DiabetesLookAHEADNCT00017953
Look AHEAD: Action for Health in Diabetes
A study testing Lifestyle Intervention and Diabetes Support and Education in people with Diabetes and Myocardial Infarction, run by Wake Forest University Health Sciences at 18 sites in United States.
Trial summary
The Look AHEAD study is a multi-center, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss. The study will investigate the effects of the intervention on heart attacks, stroke and cardiovascular-related death in individuals with type 2… Read more about this study
- Who is it for?
- Ages 55 to 76 years
- Conditions the study is for
- Diabetes, Myocardial Infarction, Stroke
- What is being tested?
- Lifestyle Intervention and Diabetes Support and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,145 participants
- Where
- 18 sitesUnited States
- Study dates
- Jun 2001to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Overweight
- BMI of 25 kg/m2 or greater
- If on insulin, BMI of 27 kg/m2 or greater
- Blood pressure less than 160/100 mmHg
- HbA1c less or equal to 11%
- Triglycerides less than 600 mg/dl
- Willingness to participate
Who cannot join
- Unable or unwilling to give informed consent or communicate with local study staff.
- Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder.
- Hospitalization for depression in past six months.
- Self-report of alcohol or substance abuse within the past twelve months.
- Current consumption of more than 14 alcoholic drinks per week.
- Current acute treatment or rehabilitation program for these problems.
Show all 50Show fewer
- Plans to relocate to an area not served by Look AHEAD or travel plans that do not permit full participation in the study.
- Lack of support from primary care health provider or family members.
- Failure to complete the two-week run-in for dietary intake and exercise.
- Weight loss exceeding 10 lbs. in past three months.
- Current use of medications for weight loss.
- Self reported inability to walk two blocks.
- History of bariatric surgery, small bowel resection, or extensive bowel resection.
- Chronic treatment with systemic corticosteroids.
- Another member of the household is a participant or staff member in Look AHEAD.
- Currently pregnant or nursing.
- Cancer requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured.
- HIV positive (self-report), due to effects on weight and body composition of HIV and medications used to treat HIV.
- Active tuberculosis (self-report).
- Cardiovascular disease (heart attack or procedure within the past three months).
- Participation in a cardiac rehabilitation program within last three months.
- Stroke or history/treatment for transient ischemic attacks in the past three months.
- Pulmonary embolus in past six months.
- Unstable angina pectoris or angina pectoris at rest.
- A history of cardiac arrest.
- Complex ventricular arrhythmia at rest or with exercise (e.g., ventricular tachycardia).
- Uncontrolled atrial fibrillation (heart rate of 100 beats per minute or more).
- New York Heart Association (NYHA) Class III or IV congestive heart failure.
- Acute myocarditis, pericarditis or hypertrophic myocardiopathy.
- Clinically significant aortic stenosis.
- Left bundle branch block or cardiac pacemaker unless evaluated and cleared for participation by a cardiologist.
- Cardiac defibrillator.
- Heart transplant.
- History of aortic aneurysm of at least 7 cm in diameter or aortic aneurysm repair.
- Resting heart rate less than 45 beats per minute or greater than 100 beats per minute.
- Any abnormality during the maximum exercise stress test that indicates that it would be unsafe to participate in the Lifestyle Intervention.
- Angina pectoris.
- Significant ST segment depression at low levels of exercise. (ST segment is the flat, isoelectric section of the ECG between the end of the S wave (the J point) and the beginning of the T wave)
- Exercise induced ventricular arrhythmias.
- Abnormal hemodynamics, such as flat or decreasing systolic blood pressure with increasing workload.
- Those at moderate to high risk for cardiac complications during exercise.
- Those who are unable to self-regulate activity or understand the recommended activity level.
- Renal disease or dialysis.
- Chronic obstructive pulmonary disease that would limit ability to follow the protocol.
- Self-reported chronic hepatitis B or C or cirrhosis.
- Inflammatory bowel disease requiring treatment in past year.
- Cushing's syndrome.
- Acromegaly.
- Amputation of lower limbs as result of non-traumatic causes.
