ACT1ON DP3: ACT1ON Phase 2 (SMART Pilot) and Phase 3 (Efficacy Trial Development)
Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Completed
CT.gov ID
NCT03651622
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
68
2
3
28.6
34
1.2
Study Details
Study Description
Brief Summary
An initial pilot and feasibility study will be conducted using a Sequential, Multiple Assignment, Randomized Trial (SMART) design to identify acceptable and effective dietary strategies to optimize both glycemic control and weight management in young adults with Type 1 diabetes (T1D). This pilot trial will include a ten-and-a-half month behavioral intervention, with co-primary outcomes of glycemic control (HbA1C and hypoglycemia) and weight loss. The pilot trial will assess acceptability and adherence to three distinct, evidence-based dietary approaches designed to address weight management and glycemic control. Behavioral counseling strategies, use of carbohydrate counting for insulin dosing, and encouragement of physical activity will be the same across the three dietary approaches.
COVID-19 PROVISIONS: Due to restrictions in place on in-person visits due to COVID-19 precautions, some subjects may remain in the study longer than 10.5 months. As of June 2020, the study transitioned to a completely virtual format. Those who were due for a measurement visit during the time that research activities were halted, prior to the approval of the virtual procedures, remained on the diet they were currently assigned to, supported by bi-weekly Registered Dietitian (RD) counseling, until they were able to be scheduled for a virtual visit.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Eight-four participants will be randomized in total; 42 at the University of North Carolina (UNC), 42 at Stanford.
COVID-19 Provisions: Due to impacts of COVID-19, the study was forced to cease recruitment early. 40 subjects were randomized at UNC and 29 were randomized at Stanford, for a total of 69 subjects across sites.
Procedures (methods):
Three distinct dietary approaches will be tested. Dietary approaches are as follows:
Diet 1: hypocaloric, moderate low fat (30% calories from fat) weight management based on the Look AHEAD study Diet 2: hypocaloric, low carbohydrate (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat) Diet 3: advice to select a healthy Mediterranean dietary pattern with no caloric restriction
Participants will complete measurement visits at baseline (-14 days), 3 mos, 6.5 mos, and 10 mos. All visits transitioned to a virtual format as of 6/2020 due to COVID-19 provisions.
Participants will complete a total of 23 intervention sessions over an approximately 10-and-a-half month period (Eight longer sessions (teleconference) and 15 telephone check-ins)
Participants will be randomized to one of the three diets for a minimum of a three-and-a-half month period. Re-randomization is possible following the 3 month and/or 6.5 month measurement visits. Re-randomization is based on acceptability of diet (self-report), non-severe hypoglycemic events (self-report), and not achieving significant weight change (defined as losing at least 2% of body weight from previous study visit), and worsening glycemic control (increase in Hemoglobin A1c of >/= 0.5% from previous study visit). Re-randomization will occur after the 14-day continuous glucose monitoring (CGM) wear period that will be initiated at each measurement visit.
Study Design
Study Type:
Interventional
Actual Enrollment
:
68 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
This initial pilot and feasibility study uses a Sequential, Multiple Assignment, Randomized Trial (SMART) design to identify acceptable and effective dietary strategies to optimize both glycemic control and weight management. The study will be done at UNC and Stanford. Sequential randomization will occur at 0, 3.5, and 7 months. Following the baseline measurement visit and two week run-in period, participants will be randomized to one of three diets (stratified by site with block size of 4). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the assigned diet is not acceptable or effective will be re-randomized (or re-assigned if only one diet remains untried). 10.5 months of follow-up time allows for evaluation of the effect of diets on initial weight loss and on early maintenance of initial weight loss. Decision criteria for re-randomization will incorporate clinical outcomes (glycemic control and weight change) and acceptability of the diet.This initial pilot and feasibility study uses a Sequential, Multiple Assignment, Randomized Trial (SMART) design to identify acceptable and effective dietary strategies to optimize both glycemic control and weight management. The study will be done at UNC and Stanford. Sequential randomization will occur at 0, 3.5, and 7 months. Following the baseline measurement visit and two week run-in period, participants will be randomized to one of three diets (stratified by site with block size of 4). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the assigned diet is not acceptable or effective will be re-randomized (or re-assigned if only one diet remains untried). 10.5 months of follow-up time allows for evaluation of the effect of diets on initial weight loss and on early maintenance of initial weight loss. Decision criteria for re-randomization will incorporate clinical outcomes (glycemic control and weight change) and acceptability of the diet.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Accelerating Solutions to Optimize Glycemic Control and Weight Management In Young Adults With Type 1 Diabetes
Actual Study Start Date
:
Nov 12, 2018
Actual Primary Completion Date
:
Mar 31, 2021
Actual Study Completion Date
:
Mar 31, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Behavioral: Hypocaloric, low carbohydrate diet
Participants will be advised on use of a hypocaloric, low carbohydrate diet using lifestyle counseling to include motivational interviewing and problem solving skills training strategies.
