Pediatric Obesity Are diet and exercise enough

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Pediatric ObesityAre diet and exercise enough?

• Brina Boyle, Julie Hanselman, Julie Nevins,
• Melinda Rose, Teresa Wooten
• May 1, 2009
• University of Oklahoma College of Nursing
• N4134 The Practice of Leadership

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• For children with obesity, are diet and
• exercise alone as effective for weight
• loss as diet and exercise with
• medication as an adjunct treatment?

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Pediatric Obesity

• Population Adolescents, ages 12-19
• Intervention Medication as adjunct treatment to
  diet exercise
• Comparison Diet exercise alone
• Outcome Weight loss

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Obesity

• U.S. Surgeon General Richard Carmona, M.D. states
  obesity
• Greatest threat to public health
• Kills more people per year than
• AIDS
• all cancers
• all accidents combined

(American Medical Association (AMA), 2009)
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Pediatric Obesity Statistics

• Has tripled
• 5 to 17.6 from 1980-2006
• Over 9 million children are overweight/obese
• In 2000, estimated cost 117 billion
• (Centers for Disease Control, 2009)

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Childhood Obesity

• Current US estimates increase from
• 15.5 to 23.4
• European countries estimates increase from
• 8 to 21

(Chanione, J.P. et. al., 2005)
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• What has been done ?

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Effect of Orlistat on Weight and Body Composition
in Obese Adolescents

• Population
• n 539
• age12-16 years
• Int/Comp
• Orlistat 120 mg vs. placebo
• Prescribed three times daily for 52 wk
• Exercise, diet, behavior modification therapy

(Chanione, 2005)
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Outcomes of Orlistat

• 5 -10 decreased BMI
• Changes in fat mass
• lt2.61 kg than placebo
• Waist circumference decreased
• 1.33 cm in test group
• Placebo group ? 0.12 cm
• (Chanione, 2005)

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Outcomes

• At 12 wks both groups BMI decreased
• End of Study Orlistat group - 5-10 greater
  reduction in BMI than placebo group
• 190 of 539 participants dropped out
• 25 developed metabolic syndrome
• lt 3 of population had elevated blood pressure
• (Chanione, 2005)

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Risks

• Adverse Effects
• Abdominal discomfort/pain
• Steatorrhea, Oily spotting/evacuation
• Fecal Urgency
• Flatus with discharge

(Chanione, 2005)
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The Effects of Sibutramine on Energy Expenditure
Body Composition in Obese Adolescents

• Population n24, age12-17 years
• Int/Comp
• 12 week test period
• Sibutramine 10 mg vs. placebo every day
• Prescribed exercise diet
• 12 week follow-up period
• no medications
• Prescribed exercise diet

(Van Mil, 2009)
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Outcomes of Sibutramine

• BMI decreased equally in test control group
• During intervention
• Basal Metabolic Rate (BMR) ?? in placebo group
• During follow-up
• BMR
• - ? in test group
• - ? in control group

(Van Mil, 2009)
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Outcomes

• During intervention period
• No significant changes in body composition
• Follow-up period
• BMI ? in placebo group
• BMI ? in test group
• BMR ? in test group
• BMR ? in placebo

(Van Mil, 2009)
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Outcomes

• Four participants dropped out
• No statistically significant changes
• Heart rate
• Blood pressure

(Van Mil, 2009)
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Risks

• Adverse Effects
• ? blood pressure
• ?heart rate
• Abdominal complaints
• Dry mouth constipation
• Headache

(Berokowitz, 2006) (Budd, 2007) (Godoy-Matos,
2005) (McGovern, 2008)
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Weight Loss in Obese African American and
Caucasian Adolescents

• Population, age13-17 years
• n34 African American
• n45 Caucasian adolescents
• Int/Comp
• 6 month test period
• Wk 1 test control received placebo
• Wks 2, 3, 7 increasing dosages

(Budd, 2007)
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Outcomes of Study

• Caucasian test group
• ? weight loss than placebo group
• African American test group
• No significant difference between groups
• All groups lost weight
• More weight loss in test groups

(Budd, 2007)
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Outcomes

• All groups
• Significant reductions
• Glucose, lipid levels, cholesterol levels
• Cardio-metabolic risk factors
• Sibutramine
• ? weight loss

(Budd, 2007)
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Treatment of Pediatric Obesity A Systematic
Review Meta-Analysis of Randomized Trials

• 61 trials for the Meta-Analysis
• 76 trials for Systematic Review
• Population n unknown
• Int/Comp
• Sibutramine
• Orlistat
• Metformin

(McGovern, 2008)
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Outcomes

• Medication
• Long-term efficacy safety remains unclear
• Moderate treatment effect of exercise on
  adiposity
• No treatment effect on BMI
• Exercise and diet
• Small-to-moderate treatment effect on BMI

(McGovern, 2008)
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Pros in Literature Review

• Pharmacotherapy promotes behavior modification
• Sibutramine does not cause valvular abnormalities
• Adolescents with family-based weight loss
  treatments
• maintain their weight loss better
• Medication enhances weight loss
• Within 6-12 months

