Managing Overweight and Obesity in Adults Systematic Evidence Review From the Obesity Expert Panel, 2013 Contents Foreword ...........................................................................................................................................xiii Overweight and Obesity Expert Panel ............................................................................................... xv Section 1: Background and Description of the NHLBI Cardiovascular Risk Reduction Project ........... 1 A. Background .............................................................................................................................. 1 B. Overview of the Evidence-Based Methodology ........................................................................ 2 C. Scope of the Problem ............................................................................................................... 3 D. History ...................................................................................................................................... 5 E. Critical Questions on Overweight and Obesity ......................................................................... 6 i. Critical Questions on Weight-Related Health Risks and Benefits of Weight Loss ............... 6 ii. Critical Questions on Treatments for Overweight and Obesity ............................................ 6 F. Challenges of Achieving Weight Loss in Primary Care Practice ............................................... 7 Section 2: Process and Methods Overview ....................................................................................... 8 A. Overview of Evidence-Based Methodology .............................................................................. 8 i. System for Grading the Body of Evidence .......................................................................... 9 ii. Peer-Review Process ....................................................................................................... 10 B. Critical Question-Based Approach ......................................................................................... 11 i. Critical Questions on Overweight and Obesity .................................................................. 11 Section 3: Critical Question 1 .......................................................................................................... 13 A. Statement of the Question ...................................................................................................... 13 i. By Population Subgroups ................................................................................................. 13 ii. By Amount of Weight Loss ............................................................................................... 14 iii. By Weight Loss Maintenance ........................................................................................... 14 B. Selection of the Inclusion/Exclusion Criteria ........................................................................... 14 C. Introduction and Rationale for Question and Inclusion/Exclusion Criteria ............................... 16 D. Methods for Critical Question 1 .............................................................................................. 16 E. Evidence Statements and Summaries.................................................................................... 18 i. Weight Loss and Risk for Diabetes: Spreadsheets 1.1.–1.4b. ........................................ 18 F. Weight Loss and Impact on Cholesterol/Lipid Profile—Spreadsheet 1.5a–1.5c. ..................... 22 G. Weight Loss and Hypertension Risk—Spreadsheets 1.6a–f. .................................................. 25 H. Gaps in Evidence and Future Research Needs ...................................................................... 27 Section 4: Critical Question 2 .......................................................................................................... 28 A. Statement of the Question ...................................................................................................... 28 i. Subgroup Analyses .......................................................................................................... 28 B. Selection of the Inclusion/Exclusion Criteria ........................................................................... 29 C. Introduction and Rationale for Question and Inclusion/Exclusion Criteria ............................... 31 D. Methods for Critical Question 2 .............................................................................................. 32 E. Evidence Statements and Summaries.................................................................................... 35 i. BMI Cutpoints and CVD-Related Risk .............................................................................. 36 ii. Waist Circumference Cutpoints and CVD-Related Risk .................................................... 43 F. Gaps in Evidence and Future Research Needs ...................................................................... 45 Section 5: Critical Question 3 .......................................................................................................... 48 A. Statement of the Question ...................................................................................................... 