Long-term Effects of a Lifestyle Intervention on Weight and Cardiovascular Risk Factors in Individuals With Type 2 Diabetes Mellitus: Four-Year Results of the Look AHEAD Trial
Open accessAbstract
BACKGROUND: Lifestyle interventions produce short-term improvements in glycemia and cardiovascular disease (CVD) risk factors in individuals with type 2 diabetes mellitus, but no long-term data are available. We examined the effects of lifestyle intervention on changes in weight, fitness, and CVD risk factors during a 4-year study. METHODS: The Look AHEAD (Action for Health in Diabetes) trial is a multicenter randomized clinical trial comparing the effects of an intensive lifestyle intervention (ILI) and diabetes support and education (DSE; the control group) on the incidence of major CVD events in 5145 overweight or obese individuals (59.5% female; mean age, 58.7 years) with type 2 diabetes mellitus. More than 93% of participants provided outcomes data at each annual assessment. RESULTS: Averaged across 4 years, ILI participants had a greater percentage of weight loss than DSE participants (-6.15% vs -0.88%; P < .001) and greater improvements in treadmill fitness (12.74% vs 1.96%; P < .001), hemoglobin A(1c) level (-0.36% vs -0.09%; P < .001), systolic (-5.33 vs -2.97 mm Hg; P < .001) and diastolic (-2.92 vs -2.48 mm Hg; P = .01) blood pressure, and levels of high-density lipoprotein cholesterol (3.67 vs 1.97 mg/dL; P < .001) and triglycerides (-25.56 vs -19.75 mg/dL; P < .001). Reductions in low-density lipoprotein cholesterol levels were greater in DSE than ILI participants (-11.27 vs -12.84 mg/dL; P = .009) owing to greater use of medications to lower lipid levels in the DSE group. At 4 years, ILI participants maintained greater improvements than DSE participants in weight, fitness, hemoglobin A(1c) levels, systolic blood pressure, and high-density lipoprotein cholesterol levels. CONCLUSIONS: Intensive lifestyle intervention can produce sustained weight loss and improvements in fitness, glycemic control, and CVD risk factors in individuals with type 2 diabetes. Whether these differences in risk factors translate to reduction in CVD events will ultimately be addressed by the Look AHEAD trial. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00017953.
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Evidence of T2D remission beyond two years is sparse.
“Evidence of T2D remission beyond two years is sparse, with examples in bariatric surgery and following the three lifestyle interventions: 1) meal replacements for caloric restriction and physical activity [5,7,8]; 2) short-term total diet replacement with rescue therapy for weight maintenance [9]; and 3) a calorie-restricted Mediterranean diet [10].”
From 5-Year effects of a novel continuous remote care model with carbohydrate-restricted nutrition therapy including nutritional ketosis in type 2 diabetes: An extension study (2024) · cites this paper as [8]
The Introduction says evidence for lifestyle interventions in type 2 diabetes was largely limited to studies under one year, and the Conclusions say the authors found no prior intervention study following people with diabetes for four years. The Methods describe meal replacements, calorie restriction, and physical activity, with four years of follow-up. But the paper reports weight loss and improved glycemic control, not diabetes remission; it does not establish that evidence of remission beyond two years is sparse or provide an example of it. (LLM, conf=0.82)
Experimental — accuracy not yet measuredWe previously reported improvements in glycemia, body weight, markers of liver disease and cardiovascular risk over two years among participants with T2D receiving CCI.
“We previously reported improvements in glycemia, body weight, markers of liver disease and cardiovascular risk over two years among participants with T2D receiving a continuous care intervention (CCI) delivered via telemedicine by a care team who counseled participants on a very low carbohydrate diet including nutritional ketosis [8,19].”
From 5-Year effects of a novel continuous remote care model with carbohydrate-restricted nutrition therapy including nutritional ketosis in type 2 diabetes: An extension study (2024) · cites this paper as [8]
The Results report improved weight, HbA1c, and cardiovascular risk factors in participants with type 2 diabetes. But the Methods describe the Look AHEAD intensive lifestyle intervention, with calorie and fat targets, rather than a telemedicine-delivered continuous care intervention involving nutritional ketosis. The paper reports four-year follow-up and does not establish the claimed improvement in liver-disease markers. (LLM, conf=0.88)
Experimental — accuracy not yet measuredThe trajectory of outcomes in the usual care group followed for two years showed no change in HbA1c and body weight concurrent with greater medication use.
“the trajectory of outcomes in the usual care group followed for two years (showing no change in HbA1c and body weight concurrent with greater medication use [8])”
From 5-Year effects of a novel continuous remote care model with carbohydrate-restricted nutrition therapy including nutritional ketosis in type 2 diabetes: An extension study (2024) · cites this paper as [8]
The Results (page unavailable) report that usual-care (DSE) participants used diabetes medication more often than intervention participants, and that DSE had a small weight loss at year 4. The reported four-year average changes were small, but the passages do not establish that both HbA1c and weight were unchanged specifically over two years. (LLM, conf=0.80)
Experimental — accuracy not yet measuredIn overweight and obese adults with type 2 diabetes, the reduction in hemoglobin A1c after partial weight regain during comprehensive lifestyle treatment over 4 years remains clinically meaningful.