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Cons in Literature Review

• Treatment
• Notoriously difficult in adolescents
• Limited research
• Small sample sizes
• Lack of inter-ethnic comparisons
• Lack of studies comparing pharmacotherapies

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Cons in Literature Review

• Pharmacotherapy
• Limited studies in adolescent group
• Potential safety concerns
• Blood pressure ? 10 mmHg
• Pulse ? 10 bpm

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Summary Comparison

• Medications
• Sibutramine
• Overall weight loss greater than Orlistat
• Fewer GI side effects
• Orlistat
• Small to moderate effect on obesity outcomes
• ? GI side effects

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Summary Comparison

• Dietary Interventions
• Physical Activity Interventions
• Combined Lifestyle Interventions
• Targeting family
• Targeting children

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Group Recommendations for Adolescent Weight Loss

• Diet and exercise
• FIRST BEST choice
• Nutritional counseling
• Prescribed exercise regimen
• Parental/family involvement
• in weight control
• (Van Mil, 2009)
• (Budd, 2007)

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Group Recommendations for Adolescent Weight Loss

• Pharmacological Therapy
• Short term use only
• Frequent physician supervision
• Contraindicated in certain populations
• In conjunction with
• Behavior Modification
• Journaling
• Family Support
• Diet Exercise

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Methods for Evaluating Effectiveness

• Evaluations at baseline every 3 months
• Weight measurements
• Waist / hip circumference
• BMI
• Vital signs

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Methods for Evaluating Effectiveness

• Evaluations at baseline every 3 months
• Bone density
• EKG
• Labs

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Recommendations for Future Studies

• Diversified studies
• Ethnic groups
• Male vs. female
• Psychological developmental age
• Physical develop. adjustments for differences
• Familial involvement in therapy

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Recommendations for Future Studies

• Continued follow-up evaluations
• Standardized prescribed diet and exercise
• Long-term and longitudinal studies
• Larger sampling sizes

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Future Research Questions

• Are obese adolescents more responsive to
  Sibutramine than obese adults?
• Are there differences/similarities between ethnic
  groups?
• Is Sibutramine safe long-term?

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Future Research Questions

• Which participants will benefit most from
  pharmacotherapy?
• Does energy restriction in adolescents lead to
  decrease in energy expenditure or weight loss?

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• Questions???

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References

• Abbot Laboratories. (2007) Meridia. Retrieved on
  April 4, 2009 from the World Wide Web
  athttp//www.rxabbott.com/pdf/meridia.pdf.
• American Medical Association. (2009). Obesity.
  Retrieved April 3, 2009 from the World Wide Web
  at http//www.ama-assn.org/ama/pub/physician-resou
  rces/public-health/promoting-healthy-lifestyles/ob
  esity.shtml.
• Berkowitz, R., et.al (2006, July). Effects of
  Sibutramine treatment in obese adolescents A
  randomized
• trial. Annals of Internal Medicine. 145(2)
  81-W20 (11 pages).
• Budd, G.M. (2007). Weight Loss in Obese African
  American and Caucasian Adolescents. Journal of
  Cardiovascular Nursing. 22(4), 288-296.
• Centers for Disease Control and Prevention.
  (2009, April). Childhood obesity. Retrieved April
  4, 2009 from the World Wide Web at
  http//www.cdc.gov/healthyYouth/obesity/index.htm.
  
• Centers for Disease Control and Prevention.
  (2009, April) Obesity prevalence. Retrieved April
  3, 2009 from the World Wide Web at
  http//www.cdc.gov/nccdphp/dnpa/obesity/childhood/
  prevalence.htm.
• Centers for Disease Control and Prevention.
  (2007) The obesity epidemic and U.S. students.
  Retrieved April 3, 2009 from the World Wide Web
  at http//www.cdc.gov/HealthyYouth/yrbs/pdf/yrbs0
  7_us_obesity.pdf.

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References

• Chanione, J.P. et. al. ( 2005 June). Effect of
  Orlistat on weight and body composition in obese
  adolescents. Journal of American Medical
  Association. 293(23) 2873-2883.
• Godoy-Matos, A et.al. (2005, March). Treatment
  of obese adolescents with Sibutramine A
  randomized, double-blind, controlled study. The
  Journal of Endocrinology Metabolism. 90(3)
  1460-1465.
• McGovern, L. et. al (2008, December). Treatment
  of pediatric obesity A systematic review and
  meta-analysis of randomized trials. Journal of
  Clinical Endocrinology Metabolism. 93(12)
  4600-4605.
• Myers, T. (2005). Mosbys nursing drug reference.
  St Louis Elsevier.
• Speiser, P.W. et. al (2005). Consensus
  statement Childhood obesity. The Journal of
  Clinical Endocrinology Metabolism. 90(3),
  1871-1887.
• Van Mil, E.G. et.al. (2009, April). The effect
  of Sibutramine on energy expenditure and body
  composition in obese adolescents. The Journal of
  Endocrinology and Metabolism. 92(4) 1409-1414.