Other Names:
|
| Experimental: 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. |
Behavioral: Hypocaloric, moderate low fat diet
Participants will be advised on use of a hypocaloric, moderate low fat diet using lifestyle counseling to include motivational interviewing and problem solving skills training strategies.
Other Names:
|
| Experimental: 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. |
Behavioral: Mediterranean diet, no caloric restriction
Participants will be advised on use of a healthy Mediterranean-based eating plan using lifestyle counseling to include motivational interviewing and problem solving skills training strategies.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Weight - Randomization 1 [Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit]
Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
- Change in Weight - Randomization 2 [3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit]
Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
- Change in Weight - Randomization 3 [6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit]
Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
- Change in HbA1C - Randomization 1 [Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit]
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.
- Change in HbA1C - Randomization 2 [3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit]
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.
- Change in HbA1C - Randomization 3 [6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit]
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.
- Change in Time in Clinical Hypoglycemia - Randomization 1 [2 weeks of wear from Baseline Visit (-14 Days), 2 weeks of wear from 3 Month (Measurement 2) Visit]
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.
- Change in Time in Clinical Hypoglycemia - Randomization 2 [2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit]
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.
- Change in Time in Clinical Hypoglycemia - Randomization 3 [2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) Visit]
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.
Secondary Outcome Measures
- Change in Body Fat - Randomization 1 [Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit]
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.
- Change in Body Fat - Randomization 2 [3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit]
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.
- Change in Body Fat - Randomization 3 [6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit]
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.
- Change in Time in Target Glucose Range - Randomization 1 [2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit]
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.
- Change in Time in Target Glucose Range - Randomization 2 [2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit]
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.
- Change in Time in Target Glucose Range - Randomization 3 [2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) Visit]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Individuals 19-30 years old at enrollment
-
History of Type 1 diabetes for greater than one year
-
Latest hemoglobin A1c less than 13%
-
BMI of 27-39
Exclusion Criteria:
-
Individuals with other metabolic disorders, unstable thyroid disease, diagnosed eating disorder, prohibitive strict dietary restrictions or those with other serious condition that renders participation inappropriate
-
Individuals who have experience diabetic ketoacidosis (DKA) or severe hypoglycemia requiring outside assistance in the last 6 months
-
Females who are pregnant, breastfeeding, have delivered a baby in the last 12 months, or are planning to become pregnant during the study period.