- Any major organ transplant.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
University of Colorado Health Sciences Center
Aurora, Colorado, 80045-0808
Johns Hopkins Pro-Health
Baltimore, Maryland, 21207
Louisiana State University
Baton Rouge, Louisiana, 70808
The University of Alabama at Birmingham
Birmingham, Alabama, 35205
Diabetes Center
Boston, Massachusetts, 02114
Joslin Diabetes Center
Boston, Massachusetts, 02114
Baylor College of Medicine
Houston, Texas, 77030
University of Southern California
Los Angeles, California, 90022
The University of Tennessee, Memphis
Memphis, Tennessee, 38105
University of Minnesota
Minneapolis, Minnesota, 55415-1226
Columbia University
New York, New York, 10019
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
Southwestern American Indian Center
Phoenix, Arizona, 85014
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
The Miriam Hospital
Providence, Rhode Island, 02906
University of Texas Health Sciences Center
San Antonio, Texas, 78229
University of Washington
Seattle, Washington, 98108
Northern Navajo Medical Center
Shiprock, New Mexico, 87420
About this study
The Look AHEAD study is a multi-center, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss. The study will investigate the effects of the intervention on heart attacks, stroke and cardiovascular-related death in individuals with type 2 diabetes who are also overweight or obese.
Read the detailed description
Look AHEAD is examining, in overweight volunteers with type 2 diabetes, the long-term effects of an intensive lifestyle intervention program designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity. This program will be compared to a control condition involving a program of diabetes support and education.
The primary hypothesis is that the incidence rate of the first post-randomization occurrence of a composite outcome, which includes
cardiovascular death (including fatal myocardial infarction and stroke), non-fatal myocardial infarction, hospitalized angina, and non-fatal stroke,
over a planned follow-up period of up to 13.5 years will be reduced among participants assigned to the Lifestyle Intervention compared to those assigned to the control condition, Diabetes Support and Education.
Look AHEAD will also test for reductions in the incidence of three secondary composite outcomes and examine the effect of the intervention on cardiovascular disease risk factors, diabetes control and complications, general health, and quality of life, and psychological outcomes. The cost and cost-effectiveness of the Lifestyle Intervention relative to Diabetes Support and Education will be assessed.
The Look AHEAD intensive lifestyle intervention ended September, 2012. Participants continue to be followed to determine the long-term effects of the intervention on health outcomes.
- Conditions
- Diabetes, Myocardial Infarction, Stroke, Kidney Diseases, Bone Diseases, Dyslipidemia
- Being tested
- Lifestyle Intervention, Diabetes Support and Education
- Keywords
- Diabetes, Weight loss, Heart Attack, Heart disease, Lifestyle Intervention, Physical Fitness/Physical Activity, Psychosocial outcomes (e.g., depression, eating disorders), Bone Density
- Medical subject headings
- Diabetes Mellitus, Myocardial Infarction, Stroke, Kidney Diseases, Bone Diseases, Dyslipidemias, Weight Loss, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
The lifestyle intervention is implemented with individual supervision and group sessions and is aimed at achieving and maintaining at least a 7% decrease in weight from baseline and 175 minutes per week in physical activity. It is implemented during a four-year period with the most intensive application during the first year, less frequent attention during the next three years, and a minimum of twice yearly contacts during an extended follow-up period. To help participants achieve and maintain weight loss, a variety of diet strategies (e.g. prepared meals and liquid formula), exercise strategies, and optional weight loss medications are utilized based on a preset algorithm and participant progress.
