Baseline characteristics of the randomised cohort from the Look AHEAD (Action for Health in Diabetes) study

The Look AHEAD Research Group

Research output: Contribution to journalArticle

93 Citations (Scopus)

Abstract

Objective. The Look AHEAD (Action for Health in Diabetes) study is a 16-centre randomised clinical trial in overweight and obese individuals with type 2 diabetes, designed to evaluate the long-term effects (up to 11.5 years) of intensive weight loss intervention on the time to incidence of major cardiovascular events. Research design and methods. Eligibility requirements are diagnosis of type 2 diabetes (determined by self-report and verification) in individuals aged 45-74 years and body mass index (BMI) > 25 kg/m2 (> 27 kg/m2 if currently taking insulin). The intensive lifestyle intervention is designed to achieve and maintain weight loss through decreased caloric intake and increased physical activity. The study is designed to provide 90% probability of detecting an 18% difference in major cardiovascular disease event rates in patients randomised to the intensive lifestyle intervention compared to the control group receiving standard diabetes support and education. Results. The 5,145 participants who were randomised between 2001 and 2004 were 63.3% white, 15.6% African-American, 13.2% Hispanic, 5.0% American Indian and 1.0% Asian-American, which closely paralleled the ethnic distribution of diabetes in the National Health and Nutrition Examination Survey (NHANES) 1999-2000 survey. Their average age at entry was 59± 6.8 years (mean ± SD), and 60% were women. There were 31.5% between 45-55 years of age, 51.5% were 56-65, and 17.0% were 66-76 years of age. Some 15.4% of participants were taking insulin at the time of randomisation and 14.0% had a history of cardiovascular disease. More men (21.3%) than women (9.2%) had a history of cardiovascular disease. Few participants (4.4%) were current cigarette smokers, compared to 16.2% in the NHANES 1999-2000 survey. Furthermore, 65.0% of participants had a first-degree relative with diabetes. Overall, BMI averaged 36±5.9 kg/m2 at baseline, with 83.6% of the men and 86.1% of women having a BMI > 30 kg/m2 and 17.9% of men and 25.4% of women having a BMI > 40 kg/m2. Conclusions. The Look AHEAD study has successfully randomised a large cohort of participants who have type 2 diabetes with a wide distribution of age, obesity, ethnicity and racial background and will examine the effects of lifestyle intervention on the incidence of major cardiovascular events.

Original languageEnglish (US)
Pages (from-to)202-215
Number of pages14
JournalDiabetes and Vascular Disease Research
Volume3
Issue number3
DOIs
StatePublished - Dec 1 2006

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Body Mass Index
Type 2 Diabetes Mellitus
Life Style
Cardiovascular Diseases
Nutrition Surveys
Health
Weight Loss
Insulin
Asian Americans
North American Indians
Incidence
Age Distribution
Random Allocation
Energy Intake
Hispanic Americans
Tobacco Products
African Americans
Self Report
Research Design
Randomized Controlled Trials

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Cardiology and Cardiovascular Medicine

Cite this

Baseline characteristics of the randomised cohort from the Look AHEAD (Action for Health in Diabetes) study. / The Look AHEAD Research Group.

In: Diabetes and Vascular Disease Research, Vol. 3, No. 3, 01.12.2006, p. 202-215.

