{ "release_id": "f6f6f1b6f50379ed", "id": "cardio:look-ahead", "owner": "cardio", "kind": "study", "slug": "look-ahead", "name": "Look AHEAD: intensive lifestyle intervention in type 2 diabetes", "aliases": [ "Look AHEAD", "Action for Health in Diabetes" ], "atlases": [ "cardio" ], "summary_plain": "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.", "summary_technical": "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.", "editorial_state": "draft", "last_substantive_edit": "2026-10-14", "last_evidence_check": null, "next_review_due": null, "identifiers": [ { "scheme": "nct", "value": "NCT00017953", "normalized_value": "NCT00017953", "match": "exact", "version": null, "label": null, "from_source": false } ], "navigation": { "cardio": { "system": [ "metabolism" ], "condition-area": [ "diabetes-and-metabolic-disease", "risk-and-prevention" ] } }, "payload": { "design": "Randomized, parallel-group trial at 16 US centers. The registry records no drug phase (not applicable) and no masking.", "drug_phase": "not_applicable", "registry_statuses": [ { "status": "COMPLETED", "snapshot": "cardio:ctgov-nct00017953-2026-10-14" } ], "start_date": { "date": "2001-06", "type": "actual", "snapshot": "cardio:ctgov-nct00017953-2026-10-14" }, "primary_completion_date": { "date": "2012-09", "type": "actual", "snapshot": "cardio:ctgov-nct00017953-2026-10-14" }, "completion_date": { "date": "2020-06-30", "type": "actual", "snapshot": "cardio:ctgov-nct00017953-2026-10-14" }, "results_first_posted": { "date": "2023-08-02", "type": "actual", "snapshot": "cardio:ctgov-nct00017953-2026-10-14" }, "countries": [ { "code": "US", "snapshot": "cardio:ctgov-nct00017953-2026-10-14" } ], "care_setting": null, "stopped_early": { "scope": "trial", "date": null, "reason": "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.", "snapshot": "cardio:pubmed-23796131-2026-10-14" }, "enrollment": [ { "count": 5145, "basis": "enrolled", "unit": "participants", "snapshot": "cardio:ctgov-nct00017953-2026-10-14" } ], "arms": [ { "id": "cardio:look-ahead-arm-lifestyle", "label": "Intensive lifestyle intervention", "intervention": null, "description": "A program that promoted weight loss through decreased caloric intake and increased physical activity." }, { "id": "cardio:look-ahead-arm-support", "label": "Diabetes support and education", "intervention": null, "description": "Diabetes support and education (the control group)." } ], "findings": [] }, "content_digest": "cb9c8c27a36ea5fe695ea01daba1d7cb7b5e424de5c1c35ea1e6cf280a1ebc78", "review": { "content_digest": "cb9c8c27a36ea5fe695ea01daba1d7cb7b5e424de5c1c35ea1e6cf280a1ebc78", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "f6f6f1b6f50379ed", "id": "cardio:claim-look-ahead-no-cardiovascular-effect", "owner": "cardio", "subject_entity_id": "cardio:look-ahead", "category": "effect", "statement": "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.", "context": { "id": "cardio:ctx-look-ahead-adults-overweight-type-2-diabetes", "label": "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_note": "Adults; registry age range 55 to 76 years", "life_stage_terms": null, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "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": { "inclusion": [ "Overweight or obese", "Type 2 diabetes" ], "exclusion": [] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "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.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Abstract, RESULTS, sentence 4", "applicability_note": "Primary outcome counts by arm, rates and hazard ratio.", "snapshot": { "id": "cardio:pubmed-23796131-2026-10-14", "retrieved_at": "2026-10-14T18:18:50Z", "content_hash": "a97161581863ac0095895b445485504906a521da53127302f39e9693846cd1db", "source_effective_date": null, "public_archive_url": null, "source_state": "corrected" }, "source": { "id": "cardio:pubmed-10-1056-nejmoa1212914", "source_type": "publication", "title": "Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes", "canonical_url": "https://doi.org/10.1056/NEJMoa1212914", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa1212914", "normalized_value": "10.1056/nejmoa1212914", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "23796131", "normalized_value": "23796131", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmcid", "value": "PMC3791615", "normalized_value": "PMC3791615", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2013-07-11", "publisher": "The New England journal of medicine", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities. 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