Diabetes Support and EducationBehavioural
Participants assigned to diabetes support and education are offered three sessions each year in diabetes management and social support.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Intervention | Experimental | Participants in the lifestyle intervention arm are offered individual and group sessions designed to help achieve and maintain weight loss. Receives: Behavioral: Lifestyle Intervention |
| Diabetes Support and Education | Active comparator | The diabetes support and education arm provides group sessions on diabetes management and social support. Receives: Behavioral: Diabetes Support and Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Occurrence of a Severe Cardiovascular Event
Number of participants with first on-study occurrence of one of the following major cardiovascular events: fatal and non-fatal myocardial infarctions and strokes, hospitalizations for angina, and cardiovascular deaths
Measured: up to 11 years
Secondary outcomes (3)
First Occurrence of Cardiovascular Death, Myocardial Infarction, or Stroke
Number of participants with first occurrence of one of the following: cardiovascular death, myocardial infarction (fatal or nonfatal), or stroke (fatal or non-fatal)
Measured: up to 11 years
First Occurrence of Death, Myocardial Infarction, or Hospitalized Angina
Number of participants with first occurrence of one of the following: death (all causes), myocardial infarction, stroke, or hospitalizations for angina
Measured: up to 11 years
First Occurrence of Major Clinical Events
Number of participants with first occurrence of one of the following: death (all causes), myocardial infarction, stroke, hospitalization for angina, coronary artery bypass grafting, percutaneous coronary angioplasty, hospitalization for congestive heart failure, carotid endarterectomy, or peripheral vascular procedures such as bypass or angioplasty
Measured: up to 11 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2001 (estimated)
- Study startJun 2001
- Primary completionSep 2012
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (105)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Nursing Research (NINR), National Institute on Minority Health and Health Disparities (NIMHD), Office of Research on Women's Health (ORWH), Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Mark A Espeland, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00017953
- Sponsor's protocol ID
- BG99-042
- Other IDs
- U01DK057136, U01DK057149, U01DK056990, U01DK057177, U01DK057171, U01DK057151, U01DK057182, U01DK057131
- Acronym
- LookAHEAD
- Status last verified
- May 2023
- First submitted
- 21 Jun 2001
- Last updated
- 2 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share data sets through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) repository, baseline data sets are currently available. Outcome data will be available approximately 1 year after the study is over.
Publications
Look AHEAD Research Group; Wing RR, Bolin P, Brancati FL, Bray GA, Clark JM, Coday M, Crow RS, Curtis JM, Egan CM, Espeland MA, Evans M, Foreyt JP, Ghazarian S, Gregg EW, Harrison B, Hazuda HP, Hill JO, Horton ES, Hubbard VS, Jakicic JM, Jeffery RW, Johnson KC, Kahn SE, Kitabchi AE, Knowler WC, Lewis CE, Maschak-Carey BJ, Montez MG, Murillo A, Nathan DM, Patricio J, Peters A, Pi-Sunyer X, Pownall H, Reboussin D, Regensteiner JG, Rickman AD, Ryan DH, Safford M, Wadden TA, Wagenknecht LE, West DS, Williamson DF, Yanovski SZ. Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes. N Engl J Med. 2013 Jul 11;369(2):145-54. doi: 10.1056/NEJMoa1212914. Epub 2013 Jun 24.
PubMed 23796131Patel KV, Chiu L, Garcia KR, Belalcazar LM, Segar MW, Butler J, Espeland M, Ballantyne CM, Pandey A. Residual Inflammatory Risk of Heart Failure and Atherosclerotic CVD in Diabetes: Look AHEAD Ancillary Study. JACC Heart Fail. 2026 Sep 2:103296. doi: 10.1016/j.jchf.2026.103296. Online ahead of print.
PubMed 42687462Golchin A, Johnson KC, Houston DK, Luchsinger JA, Beavers KM, Bertoni AG, Chen H, Wagenknecht L, Espeland MA; Action for Health in Diabetes (Look AHEAD) Aging Study Group. Associations of modifiable lifestyle and clinical factors with cognitive function in adults with type 2 diabetes. J Diabetes Complications. 2026 Jan;40(1):109227. doi: 10.1016/j.jdiacomp.2025.109227. Epub 2025 Nov 10.
PubMed 41237447Chunawala Z, Patel KV, Garcia KR, Segar MW, Verma S, Bayes-Genis A, Pop-Busui R, Bhatt DL, Januzzi JL Jr, Butler J, Lam CSP, Bertoni AG, Espeland M, Pandey A. Cardiac Biomarkers, Intensive Lifestyle Intervention, and Heart Failure Subtypes in Diabetes: Look AHEAD Cardiac Biomarker Ancillary Study. JACC Heart Fail. 2026 Mar;14(3):102726. doi: 10.1016/j.jchf.2025.102726. Epub 2025 Nov 7.