48 B. Selection of the Inclusion/Exclusion Criteria ........................................................................... 48 C. Introduction and Rationale for Question and Inclusion/Exclusion Criteria ............................... 50 MANAGING OVERWEIGHT AND OBESITY IN ADULTS: SYSTEMATIC EVIDENCE REVIEW FROM THE OBESITY EXPERT PANEL, 2013 iii D. Methods for Critical Question 3 .............................................................................................. 51 E. Evidence Statements and Summaries.................................................................................... 53 F. Overall Dietary Intervention and Composition—Summary Table 3.1 ...................................... 53 i. Creating Reduced Dietary Energy Intake ......................................................................... 53 ii. Diets of Differing Forms and Structures (Macronutrient Content, Carbohydrate and Fat Quality, Nutrient Density, Amount of Energy Deficit, Dietary Pattern) or Other Dietary Weight Loss Strategies (e.g., Meal Timing, Portion-Controlled Meal Replacements) ................................................................................................................. 55 iii. Pattern of Weight Loss Over Time With Dietary Intervention ............................................ 56 G. Low-Fat Approaches—Summary Table 3.2 ............................................................................ 57 H. Higher Protein (25 to 30 Percent of Energy) Approaches—Summary Table 3.3 ..................... 58 I. Low-Carbohydrate (<30g/Day) Approaches—Summary Table 3.4 ......................................... 59 J. Complex Versus Simple Carbohydrates—Summary Table 3.5 .............................................. 60 K. Glycemic Load Dietary Approaches—Summary Table 3.6 ..................................................... 60 L. Dietary Pattern (Mediterranean Style and Vegetarian and Other Dietary Pattern) Approaches—Summary Table 3.7 ......................................................................................... 61 M. Meal Replacements and Adding Foods to Liquid Diets—Summary Table 3.8 ........................ 63 N. Very Low-Calorie Diet Approaches—Summary Table 3.9 ...................................................... 63 O. Gaps in Evidence and Future Research Needs ...................................................................... 64 Section 6: Critical Question 4 .......................................................................................................... 66 A. Statement of the Question ...................................................................................................... 66 B. Selection of the Inclusion/Exclusion Criteria ........................................................................... 66 C. Introduction and Rationale for Question and Inclusion/Exclusion Criteria ............................... 68 i. A Dictionary of Lifestyle Intervention Terms...................................................................... 69 ii. Comprehensive Lifestyle Intervention ............................................................................... 69 iii. Intervention Delivery ......................................................................................................... 69 iv. Intervention Intensity ........................................................................................................ 70 v. Intervention Duration ........................................................................................................ 70 vi. Individual Versus Group Intervention ................................................................................ 70 vii. Trained Interventionist ...................................................................................................... 70 viii. Trials of Weight Loss Induction Versus Maintenance of Lost Weight ................................ 70 D. Methods for Critical Question 4 .............................................................................................. 71 E. Evidence Statements and Summaries.................................................................................... 74 i. Introduction of Evidence Statements ................................................................................ 74 F. Diet, Physical Activity, and Behavior Therapy Components in High-Intensity, Onsite Lifestyle Interventions—Summary Tables 4.1a–c ................................................................... 75 G. Comprehensive Interventions Compared With Usual Care, Minimal Care, or No-Treatment Control—Summary Tables 4.2a–d .................................................................. 76 H. Efficacy/Effectiveness of Electronically Delivered, Comprehensive Interventions in Achieving Weight Loss—Summary Tables 4.3a–n ................................................................. 78 I. Efficacy/Effectiveness of Comprehensive, Telephone-Delivered Lifestyle Interventions in Achieving Weight Loss—Summary Tables 4.4a–b ............................................................. 80 J. Efficacy/Effectiveness of Comprehensive Weight Loss Programs in Patients Within a Primary Care Practice Setting Compared With Usual Care—Summary Tables 4.5a–f ........... 