Research output: Contribution to journalArticle

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title = "Baseline characteristics of the randomised cohort from the Look AHEAD (Action for Health in Diabetes) study",
abstract = "Objective. The Look AHEAD (Action for Health in Diabetes) study is a 16-centre randomised clinical trial in overweight and obese individuals with type 2 diabetes, designed to evaluate the long-term effects (up to 11.5 years) of intensive weight loss intervention on the time to incidence of major cardiovascular events. Research design and methods. Eligibility requirements are diagnosis of type 2 diabetes (determined by self-report and verification) in individuals aged 45-74 years and body mass index (BMI) > 25 kg/m2 (> 27 kg/m2 if currently taking insulin). The intensive lifestyle intervention is designed to achieve and maintain weight loss through decreased caloric intake and increased physical activity. The study is designed to provide 90{\%} probability of detecting an 18{\%} difference in major cardiovascular disease event rates in patients randomised to the intensive lifestyle intervention compared to the control group receiving standard diabetes support and education. Results. The 5,145 participants who were randomised between 2001 and 2004 were 63.3{\%} white, 15.6{\%} African-American, 13.2{\%} Hispanic, 5.0{\%} American Indian and 1.0{\%} Asian-American, which closely paralleled the ethnic distribution of diabetes in the National Health and Nutrition Examination Survey (NHANES) 1999-2000 survey. Their average age at entry was 59± 6.8 years (mean ± SD), and 60{\%} were women. There were 31.5{\%} between 45-55 years of age, 51.5{\%} were 56-65, and 17.0{\%} were 66-76 years of age. Some 15.4{\%} of participants were taking insulin at the time of randomisation and 14.0{\%} had a history of cardiovascular disease. More men (21.3{\%}) than women (9.2{\%}) had a history of cardiovascular disease. Few participants (4.4{\%}) were current cigarette smokers, compared to 16.2{\%} in the NHANES 1999-2000 survey. Furthermore, 65.0{\%} of participants had a first-degree relative with diabetes. Overall, BMI averaged 36±5.9 kg/m2 at baseline, with 83.6{\%} of the men and 86.1{\%} of women having a BMI > 30 kg/m2 and 17.9{\%} of men and 25.4{\%} of women having a BMI > 40 kg/m2. Conclusions. The Look AHEAD study has successfully randomised a large cohort of participants who have type 2 diabetes with a wide distribution of age, obesity, ethnicity and racial background and will examine the effects of lifestyle intervention on the incidence of major cardiovascular events.",
author = "{The Look AHEAD Research Group} and Frederick Brancati and Coda Davison and Jeanne Clark and Jeanne Charleston and Lawrence Cheskin and Kerry Stewart and Richard Rubin and Kathy Horak and Bray, {George A.} and Kristi Rau and Allison Strate and Greenway, {Frank L.} and Ryan, {Donna H.} and Donald Williamson and Elizabeth Tucker and Brandi Armand and Mandy Shipp and Kim Landry and Jennifer Perault and Lewis, {Cora E.} and Sheikilya Thomas and Vicki DiLillo and Monika Safford and Stephen Glasser and Clara Smith and Cathy Roche and Charlotte Bragg and Nita Webb and Staci Gilbert and Amy Dobelstein and {Christie Oden}, L. and Trena Johnsey and Nathan, {David M.} and Heather Turgeon and Schumann, {Kristina P.} and Enrico Cagliero and Kathryn Hayward and Linda Delahanty and Barbara Steiner and Valerie Goldman and Ellen Anderson and Laurie Bissett and Alan McNamara and Richard Ginsburg and Virginia Harlan and Theresa Michel and Horton, {Edward S.} and Jackson, {Sharon D.} and Osama Hamdy and Karen Johnson",
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pages = "202--215",
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TY - JOUR

T1 - Baseline characteristics of the randomised cohort from the Look AHEAD (Action for Health in Diabetes) study

AU - The Look AHEAD Research Group

AU - Brancati, Frederick

AU - Davison, Coda

AU - Clark, Jeanne

AU - Charleston, Jeanne

AU - Cheskin, Lawrence

AU - Stewart, Kerry

AU - Rubin, Richard

AU - Horak, Kathy

AU - Bray, George A.

AU - Rau, Kristi

AU - Strate, Allison

AU - Greenway, Frank L.

AU - Ryan, Donna H.

AU - Williamson, Donald

AU - Tucker, Elizabeth

AU - Armand, Brandi

AU - Shipp, Mandy

AU - Landry, Kim

AU - Perault, Jennifer

AU - Lewis, Cora E.

AU - Thomas, Sheikilya

AU - DiLillo, Vicki

AU - Safford, Monika

AU - Glasser, Stephen

AU - Smith, Clara

AU - Roche, Cathy

AU - Bragg, Charlotte

AU - Webb, Nita

AU - Gilbert, Staci

AU - Dobelstein, Amy

AU - Christie Oden, L.

AU - Johnsey, Trena

AU - Nathan, David M.

AU - Turgeon, Heather

AU - Schumann, Kristina P.

AU - Cagliero, Enrico

AU - Hayward, Kathryn

AU - Delahanty, Linda

AU - Steiner, Barbara

AU - Goldman, Valerie

AU - Anderson, Ellen

AU - Bissett, Laurie

AU - McNamara, Alan

AU - Ginsburg, Richard

AU - Harlan, Virginia

AU - Michel, Theresa

AU - Horton, Edward S.

AU - Jackson, Sharon D.

