Therapeutics
In overweight or obese patients with diabetes, a lifestyle intervention increased weight loss at 8 years
The Look AHEAD Research Group. Eight-year weight losses with an intensive lifestyle intervention: the Look AHEAD study. Obesity (Silver Spring). 2014;22:5-13.
Clinical impact ratings: F ★★★★★✩✩ e ★★★★★✩✩ Question
*Information provided by author.
In obese or overweight patients with type 2 diabetes mellitus, does an intensive lifestyle intervention increase weight loss at 8 years?
†See Glossary.
Methods Design: Randomized controlled trial (RCT) (Look Action for Health for Diabetes [Look AHEAD] trial). ClinicalTrials.gov NCT00017953. Allocation: {Concealed}*.† Blinding: Blinded† ({data collectors}* and outcome assessors). Follow-up period: 8 years. Setting: 16 research centers in the USA. Patients: 5145 adults 45 to 76 years of age (mean age 59 y, mean body mass index [BMI] 36.0 kg/m2, 60% women, 63% nonHispanic White, 16% African American, 13% Hispanic/Latino) who had type 2 diabetes and a BMI ≥ 25 kg/m2 or ≥ 27 kg/m2 if using insulin. Intervention: Intensive lifestyle intervention (ILI) (n = 2570) or diabetes support and education (DSE) (n = 2575). ILI comprised 6 months of 3 weekly group and 1 individual counseling session followed by 2 group and 1 individual session/mo for the next 6 months, and twice-monthly contact and regular refresher group sessions in years 2 to 8. Target intake was 1200 to 1800 kcal/d with reduced fat intake plus 175 to 200 minutes/wk of moderateintensity physical activity. Counselling included cognitive–behavioral therapy, problem solving, motivational interviewing, and cultural tailoring by registered dietitians, psychologists, and exercise specialists. Patients in the DSE group were offered 3 group sessions/y focusing on diet, physical activity, and social support in years 1 to 4 and 1 session/y in years 5 to 8. Outcomes: Change in weight. Patient follow-up: 89% (intention-to-treat analysis). 160 (3%) patients were censored at time of bariatric surgery.
Main results The ILI group had greater weight loss at 8 years than the DSE group (Table).
Conclusion In overweight or obese patients with type 2 diabetes, an intensive lifestyle intervention increased weight loss at 8 years compared with diabetes support and education. Intensive lifestyle intervention (ILI) vs diabetes support and education (DSE) in overweight or obese patients with type 2 diabetes‡ Outcomes
Group
Weight loss (% reduction from baseline)
P value at 8 y
ILI
DSE
4.7%
2.1%
< 0.001
Event rates > 5% weight loss§
50%
36%
< 0.001
> 10% weight loss§
27%
17%
< 0.001
> 15% weight loss§
11%
7%
< 0.001
‡160 patients were censored at time of bariatric surgery (76 ILI group and 84 DSE group). §Percentages are cumulative (e.g., patients who lost > 5% of initial weight include those who also lost > 10% and > 15%).