-
Individuals unwilling to follow any of the three study diets
-
Individuals who monitor blood glucose less than 3 times a day
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University | Palo Alto | California | United States | 94304 |
| 2 | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | United States | 27599 |
Sponsors and Collaborators
- University of North Carolina, Chapel Hill
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Principal Investigator: Elizabeth Mayer-Davis, PhD, UNC Chapel Hill
- Principal Investigator: David M Maahs, MD, PhD, Stanford University
- Principal Investigator: Richard Pratley, MD, Florida Hospital, Translational Research Institute
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT03651622
Other Study ID Numbers:
- 18-1025
- 1DP3DK113358-01
First Posted:
Aug 29, 2018
Last Update Posted:
Mar 4, 2022
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of North Carolina, Chapel Hill
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Hypocaloric, Low Carbohydrate | Hypocaloric, Moderate Low Fat | Mediterranean, no Caloric Restriction |
|---|---|---|---|
| Arm/Group Description | 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. Hypocaloric, low carbohydrate diet: Participants will be advised on use of a hypocaloric, low carbohydrate diet using lifestyle counseling to include motivational interviewing and problem solving skills training strategies. | 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. Hypocaloric, moderate low fat diet: Participants will be advised on use of a hypocaloric, moderate low fat diet using lifestyle counseling to include motivational interviewing and problem solving skills training strategies. | 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. Mediterranean diet, no caloric restriction: Participants will be advised on use of a healthy Mediterranean-based eating plan using lifestyle counseling to include motivational interviewing and problem solving skills training strategies. |
| Period Title: Diet Period 1 (Randomization 1) | |||
| STARTED | 23 | 24 | 21 |
| COMPLETED | 19 | 17 | 12 |
| NOT COMPLETED | 4 | 7 | 9 |
| Period Title: Diet Period 1 (Randomization 1) | |||
| STARTED | 19 | 15 | 14 |
| Number of Participants Rerandomized From Hypocaloric, Low Carbohydrate Diet | 0 | 5 | 5 |
| Number of Participants Rerandomized From Hypocaloric, Moderate Low Fat Diet | 5 | 0 | 6 |
| Number of Participants Rerandomized From Mediterranean, no Caloric Restriction Diet | 5 | 4 | 0 |
| Number of Participants Not Rerandomized | 9 | 6 | 3 |
| COMPLETED | 17 | 13 | 11 |
| NOT COMPLETED | 2 | 2 | 3 |
| Period Title: Diet Period 1 (Randomization 1) | |||
| STARTED | 14 | 9 | 18 |
| Number of Participants Rerandomized From Hypocaloric, Low Carbohydrate Diet | 0 | 2 | 10 |
| Number of Participants Rerandomized From Hypocaloric, Moderate Low Fat Diet | 4 | 0 | 6 |
| Number of Participants Rerandomized From Mediterranean | 6 | 4 | 0 |
| Number of Participants Not Rerandomized | 4 | 3 | 2 |
| COMPLETED | 14 | 9 | 17 |
| NOT COMPLETED | 0 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Hypocaloric, Low Carbohydrate | Hypocaloric, Moderate Low Fat | Mediterranean, no Caloric Restriction | Total |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | Total of all reporting groups |
| Overall Participants | 23 | 24 | 21 | 68 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
25.5
(3.3)
|
24.9
(2.8)
|
26.1
(3.2)
|
25.5
(3.1)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
15
65.2%
|
14
58.3%
|
20
95.2%
|
49
72.1%
|
| Male |
8
34.8%
|
10
41.7%
|
1
4.8%
|
19
27.9%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
2
8.7%
|
5
20.8%
|
4
19%
|
11
16.2%
|
| Not Hispanic or Latino |
21
91.3%
|
19
79.2%
|
17
81%
|
57
83.8%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
4.3%
|
1
4.2%
|
0
0%
|
2
2.9%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
1
4.2%
|
0
0%
|
1
1.5%
|
| Black or African American |
3
13%
|
1
4.2%
|
2
9.5%
|
6
8.8%
|
| White |
17
73.9%
|
19
79.2%
|
13
61.9%
|
49
72.1%
|
| More than one race |
1
4.3%
|
1
4.2%
|
4
19%
|
6
8.8%
|
| Unknown or Not Reported |
1
4.3%
|
1
4.2%
|
2
9.5%
|
4
5.9%
|
| Region of Enrollment (Count of Participants) | ||||
| United States |
23
100%
|
24
100%
|
21
100%
|
68
100%
|
| Weight (kg) (kilograms) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kilograms] |
86.2
(10.7)
|
91.9
(15.4)
|
90.2
(15.6)
|
89.4
(14.0)
|
| Hemoglobin A1c (%) (percent glycated hemoglobin) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [percent glycated hemoglobin] |
7.3
(1.5)
|
8.2
(1.3)
|
8.2
(1.3)
|
7.9
(1.4)
|
| Body fat (Percent body fat) [Median (Inter-Quartile Range) ] | ||||
| Median (Inter-Quartile Range) [Percent body fat] |
39.4
|
39.8
|
41.6
|
40.4
|
| Time in clinical hypoglycemia (Percent of time) [Median (Inter-Quartile Range) ] | ||||
