1. Conservative Interventions for Treatment of Overweight and Obesity in Children Deanna M. Hoelscher, PhD, RD, LD, CNS University of Texas Houston Health Science Center School of Public Health Human Nutrition Center/Center for Health Promotion & Prevention Research November 16, 2005

2. Outline of Talk Definitions & prevalence of child overweight Why use conservative approaches? Different methods –Diet Protein Sparing Modified Fasts (PSMF) –Physical activity –Behavioral treatments –Use of pharmacologic agents Conclusions/Recommendations

3. Overview of Child Overweight and Interventions Overweight is defined as > 95 th percentile based on CDC BMI chart At risk of Overweight is defined as > 85 th but 85 th but < 95 th percentile based on BMI charts The prevalence of overweight among children varies by gender and race/ethnicity The prevalence of overweight is not a normal distribution, with skew to heavier weights Primary aim of overweight interventions is energy balance (energy intake versus energy expenditure) Very little data on preschool children Practice is not evidence-based (not enough data)

4. How Do Children Differ From Adults with Regard to Weight Loss? Reliance on parents as gatekeepers for food and physical activity Consideration of growth and development from a biological standpoint Cognitive/emotional development Degree of overweight School environment Concern for eating disorders Critical periods of adiposity increase (adiposity rebound, puberty) Source: Kirk et al., 2005

5. Rationale for Conservative Approaches to Child Overweight Traditional view: –Overweight in children is benign or cosmetic –Children will “grow out” of overweight –Treatment paradigm: Keep weight stable and let “grow into weight” Weight loss, if any, should be modest so as to not affect growth and development Use diet primarily, together with physical activity and behavioral counseling

6. Weight Gain for Children at the 75 th Percentile from Age 6.5 to 18.5 Source: CDC weight charts, Butte & Ellis, 2003 OW = overweight, N = normal wt OW/OW N/OW N/N

7. Rationale for Conservative Approaches to Child Overweight Current view: –Overweight in children is associated with both morbidity & mortality –Obesity in childhood leads to increased risk for severe obesity in adulthood Child BMI tracks over time –With children at extreme weights (e.g., BMI >35), “growing into weight” is not an option –Treatment paradigms need to change Source: Dietz, 2004; Kirk et al., 2005; Baker et al., 2005; Kelder et al., 1994

8. How Growth and Weight Relate in Children over Time If a boy is age… and weighs an excess of …… lbs over his tracking percentile (75 th ), he cannot “grow into his weight” 6.5 115.1 lbs 10.5 83 lbs 12.5 59.3 lbs 14.5 33.4 lbs 16.5 12.3 lbs Source: CDC weight charts

9. Determination of Energy Intake in Children To lose weight, need to determine how much change in energy intake Difficult to determine energy intake in growing children Estimates from Butte & Ellis, Science, 2003: –Deficit of about 300 kcal/day to prevent further weight gain in overweight children (range: 204-263 kcal/d) –Equates to 2, 12-oz sweetened beverages –Equates to walking about 60-120 minutes/day Source: Butte & Ellis, 2003

10. Conservative Interventions: Overview of Behavior Modification, Diet and Physical Activity Programs Many diet and physical activity programs have behavior modification component Most programs have all three components: behavior modification, diet and physical activity Studies to date have mostly been conducted in clinic settings

11. Conservative Interventions: Diets in Children Definition: Regulation of food intake either through change in macronutrient composition (e.g., fat, CHO content) or reduction in energy intake Duration of treatment (in trials with adolescents): several weeks to 3 years Maintenance of effects: Limited data Compliance: Varies Side effects: With Protein-Sparing Modified Fast (PSMF), protein losses, hypokalemia, hypoglycemia, inadequate calcium intake and orthostatic hypotension Source: Baker et al., 2005; Kirk et al., 2005

12. Conservative Interventions: Diets in Children Weight loss achieved: 1-2 kg (2.2-4.4 pounds)/week, up to 1 kg/week with diet alone Pros: Safe for more moderate diets Cons: Usually involves a parent, costly, long- term, limited data on effectiveness, side effects for PSMF Diets with altered macronutrient content (e.g., low glycemic load diets, low carbohydrate diets) have only been evaluated in small trials for limited periods of time. Source: Baker et al., 2005; Kirk et al., 2005

