# Look AHEAD: intensive lifestyle intervention in type 2 diabetes

Study · id `cardio:look-ahead` · Cardiovascular Atlas · release `f6f6f1b6f50379ed` (public)

> General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here.

The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations.

Also called: Look AHEAD; Action for Health in Diabetes

Browse, organ or system: Metabolism  
Browse, condition area: Risk and prevention; Diabetes and metabolic disease  

## In plain language

A large US trial of overweight or obese people with type 2 diabetes. Half joined an intensive program of eating less and being more active, aimed at weight loss, and half got diabetes support and education. The program led to more weight loss and better blood sugar and fitness. It did not lower the chance of heart attack, stroke, heart-related death or admission for angina. The trial was stopped early because it was unlikely to show a difference.

## Technical summary

Randomized trial (NCT00017953) sponsored by Wake Forest University Health Sciences, with NIDDK and NHLBI among the registry collaborators. 5145 overweight or obese patients with type 2 diabetes at 16 US centers, maximum follow-up 13.5 years. Primary outcome (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke or hospitalization for angina): 403 against 418 patients (1.83 and 1.92 events per 100 person-years), hazard ratio 0.95 (95% CI 0.83 to 1.09; P=0.51). The trial was stopped early on the basis of a futility analysis at a median follow-up of 9.6 years.

## Key facts

- Design: Randomized, parallel-group trial at 16 US centers. The registry records no drug phase (not applicable) and no masking.
- Phase: Not applicable
- Enrolled: 5145 participants (enrolled count; Look AHEAD: Action for Health in Diabetes, snapshot `cardio:ctgov-nct00017953-2026-10-14`, retrieved 2026-10-14)
- Started: 2001-06 (actual) (Look AHEAD: Action for Health in Diabetes, snapshot `cardio:ctgov-nct00017953-2026-10-14`, retrieved 2026-10-14)
- Primary completion: 2012-09 (actual) (Look AHEAD: Action for Health in Diabetes, snapshot `cardio:ctgov-nct00017953-2026-10-14`, retrieved 2026-10-14)
- Completion: 2020-06-30 (actual) (Look AHEAD: Action for Health in Diabetes, snapshot `cardio:ctgov-nct00017953-2026-10-14`, retrieved 2026-10-14)
- Results first posted: 2023-08-02 (actual) (Look AHEAD: Action for Health in Diabetes, snapshot `cardio:ctgov-nct00017953-2026-10-14`, retrieved 2026-10-14)
- Countries: United States (Look AHEAD: Action for Health in Diabetes, snapshot `cardio:ctgov-nct00017953-2026-10-14`, retrieved 2026-10-14)
- Care setting: Not reported
- Registry status: "COMPLETED" (U.S. National Library of Medicine (ClinicalTrials.gov), snapshot `cardio:ctgov-nct00017953-2026-10-14`, retrieved 2026-10-14)
- Stopped early: The trial stopped early, date not reported. The trial was stopped early on the basis of a futility analysis, at a median follow-up of 9.6 years. The registry gives a primary completion date of 2012-09 and a completion date of 2020-06-30, and records the study as completed. (Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes, snapshot `cardio:pubmed-23796131-2026-10-14`, retrieved 2026-10-14)

## Claims, with the population each applies to

## Context: Overweight or obese adults with type 2 diabetes (Look AHEAD)

Recipient: Adult; Population: Overweight or obese patients with type 2 diabetes. The registry gives an age range of 55 to 76 years.; Care setting: Sixteen study centers in the United States (abstract).; Geography: United States; Life stage: Adults; registry age range 55 to 76 years; Follow-up: Planned maximum follow-up of 13.5 years; the trial was stopped early on the basis of a futility analysis when the median follow-up was 9.6 years.

### Look AHEAD randomly assigned 5145 overweight or obese patients with type 2 diabetes at 16 US centers to an intensive lifestyle intervention (less food energy, more physical activity) aimed at weight loss, or to diabetes support and education. Weight loss was greater in the intervention group throughout (8.6% against 0.7% at 1 year; 6.0% against 3.5% at the end of the study), with greater reductions in glycated hemoglobin and initial improvements in fitness and cardiovascular risk factors other than LDL cholesterol. This did not reduce heart events. The primary outcome (death from cardiovascular causes, nonfatal heart attack, nonfatal stroke or hospitalization for angina) occurred in 403 patients in the intervention group and 418 in the control group (1.83 and 1.92 events per 100 person-years; hazard ratio 0.95; 95% CI 0.83 to 1.09; P=0.51). The trial was stopped early on the basis of a futility analysis at a median follow-up of 9.6 years.