80 K. Efficacy/Effectiveness of Commercial-Based, Comprehensive Lifestyle Interventions in Achieving Weight Loss—Summary Table 4.6a ....................................................................... 81 L. Efficacy/Effectiveness of Very Low-Calorie Diets Used as Part of a Comprehensive Lifestyle Intervention in Achieving Weight Loss—Summary Tables 4.7a–c ............................ 82 iv MANAGING OVERWEIGHT AND OBESITY IN ADULTS: SYSTEMATIC EVIDENCE REVIEW FROM THE OBESITY EXPERT PANEL, 2013 M. Efficacy/Effectiveness of Comprehensive Lifestyle Interventions in Maintaining Lost Weight—Summary Tables 4.8a–e .......................................................................................... 83 N. Characteristics of Lifestyle Intervention Delivery That May Affect Weight Loss: Intervention Intensity—Summary Tables 4.9a–f ..................................................................... 85 O. Characteristics of Lifestyle Intervention Delivery That May Affect Weight Loss or Weight Loss Maintenance: Individual Versus Group Treatment—Summary Tables 4.1a–c ............. 87 P. Characteristics of Lifestyle Intervention Delivery That May Affect Weight Loss or Weight Loss Maintenance: Onsite Versus Electronically Delivered Interventions—Summary Tables 4.10a–j ....................................................................................................................... 87 Q. Gaps in Evidence and Future Research Needs ...................................................................... 88 Section 7: Critical Question 5 .......................................................................................................... 90 A. Statement of the Question ...................................................................................................... 90 i. Efficacy ............................................................................................................................ 90 ii. Predictors ......................................................................................................................... 90 iii. Complications ................................................................................................................... 91 B. Selection of the Inclusion/Exclusion Criteria ........................................................................... 92 C. Introduction and Rationale for Question and the Inclusion/Exclusion Criteria ......................... 95 i. Bariatric Surgical Procedures ........................................................................................... 96 ii. Currently Used Procedures .............................................................................................. 97 iii. Investigational Procedures ............................................................................................... 99 D. Methods for Critical Question 5 .............................................................................................. 99 E. Evidence Statements and Summaries.................................................................................. 101 i. Component 1: Efficacy—Summary Table 5.1 ............................................................... 101 ii. Component 2: Predictors—Patient Characteristics—Summary Table 5.2 and Types of Surgery—Summary Table 5.3 .......................................................................... 107 iii. Component 3: Complications—Summary Table 5.4 ..................................................... 109 iv. Summary ........................................................................................................................ 113 F. Gaps in Evidence and Future Research Needs .................................................................... 113 Appendixes Appendix A: Detailed Methods Applying to All Critical Questions ............................................ A–1 Appendix B: Question-Specific Methods ................................................................................. B–1 Appendix C: Spreadsheets and Summary Tables ................................................................... C–1 Critical Question 1 ............................................................................................................... C–1 Critical Question 2 ............................................................................................................. C–21 Critical Question 3 ............................................................................................................. C–38 Critical Question 4 ............................................................................................................. C–88 Critical Question 5 ........................................................................................................... C–157 Appendix D: Abbreviations and Acronyms .............................................................................. D–1 Appendix E: Names of Studies ............................................................................................... E–1 References ............................................................................................................................... R–1 MANAGING OVERWEIGHT AND OBESITY IN ADULTS: SYSTEMATIC EVIDENCE REVIEW FROM THE OBESITY EXPERT PANEL, 2013 v List of Figures Figure 1. Trends in Overweight, Obesity, and Extreme Obesity Among Adults Aged 20 to 74 years: United States, 1960–1962 Through 2009–2010 ................................................................ 