| Primary | Change in Weight - Randomization 1 | Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period. | | Posted | | Mean | Standard Deviation | kilograms | | Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit | | | | ID | Title | Description |
|---|
| OG000 | Hypocaloric, Low Carbohydrate | Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. | | OG001 | Hypocaloric, Moderate Low Fat | Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. | | OG002 | Mediterranean, no Caloric Restriction | Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-1.6± 3.4
- OG001-1.8± 5.7
- OG002-1.5± 3.2
|
|
| | 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 |
|---|
| | ANOVA | | 0.98 | | | | | | | | | | | | | | Superiority | | |
|
| Primary | Change in Weight - Randomization 2 | Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period. | Completers for each diet period were participants who had sufficient data to be rerandomized. However, one participant on the Mediterranean diet who had insufficient data to be rerandomized had available weight data and was included in the weight analysis. Therefore, there is one more participant assigned to the Mediterranean diet for the weight analysis. | Posted | | Mean | Standard Deviation | kilograms | | 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit | | | | ID | Title | Description |
|---|
| OG000 | Hypocaloric, Low Carbohydrate | Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. | | OG001 | Hypocaloric, Moderate Low Fat | Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. |
|
| Primary | Change in Weight - Randomization 3 | Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period. | Data for one participant on the Mediterranean diet was excluded from analysis. | Posted | | Mean | Standard Deviation | kilograms | | 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit | | | | ID | Title | Description |
|---|
| OG000 | Hypocaloric, Low Carbohydrate | Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. | | OG001 | Hypocaloric, Moderate Low Fat | Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. | | OG002 | Mediterranean, no Caloric Restriction | |
|
| Primary | Change in HbA1C - Randomization 1 | HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period. | | Posted | | Mean | Standard Deviation | Percent glycated hemoglobin | | Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit | | | | ID | Title | Description |
|---|
| OG000 | Hypocaloric, Low Carbohydrate | Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. | | OG001 | Hypocaloric, Moderate Low Fat | Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. | | OG002 | Mediterranean, no Caloric Restriction | |
|
| Primary | Change in HbA1C - Randomization 2 | HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period. | | Posted | | Mean | Standard Deviation | Percent glycated hemoglobin | | 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit | | | | ID | Title | Description |
|---|
| OG000 | Hypocaloric, Low Carbohydrate | Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. | | OG001 | Hypocaloric, Moderate Low Fat | Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. | | OG002 | Mediterranean, no Caloric Restriction | Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. |
|
| Primary | Change in HbA1C - Randomization 3 | HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period. | | Posted | | Mean | Standard Deviation | Percent glycated hemoglobin | | 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit | | | | ID | Title | Description |
|---|
| OG000 | Hypocaloric, Low Carbohydrate | Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. | | OG001 | Hypocaloric, Moderate Low Fat | Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. | | OG002 | Mediterranean, no Caloric Restriction | Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. |
|
| Primary | Change in Time in Clinical Hypoglycemia - Randomization 1 | Change in the percent of time spent in clinical hypoglycemia (54-69 mg/dl) during Continuous Glucose Monitor (CGM) wear time will be assessed between the two weeks of wear from CGM insertion at Baseline Visit (-14 days) and the two weeks of wear from the insertion of the CGM at Measurement Visit 2. | The number of participants analyzed is fewer than the number of participants who completed the randomization period in each diet group due to missing data for continuous glucose monitoring. | Posted | | Mean | Standard Deviation | Percent of time | | 2 weeks of wear from Baseline Visit (-14 Days), 2 weeks of wear from 3 Month (Measurement 2) Visit | | | | ID | Title | Description |
|---|
| OG000 | Hypocaloric, Low Carbohydrate | Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. | | OG001 | Hypocaloric, Moderate Low Fat | Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. |
|
| Primary | Change in Time in Clinical Hypoglycemia - Randomization 2 | Change in the percent of time spent in clinical hypoglycemia (54-69 mg/dl) during CGM wear time will be assessed between the two weeks of wear from CGM insertion at Measurement 2 Visit and from CGM insertion at Measurement 3 Visit. | The number of participants analyzed is fewer than the number of participants who completed the randomization period in each diet group due to missing data for continuous glucose monitoring. | Posted | | Mean | Standard Deviation | Percent of time | | 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit | | | | ID | Title | Description |
|---|
| OG000 | Hypocaloric, Low Carbohydrate | Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. | | OG001 | Hypocaloric, Moderate Low Fat | Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. |
|
| Primary | Change in Time in Clinical Hypoglycemia - Randomization 3 | Change in the percent of time spent in clinical hypoglycemia (54-69 mg/dl) during CGM wear time will be assessed between the two weeks of wear from CGM insertion at Measurement 3 Visit and from CGM insertion at Measurement 4 Visit. | The number of participants analyzed is fewer than the number of participants who completed the randomization period in each diet group due to missing data for continuous glucose monitoring. | Posted | | Mean | Standard Deviation | Percent of time | | 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) Visit | | | | ID | Title | Description |
