Action To Prevent and Decrease Overweight and Obesity, 2007

7. Cause of obesity disparities The higher rates of obesity in the poor and in ethnic minorities due to multiple factors : Lower cost of high fat, high sugar, energy dense foods Lower cost of high fat, high sugar, energy dense foods Urbanization Urbanization High concentrations of poor-quality retail food establishments in disadvantaged areas High concentrations of poor-quality retail food establishments in disadvantaged areas Reduction in physical activity Reduction in physical activity Lack of knowledge of proper nutrition Lack of knowledge of proper nutrition Drewnowski, A. et al. Poverty and obesity: the role of energy density and energy costs. American Journal of Clinical Nutrition, Vol. 79, No. 1, 6- 16, January 2004 Ford PB et al. Disparities in obesity prevalence due to variation in the retail food environment: three testable hypotheses. Nutr Rev. 2008 Apr;66(4):216-28.

8. Obesity Solution Eat less Move more

9. Obesity Treatments Lifestyle changes Lifestyle changes Calorie restriction Calorie restriction Addition of exercise/physical activity Addition of exercise/physical activity Most studies show 3-5kg weight loss over 1 year Most studies show 3-5kg weight loss over 1 year Cognitive behavioral therapy Cognitive behavioral therapy Addition of CBT improves weight loss compared to diet and exercise alone Addition of CBT improves weight loss compared to diet and exercise alone Meal replacement Meal replacement Commercially available energy-reduced, vitamin/mineral fortified Commercially available energy-reduced, vitamin/mineral fortified Meta-analysis showed twice the weight loss when compared to calorie restricted diets alone Meta-analysis showed twice the weight loss when compared to calorie restricted diets alone Pharmacologic agents Pharmacologic agents Orlistat, sibutramine Orlistat, sibutramine Similar weight loss to diet and exercise Similar weight loss to diet and exercise Surgical approaches Surgical approaches limited to patients with BMI >40 or >35 with co-morbidities limited to patients with BMI >40 or >35 with co-morbidities Gastric bypass, vertical gastroplasty, adjustable gastric banding Gastric bypass, vertical gastroplasty, adjustable gastric banding >100kg weight loss possible over 1 year >100kg weight loss possible over 1 year McTingue, K et al.“Screening and Interventions for Obesity in Adults.” USPSTF 2004 Heymsfield, SB et al. “Weight management using a meal replacement strategy: meta and pooling analysis form six studies.” International Journal of Obesity Related Metabolic Disorders. 2003 may;27 (5): 537-47

10. USPSTF recommendations for obesity screening and treatment Screen all adult patients for obesity Screen all adult patients for obesity Grade: B Recommendation B RecommendationB Recommendation Screen children aged 6 years and older for obesity (BMI over 95%ile) Screen children aged 6 years and older for obesity (BMI over 95%ile) Grade: B Recommendation. Grade: B Recommendation.B RecommendationB Recommendation Offer high intensity counseling and behavioral interventions for obese adults. Grade: B Recommendation. Offer high intensity counseling and behavioral interventions for obese adults. Grade: B Recommendation.B RecommendationB Recommendation Offer or refer moderate to high intensity interventions for obese children. Offer or refer moderate to high intensity interventions for obese children. Grade: B recommendation B recommendationB recommendation The evidence is insufficient to recommend for or against the use of moderate- or low-intensity counseling together with behavioral interventions to promote sustained weight loss in obese adults. Grade: I Statement. The evidence is insufficient to recommend for or against the use of moderate- or low-intensity counseling together with behavioral interventions to promote sustained weight loss in obese adults. Grade: I Statement.I StatementI Statement The evidence is insufficient to recommend for or against the use of counseling of any intensity and behavioral interventions to promote sustained weight loss in overweight adults or children. Grade: I Statement. The evidence is insufficient to recommend for or against the use of counseling of any intensity and behavioral interventions to promote sustained weight loss in overweight adults or children. Grade: I Statement.I StatementI Statement