JC4
© 2014 American College of Physicians
Sources of funding: National Institutes of Health; National Institute of Diabetes and Digestive and Kidney Diseases; National Heart, Lung, and Blood Institute; National Institute of Nursing Research; National Center on Minority Health and Health Disparities; Centers for Disease Control and Prevention. For correspondence: Dr. T.A. Wadden, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA. E-mail [email protected]. ■
Commentary This substudy of the Look AHEAD trial, which was stopped early due to a lack of benefit in cardiac events (1), showed 4.7% weight loss over 8 years with an “intensive” lifestyle intervention. One might wonder why we should even bother with lifestyle interventions? Although the Look AHEAD trial was intended to assess the effect of weight loss, it couldn’t because of the lack of sustained weight loss in the ILI group. That group lost 8.5% body weight after the first year, but subsequent regain reduced weight loss to 4.7% at study end. At baseline, average BMI was 36 kg/m2. Is it plausible to expect that modest weight loss would be sufficient to reduce cardiac events? The authors acknowledged that a different dietary composition might have had a different effect (1). The ILI did not have an intensive nutritional component. 2 large RCTs have shown that a similar reduced-fat, restricted-calorie, nutritional intervention had little to no mortality benefit for participants with or without diabetes (2, 3). However, 3 RCTs comparing dietary interventions showed a reduction in cardiac endpoints or carotid intimal thickness (4-6). A glycemic index–based carbohydrate restriction approach makes more pathophysiologic sense as treatment for diabetes than a low-fat, calorie-restricted diet (7). The Look AHEAD trial did not examine the stronger weight loss approaches used by obesity specialists to achieve substantial, sustained weight loss (8) (e.g., individualized lifestyle counselling, medication, or meal replacements); the effects of these alternate strategies on hard outcomes still need to be tested. Eric C. Westman, MD, MHS Duke University Health System Durham, North Carolina, USA References 1. Look AHEAD Research Group, Wing RR, Bolin P, Brancati FL, et al. N Engl J Med. 2013;369:145-54. 2. Knowler WC, Barrett-Connor E, Fowler SE, et al; Diabetes Prevention Program Research Group. N Engl J Med. 2002;346:393-403. 3. Howard BV, Van Horn L, Hsia J, et al. JAMA. 2006;295:655-66. 4. de Lorgeril M, Salen P, Martin JL, et al. Circulation. 1999;99:779-85. 5. Estruch R, Ros E, Salas-Salvadó J, et al; PREDIMED Study Investigators. N Engl J Med. 2013;368:1279-90. 6. Shai I, Spence JD, Schwarzfuchs D, et al; DIRECT Group. Circulation. 2010;121:1200-8. 7. Accurso A, Bernstein RK, Dahlqvist A, et al. Nutr Metab (Lond). 2008;5:9. 8. Seger JC, Horn DB, Westman EC, et al. Obesity algorithm. Presented by the American Society of Bariatric Physicians. www.obesityalgorithm.org (accessed 17 Apr 2014).
17 June 2014 | ACP Journal Club | Volume 160 • Number 12
Downloaded From: http://annals.org/pdfaccess.ashx?url=/data/journals/aim/930364/ by a NYU Medical Center Library User on 04/04/2017
In overweight or obese patients with diabetes, a lifestyle intervention increased weight loss at 8 years
The Look AHEAD Research Group. Eight-year weight losses with an intensive lifestyle intervention: the Look AHEAD study. Obesity (Silver Spring). 2014;22:5-13.
Clinical impact ratings: F ★★★★★✩✩ e ★★★★★✩✩ Question
*Information provided by author.
In obese or overweight patients with type 2 diabetes mellitus, does an intensive lifestyle intervention increase weight loss at 8 years?
†See Glossary.
Methods Design: Randomized controlled trial (RCT) (Look Action for Health for Diabetes [Look AHEAD] trial). ClinicalTrials.gov NCT00017953. Allocation: {Concealed}*.† Blinding: Blinded† ({data collectors}* and outcome assessors). Follow-up period: 8 years. Setting: 16 research centers in the USA. Patients: 5145 adults 45 to 76 years of age (mean age 59 y, mean body mass index [BMI] 36.0 kg/m2, 60% women, 63% nonHispanic White, 16% African American, 13% Hispanic/Latino) who had type 2 diabetes and a BMI ≥ 25 kg/m2 or ≥ 27 kg/m2 if using insulin. Intervention: Intensive lifestyle intervention (ILI) (n = 2570) or diabetes support and education (DSE) (n = 2575). ILI comprised 6 months of 3 weekly group and 1 individual counseling session followed by 2 group and 1 individual session/mo for the next 6 months, and twice-monthly contact and regular refresher group sessions in years 2 to 8. Target intake was 1200 to 1800 kcal/d with reduced fat intake plus 175 to 200 minutes/wk of moderateintensity physical activity. Counselling included cognitive–behavioral therapy, problem solving, motivational interviewing, and cultural tailoring by registered dietitians, psychologists, and exercise specialists. Patients in the DSE group were offered 3 group sessions/y focusing on diet, physical activity, and social support in years 1 to 4 and 1 session/y in years 5 to 8. Outcomes: Change in weight. Patient follow-up: 89% (intention-to-treat analysis). 160 (3%) patients were censored at time of bariatric surgery.