- Category: Effect
- Evidence stage: Interventional
- Certainty: Certainty not assessed
- Applies to: Recipient: Adult; Population: Overweight or obese patients with type 2 diabetes. The registry gives an age range of 55 to 76 years.; Care setting: Sixteen study centers in the United States (abstract).; Geography: United States; Life stage: Adults; registry age range 55 to 76 years; Follow-up: Planned maximum follow-up of 13.5 years; the trial was stopped early on the basis of a futility analysis when the median follow-up was 9.6 years.
- Limitations: A null result for the main question: the intensive lifestyle intervention did not reduce cardiovascular events in this population. The trial was stopped for futility, not for harm or benefit. Participants were overweight or obese adults with type 2 diabetes, aged 55 to 76 in the registry, so the result does not cover other groups. The control group got diabetes support and education, not no care. Funded by the National Institutes of Health and others (named in the abstract). Only the PubMed abstract was read; the PMC copy is not in the open-access subset. This claim is about the trial because the atlas has no record for the lifestyle intervention itself. PubMed links a published erratum to the paper (N Engl J Med. 2014 May 8;370(19):1866). What it changes was not read, so the numbers here may not match the corrected paper.
- Last checked: 2026-10-14
- Source problem: a cited source is corrected. Check the sources before relying on this claim.
- Sources:
  1. Supports: Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa1212914>
     Locator: Abstract, RESULTS, sentence 4. Retrieved 2026-10-14T18:18:50Z. Source state: Corrected. Snapshot hash: a97161581863ac0095895b445485504906a521da53127302f39e9693846cd1db.
     How it applies: Primary outcome counts by arm, rates and hazard ratio.
  2. Supports: Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa1212914>
     Locator: Abstract, RESULTS, sentence 2; Abstract, RESULTS, sentence 3. Retrieved 2026-10-14T18:18:50Z. Source state: Corrected. Snapshot hash: a97161581863ac0095895b445485504906a521da53127302f39e9693846cd1db.
     How it applies: Weight loss, glycated hemoglobin and risk-factor changes.
  3. Supports: Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa1212914>
     Locator: Abstract, RESULTS, sentence 1. Retrieved 2026-10-14T18:18:50Z. Source state: Corrected. Snapshot hash: a97161581863ac0095895b445485504906a521da53127302f39e9693846cd1db.
     How it applies: Early stop for futility.
  4. Supports: Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa1212914>
     Locator: Abstract, CONCLUSIONS, sentence 1. Retrieved 2026-10-14T18:18:50Z. Source state: Corrected. Snapshot hash: a97161581863ac0095895b445485504906a521da53127302f39e9693846cd1db.
     How it applies: The authors conclusion.
  5. Background: Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa1212914>
     Locator: Abstract, METHODS, sentence 1; Abstract, METHODS, sentence 2. Retrieved 2026-10-14T18:18:50Z. Source state: Corrected. Snapshot hash: a97161581863ac0095895b445485504906a521da53127302f39e9693846cd1db.
     How it applies: Design, population and primary outcome.
  6. Background: Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa1212914>
     Locator: Abstract, CONCLUSIONS, sentence 2. Retrieved 2026-10-14T18:18:50Z. Source state: Corrected. Snapshot hash: a97161581863ac0095895b445485504906a521da53127302f39e9693846cd1db.
     How it applies: Funding line.

## Connected pages

- Enrolled overweight or obese people with type 2 diabetes: Type 2 diabetes (`cardio:type-2-diabetes`)
- Lead sponsor: Wake Forest University Health Sciences (`cardio:wake-forest-health-sciences`)
- Registry collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (`cardio:niddk`)
- Registry collaborator: National Heart, Lung, and Blood Institute (`cardio:nhlbi`)
- Collaborator on the registry record: Centers for Disease Control and Prevention (`core:cdc`)

## Provenance

Content hash: cb9c8c27a36ea5fe695ea01daba1d7cb7b5e424de5c1c35ea1e6cf280a1ebc78
Last substantive edit: 2026-10-14
Evidence last checked: Not recorded