PubMed 41204924Vaidya D, Yeboah-Kordieh Y, Howard M, Hugenschmidt CE, Nyquist PA, Michos ED, Kalyani RR, Yasar S, Robusto BA, Yassine HN, Clark JM, Espeland MA, Bennett WL. Sex specific associations of sex hormones with brain volumes and cerebral blood flow: A cross sectional observational study within the look AHEAD type 2 diabetes cohort. J Diabetes Complications. 2025 Oct;39(10):109161. doi: 10.1016/j.jdiacomp.2025.109161. Epub 2025 Aug 27.
PubMed 40886675Whitmer RA, Baker LD, Carrillo MC, Snyder HM, Cleveland ML, Gitelman DR, Kivipelto M, Leng XI, Lovato L, Papp KV, Pavlik VN, Salloway SP, Tangney CC, Farias ST, Williamson JD, Wilmoth S, Woolard N, Yu M, Espeland MA; U.S. POINTER Study Group. Baseline characteristics of the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER): Successful enrollment of a diverse clinical trial cohort at risk for cognitive decline. Alzheimers Dement. 2025 Jun;21(6):e70351. doi: 10.1002/alz.70351.
PubMed 40556311Vaidya D, Yeboah-Kordieh Y, Howard M, Hugenschmidt CE, Nyquist PA, Michos ED, Kalyani RR, Yasar S, Robusto BA, Yassine HN, Clark JM, Espeland MA, Bennett WL. Sex Specific Associations of Sex hormone With Brain Volumes and Cerebral Blood Flow: A Cross Sectional Observational Study Within the Look AHEAD Type 2 Diabetes Cohort. Res Sq [Preprint]. 2024 Apr 29:rs.3.rs-4254188. doi: 10.21203/rs.3.rs-4254188/v1.
PubMed 38746210Gregg EW, Chen H, Bancks MP, Manalac R, Maruthur N, Munshi M, Wing R; Look AHEAD Research Group. Impact of remission from type 2 diabetes on long-term health outcomes: findings from the Look AHEAD study. Diabetologia. 2024 Mar;67(3):459-469. doi: 10.1007/s00125-023-06048-6. Epub 2024 Jan 18.
PubMed 38233592Olson K, Houston DK, Ross J, Wing RR, Simpson FR, Pandey A, Walkup MP, Yang M, Espeland MA. Associations that Cardiorespiratory Fitness and Body Mass Index Loss Have with Deficit Accumulation Frailty. Med Sci Sports Exerc. 2024 Apr 1;56(4):717-724. doi: 10.1249/MSS.0000000000003353. Epub 2023 Nov 27.
PubMed 38051041Johnson KC, Anderson A, Beavers KM, Crandall CJ, Hazuda HP, Lewis CE, Lipkin E, Schwartz AV, Pi-Sunyer FX, Zhao Q; and the Look AHEAD Research Group. The long-term effect of intentional weight loss on changes in bone mineral density in persons with type 2 diabetes: results from the Look AHEAD randomized trial. Arch Osteoporos. 2023 Jul 14;18(1):97. doi: 10.1007/s11657-023-01303-0.
PubMed 37452151Evans JK, Usoh CO, Simpson FR, Espinoza S, Hazuda H, Pandey A, Beckner T, Espeland MA. Long-term Impact of a 10-Year Intensive Lifestyle Intervention on a Deficit Accumulation Frailty Index: Action for Health in Diabetes Trial. J Gerontol A Biol Sci Med Sci. 2023 Oct 28;78(11):2119-2126. doi: 10.1093/gerona/glad088.
PubMed 36946420Bancks MP, Lovato J, Balasubramanyam A, Coday M, Johnson KC, Munshi M, Rebello C, Wagenknecht LE, Espeland MA. Association of Type 2 Diabetes Subgroups With Cognitive Status Without Modification From Lifestyle Intervention. J Clin Endocrinol Metab. 2023 May 17;108(6):e334-e342. doi: 10.1210/clinem/dgac706.
PubMed 36472933Espeland MA, Howard M, Bennett W, Robusto BA, Yasar S, Hugenschmidt CE, Luchsinger JA, Bahnson J, Yassine H, Johnson KC, Cook D, Hayden KM; Action for Health in Diabetes (Look AHEAD) MIND Ancillary Study Group. Associations between cognitive function and endogenous levels of estradiol and testosterone in adults with type 2 diabetes. J Diabetes Complications. 2022 Sep;36(9):108268. doi: 10.1016/j.jdiacomp.2022.108268. Epub 2022 Jul 26.