Main results The ILI group had greater weight loss at 8 years than the DSE group (Table).
Conclusion In overweight or obese patients with type 2 diabetes, an intensive lifestyle intervention increased weight loss at 8 years compared with diabetes support and education. Intensive lifestyle intervention (ILI) vs diabetes support and education (DSE) in overweight or obese patients with type 2 diabetes‡ Outcomes
Group
Weight loss (% reduction from baseline)
P value at 8 y
ILI
DSE
4.7%
2.1%
< 0.001
Event rates > 5% weight loss§
50%
36%
< 0.001
> 10% weight loss§
27%
17%
< 0.001
> 15% weight loss§
11%
7%
< 0.001
‡160 patients were censored at time of bariatric surgery (76 ILI group and 84 DSE group). §Percentages are cumulative (e.g., patients who lost > 5% of initial weight include those who also lost > 10% and > 15%).
JC4
© 2014 American College of Physicians
Sources of funding: National Institutes of Health; National Institute of Diabetes and Digestive and Kidney Diseases; National Heart, Lung, and Blood Institute; National Institute of Nursing Research; National Center on Minority Health and Health Disparities; Centers for Disease Control and Prevention. For correspondence: Dr. T.A. Wadden, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA. E-mail [email protected]. ■
Commentary This substudy of the Look AHEAD trial, which was stopped early due to a lack of benefit in cardiac events (1), showed 4.7% weight loss over 8 years with an “intensive” lifestyle intervention. One might wonder why we should even bother with lifestyle interventions? Although the Look AHEAD trial was intended to assess the effect of weight loss, it couldn’t because of the lack of sustained weight loss in the ILI group. That group lost 8.5% body weight after the first year, but subsequent regain reduced weight loss to 4.7% at study end. At baseline, average BMI was 36 kg/m2. Is it plausible to expect that modest weight loss would be sufficient to reduce cardiac events? The authors acknowledged that a different dietary composition might have had a different effect (1). The ILI did not have an intensive nutritional component. 2 large RCTs have shown that a similar reduced-fat, restricted-calorie, nutritional intervention had little to no mortality benefit for participants with or without diabetes (2, 3). However, 3 RCTs comparing dietary interventions showed a reduction in cardiac endpoints or carotid intimal thickness (4-6). A glycemic index–based carbohydrate restriction approach makes more pathophysiologic sense as treatment for diabetes than a low-fat, calorie-restricted diet (7). The Look AHEAD trial did not examine the stronger weight loss approaches used by obesity specialists to achieve substantial, sustained weight loss (8) (e.g., individualized lifestyle counselling, medication, or meal replacements); the effects of these alternate strategies on hard outcomes still need to be tested. Eric C. Westman, MD, MHS Duke University Health System Durham, North Carolina, USA References 1. Look AHEAD Research Group, Wing RR, Bolin P, Brancati FL, et al. N Engl J Med. 2013;369:145-54. 2. Knowler WC, Barrett-Connor E, Fowler SE, et al; Diabetes Prevention Program Research Group. N Engl J Med. 2002;346:393-403. 3. Howard BV, Van Horn L, Hsia J, et al. JAMA. 2006;295:655-66. 4. de Lorgeril M, Salen P, Martin JL, et al. Circulation. 1999;99:779-85. 5. Estruch R, Ros E, Salas-Salvadó J, et al; PREDIMED Study Investigators. N Engl J Med. 2013;368:1279-90. 6. Shai I, Spence JD, Schwarzfuchs D, et al; DIRECT Group. Circulation. 2010;121:1200-8. 7. Accurso A, Bernstein RK, Dahlqvist A, et al. Nutr Metab (Lond). 2008;5:9. 8. Seger JC, Horn DB, Westman EC, et al. Obesity algorithm. Presented by the American Society of Bariatric Physicians. www.obesityalgorithm.org (accessed 17 Apr 2014).
17 June 2014 | ACP Journal Club | Volume 160 • Number 12
Downloaded From: http://annals.org/pdfaccess.ashx?url=/data/journals/aim/930364/ by a NYU Medical Center Library User on 04/04/2017