| Median (Inter-Quartile Range) [Percent of time] |
3.5
|
3.3
|
4.1
|
3.6
|
| Time in target glucose range (Percent of time) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Percent of time] |
54.1
(23.5)
|
48.1
(19.3)
|
48.0
(23.0)
|
50.0
(21.7)
|
Outcome Measures
| Title | Change in Weight - Randomization 1 |
|---|---|
| Description | Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period. |
| Time Frame | Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Hypocaloric, Low Carbohydrate | Hypocaloric, Moderate Low Fat | Mediterranean, no Caloric Restriction |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 19 | 17 | 12 |
| Mean (Standard Deviation) [kilograms] |
-1.6
(3.4)
|
-1.8
(5.7)
|
-1.5
(3.2)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Hypocaloric, Low Carbohydrate, Hypocaloric, Moderate Low Fat, Mediterranean, no Caloric Restriction |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.98 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Change in Weight - Randomization 2 |
|---|---|
| Description | Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period. |
| Time Frame | 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Hypocaloric, Low Carbohydrate | Hypocaloric, Moderate Low Fat | Mediterranean, no Caloric Restriction |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 17 | 13 | 12 |
| Mean (Standard Deviation) [kilograms] |
0.27
(3.8)
|
0.99
(4.1)
|
0.86
(3.0)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Hypocaloric, Low Carbohydrate, Hypocaloric, Moderate Low Fat, Mediterranean, no Caloric Restriction |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.85 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Change in Weight - Randomization 3 |
|---|---|
| Description | Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period. |
| Time Frame | 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data for one participant on the Mediterranean diet was excluded from analysis. |
| Arm/Group Title | Hypocaloric, Low Carbohydrate | Hypocaloric, Moderate Low Fat | Mediterranean, no Caloric Restriction |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 14 | 9 | 16 |
| Mean (Standard Deviation) [kilograms] |
0.68
(2.4)
|
-0.85
(2.3)
|
-0.64
(3.4)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Hypocaloric, Low Carbohydrate, Hypocaloric, Moderate Low Fat, Mediterranean, no Caloric Restriction |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.40 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Change in HbA1C - Randomization 1 |
|---|---|
| Description | 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. |
| Time Frame | Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Hypocaloric, Low Carbohydrate | Hypocaloric, Moderate Low Fat | Mediterranean, no Caloric Restriction |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 19 | 17 | 12 |
| Mean (Standard Deviation) [Percent glycated hemoglobin] |
-0.03
(0.55)
|
-0.48
(0.83)
|
0.37
(0.88)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Hypocaloric, Low Carbohydrate, Hypocaloric, Moderate Low Fat, Mediterranean, no Caloric Restriction |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.02 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Change in HbA1C - Randomization 2 |
|---|---|
| Description | 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. |
| Time Frame | 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Hypocaloric, Low Carbohydrate | Hypocaloric, Moderate Low Fat | Mediterranean, no Caloric Restriction |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 17 | 13 | 11 |
| Mean (Standard Deviation) [Percent glycated hemoglobin] |
-0.11
(0.65)
|
-0.008
(0.52)
|
-0.36
(0.66)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Hypocaloric, Low Carbohydrate, Hypocaloric, Moderate Low Fat, Mediterranean, no Caloric Restriction |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.38 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Change in HbA1C - Randomization 3 |
|---|---|
| Description | 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. |
| Time Frame | 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Hypocaloric, Low Carbohydrate | Hypocaloric, Moderate Low Fat | Mediterranean, no Caloric Restriction |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 14 | 9 | 17 |
| Mean (Standard Deviation) [Percent glycated hemoglobin] |
0.25
(0.72)
|
0.72
(1.7)
|
-0.16
(0.74)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Hypocaloric, Low Carbohydrate, Hypocaloric, Moderate Low Fat, Mediterranean, no Caloric Restriction |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.18 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Change in Time in Clinical Hypoglycemia - Randomization 1 |
|---|---|
| Description | 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. |