13. Example - Stop Light/Traffic Light Diet Uses traffic light colors to characterize foods: –Green: low-calorie, high fiber foods, no restrictions –Yellow: essential foods, but because of higher nutrient density, eaten in moderation –Red: high in fat and/or simple sugars, limit to < 4 servings/d Energy goals: 900-1300 kcal/d Record all food and drinks Adapted in various forms Follows U.S. Dietary Guidelines where appropriate Source: Epstein & Squires, 1988

14. Promising Direction? Reduced Carbohydrate/Glycemic Load Diets Ebbeling et al., 2003 –RCT, 6 month intervention and 6 month follow-up, n = 16 obese adolescents, aged 13-21 –Emphasized selection of foods with low to moderate GI, 30-35% energy from fat versus low-fat, 25 to 30% energy from fat –Difference of 2 kg/m 2 Spieth et al., 2000 –Retrospective cohort, n = 107 obese children, mean age about 10, mean length of time = 4 months –Low-GI diet versus standard reduced fat diet –Difference of 1.12 kg/m 2 and 2.6 kg Summary: relatively small studies, eliminate sugared beverages, sweets

15. Protein-Sparing Modified Fast (PSMF) PSMF: around 1/5 g pro/kg IBW For children, usually need a hospital stay, vitamins/minerals, K, calcium Involves consistent monitoring of ketones Gradual re-introduction of carbohydrates Limited period of time (usually 3 months or less) In one study with 8 adolescents (age 11-18), mean weight loss of 13.5 kg over 5 weeks Published trials with children – few subjects, no RCTs Source: Brown et al., 1983; Merritt et al., 1981; Stallings et al., 1988

16. Conservative Interventions: Physical Activity/Sedentary Activity Interventions in Children Definition: Programs designed to promote adolescent weight loss by increasing activity or decreasing sedentary behavior Duration of treatment (in trials with adolescents): 3 months to 54 weeks (30- 60 minutes/day for 3-7 days/week) Maintenance of effects: No data Compliance: Varies Source: Gutin et al., 2002; Owens et al., 1999; Epstein et al., 1995

17. Conservative Interventions: Physical Activity/Sedentary Activity Interventions in Children Weight loss achieved: Difficult to quantify Pros: Easier to maintain than diet over time, builds on usual child activities Cons: Safety issues, time and money if parent is involved, sedentary activities are self-reinforcing Source: Gutin et al., 2002; Owens et al., 1999; Epstein et al., 1995

18. Examples of Physical Activity and/or Sedentary Activity Interventions Owens et al., 1999 –74 obese children (by TSF), 7-11 years old –4 months training, 5 days/week, 40 min/day –Significant decrease in visceral adipose tissue (VAT) & total body fat mass (BMI not reported) Gutin et al., 2002 –80 obese (TSF), 13-16 years old –8 month intervention, 5 days/week, 30 min/day –Significant decrease in VAT & % body fat –No differences between moderate and high intensity exercise

19. Conservative Interventions: Use of Behavior Modification in Children Definition: Use of behavior modification strategies & counseling techniques (e.g., goal setting, stimulus control, etc.) in modifying dietary habits, physical activity patterns, addressing underlying psychological issues related to food and physical activity Duration of treatment (in trials with adolescents): 1 session to 3 years (most are 4-6 months to 1 year) Maintenance of effects: Follow up studies (1-10 years) show some maintenance effects Compliance: Varies Source: Coates & Thoresen, 1978; Baker et al., 2005; Kirk et al., 2005

20. Conservative Interventions: Use of Behavior Modification in Children Side effects: Few Weight loss achieved: 4-15 pounds Pros: Safe Cons: Costly, long-term, personnel intensive, results are not consistent, involve considerable family involvement Source: Coates & Thoresen, 1978; Baker et al., 2005; Kirk et al., 2005

21. Examples of Successful Behavioral Interventions Epstein work (Epstein et al.,1994, 1998, 1995) –4 RCTs, n = 154 OW children, ages 6-12, 6 month treatment –Involvement of parents (family counseling) Intensive family counseling not otherwise described –Long-term effects 30% no longer overweight after 10 years (5 years and 10 years) –Cons: specialized population (mostly white), omitted population with “psychological problems”