11. Behavioral Obesity Treatments High intensity counseling High intensity counseling At least 2 visits per month for 3 months or >75 hours in 6 month period At least 2 visits per month for 3 months or >75 hours in 6 month period Limited by lack of time, resources, reimbursement Limited by lack of time, resources, reimbursement Effective in adult and children Effective in adult and children Moderate intensity counseling Moderate intensity counseling Monthly visits or 26-75 hours in 6 month period Monthly visits or 26-75 hours in 6 month period Insufficient evidence for adults per USPSTF Insufficient evidence for adults per USPSTF Effective in children Effective in children Low intensity counseling Low intensity counseling Less than once a month or less than 25 hours in 6 months period Less than once a month or less than 25 hours in 6 months period Insufficient evidence for adults and children per USPSTF Insufficient evidence for adults and children per USPSTF

12. Study hypothesis Primary-care oriented weight loss interventions promote readiness to change and weight reduction in the medically underserved. Primary-care oriented weight loss interventions promote readiness to change and weight reduction in the medically underserved. Clinical questions: Clinical questions: Is a low-moderate intensity intervention of longer duration is as effective as a moderate-high intensity intervention of a shorter duration? Is a low-moderate intensity intervention of longer duration is as effective as a moderate-high intensity intervention of a shorter duration? Does the direct involvement of a physician improve the effectiveness of weight management programs? Does the direct involvement of a physician improve the effectiveness of weight management programs?

13. Limitations of care for the underserved Underserved and uninsured patients have limited access to expensive pharmacologic and surgical interventions Underserved and uninsured patients have limited access to expensive pharmacologic and surgical interventions Primary care treatment for the underserved must focus on behavioral and educational interventions Primary care treatment for the underserved must focus on behavioral and educational interventions Nutrition education Nutrition education meal planning with food groups meal planning with food groups portion control portion control Physical activity promotion Physical activity promotion Stress reduction, coping skills Stress reduction, coping skills

14. Readiness to change  The motivational state relative to changing a specific behavior  Based on the trans-theoretical model of behavior change developed by Prochaska and DiClemente in the 1980s  A major factor in determining success of behavioral interventions  5 stages of change: 1. Pre-contemplation 2. Contemplation 3. Preparation 4. Action 5. Maintenance

15. Assessing readiness to change How ready are you to lose weight? Pre-contemplation: “I am not thinking about losing weight.” Contemplation: “I am thinking about losing weight.” Preparation: “I am planning and making a commitment to lose weight.” Action: “I am currently losing weight.” Maintenance: “I have met my weight loss goal.”

16. Outcome measures Improvement in readiness to change Improvement in readiness to change Reduction in weight Reduction in weight Reduction in waist circumference Reduction in waist circumference Improvement in co-morbid conditions such as diabetes, hypertension, and hyperlipidemia Improvement in co-morbid conditions such as diabetes, hypertension, and hyperlipidemia

17. Study design Conducted at community health centers in the Harris County Hospital District, Houston Texas Conducted at community health centers in the Harris County Hospital District, Houston Texas From 2007 to 2009, patients recruited to attend 1 of 2 weight management programs: From 2007 to 2009, patients recruited to attend 1 of 2 weight management programs: weight management classes weight management classes weight management group visits weight management group visits Due to financial and resource restraints, patients were not randomized, but chose program based on preference and availability Due to financial and resource restraints, patients were not randomized, but chose program based on preference and availability

18. Inclusion Criteria BMI greater than 30 kg/m2 BMI greater than 30 kg/m2 Eligible to receive services at the Harris County Hospital District Eligible to receive services at the Harris County Hospital District Age 18 or over Age 18 or over Evaluation and referral by PCP Evaluation and referral by PCP

19. Weight management class Held every week for 9 weeks Held every week for 9 weeks Available in English and Spanish Available in English and Spanish Occurred at 5 community health centers Occurred at 5 community health centers Taught by trained health educators Taught by trained health educators 2-hour sessions 2-hour sessions Set curriculum Set curriculum