| Time Frame | 2 weeks of wear from Baseline Visit (-14 Days), 2 weeks of wear from 3 Month (Measurement 2) Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Hypocaloric, Low Carbohydrate | Hypocaloric, Moderate Low Fat | Mediterranean, no Caloric Restriction |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 15 | 13 | 9 |
| Mean (Standard Deviation) [Percent of time] |
-0.30
(4.1)
|
0.65
(5.4)
|
-0.45
(1.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Hypocaloric, Low Carbohydrate, Hypocaloric, Moderate Low Fat, Mediterranean, no Caloric Restriction |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.79 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Change in Time in Clinical Hypoglycemia - Randomization 2 |
|---|---|
| Description | 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. |
| Time Frame | 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Hypocaloric, Low Carbohydrate | Hypocaloric, Moderate Low Fat | Mediterranean, no Caloric Restriction |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 13 | 12 | 9 |
| Mean (Standard Deviation) [Percent of time] |
0.2
(3.2)
|
1.4
(4.2)
|
2.6
(4.9)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Hypocaloric, Low Carbohydrate, Hypocaloric, Moderate Low Fat, Mediterranean, no Caloric Restriction |
|---|---|---|
| Comments | The proposed sample size of n=72 was sufficient to ensure 60% power to detect a moderate effect size (Cohen h=0.68) and 80% to detect a large effect size (Cohen h=0.85) at a significance level of 0.10 for comparing difference in change among the 3 diets. By design, our primary goal for this pilot work is to inform the final efficacy design of a fully powered SMART, and the pilot SMART was therefore not designed to be fully powered for all analyses. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.39 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Change in Time in Clinical Hypoglycemia - Randomization 3 |
|---|---|
| Description | 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. |
| Time Frame | 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Hypocaloric, Low Carbohydrate | Hypocaloric, Moderate Low Fat | Mediterranean, no Caloric Restriction |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 13 | 8 | 15 |
| Mean (Standard Deviation) [Percent of time] |
0.086
(2.5)
|
0.97
(4.4)
|
-0.47
(5.3)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Hypocaloric, Low Carbohydrate, Hypocaloric, Moderate Low Fat, Mediterranean, no Caloric Restriction |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.75 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Change in Body Fat - Randomization 1 |
|---|---|
| Description | 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. |
| Time Frame | Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Hypocaloric, Low Carbohydrate | Hypocaloric, Moderate Low Fat | Mediterranean, no Caloric Restriction |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 16 | 12 | 10 |
| Mean (Standard Deviation) [Percent body fat] |
-0.87
(1.5)
|
-0.058
(1.2)
|
-0.57
(1.8)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Hypocaloric, Low Carbohydrate, Hypocaloric, Moderate Low Fat, Mediterranean, no Caloric Restriction |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.66 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Change in Body Fat - Randomization 2 |
|---|---|
| Description | 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. |
| Time Frame | 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Hypocaloric, Low Carbohydrate | Hypocaloric, Moderate Low Fat | Mediterranean, no Caloric Restriction |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 4 | 4 | 4 |
| Mean (Standard Deviation) [Percentage of body fat] |
-0.38
(2.7)
|
-0.28
(1.7)
|
0.05
(2.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Hypocaloric, Low Carbohydrate, Hypocaloric, Moderate Low Fat, Mediterranean, no Caloric Restriction |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.96 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Change in Body Fat - Randomization 3 |
|---|---|
| Description | 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. |
| Time Frame | 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Hypocaloric, Low Carbohydrate | Hypocaloric, Moderate Low Fat | Mediterranean, no Caloric Restriction |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 2 | 1 | 1 |
| Mean (Standard Deviation) [Percent body fat] |
1.4
(0.7)
|
0.1
|
-0.9
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Hypocaloric, Low Carbohydrate, Hypocaloric, Moderate Low Fat, Mediterranean, no Caloric Restriction |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.34 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Change in Time in Target Glucose Range - Randomization 1 |
|---|---|
| Description | 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. |