22. School-Based Overweight Tertiary Prevention Interventions Author Study Population Intervention Type DurationResults Lansky, 1983 (RCT) 114 OW junior high D, PA, B (45-min group/wk with PE teacher) 12 weeks ↓ wt & % OW Brownell, 1982 77 OW 5-12 y D, PA, B (behavior mod with nutr., PE, meals) 10 weeks ↓ % OW & ↑ wt loss Foster, 1985 84 OW 2-5 th grade D, PA, B (3 sessions/wk with 8 th gr peer counselors) 12 weeks ↓ wt, ↓ % OW Chang, 1998 270 OW 9-12 y D (Nutrition ed sessions, daily records) 13 weeks ↓ RI Sasaki, 1987 60 OW 11 y PA (special exercise class 20 m 7x/week) 2 yr ↓ % obesity index

23. Promising Direction? Weight Loss Camps Kirschenbaum DS, Craig R. Wellspring camps (North Carolina, California, New York), ages 10-23 –www.wellspringcamps.com www.wellspringcamps.com Camps include diet, physical activity, behavioral therapy 4 x/week, family program, After-Care program online Preliminary results- NAASO abstracts, 2005 –Mean weight loss = 1.78 kg/week –Weight loss continued during 6 month follow-up Source: Kirschenbaum et al., Obesity Res, 2005;13

24. Conservative Interventions: Use of Weight Loss Drugs in Children Definition: Use of pharmacotherapy to lose excess body weight Duration of treatment (in trials with adolescents): 3 months to 54 weeks Maintenance of effects: No data Compliance: For Orlistat, over 54 weeks, 65% remained in study Side effects: Range from HTN to loose stools to risk of fat-soluble vitamin deficiency Source: Molnar, 2005; Chanoine et al., 2005; Berkowitz et al., 2003

25. Conservative Interventions: Use of Weight Loss Drugs in Children Weight loss achieved: mean difference of 2.61 kg weight change between placebo & control for orlistat (1-2 lbs/wk) Pros: Consistent weight loss, little parental involvement, little behavioral change necessary Cons: Long term safety has not been evaluated, side effects Other drugs proposed, including metformin Most pharmacologic regimes work best in combination with behavioral diet and physical activity changes Source: Molnar, 2005; Chanoine et al., 2005; Berkowitz et al., 2003; Freemark & Bursey, 2001

26. Drugs Currently Approved for Treatment of Obesity in Adults & Children in the U.S. Generic name Mechanism Side effects PhendimetrazineNoradrenergic Palpitations, tachycardia, insomnia, HTN, dry mouth, constipation BenzphetamineNoradrenergicSame DiethylpropionNoradrenergicSame PhentermineNoradrenergicSame Sibutramine Noradrenergic & seotoninergic HTN, tachycardia, headache, insomnia, dry mouth, constipation Orlistat* GI lipase inhibitor Loose stools, increased defecation, oily discharge, fecal urgency, def. of fat-soluble vitamins Source: Molnar, 2005 * Approved for use in children in 2003

27. Drug Studies in Adolescents Orlistat –Chanoine et al., JAMA 2005:293:2873-2883 –Multicenter, 54-week RCT, double blind, n = 539 obese adolescents, BMI > 2 units above 95 th percentile, 12-16 years old –120- mg dose of orlistat, plus mildly hypocaloric diet (30% kcal from fat), exercise, behavioral therapy –Results: Difference in 0.86 BMI units (2.61 kg) 35% attrition

28. Drug Studies in Adolescents Sibutramine –Berkowitz et al., JAMA 2003;289:1805-1812 –RCT, double-blind (n = 82, 13-17 year olds, BMI = 32-44), 6 months, then open label for additional 6 months –Family-based behavioral program with sibutramine versus behavioral treatment –Difference of 4.6 kg between groups

29. Conclusions There are limited data on obesity treatment and/or prevention studies conducted using preschool children. Pharmacologic treatment has been evaluated on adolescents only (ages 12 and older). Behavior modification programs that target diet and physical activity have been evaluated and are effective in children younger than 12, but need family involvement. Increases in physical activity and decreases in sedentary activity are promising intervention strategies.

