Cardiovascular Atlas
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Look AHEAD: intensive lifestyle intervention in type 2 diabetes

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.

Also called Look AHEAD · Action for Health in Diabetes

  • Study
  • In this atlas

Overview

Design
Randomized, parallel-group trial at 16 US centers. The registry records no drug phase (not applicable) and no masking.
Phase
Not applicable
Enrolled
  • 5,145 participants (enrolled count) (Look AHEAD: Action for Health in Diabetes, retrieved )
Funder
Not recorded
Registry
  • NCT NCT00017953
Started
(actual) (Look AHEAD: Action for Health in Diabetes, retrieved )
Primary completion
(actual) (Look AHEAD: Action for Health in Diabetes, retrieved )
Completion
(actual) (Look AHEAD: Action for Health in Diabetes, retrieved )
Results first posted
(actual) (Look AHEAD: Action for Health in Diabetes, retrieved )
Countries
United States (Look AHEAD: Action for Health in Diabetes, retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )
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, retrieved )

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.

Arms

  • Intensive lifestyle intervention

    Intervention None named

    A program that promoted weight loss through decreased caloric intake and increased physical activity.

  • Diabetes support and education

    Intervention None named

    Diabetes support and education (the control group).

Findings

No findings are published for this study.

Claims and evidence

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.
Eligibility: 2 inclusion criteria; exclusion criteria not stated
Included
  • Overweight or obese
  • Type 2 diabetes
Excluded
None stated

  • Effect Interventional Certainty not assessed

    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.

    Source problem. A cited source is corrected. Check the sources before relying on this claim.

    Applies to Adult
    • Overweight or obese patients with type 2 diabetes. The registry gives an age range of 55 to 76 years.
    • Sixteen study centers in the United States (abstract).
    • United States
    • 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.
    Certainty method
    Not assessed
    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
    Next evidence check due
    Not scheduled
    Sources and citations (6)

    1. Supports Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2013-07-11 · DOI: 10.1056/NEJMoa1212914 · PMID: 23796131 · PMCID: PMC3791615

      Locator
      Abstract, RESULTS, sentence 4
      How it applies
      Primary outcome counts by arm, rates and hazard ratio.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      a97161581863ac0095895b445485504906a521da53127302f39e9693846cd1db
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    2. Supports Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2013-07-11 · DOI: 10.1056/NEJMoa1212914 · PMID: 23796131 · PMCID: PMC3791615

      Locator
      Abstract, RESULTS, sentence 2; Abstract, RESULTS, sentence 3
      How it applies
      Weight loss, glycated hemoglobin and risk-factor changes.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      a97161581863ac0095895b445485504906a521da53127302f39e9693846cd1db
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    3. Supports Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2013-07-11 · DOI: 10.1056/NEJMoa1212914 · PMID: 23796131 · PMCID: PMC3791615

      Locator
      Abstract, RESULTS, sentence 1
      How it applies
      Early stop for futility.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      a97161581863ac0095895b445485504906a521da53127302f39e9693846cd1db
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    4. Supports Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2013-07-11 · DOI: 10.1056/NEJMoa1212914 · PMID: 23796131 · PMCID: PMC3791615

      Locator
      Abstract, CONCLUSIONS, sentence 1
      How it applies
      The authors conclusion.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      a97161581863ac0095895b445485504906a521da53127302f39e9693846cd1db
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    5. Background Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2013-07-11 · DOI: 10.1056/NEJMoa1212914 · PMID: 23796131 · PMCID: PMC3791615

      Locator
      Abstract, METHODS, sentence 1; Abstract, METHODS, sentence 2
      How it applies
      Design, population and primary outcome.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      a97161581863ac0095895b445485504906a521da53127302f39e9693846cd1db
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    6. Background Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2013-07-11 · DOI: 10.1056/NEJMoa1212914 · PMID: 23796131 · PMCID: PMC3791615

      Locator
      Abstract, CONCLUSIONS, sentence 2
      How it applies
      Funding line.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      a97161581863ac0095895b445485504906a521da53127302f39e9693846cd1db
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

Record details

Record id
cardio:look-ahead
Content hash
cb9c8c27a36ea5fe695ea01daba1d7cb7b5e424de5c1c35ea1e6cf280a1ebc78