4 Figure 2. The 1998 Clinical Guidelines: Classification of Overweight and Obesity by BMI, Waist Circumference, and Associated Disease Risk ...................................................................... 5 Figure 3. PRISMA Diagram Showing Selection of Articles for Critical Question 1 ............................ 18 Figure 4. PRISMA Diagram Showing Selection of Articles for Critical Question 2 ............................ 33 Figure 5. PRISMA Diagram Showing Selection of Articles for Critical Question 3 ............................ 52 Figure 6. PRISMA Diagram Showing Selection of Articles for Critical Question 4 ............................ 73 Figure 7. Vertical Banded Gastroplasty ........................................................................................... 97 Figure 8. Roux-en-Y Gastric Bypass ............................................................................................... 97 Figure 9. Laparoscopic Adjustable Gastric Banding ......................................................................... 98 Figure 10. Biliopancreatic Diversion With or Without Duodenal Switch ............................................ 98 Figure 11. Sleeve Gastrectomy ....................................................................................................... 99 Figure 12. PRISMA Diagram Showing Selection of Articles for Critical Question 5 ........................ 100 Figure B–1. PRISMA Diagram Showing Selection of Articles for CQ1 ........................................... B–8 Figure B–2. PRISMA Diagram Showing Selection of Articles for CQ2 ......................................... B–13 Figure B–3. PRISMA Diagram Showing Selection of Articles for CQ3 ......................................... B–19 Figure B–4. PRISMA Diagram Showing Selection of Articles for CQ4 ......................................... B–26 Figure B–5. PRISMA Diagram Showing Selection of Articles for CQ5 ......................................... B–32 List of Tables Table 1. Evidence Quality Grading System...................................................................................... 10 Table 2. Criteria for Selection of Publications for CQ1 ..................................................................... 14 Table 3. Criteria for Selection of Publications for CQ2 ..................................................................... 30 Table 4. Criteria for Selection of Publications for CQ3 ..................................................................... 48 Table 5. Criteria for Selection of Publications for CQ4 ..................................................................... 66 Table 6. Criteria for Selection of Publications for CQ5 ..................................................................... 92 Table A–1. Quality Assessment Tool for Controlled Intervention Studies ....................................... A–6 Table A–2. Quality Assessment Tool for Systematic Reviews and Meta-Analyses ...................... A–11 Table A–3. Quality Assessment Tool for Cohort and Cross-Sectional Studies ............................. A–14 Table A–4. Quality Assessment Tool for Case-Control Studies ................................................... A–21 Table A–5. Quality Assessment Tool for Before-After (Pre-Post) Studies With No Control Group ...................................................................................................................................... A–27 Table A–6. Quality Assessment Tool for Case Series Studies ..................................................... A–31 Table A–7. Evidence Quality Grading System ............................................................................. A–34 Table B–1. Examples of Simple Queries ....................................................................................... B–1 Table B–2. Attributes, Their Values, and Explanation .................................................................... B–2 Table B–3. Common Macro Queries Used in Search Strategies.................................................... B–2 Table B–4. Criteria for Selection of Publications for CQ1 ............................................................... B–8 Table B–5. Criteria for Selection of Publications for CQ2 ............................................................. B–13 Table B–6. Criteria for Selection of Publications for CQ3 ............................................................. B–20 Table B–7. Criteria for Selection of Publications for CQ4 ............................................................. B–27 Table B–8. Criteria for Selection of Publications for CQ5 ............................................................. B–33 Table B–9. CQ1 Studies Rated Fair or Good ............................................................................... B–36 Table B–10. CQ1 Studies Rated as Poor With Rationale............................................................. B–38 Table B–11. CQ2 Studies Rated Fair or Good ............................................................................. B–40 Table B–12. CQ2 Studies Rated as Poor With Rationale............................................................. B–41 Table B–13. CQ3 Studies Rated Fair or Good ............................................................................. B–43 