PubMed 35926332Espeland MA, Evans JK, Carmichael O, Luchsinger JA, Marcovina SM, Neiberg R, Johnson KC, Kahn SE, Hayden KM; Action for Health in Diabetes (Look AHEAD) MIND Ancillary Study Group. Association of cognition with leptin and vascular endothelial growth factor in individuals with type 2 diabetes mellitus. Obesity (Silver Spring). 2022 Sep;30(9):1863-1874. doi: 10.1002/oby.23495. Epub 2022 Aug 3.
PubMed 35920161Ip EH, Chen SH, Rejeski WJ, Bandeen-Roche K, Hayden KM, Hugenschmidt CE, Pierce J, Miller ME, Speiser JL, Kritchevsky SB, Houston DK, Newton RL, Rapp SR, Kitzman DW. Gradient and Acceleration of Decline in Physical and Cognitive Functions in Older Adults: A Disparity Analysis. J Gerontol A Biol Sci Med Sci. 2022 Aug 12;77(8):1603-1611. doi: 10.1093/gerona/glac109.
PubMed 35562076
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Look AHEAD: Action for Health in Diabetes
- ClinicalTrials.gov ID
- NCT00017953
- Acronym / sponsor ID
- LookAHEAD / BG99-042
- Conditions
- Diabetes, Myocardial Infarction, Stroke, Kidney Diseases, Bone Diseases, Dyslipidemia
- Keywords
- Diabetes, Weight loss, Heart Attack, Heart disease, Lifestyle Intervention, Physical Fitness/Physical Activity, Psychosocial outcomes (e.g., depression, eating disorders), Bone Density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,145 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Nursing Research (NINR), National Institute on Minority Health and Health Disparities (NIMHD), Office of Research on Women's Health (ORWH), Centers for Disease Control and Prevention
- Study start
- Jun 2001 (actual)
- Primary completion
- Sep 2012 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 21 Jun 2001 (estimated)
- Results
- Posted 2 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Look AHEAD study is a multi-center, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss. The study will investigate the effects of the intervention on heart attacks, stroke and cardiovascular-related death in individuals with type 2 diabetes who are also overweight or obese.
Detailed description
Look AHEAD is examining, in overweight volunteers with type 2 diabetes, the long-term effects of an intensive lifestyle intervention program designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity. This program will be compared to a control condition involving a program of diabetes support and education.
The primary hypothesis is that the incidence rate of the first post-randomization occurrence of a composite outcome, which includes
cardiovascular death (including fatal myocardial infarction and stroke), non-fatal myocardial infarction, hospitalized angina, and non-fatal stroke,
over a planned follow-up period of up to 13.5 years will be reduced among participants assigned to the Lifestyle Intervention compared to those assigned to the control condition, Diabetes Support and Education.
Look AHEAD will also test for reductions in the incidence of three secondary composite outcomes and examine the effect of the intervention on cardiovascular disease risk factors, diabetes control and complications, general health, and quality of life, and psychological outcomes. The cost and cost-effectiveness of the Lifestyle Intervention relative to Diabetes Support and Education will be assessed.
The Look AHEAD intensive lifestyle intervention ended September, 2012. Participants continue to be followed to determine the long-term effects of the intervention on health outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention | Experimental | Behavioral: Lifestyle InterventionParticipants in the lifestyle intervention arm are offered individual and group sessions designed to help achieve and maintain weight loss. |
| Diabetes Support and Education | Active comparator | Behavioral: Diabetes Support and EducationThe diabetes support and education arm provides group sessions on diabetes management and social support. |
Who may qualify
- Ages
- 55 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type 2 diabetes
- Overweight
- BMI of 25 kg/m2 or greater
- If on insulin, BMI of 27 kg/m2 or greater
- Blood pressure less than 160/100 mmHg
Key exclusion criteria (50 listed)
- Unable or unwilling to give informed consent or communicate with local study staff.
- Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder.
- Hospitalization for depression in past six months.
- Self-report of alcohol or substance abuse within the past twelve months.