20. Group visits Groups visit were held monthly for 6 months Groups visit were held monthly for 6 months Collaborative approach Collaborative approach Led by a family physician Led by a family physician Assisted by RN and health educator Assisted by RN and health educator Focus on monthly goal setting Focus on monthly goal setting Calorie reduction through portion control Calorie reduction through portion control plate method plate method carbohydrate counting carbohydrate counting Monthly topics set by participants Monthly topics set by participants

21. Advantages of group visits Allow physicians to see patients with similar problems at once Allow physicians to see patients with similar problems at once Improves physician productivity Improves physician productivity Provide patients with peer interaction and support Provide patients with peer interaction and support

22. Format of group visit 8:30 - 9:00Individual physician visit Readiness to change questionnaire Review of food log Measurements 9:00 - 9:30Review of diet/exericise guidelines 9:30 - 10:00Goal setting (diet, exercise, personal) 10:00 – 10:20Group discussion of monthly topic 10:00 – 10:20Group discussion of monthly topic 10:20 - 10:30Group discussion next month’s topic

23. Study demographics Weight Management Program (n=169) Group Visit (n=51) Completers (n=55) Non-completers (n=114) Completers (n=19) Non-completers (n=32) Age, mean (SD), year52.31 (11.36)46.89 (11.43)47.95 (11.33)44.25 (11.92) Female sex, %96.491.394.791.9 Race, % Black White Hispanic Other 65.5 14.5 20.0 0 55.8 11.6 26.7 1.2 68.4 10.5 15.8 5.3 66.7 7.8 19.6 5.9 BMI,kg/m241.341.942.741.2

24. Demographics WMGV The completers and non-completers did not differ on gender, race, age, BMI, waist, hip, or readiness to change The completers and non-completers did not differ on gender, race, age, BMI, waist, hip, or readiness to changeAWMP Completers are significantly older than non- completers. Completers are significantly older than non- completers. Likely due to intensity of program and conflict with job schedules Likely due to intensity of program and conflict with job schedules Completers had significantly higher importance levels than non-completers. Completers had significantly higher importance levels than non-completers. The completers and non-completers did not differ on gender, race, BMI, waist, hip, or readiness to change The completers and non-completers did not differ on gender, race, BMI, waist, hip, or readiness to change

25. Results: Adult weight management program Outcome measure Change in value P value Readiness to change t 0.380.002 Weight (lb) -6.830.008 Waist circumference (in) -1.200.001 t pre-contemplation = 1, contemplation = 2, preparation = 3, action = 4, maintenance = 5

26. Results: Adult weight management program Improvement in readiness to change significantly correlated with weight loss (p<.01) Improvement in readiness to change significantly correlated with weight loss (p<.01) As patients moved from preparation to action, they lost weight. As patients moved from preparation to action, they lost weight. Increased BMI correlated with decreased readiness to change (p=.022) Increased BMI correlated with decreased readiness to change (p=.022) If patient gained weight on the program, they lost confidence and moved from action to preparation or contemplation. If patient gained weight on the program, they lost confidence and moved from action to preparation or contemplation. Gender and readiness to change were significantly correlated (p=.05) Gender and readiness to change were significantly correlated (p=.05) Men tended to have more improvement in readiness to change than women. Men tended to have more improvement in readiness to change than women.

27. Results: Weight management group visit Outcome measure Change in value P value Readiness to change 0.370.02 Weight (lb) -3.080.04 Waist circumference (in) -1.590.011

28. Results: Weight management group visit Improvement in readiness to change significantly correlated with weight loss Improvement in readiness to change significantly correlated with weight loss (p<.01) As patients moved from preparation to action, weight decreased As patients moved from preparation to action, weight decreased Being in action phase at baseline correlated with correlated with weight gain (p=.04) Being in action phase at baseline correlated with correlated with weight gain (p=.04) They may have thought that they were losing weight but they really were not They may have thought that they were losing weight but they really were not Perception did not match reality Perception did not match reality “Plateau Effect” “Plateau Effect” Confidence dropped as they failed to see rapid results Confidence dropped as they failed to see rapid results