30. Conclusions Children with extreme BMI/weight or have associated morbidity associated with overweight may need to engage in more aggressive interventions than those presented here. Currently, conservative interventions are not complemented by a supportive environment for food availability and physical activity in most schools and communities.

31. Acknowledgements Steve Kelder, MPH, PhD Denny Bier, MD, PhD William Klish, MD Kristi King, MPH, RD Tom Baranowski, PhD Children’s Nutrition Research Center, Baylor College of Medicine, Houston, TX

32. Contact Information Deanna M. Hoelscher, PhD, RD, LD Associate Professor University of Texas-Houston School of Public Health 1200 Herman Pressler, RAS W942 Houston, TX 77030 713.500.9335 713.500.9329 (fax) Deanna.M.Hoelscher@uth.tmc.edu Deanna.M.Hoelscher@uth.tmc.edu Website for SPAN survey: http://www.sph.uth.tmc.edu/hnc/SPANproject/SPAN%20Home.htm http://www.sph.uth.tmc.edu/hnc/SPANproject/SPAN%20Home.htm

33. References Chanoine et al. Effect of orlistat on weight and body composition in obese adolescents. JAMA 2005;293:2873-2883. Berkowitz et al., Behavior therapy and sibutramine for the treatment of adolescent obesity. JAMA 2003;289:1805-1812. Freemark M & Bursey D. The effects of metformin on body mass index and glucose tolerance in obese adolescents with fasting hyperinsulinemia and a family history of type 2 diabetes. Pediatrics 2001;107:55.

34. References Ebbeling et al. A reduced-glycemic load diet in the treatment of adolescent obesity. Arch Pediatr Adolesc Med 2003;157:773-779. Spieth et al. A low-glycemic index diet in the treatment of pediatric obesity. Arch Pediatr Adolesc Med 2000;154:947-951. Gutin et al., Effects of exercise intensity on cardiovascular fitness, total body composition, and visceral adiposity of obese adolescents. Am J Clin Nutr 2002;75:818-826.

35. References Owens et al. Effect of physical training on total and visceral fat in obese children. Med Sci Sports Exercise 1999;31:143-148. Kirk et al., Pediatric obesity epidemic: treatment options. J Am Diet Assoc. 2005;105:S44-S51. Baker et al., Overweight children and adolescents: A clinical report of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. JPGN 2005;40:533-543. Coates TJ & Thoresen CE. Treating obesity in children and adolescents: A review. Am J Public Health 1978:68:143-151.

36. References Brown et al., A high protein, low calorie liquid diet in the treatment of very obese adolescents: long-term effect on lean body mass. Am J Clin Nutr 1983;38:20-31. Stallings et al., One-year follow-up of weight, total body potassium, and total body nitrogen in obese adolescents treated wth the protein- sparing modified fast. Am J Clin Nutr. 1988;48:91-94. Merritt et al. Consequences of modified fasting in obese pediatric and adolescent patients: effect of a carbohydrate-free diet on serum proteins. Am J Clin Nutr. 1981;34:2752-2755.

37. References Butte N & Ellis K. Comment on “Obesity and the environment: Where do we go from here?” Science. 2003;301:598b. Epstein et al. Ten-year follow-up of behavioral family-based treatment for obese children. JAMA 1990;264:2519-2523. Epstein et al. Ten-year outcomes of behavioral family-based treatment for childhood obesity. Health Psychol. 1994;13:373-383. Epstein et al., Treatment of pediatric obesity. Pediatrics. 1998;101:554-570.

38. References Epstein et al., Do children lose and maintain weight easier than adults: A comparison of child and parent weight changes from six months to 10 years. Obesity Res. 1995;3:411-417. Epstein LH & Squires S. The Stoplight Diet for Children. Toronto, CA: Little, Brown & Company, 1988. Dietz WH. Overweight in childhood and adolescence. NEJM 2004;350:855-857

39. References Molnar D. New drug policy in childhood obesity. Int J Obes 2005;29:S62-S65. Kirschenbaum et al. The first significant weight losses during a follow-up period in an evaluation of weight loss camps for young people: Highly consistent self- monitoring at Wellspring Camps predicts even better long term results. Obes Res. 2005;13:A205.