AU - Hamdy, Osama

AU - Johnson, Karen

PY - 2006/12/1

Y1 - 2006/12/1

N2 - Objective. The Look AHEAD (Action for Health in Diabetes) study is a 16-centre randomised clinical trial in overweight and obese individuals with type 2 diabetes, designed to evaluate the long-term effects (up to 11.5 years) of intensive weight loss intervention on the time to incidence of major cardiovascular events. Research design and methods. Eligibility requirements are diagnosis of type 2 diabetes (determined by self-report and verification) in individuals aged 45-74 years and body mass index (BMI) > 25 kg/m2 (> 27 kg/m2 if currently taking insulin). The intensive lifestyle intervention is designed to achieve and maintain weight loss through decreased caloric intake and increased physical activity. The study is designed to provide 90% probability of detecting an 18% difference in major cardiovascular disease event rates in patients randomised to the intensive lifestyle intervention compared to the control group receiving standard diabetes support and education. Results. The 5,145 participants who were randomised between 2001 and 2004 were 63.3% white, 15.6% African-American, 13.2% Hispanic, 5.0% American Indian and 1.0% Asian-American, which closely paralleled the ethnic distribution of diabetes in the National Health and Nutrition Examination Survey (NHANES) 1999-2000 survey. Their average age at entry was 59± 6.8 years (mean ± SD), and 60% were women. There were 31.5% between 45-55 years of age, 51.5% were 56-65, and 17.0% were 66-76 years of age. Some 15.4% of participants were taking insulin at the time of randomisation and 14.0% had a history of cardiovascular disease. More men (21.3%) than women (9.2%) had a history of cardiovascular disease. Few participants (4.4%) were current cigarette smokers, compared to 16.2% in the NHANES 1999-2000 survey. Furthermore, 65.0% of participants had a first-degree relative with diabetes. Overall, BMI averaged 36±5.9 kg/m2 at baseline, with 83.6% of the men and 86.1% of women having a BMI > 30 kg/m2 and 17.9% of men and 25.4% of women having a BMI > 40 kg/m2. Conclusions. The Look AHEAD study has successfully randomised a large cohort of participants who have type 2 diabetes with a wide distribution of age, obesity, ethnicity and racial background and will examine the effects of lifestyle intervention on the incidence of major cardiovascular events.

AB - Objective. The Look AHEAD (Action for Health in Diabetes) study is a 16-centre randomised clinical trial in overweight and obese individuals with type 2 diabetes, designed to evaluate the long-term effects (up to 11.5 years) of intensive weight loss intervention on the time to incidence of major cardiovascular events. Research design and methods. Eligibility requirements are diagnosis of type 2 diabetes (determined by self-report and verification) in individuals aged 45-74 years and body mass index (BMI) > 25 kg/m2 (> 27 kg/m2 if currently taking insulin). The intensive lifestyle intervention is designed to achieve and maintain weight loss through decreased caloric intake and increased physical activity. The study is designed to provide 90% probability of detecting an 18% difference in major cardiovascular disease event rates in patients randomised to the intensive lifestyle intervention compared to the control group receiving standard diabetes support and education. Results. The 5,145 participants who were randomised between 2001 and 2004 were 63.3% white, 15.6% African-American, 13.2% Hispanic, 5.0% American Indian and 1.0% Asian-American, which closely paralleled the ethnic distribution of diabetes in the National Health and Nutrition Examination Survey (NHANES) 1999-2000 survey. Their average age at entry was 59± 6.8 years (mean ± SD), and 60% were women. There were 31.5% between 45-55 years of age, 51.5% were 56-65, and 17.0% were 66-76 years of age. Some 15.4% of participants were taking insulin at the time of randomisation and 14.0% had a history of cardiovascular disease. More men (21.3%) than women (9.2%) had a history of cardiovascular disease. Few participants (4.4%) were current cigarette smokers, compared to 16.2% in the NHANES 1999-2000 survey. Furthermore, 65.0% of participants had a first-degree relative with diabetes. Overall, BMI averaged 36±5.9 kg/m2 at baseline, with 83.6% of the men and 86.1% of women having a BMI > 30 kg/m2 and 17.9% of men and 25.4% of women having a BMI > 40 kg/m2. Conclusions. The Look AHEAD study has successfully randomised a large cohort of participants who have type 2 diabetes with a wide distribution of age, obesity, ethnicity and racial background and will examine the effects of lifestyle intervention on the incidence of major cardiovascular events.

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DO - 10.3132/dvdr.2006.031

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