“As comprehensive lifestyle treatment of overweight and obese adults with type 2 diabetes continues over 4 years, some weight regain will occur on average; partial weight regain is associated with an increase in hemoglobin A1c, but hemoglobin A1c remains below preintervention levels, and the reduction remains clinically meaningful.23”
From 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults (2014) · cites this paper as [23]
The Conclusions (page unavailable) report partial weight regain over four years and say HbA1c moved back toward baseline, likely in part because of weight regain. The Results (page unavailable) report greater HbA1c reductions in the lifestyle group than in the comparison group at every year. The paper does not specifically establish that the remaining reduction after regain was clinically meaningful, and it presents the link between regain and rising HbA1c as a possible explanation rather than a demonstrated association. (LLM, conf=0.83)
Experimental — accuracy not yet measuredStructured weight loss programs with regular visits and use of meal replacements have been shown to enhance weight loss in people with diabetes.
“Structured weight loss programs with regular visits and use of meal replacements have been shown to enhance weight loss in people with diabetes (138 -140).”
From Nutrition Therapy for Adults With Diabetes or Prediabetes: A Consensus Report (2019) · cites this paper as [140]
Current evidence for carbohydrate restricted nutrition therapy is limited to two-years of follow-up.
“It is well recognized among professional society guidelines that carbohydrate restricted nutrition therapy results in improved glycemia, most cardiovascular risk markers and reduced need for medication [11][12][13][14], yet current evidence is limited to two-years of follow-up [8,15,16,17,18].”
From 5-Year effects of a novel continuous remote care model with carbohydrate-restricted nutrition therapy including nutritional ketosis in type 2 diabetes: An extension study (2024) · cites this paper as [8]
The Introduction says evidence for lifestyle-based weight-loss interventions in people with type 2 diabetes was typically limited to studies under one year, but it does not make a claim about carbohydrate-restricted therapy. The Methods describe a calorie-controlled, low-fat diet, and the Conclusions report four years of follow-up for that broader intervention. A search for carbohydrate restriction and two-year follow-up found no passage establishing the claimed limit. (LLM, conf=0.76)
Experimental — accuracy not yet measuredThe slight increase in LDL-C at one and two years regressed back to baseline at five years despite no significant changes in statin use, potentially reflecting transient hypercholesterolemia associated with significant weight loss.
“The slight increase in LDL-C encountered at one [19] and two years [8] (Fig. 2C) of the intervention regressed back to the baseline level at five years despite no significant changes in statin use, potentially reflecting the transient hypercholesterolemia associated with significant weight loss [31].”
From 5-Year effects of a novel continuous remote care model with carbohydrate-restricted nutrition therapy including nutritional ketosis in type 2 diabetes: An extension study (2024) · cites this paper as [8]
Citation [31] is attached to the proposed explanation of transient hypercholesterolemia with significant weight loss. The Results and Conclusions (pages unavailable) instead report LDL-C reductions over four years and discuss statin use; they do not address a transient LDL-C increase caused by weight loss. I searched for transient hypercholesterolemia and weight-loss-related LDL-C elevation. (LLM, conf=0.76)
Experimental — accuracy not yet measuredStructured weight loss programs with regular visits have been shown to enhance weight loss in T2DM.
“Structured weight loss programs with regular visits have been shown to enhance weight loss in T2DM [121,122,123].”
From Effects of diet, lifestyle, Chrononutrition and alternative dietary interventions on postprandial Glycemia and insulin resistance (2022) · cites this paper as [123]
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- Authors
- The Look AHEAD Research Group
- Affiliations
- Miriam Hospital (US)
- Corresponding author
- The Look AHEAD Research Group
- Venue
- Archives of Internal Medicine
- Publisher
- American Medical Association (AMA)
- Published
- 2010-09-27
- Volume
- 170
- Issue
- 17
- Pages
- 1566-75
- ISSN
- 0003-9926 (ISSN-L)
- PMC
- PMC3084497
- OpenAlex
- W1580839177
- Cited by
- 1,162
- References
- 61
- Citations by year
- 2026: 19 · 2025: 33 · 2024: 31 · 2023: 38 · 2022: 37 · 2021: 54 · 2020: 75 · 2019: 66 · 2018: 84 · 2017: 96 · 2016: 90 · 2015: 83 · 2014: 102 · 2013: 146 · 2012: 113
- FWCI
- 84.72
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Archives of Internal Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (5p30dk046204-15)
- National Institute of Diabetes and Digestive and Kidney Diseases (DK-57171, DK 57136, DK57149, DK 57002, DK57182, DK56990, (DK 046204, DK57008, DK57177, DK 57078, DK57219, U01DK057149, DK-57178, U01DK057151, U01DK057135, U01DK057131, U01DK056990, DK-57135, U01DK057136, DK-56992, DK57154, U01DK057178, U01DK057182, U01DK057078, U01DK057154, P30DK079637, U01DK057008, U01DK057171, DK57131, U01DK057219, U01DK056992, U01DK057177, P30DK017047, P30DK048520, DK 57151, P30-DK 48520)
- National Center for Research Resources (M01-RR-0021140, M01RR-00051, M01RR002719, M01RR000056, M01RR01346, M01RR000051, M01RR001066, M01RR001346, UL1RR024153, M0-1-RR-02719, M01-RR01066)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Physiology › Physical Activity and Health
- Keywords
- type 2 diabetes, intensive lifestyle intervention, weight loss, cardiovascular risk factors, glycemic control, HbA1c, blood pressure, HDL cholesterol, triglycerides, LDL cholesterol, diabetes support and education, Look AHEAD trial, long-term outcomes, overweight and obesity, cardiovascular disease prevention
- MeSH terms
- Aged, Blood Glucose, Blood Pressure, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Female, Humans, Life Style, Cholesterol, HDL, Cholesterol, LDL, Male, Middle Aged, Obesity, Patient Education as Topic, Physical Fitness, Risk Factors, Severity of Illness Index, Time Factors, Triglycerides, United States, Biomarkers, Weight Loss, Body Mass Index, Treatment Outcome, Diabetes Complications, Overweight
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
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