| Primary | Change in Hemoglobin A1c | 6-month change in Hemoglobin A1c comparing low-carbohydrate arm with usual diet arm | Data were analyzed using intention to treat. For the primary outcome (net 6-month change in HbA1c), we used linear mixed effects models with HbA1c as the dependent variable. This model included a random intercept with an unstructured covariance matrix, indicator variables for time and study group, and group by time interaction terms. | Posted | | Mean | 95% Confidence Interval | percentage | | Baseline and six months | | | | ID | Title | Description |
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| OG000 | Low-Carbohydrate Diet | Behavioral modification to reduce carbohydrate consumption. Target <40 g net carbohydrates per day for first 3 months; <60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups. At baseline, participants will receive written information with standard physical activity recommendations. Low-Carbohydrate Diet: Behavioral modification to reduce carbohydrate consumption. Target <40 g net carbohydrates per day for first 3 months; <60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups. At baseline, participants will receive written information with standard physical activity recommendations. | | OG001 | Usual Diet | No dietary intervention. At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-0.26(-0.33 to -0.19)
- OG001-0.04(-0.10 to 0.02)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | linear mixed effects model | | <0.05 | | Mean Difference (Net) | -0.23 | | | 2-Sided | 95 | -0.32 | -0.14 | | | | | Superiority | | |
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| Secondary | Change in Fasting Plasma Glucose | 6-month change in fasting plasma glucose comparing low-carbohydrate arm with usual diet arm | Intention to treat analysis. | Posted | | Mean | 95% Confidence Interval | mg/dL | | Baseline and six months | | | | ID | Title | Description |
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| OG000 | Low-Carbohydrate Diet | Behavioral modification to reduce carbohydrate consumption. Target <40 g net carbohydrates per day for first 3 months; <60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups. At baseline, participants will receive written information with standard physical activity recommendations. Low-Carbohydrate Diet: Behavioral modification to reduce carbohydrate consumption. Target <40 g net carbohydrates per day for first 3 months; <60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups. At baseline, participants will receive written information with standard physical activity recommendations. | | OG001 | Usual Diet | No dietary intervention. At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations. |
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| Secondary | Change in Systolic Blood Pressure | 6-month change in systolic blood pressure comparing low-carbohydrate arm with usual diet arm | Intention to treat analysis | Posted | | Mean | 95% Confidence Interval | mm Hg | | Baseline and six months | | | | ID | Title | Description |
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| OG000 | Low-Carbohydrate Diet | Behavioral modification to reduce carbohydrate consumption. Target <40 g net carbohydrates per day for first 3 months; <60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups. At baseline, participants will receive written information with standard physical activity recommendations. Low-Carbohydrate Diet: Behavioral modification to reduce carbohydrate consumption. Target <40 g net carbohydrates per day for first 3 months; <60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups. At baseline, participants will receive written information with standard physical activity recommendations. | | OG001 | Usual Diet | No dietary intervention. At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations. |
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| Secondary | Change in Total-to-HDL-cholesterol Ratio | 6-month change in total-to-HDL-cholesterol ratio comparing low-carbohydrate arm with usual diet arm | | Posted | | Mean | 95% Confidence Interval | ratio | | Baseline and six months | | | | ID | Title | Description |
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| OG000 | Low-Carbohydrate Diet | Behavioral modification to reduce carbohydrate consumption. Target <40 g net carbohydrates per day for first 3 months; <60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups. At baseline, participants will receive written information with standard physical activity recommendations. Low-Carbohydrate Diet: Behavioral modification to reduce carbohydrate consumption. Target <40 g net carbohydrates per day for first 3 months; <60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups. At baseline, participants will receive written information with standard physical activity recommendations. | | OG001 | Usual Diet | No dietary intervention. At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations. |
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| Secondary | Change in Body Weight | 6-month change in body weight comparing low-carbohydrate arm with usual diet arm | | Posted | | Mean | 95% Confidence Interval | kg | | Baseline and six months | | | | ID | Title | Description |
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| OG000 | Low-Carbohydrate Diet | Behavioral modification to reduce carbohydrate consumption. Target <40 g net carbohydrates per day for first 3 months; <60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups. At baseline, participants will receive written information with standard physical activity recommendations. Low-Carbohydrate Diet: Behavioral modification to reduce carbohydrate consumption. Target <40 g net carbohydrates per day for first 3 months; <60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups. At baseline, participants will receive written information with standard physical activity recommendations. | | OG001 | Usual Diet | No dietary intervention. At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations. |
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| Other Pre-specified | Change in Insulin | 6-month change in fasting insulin comparing low-carbohydrate arm with usual diet arm | Intention to treat analysis | Posted | | Mean | 95% Confidence Interval | μIU/L | | Baseline and six months | | | | ID | Title | Description |
