Trial Outcomes & Findings for Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial (NCT NCT03675360)
NCT ID: NCT03675360
Last Updated: 2023-03-01
Results Overview
6-month change in Hemoglobin A1c comparing low-carbohydrate arm with usual diet arm
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
Baseline and six months
Results posted on
2023-03-01
Participant Flow
Recruitment occurred from September 2018 through December 2020. Participants were recruited from the greater New Orleans, Louisiana area, primarily by mass mailing
After ascertaining eligibility, staff obtained randomization assignment in either a sealed envelope from or by telephoning the methodology unit at the time of randomization.
Participant milestones
| Measure |
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.
|
Usual Diet
No dietary intervention.
At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
|
Overall Study
COMPLETED
|
73
|
69
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial
Baseline characteristics by cohort
| Measure |
Low-Carbohydrate Diet
n=75 Participants
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.
|
Usual Diet
n=75 Participants
No dietary intervention.
At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
58.6 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
58.9 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=5 Participants
|
75 participants
n=7 Participants
|
150 participants
n=5 Participants
|
|
Body weight
|
102.6 kg
STANDARD_DEVIATION 21.8 • n=5 Participants
|
96.4 kg
STANDARD_DEVIATION 19.6 • n=7 Participants
|
99.5 kg
STANDARD_DEVIATION 20.9 • n=5 Participants
|
|
Waist circumference
|
115.9 cm
STANDARD_DEVIATION 14.8 • n=5 Participants
|
111.8 cm
STANDARD_DEVIATION 15.0 • n=7 Participants
|
113.9 cm
STANDARD_DEVIATION 15.0 • n=5 Participants
|
|
Hemoglobin A1c
|
6.17 %
STANDARD_DEVIATION 0.31 • n=5 Participants
|
6.14 %
STANDARD_DEVIATION 0.30 • n=7 Participants
|
6.16 %
STANDARD_DEVIATION 0.30 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and six monthsPopulation: 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.
6-month change in Hemoglobin A1c comparing low-carbohydrate arm with usual diet arm
Outcome measures
| Measure |
Low-Carbohydrate Diet
n=75 Participants
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.
|
Usual Diet
n=75 Participants
No dietary intervention.
At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.
|
|---|---|---|
|
Change in Hemoglobin A1c
|
-0.26 percentage
Interval -0.33 to -0.19
|
-0.04 percentage
Interval -0.1 to 0.02
|
SECONDARY outcome
Timeframe: Baseline and six monthsPopulation: Intention to treat analysis.
6-month change in fasting plasma glucose comparing low-carbohydrate arm with usual diet arm
Outcome measures
| Measure |
Low-Carbohydrate Diet
n=75 Participants
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.
|
Usual Diet
n=75 Participants
No dietary intervention.
At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.
|
|---|---|---|
|
Change in Fasting Plasma Glucose
|
-8.4 mg/dL
Interval -12.3 to -4.4
|
1.9 mg/dL
Interval -1.8 to 5.5
|
SECONDARY outcome
Timeframe: Baseline and six monthsPopulation: Intention to treat analysis
6-month change in systolic blood pressure comparing low-carbohydrate arm with usual diet arm
Outcome measures
| Measure |
Low-Carbohydrate Diet
n=75 Participants
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.
|
Usual Diet
n=75 Participants
No dietary intervention.
At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.
|
|---|---|---|
|
Change in Systolic Blood Pressure
|
-4.9 mm Hg
Interval -7.9 to -1.8
|
-1.6 mm Hg
Interval -4.4 to 1.2
|
SECONDARY outcome
Timeframe: Baseline and six monthsPopulation: Intention to treat
6-month change in total-to-HDL-cholesterol ratio comparing low-carbohydrate arm with usual diet arm
Outcome measures
| Measure |
Low-Carbohydrate Diet
n=75 Participants
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.
|
Usual Diet
n=75 Participants
No dietary intervention.
At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.
|
|---|---|---|
|
Change in Total-to-HDL-cholesterol Ratio
|
-0.54 ratio
Interval -0.67 to -0.4
|
-0.41 ratio
Interval -0.52 to -0.29
|
SECONDARY outcome
Timeframe: Baseline and six monthsPopulation: Intention to treat
6-month change in body weight comparing low-carbohydrate arm with usual diet arm
Outcome measures
| Measure |
Low-Carbohydrate Diet
n=75 Participants
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.
|
Usual Diet
n=75 Participants
No dietary intervention.