|---|
| OG000 | Hypocaloric, Low Carbohydrate | Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. | | OG001 | Hypocaloric, Moderate Low Fat | Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. |
|
| Secondary | Change in Body Fat - Randomization 1 | Percent fat mass and percent fat free mass were measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this time three-and-a-half-month time period. COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued as of 3/25/2020. As of this date, DXA scans at both sites were discontinued. Analysis on existing data continued, but no new DXA data were collected. | The number of participants analyzed is fewer than the number of participants who completed the randomization period in each diet group due to missing data for dual-energy x-ray absorptiometry, which was discontinued following the transition to a virtual protocol due to COVID-19. | Posted | | Mean | Standard Deviation | Percent body fat | | Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit | | | | ID | Title | Description |
|---|
| OG000 | Hypocaloric, Low Carbohydrate | Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. | | OG001 | Hypocaloric, Moderate Low Fat | Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. |
|
| Secondary | Change in Body Fat - Randomization 2 | Percent fat mass and percent fat free mass were measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this time three-and-a-half-month time period. COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued as of 3/25/2020. As of this date, DXA scans at both sites were discontinued. Analysis on existing data continued, but no new DXA data were collected. | The number of participants analyzed is fewer than the number of participants who completed the randomization period in each diet group due to missing data for dual-energy x-ray absorptiometry, which was discontinued following the transition to a virtual protocol due to COVID-19. | Posted | | Mean | Standard Deviation | Percentage of body fat | | 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit | | | | ID | Title | Description |
|---|
| OG000 | Hypocaloric, Low Carbohydrate | Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. | | OG001 | Hypocaloric, Moderate Low Fat | Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. |
|
| Secondary | Change in Body Fat - Randomization 3 | Percent fat mass and percent fat free mass were measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this time three-and-a-half-month time period. COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued as of 3/25/2020. As of this date, DXA scans at both sites were discontinued. Analysis on existing data continued, but no new DXA data were collected. | The number of participants analyzed is fewer than the number of participants who completed the randomization period in each diet group due to missing data for dual-energy x-ray absorptiometry, which was discontinued following the transition to a virtual protocol due to COVID-19. | Posted | | Mean | Standard Deviation | Percent body fat | | 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit | | | | ID | Title | Description |
|---|
| OG000 | Hypocaloric, Low Carbohydrate | Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. | | OG001 | Hypocaloric, Moderate Low Fat | Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. |
|
| Secondary | Change in Time in Target Glucose Range - Randomization 1 | Change in percent of time spent in a pre-defined range of relative euglycemia (70-180 mg/dl, for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Baseline Visit (-14 days) and the two weeks of wear from CGM insertion at Measurement Visit 2. | The number of participants analyzed is fewer than the number of participants who completed the randomization period in each diet group due to missing data for continuous glucose monitoring. | Posted | | Mean | Standard Deviation | Percent of time | | 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit | | | | ID | Title | Description |
|---|
| OG000 | Hypocaloric, Low Carbohydrate | Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. | | OG001 | Hypocaloric, Moderate Low Fat | Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. |
|
| Secondary | Change in Time in Target Glucose Range - Randomization 2 | Change in percent of time spent in a pre-defined range of relative euglycemia (70-180 mg/dl, for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Measurement 2 Visit and from CGM insertion at Measurement 3 Visit. | The number of participants analyzed is fewer than the number of participants who completed the randomization period in each diet group due to missing data for continuous glucose monitoring. | Posted | | Mean | Standard Deviation | Percent of time | | 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit | | | | ID | Title | Description |
|---|
| OG000 | Hypocaloric, Low Carbohydrate | Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. | | OG001 | Hypocaloric, Moderate Low Fat | Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. |
|
| Secondary | Change in Time in Target Glucose Range - Randomization 3 | Change in percent of time spent in a pre-defined range of relative euglycemia (70-180 mg/dl, for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Measurement 3 Visit and from CGM insertion at Measurement 4 Visit. | The number of participants analyzed is fewer than the number of participants who completed the randomization period in each diet group due to missing data for continuous glucose monitoring. | Posted | | Mean | Standard Deviation | Percent of time | | 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) Visit | | | | ID | Title | Description |
|---|
| OG000 | Hypocaloric, Low Carbohydrate | Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. | | OG001 | Hypocaloric, Moderate Low Fat | Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. |
|