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| OG000 | Low-Carbohydrate Diet | Behavioral modification to reduce carbohydrate consumption. Target <40 g net carbohydrates per day for first 3 months; <60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups. At baseline, participants will receive written information with standard physical activity recommendations. Low-Carbohydrate Diet: Behavioral modification to reduce carbohydrate consumption. Target <40 g net carbohydrates per day for first 3 months; <60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups. At baseline, participants will receive written information with standard physical activity recommendations. | | OG001 | Usual Diet | No dietary intervention. At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations. |
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| Other Pre-specified | Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | 6-month change in HOMA-IR comparing low-carbohydrate arm with usual diet arm. HOMA-IR was calculated as fasting insulin (μIU/mL) x fasting glucose (mmol/L)/22.5. | Intention to treat analysis | Posted | | Mean | 95% Confidence Interval | no units | | Baseline and six months | | | | ID | Title | Description |
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| OG000 | Low-Carbohydrate Diet | Behavioral modification to reduce carbohydrate consumption. Target <40 g net carbohydrates per day for first 3 months; <60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups. At baseline, participants will receive written information with standard physical activity recommendations. Low-Carbohydrate Diet: Behavioral modification to reduce carbohydrate consumption. Target <40 g net carbohydrates per day for first 3 months; <60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups. At baseline, participants will receive written information with standard physical activity recommendations. | | OG001 | Usual Diet |
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| Other Pre-specified | Change in Diastolic Blood Pressure | 6-month change in diastolic blood pressure comparing low-carbohydrate arm with usual diet arm | Intention to treat analysis | Posted | | Mean | 95% Confidence Interval | mm Hg | | Baseline and six months | | | | ID | Title | Description |
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| OG000 | Low-Carbohydrate Diet | Behavioral modification to reduce carbohydrate consumption. Target <40 g net carbohydrates per day for first 3 months; <60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups. At baseline, participants will receive written information with standard physical activity recommendations. Low-Carbohydrate Diet: Behavioral modification to reduce carbohydrate consumption. Target <40 g net carbohydrates per day for first 3 months; <60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups. At baseline, participants will receive written information with standard physical activity recommendations. | | OG001 | Usual Diet | No dietary intervention. At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations. |
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| Other Pre-specified | Change in Waist Circumference | 6-month change in waist circumference comparing low-carbohydrate arm with usual diet arm | Intention to treat analysis | Posted | | Mean | 95% Confidence Interval | cm | | Baseline and six months | | | | ID | Title | Description |
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| OG000 | Low-Carbohydrate Diet | Behavioral modification to reduce carbohydrate consumption. Target <40 g net carbohydrates per day for first 3 months; <60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups. At baseline, participants will receive written information with standard physical activity recommendations. Low-Carbohydrate Diet: Behavioral modification to reduce carbohydrate consumption. Target <40 g net carbohydrates per day for first 3 months; <60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups. At baseline, participants will receive written information with standard physical activity recommendations. | | OG001 | Usual Diet | No dietary intervention. At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations. |
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| Other Pre-specified | Change in Estimated Atherosclerotic Cardiovascular Disease Risk | 6-month change in estimated 10-year atherosclerotic cardiovascular disease risk comparing low-carbohydrate arm with usual diet arm. The estimated 10-year cardiovascular disease risk was assessed by 2013 American College of Cardiology/American Heart Association Atherosclerotic Cardiovascular Disease Risk Score, known as the Pooled Cohort Equations. The Pooled Cohort Equations estimate the 10-year primary risk of ASCVD (atherosclerotic cardiovascular disease) among patients without pre-existing cardiovascular disease who are between 40 and 79 years of age. Variables included in the risk score include: gender, age, race, total cholesterol, HDL cholesterol, systolic blood pressure, treatment for blood pressure, diabetes, and smoking status. Reference: Goff DC, Lloyd-Jones DM et al. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: A report of the American college of cardiology/American heart association task force on practice guidelines. Vol. 129, Circulation. 2014. | Intention to treat analysis | Posted | | Mean | 95% Confidence Interval | estimated % | | Baseline and six months | | | | ID | Title | Description |
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| OG000 | Low-Carbohydrate Diet | Behavioral modification to reduce carbohydrate consumption. Target <40 g net carbohydrates per day for first 3 months; <60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups. At baseline, participants will receive written information with standard physical activity recommendations. Low-Carbohydrate Diet: Behavioral modification to reduce carbohydrate consumption. Target <40 g net carbohydrates per day for first 3 months; <60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups. At baseline, participants will receive written information with standard physical activity recommendations. |
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