29. Group comparison Seventeen of the AWMP completers could be matched to 17 of the WMGV completers Seventeen of the AWMP completers could be matched to 17 of the WMGV completers There were no significant differences between the two matched groups based on amount of change in weight, or readiness to change from pre- to post- time points There were no significant differences between the two matched groups based on amount of change in weight, or readiness to change from pre- to post- time points

30. Post-study focus group All group visit participants were invited to participate in a focus group to explore barriers to weight loss All group visit participants were invited to participate in a focus group to explore barriers to weight loss 9 out of 51 attended 9 out of 51 attended 4 barriers to weight loss: 4 barriers to weight loss: 1. Stress: inability to cope, self-soothing with food 2. Time: Lack of time to exercise or prepare healthy meals 3. Mental problems: depression 4. Medications: insulin, TZDs

31. Conclusion A monthly group office visits and weekly weight management class are effective in promoting readiness to change and weight reduction. A monthly group office visits and weekly weight management class are effective in promoting readiness to change and weight reduction. The weight loss is statistically significant, but not clinically significant The weight loss is statistically significant, but not clinically significant Post intervention mean BMI still above 40 Post intervention mean BMI still above 40 Direct involvement of a physician does not necessarily improve the effectiveness of weight management programs Direct involvement of a physician does not necessarily improve the effectiveness of weight management programs

32. Limitations of study Not randomized Not randomized No true control group No true control group Poor attendance and completion rates Poor attendance and completion rates Post intervention weights done by chart review for AWMP group Post intervention weights done by chart review for AWMP group Data on co-morbid factors not completed Data on co-morbid factors not completed

33. Comparison to recent study ORBIT: ORBIT: Obesity Reduction Black Intervention Trial Obesity Reduction Black Intervention Trial A study of black women with mean weight of 104kg A study of black women with mean weight of 104kg Intervention group showed statistically significant weight loss of 3kg at 6 month Intervention group showed statistically significant weight loss of 3kg at 6 month Slight weight gain (0.4kg) in control group at 6 months Slight weight gain (0.4kg) in control group at 6 months Weight regain in both groups at 18 months, although less in intervention group Weight regain in both groups at 18 months, although less in intervention group Fitzgibbon ML et al. “Obesity Reduction Black Intervention Trial (ORBIT): 18-Month Results.” Obesity. 2010 Mar 18

34. Future research This cohort of patients will be followed over the next 5 years to examine: 1. Readiness to change over time 2. Long-term weight trends 3. Changes in co-morbidities

35. Obesity in the underserved Where do we go from here? Focus on areas where we can help Focus on areas where we can help Weight maintenance rather than weight loss Weight maintenance rather than weight loss Optimal management of co-morbid factors Optimal management of co-morbid factors Hypertension Hypertension Diabetes Diabetes Hyperlipidemia Hyperlipidemia Increase intensity of intervention Increase intensity of intervention Add telephone contact on weekly or biweekly basis by multi-disciplinary team Add telephone contact on weekly or biweekly basis by multi-disciplinary team Addition of meal replacements to high intensity intervention Addition of meal replacements to high intensity intervention Davis, LM. Efficacy of a meal replacement diet plan compared to a food-based diet plan after a period of weight loss and weight maintenance: a randomized controlled trial.” Journal of Nutrition. 2010 Mar 11:9 (1):11

36. Where do we go from here? Focus on pediatric population Focus on pediatric population Screening for BMI 85-94%ile (at-risk) and >95%ile (overweight) Screening for BMI 85-94%ile (at-risk) and >95%ile (overweight) Appropriate treatment Appropriate treatment Referral to high intensity programs Referral to high intensity programs Address obesity as a public health problem Address obesity as a public health problem Need for public health solutions Need for public health solutions