| Time Frame | 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Hypocaloric, Low Carbohydrate | Hypocaloric, Moderate Low Fat | Mediterranean, no Caloric Restriction |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 15 | 13 | 9 |
| Mean (Standard Deviation) [Percent of time] |
6.3
(19.1)
|
3.8
(15.1)
|
-0.96
(13.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Hypocaloric, Low Carbohydrate, Hypocaloric, Moderate Low Fat, Mediterranean, no Caloric Restriction |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.58 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Change in Time in Target Glucose Range - Randomization 2 |
|---|---|
| Description | 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. |
| Time Frame | 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Hypocaloric, Low Carbohydrate | Hypocaloric, Moderate Low Fat | Mediterranean, no Caloric Restriction |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 13 | 12 | 9 |
| Mean (Standard Deviation) [Percent of time] |
-0.60
(14.5)
|
0.90
(14.4)
|
1.0
(9.0)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Hypocaloric, Low Carbohydrate, Hypocaloric, Moderate Low Fat, Mediterranean, no Caloric Restriction |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.95 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Change in Time in Target Glucose Range - Randomization 3 |
|---|---|
| Description | 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. |
| Time Frame | 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Hypocaloric, Low Carbohydrate | Hypocaloric, Moderate Low Fat | Mediterranean, no Caloric Restriction |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 13 | 8 | 15 |
| Mean (Standard Deviation) [Percent of time] |
-2.1
(19.0)
|
-18.4
(27.0)
|
1.1
(14.3)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Hypocaloric, Low Carbohydrate, Hypocaloric, Moderate Low Fat, Mediterranean, no Caloric Restriction |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.08 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Adverse Events
| Time Frame | 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Hypocaloric, Low Carbohydrate | Hypocaloric, Moderate Low Fat | Mediterranean, no Caloric Restriction | |||
| Arm/Group Description | 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. | 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. | 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. | |||
All Cause Mortality |
||||||
| Hypocaloric, Low Carbohydrate | Hypocaloric, Moderate Low Fat | Mediterranean, no Caloric Restriction | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/43 (0%) | 0/39 (0%) | 0/48 (0%) | |||
Serious Adverse Events |
||||||
| Hypocaloric, Low Carbohydrate | Hypocaloric, Moderate Low Fat | Mediterranean, no Caloric Restriction | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/43 (2.3%) | 1/39 (2.6%) | 0/48 (0%) | |||
| Endocrine disorders | ||||||
| Diabetic ketoacidosis | 1/43 (2.3%) | 1 | 1/39 (2.6%) | 1 | 0/48 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| Hypocaloric, Low Carbohydrate | Hypocaloric, Moderate Low Fat | Mediterranean, no Caloric Restriction | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/43 (11.6%) | 1/39 (2.6%) | 8/48 (16.7%) | |||
| Endocrine disorders | ||||||
| Hyperglycemia | 0/43 (0%) | 0 | 0/39 (0%) | 0 | 2/48 (4.2%) | 2 |
| Hypoglycemia | 0/43 (0%) | 0 | 0/39 (0%) | 0 | 1/48 (2.1%) | 1 |
| Gastrointestinal disorders | ||||||
| Hematemesis | 0/43 (0%) | 0 | 1/39 (2.6%) | 1 | 0/48 (0%) | 0 |
| Nausea and diarrhea | 0/43 (0%) | 0 | 0/39 (0%) | 0 | 1/48 (2.1%) | 1 |
| General disorders | ||||||
| Cough and shortness of breath | 1/43 (2.3%) | 1 | 0/39 (0%) | 0 | 1/48 (2.1%) | 2 |
| Headache | 0/43 (0%) | 0 | 0/39 (0%) | 0 | 1/48 (2.1%) | 1 |
| Infections and infestations | ||||||
| COVID-19 infection | 1/43 (2.3%) | 2 | 0/39 (0%) | 0 | 0/48 (0%) | 0 |
| Nervous system disorders | ||||||
| Seizure - diagnosed epilepsy | 1/43 (2.3%) | 1 | 0/39 (0%) | 0 | 0/48 (0%) | 0 |
| Psychiatric disorders | ||||||
| Panic attack | 1/43 (2.3%) | 2 | 0/39 (0%) | 0 | 0/48 (0%) | 0 |
| Reproductive system and breast disorders | ||||||
| Suspected pregnancy | 0/43 (0%) | 0 | 0/39 (0%) | 0 | 1/48 (2.1%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||
| Abscess | 1/43 (2.3%) | 1 | 0/39 (0%) | 0 | 0/48 (0%) | 0 |
| Surgical and medical procedures | ||||||
| Jaw inflammation - wisdom tooth removal | 0/43 (0%) | 0 | 0/39 (0%) | 0 | 1/48 (2.1%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Elizabeth Mayer-Davis, PhD |
|---|---|
| Organization | University of North Carolina at Chapel Hill |
| Phone | 919-966-7218 |
| mayerdav@email.unc.edu |
Responsible Party:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT03651622
Other Study ID Numbers:
- 18-1025
- 1DP3DK113358-01
First Posted:
Aug 29, 2018
Last Update Posted:
Mar 4, 2022
Last Verified:
Apr 1, 2021