vi MANAGING OVERWEIGHT AND OBESITY IN ADULTS: SYSTEMATIC EVIDENCE REVIEW FROM THE OBESITY EXPERT PANEL, 2013 Table B–14. CQ3 Studies Rated Poor With Rationale ................................................................. B–44 Table B–15. CQ4 Studies Rated Fair or Good ............................................................................. B–50 Table B–16. CQ4 Studies Rated Poor With Rationale ................................................................. B–54 Table B–17. CQ5 Studies Rated Fair or Good ............................................................................. B–63 Table B–18. CQ5 Studies Rated Poor With Rationale ................................................................. B–65 List of Spreadsheet Tables Spreadsheet 1.1. Effect of Weight Loss From Lifestyle Interventions in Patients With Diabetes on Blood Glucose and HbA1c .................................................................................................... C–1 Spreadsheet 1.2. Effect of Weight Loss From Lifestyle Interventions in Persons at Risk for Developing Diabetes (Prediabetes) on Risk for Converting to Type 2 Diabetes ......................... C–3 Spreadsheet 1.3. Effect of Intentional Weight Loss From Lifestyle Interventions in Patients With or Without Diabetes on Mortality ........................................................................................ C–5 Spreadsheet 1.4a. Effect of Weight Loss From Orlistat Interventions in Patients With Diabetes on Blood Glucose and HbA1c .................................................................................................... C–5 Spreadsheet 1.4b. Effect of Weight Loss From Orlistat Interventions in Patients at Risk for Diabetes on Blood Glucose and HbA1c ..................................................................................... C–6 Spreadsheet 1.5a. Effect of Weight Loss on Serum Lipids: Lifestyle Interventions ...................... C–7 Spreadsheet 1.5b. Effect of Weight Loss on Serum Lipids: Orlistat Interventions ...................... C–10 Spreadsheet 1.5c. Effect of Weight Loss on Serum Lipids: Diabetes Subjects .......................... C–12 Spreadsheet 1.6a. Weight Loss and Hypertension Risk: Orlistat Trials, All Subjects ................. C–14 Spreadsheet 1.6b. Weight Loss and Hypertension Risk: Orlistat Trials, Diabetes Subjects ....... C–16 Spreadsheet 1.6c. Weight Loss and Hypertension Risk: Hypertension Subjects ....................... C–17 Spreadsheet 1.6d. Weight Loss and Hypertension Risk: Lifestyles Trials, All Subjects ............. C–18 Spreadsheet 1.6e. Weight Loss and Hypertension Risk: Lifestyles Trials, Diabetes Subjects ... C–19 Spreadsheet 1.6f. Weight Loss and Hypertension Risk: Lifestyles Trials, Hypertension Subjects ................................................................................................................................... C–20 Spreadsheet 2.1. Study Descriptives ........................................................................................... C–21 Spreadsheet 2.2.1a. Combined Fatal and Nonfatal CHD—Results for BMI ................................. C–25 Spreadsheet 2.2.1b. Fatal CHD—Results for BMI ....................................................................... C–25 Spreadsheet 2.2.2a. Combined Fatal and Nonfatal Stroke—Results for BMI............................... C–26 Spreadsheet 2.2.2b. Fatal Stroke—Results for BMI..................................................................... C–29 Spreadsheet 2.2.3a. Combined Fatal and Nonfatal CVD—Results for BMI ................................. C–30 Spreadsheet 2.2.3b. Fatal CVD—Results for BMI ....................................................................... C–30 Spreadsheet 2.2.4. Incident Diabetes—Results for BMI .............................................................. C–31 Spreadsheet 2.2.5. Overall Mortality—Results for BMI ................................................................ C–32 Spreadsheet 2.3.1. Combined Fatal and Nonfatal CHD—Results for Waist Circumference ......... C–35 Spreadsheet 2.3.2. Combined Fatal and Nonfatal Stroke—Results for Waist Circumference ...... C–35 Spreadsheet 2.3.3. Combined Fatal and Nonfatal CVD—Results for Waist Circumference ......... C–36 Spreadsheet 2.3.4. Overall Mortality—Results for Waist Circumference ...................................... C–36 Spreadsheet 2.3.5. Incident Diabetes—Results for Waist Circumference .................................... C–37 List of Summary Tables Summary Table 3.1. Overall Dietary Intervention and Composition ............................................. C–38 Summary Table 3.2. Low-Fat Approaches ................................................................................... C–52 Summary Table 3.3. Higher (25–30% of Energy) Protein Approaches......................................... C–60 Summary Table 3.4. Low Carbohydrate Approaches (<30 g/day for at least a period)................. C–70 MANAGING OVERWEIGHT AND OBESITY IN ADULTS: SYSTEMATIC EVIDENCE REVIEW FROM THE OBESITY EXPERT PANEL, 2013 vii Summary Table 3.5. Complex Versus Simple Carbohydrates ..................................................... C–73 Summary Table 3.6. Glycemic Load Dietary Approaches ............................................................ C–74 Summary Table 3.7. CQ3—Dietary Patterns (Mediterranean Style and Vegetarian and Other Dietary Pattern Approaches) .................................................................................................... C–76 Summary Table 3.8. Meal Replacements and Adding Foods to Liquid Diets ............................... C–83 Summary Table 3.9. Very Low-Calorie-Diet (VLCD) Approaches ................................................ C–85 Summary Table 4.1. Diet, Physical Activity, and Behavior Therapy Components in High-Intensity,* Onsite Lifestyle Interventions .......................................................................... C–88 Summary Table 4.1a. Weight Loss Trials Compared With Usual Care, Minimal Care, or No Care Control Interventions: Outcome Data at 6 Months or Less as First Time Period Reporting ................................................................................................................................. C–88 Summary Table 4.1b. Weight Loss Trials Compared With Usual Care, Minimal Care, or No Care Control Interventions: Outcome Data at Greater Than 6 Months as First Time Period Reporting ................................................................................................................................. C–92 Summary Table 4.1c. Weight Loss Trials Compared With Usual Care, Minimal Care, or No Care Control Interventions: Outcome Data at Greater Than 12 Months as First Time Period Reporting ................................................................................................................................. C–94 Summary Table 4.2. Evidence for the Comprehensive Interventions Compared With Usual Care, Minimal Care, or No-Treatment Control .......................................................................... C–95 Summary Table 4.2a. Weight Loss Trials Compared With Usual Care, Minimal Care, or No Care Control Interventions: Outcome Data at 6 Months or Less as First Time Period Reporting ................................................................................................................................. C–95 Summary Table 4.2b. Weight Loss Trials Compared With Usual Care, Minimal Care, or No Care Control Interventions: Outcome Data at Greater Than 6 Months as First Time Period Reporting ................................................................................................................................. C–99 Summary Table 4.2c. Weight Loss Trials Compared With Usual Care, Minimal Care, or No Care Control Interventions: Outcome Data at Greater Than 12 Months as First Time Period Reporting ............................................................................................................................... C–101 Summary Table 4.2d. Comprehensive Interventions Compared to Other Comprehensive Intervention That Varied the Physical Activity or Behavior Therapy Component: Outcome Data at 6 Months or Less as the First Time Period Reported ................................................. C–102 Summary Table 4.3. Efficacy/Effectiveness of Electronically Delivered, Comprehensive Interventions in Achieving Weight Loss .................................................................................. C–105 Summary Table 4.3a. Compared With Usual Care, Minimal Control, or No Intervention (Includes Self-Directed): Electronic Text Messaging—Outcome Data at 6 Months or Less as First Time Period Reporting .............................................................................................. C–105 Summary Table 4.3b. Compared With Usual Care, Minimal Control, or No Intervention (Includes Self-Directed): Electronic Internet—Outcome Data at 6 Months or Less as First Time Period Reporting ........................................................................................................... C–105 Summary Table 4.3c. Compared With Usual Care, Minimal Control, or No Intervention (Includes Self-Directed): Electronic Internet—Outcome Data at Greater Than 6 Months as First Time Period Reporting ................................................................................................... C–107 Summary Table 4.3d. Compared With Usual Care, Minimal Control, or No Intervention (Includes Self-Directed): Electronic Internet—Outcome Data at Greater Than 12 Months as First Time Period Reporting ................................................................................................... C–107 Summary Table 4.3e. Compared with Other Comprehensive Electronic Interventions: Electronic Internet—Outcome Data at 6 Months or Less as First Time Period Reporting ....... C–107 Summary Table 4.3f. Compared with Other Comprehensive Electronic Interventions: Electronic Internet—Outcome Data at Greater Than 6 Months as First Time Period Reporting ............................................................................................................................... C–108 Summary Table 4.3g. Compared with Other Comprehensive Electronic Interventions: Electronic Internet—Outcome Data at Greater Than 12 Months as First Time Period Reporting ............................................................................................................................... C–109 viii MANAGING OVERWEIGHT AND OBESITY IN ADULTS: SYSTEMATIC EVIDENCE REVIEW FROM THE OBESITY EXPERT PANEL, 2013
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