- Current consumption of more than 14 alcoholic drinks per week.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle InterventionThe lifestyle intervention is implemented with individual supervision and group sessions and is aimed at achieving and maintaining at least a 7% decrease in weight from baseline and 175 minutes per week in physical activity. It is implemented during a four-year period with the most intensive application during the first year, less frequent attention during the next three years, and a minimum of twice yearly contacts during an extended follow-up period. To help participants achieve and maintain weight loss, a variety of diet strategies (e.g. prepared meals and liquid formula), exercise strategies, and optional weight loss medications are utilized based on a preset algorithm and participant progress. | Behavioural | Lifestyle Intervention |
| Diabetes Support and EducationParticipants assigned to diabetes support and education are offered three sessions each year in diabetes management and social support. | Behavioural | Diabetes Support and Education |
Primary outcome
First Occurrence of a Severe Cardiovascular Event
Time frame: up to 11 years
Number of participants with first on-study occurrence of one of the following major cardiovascular events: fatal and non-fatal myocardial infarctions and strokes, hospitalizations for angina, and cardiovascular deaths
3 secondary outcomes
First Occurrence of Cardiovascular Death, Myocardial Infarction, or Stroke
Time frame: up to 11 years
First Occurrence of Death, Myocardial Infarction, or Hospitalized Angina
Time frame: up to 11 years
First Occurrence of Major Clinical Events
Time frame: up to 11 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23796131Look AHEAD Research Group; Wing RR, Bolin P, Brancati FL, Bray GA, Clark JM, Coday M, Crow RS, Curtis JM, Egan CM, Espeland MA, Evans M, Foreyt JP, Ghazarian S, Gregg EW, Harrison B, Hazuda HP, Hill JO, Horton ES, Hubbard VS, Jakicic JM, Jeffery RW, Johnson KC, Kahn SE, Kitabchi AE, Knowler WC, Lewis CE, Maschak-Carey BJ, Montez MG, Murillo A, Nathan DM, Patricio J, Peters A, Pi-Sunyer X, Pownall H, Reboussin D, Regensteiner JG, Rickman AD, Ryan DH, Safford M, Wadden TA, Wagenknecht LE, West DS, Williamson DF, Yanovski SZ. Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes. N Engl J Med. 2013 Jul 11;369(2):145-54. doi: 10.1056/NEJMoa1212914. Epub 2013 Jun 24.
- Derived from this study: PubMed 42687462Patel KV, Chiu L, Garcia KR, Belalcazar LM, Segar MW, Butler J, Espeland M, Ballantyne CM, Pandey A. Residual Inflammatory Risk of Heart Failure and Atherosclerotic CVD in Diabetes: Look AHEAD Ancillary Study. JACC Heart Fail. 2026 Sep 2:103296. doi: 10.1016/j.jchf.2026.103296. Online ahead of print.
- Derived from this study: PubMed 41237447Golchin A, Johnson KC, Houston DK, Luchsinger JA, Beavers KM, Bertoni AG, Chen H, Wagenknecht L, Espeland MA; Action for Health in Diabetes (Look AHEAD) Aging Study Group. Associations of modifiable lifestyle and clinical factors with cognitive function in adults with type 2 diabetes. J Diabetes Complications. 2026 Jan;40(1):109227. doi: 10.1016/j.jdiacomp.2025.109227. Epub 2025 Nov 10.
- Derived from this study: PubMed 41204924Chunawala Z, Patel KV, Garcia KR, Segar MW, Verma S, Bayes-Genis A, Pop-Busui R, Bhatt DL, Januzzi JL Jr, Butler J, Lam CSP, Bertoni AG, Espeland M, Pandey A. Cardiac Biomarkers, Intensive Lifestyle Intervention, and Heart Failure Subtypes in Diabetes: Look AHEAD Cardiac Biomarker Ancillary Study. JACC Heart Fail. 2026 Mar;14(3):102726. doi: 10.1016/j.jchf.2025.102726. Epub 2025 Nov 7.
- Derived from this study: PubMed 40886675Vaidya D, Yeboah-Kordieh Y, Howard M, Hugenschmidt CE, Nyquist PA, Michos ED, Kalyani RR, Yasar S, Robusto BA, Yassine HN, Clark JM, Espeland MA, Bennett WL. Sex specific associations of sex hormones with brain volumes and cerebral blood flow: A cross sectional observational study within the look AHEAD type 2 diabetes cohort. J Diabetes Complications. 2025 Oct;39(10):109161. doi: 10.1016/j.jdiacomp.2025.109161. Epub 2025 Aug 27.
- Derived from this study: PubMed 40556311Whitmer RA, Baker LD, Carrillo MC, Snyder HM, Cleveland ML, Gitelman DR, Kivipelto M, Leng XI, Lovato L, Papp KV, Pavlik VN, Salloway SP, Tangney CC, Farias ST, Williamson JD, Wilmoth S, Woolard N, Yu M, Espeland MA; U.S. POINTER Study Group. Baseline characteristics of the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER): Successful enrollment of a diverse clinical trial cohort at risk for cognitive decline. Alzheimers Dement. 2025 Jun;21(6):e70351. doi: 10.1002/alz.70351.
- Derived from this study: PubMed 38746210Vaidya D, Yeboah-Kordieh Y, Howard M, Hugenschmidt CE, Nyquist PA, Michos ED, Kalyani RR, Yasar S, Robusto BA, Yassine HN, Clark JM, Espeland MA, Bennett WL. Sex Specific Associations of Sex hormone With Brain Volumes and Cerebral Blood Flow: A Cross Sectional Observational Study Within the Look AHEAD Type 2 Diabetes Cohort. Res Sq [Preprint]. 2024 Apr 29:rs.3.rs-4254188. doi: 10.21203/rs.3.rs-4254188/v1.
- Derived from this study: PubMed 38233592Gregg EW, Chen H, Bancks MP, Manalac R, Maruthur N, Munshi M, Wing R; Look AHEAD Research Group. Impact of remission from type 2 diabetes on long-term health outcomes: findings from the Look AHEAD study. Diabetologia. 2024 Mar;67(3):459-469. doi: 10.1007/s00125-023-06048-6. Epub 2024 Jan 18.
- Derived from this study: PubMed 38051041Olson K, Houston DK, Ross J, Wing RR, Simpson FR, Pandey A, Walkup MP, Yang M, Espeland MA. Associations that Cardiorespiratory Fitness and Body Mass Index Loss Have with Deficit Accumulation Frailty. Med Sci Sports Exerc. 2024 Apr 1;56(4):717-724. doi: 10.1249/MSS.0000000000003353. Epub 2023 Nov 27.
- Derived from this study: PubMed 37452151Johnson KC, Anderson A, Beavers KM, Crandall CJ, Hazuda HP, Lewis CE, Lipkin E, Schwartz AV, Pi-Sunyer FX, Zhao Q; and the Look AHEAD Research Group. The long-term effect of intentional weight loss on changes in bone mineral density in persons with type 2 diabetes: results from the Look AHEAD randomized trial. Arch Osteoporos. 2023 Jul 14;18(1):97. doi: 10.1007/s11657-023-01303-0.
- Derived from this study: PubMed 36946420Evans JK, Usoh CO, Simpson FR, Espinoza S, Hazuda H, Pandey A, Beckner T, Espeland MA. Long-term Impact of a 10-Year Intensive Lifestyle Intervention on a Deficit Accumulation Frailty Index: Action for Health in Diabetes Trial. J Gerontol A Biol Sci Med Sci. 2023 Oct 28;78(11):2119-2126. doi: 10.1093/gerona/glad088.
- Derived from this study: PubMed 36472933Bancks MP, Lovato J, Balasubramanyam A, Coday M, Johnson KC, Munshi M, Rebello C, Wagenknecht LE, Espeland MA. Association of Type 2 Diabetes Subgroups With Cognitive Status Without Modification From Lifestyle Intervention. J Clin Endocrinol Metab. 2023 May 17;108(6):e334-e342. doi: 10.1210/clinem/dgac706.
- Individual participant dataSharing planned: Yes. We plan to share data sets through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) repository, baseline data sets are currently available. Outcome data will be available approximately 1 year after the study is over.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A Espeland, PhD principal investigator
Wake Forest University Health Sciences
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention and Diabetes Support and Education in people with Diabetes and Myocardial Infarction, run by Wake Forest University Health Sciences at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 50 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Occurrence of a Severe Cardiovascular Event (time frame: up to 11 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00017953, which also lists 105 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.