At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.
|
|---|---|---|
|
Change in Body Weight
|
-6.4 kg
Interval -7.8 to -5.1
|
-0.5 kg
Interval -1.2 to 0.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and six monthsPopulation: Intention to treat analysis
6-month change in fasting insulin comparing low-carbohydrate arm with usual diet arm
Outcome measures
| Measure |
Low-Carbohydrate Diet
n=75 Participants
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.
|
Usual Diet
n=75 Participants
No dietary intervention.
At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.
|
|---|---|---|
|
Change in Insulin
|
-4.0 μIU/L
Interval -7.2 to -0.8
|
2.3 μIU/L
Interval -0.5 to 5.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and six monthsPopulation: Intention to treat analysis
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.
Outcome measures
| Measure |
Low-Carbohydrate Diet
n=75 Participants
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.
|
Usual Diet
n=75 Participants
No dietary intervention.
At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.
|
|---|---|---|
|
Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
|
-1.6 no units
Interval -2.6 to -0.7
|
0.8 no units
Interval -0.2 to 1.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and six monthsPopulation: Intention to treat analysis
6-month change in diastolic blood pressure comparing low-carbohydrate arm with usual diet arm
Outcome measures
| Measure |
Low-Carbohydrate Diet
n=75 Participants
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.
|
Usual Diet
n=75 Participants
No dietary intervention.
At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.
|
|---|---|---|
|
Change in Diastolic Blood Pressure
|
-3.2 mm Hg
Interval -5.2 to -1.2
|
-0.6 mm Hg
Interval -2.3 to 1.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and six monthsPopulation: Intention to treat analysis
6-month change in waist circumference comparing low-carbohydrate arm with usual diet arm
Outcome measures
| Measure |
Low-Carbohydrate Diet
n=75 Participants
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.
|
Usual Diet
n=75 Participants
No dietary intervention.
At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.
|
|---|---|---|
|
Change in Waist Circumference
|
-5.2 cm
Interval -6.9 to -3.5
|
-0.5 cm
Interval -1.6 to 0.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and six monthsPopulation: Intention to treat analysis
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.
Outcome measures
| Measure |
Low-Carbohydrate Diet
n=75 Participants
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.
|
Usual Diet
n=75 Participants
No dietary intervention.
At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.
|
|---|---|---|
|
Change in Estimated Atherosclerotic Cardiovascular Disease Risk
|
-1.7 estimated %
Interval -2.5 to -0.9
|
-0.9 estimated %
Interval -1.6 to -0.2
|
Adverse Events
Low-Carbohydrate Diet
Serious events: 4 serious events
Other events: 2 other events
Deaths: 0 deaths
Usual Diet
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low-Carbohydrate Diet
n=75 participants at risk
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.
|
Usual Diet
n=75 participants at risk
No dietary intervention.
At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.
|
|---|---|---|
|
Infections and infestations
Emergency room visit
|
1.3%
1/75 • Number of events 1 • For each participant, adverse event data was collected over the 6-month intervention period.
|
1.3%
1/75 • Number of events 1 • For each participant, adverse event data was collected over the 6-month intervention period.
|
|
Musculoskeletal and connective tissue disorders
Emergency Room Visit
|
1.3%
1/75 • Number of events 1 • For each participant, adverse event data was collected over the 6-month intervention period.
|
0.00%
0/75 • For each participant, adverse event data was collected over the 6-month intervention period.
|
|
Infections and infestations
Hospitalization
|
0.00%
0/75 • For each participant, adverse event data was collected over the 6-month intervention period.
|
1.3%
1/75 • Number of events 1 • For each participant, adverse event data was collected over the 6-month intervention period.
|
|
General disorders
Hospitalization
|
1.3%
1/75 • Number of events 1 • For each participant, adverse event data was collected over the 6-month intervention period.
|
0.00%
0/75 • For each participant, adverse event data was collected over the 6-month intervention period.
|
|
Vascular disorders
Emergency Room Visit
|
0.00%
0/75 • For each participant, adverse event data was collected over the 6-month intervention period.
|
1.3%
1/75 • Number of events 1 • For each participant, adverse event data was collected over the 6-month intervention period.
|
|
Cardiac disorders
Surgery and hospitalization
|
1.3%
1/75 • Number of events 1 • For each participant, adverse event data was collected over the 6-month intervention period.
|
0.00%
0/75 • For each participant, adverse event data was collected over the 6-month intervention period.
|
Other adverse events
| Measure |
Low-Carbohydrate Diet
n=75 participants at risk
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.
|
Usual Diet
n=75 participants at risk
No dietary intervention.
At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.
|
|---|---|---|
|
Reproductive system and breast disorders
Surgery
|
2.7%
2/75 • Number of events 2 • For each participant, adverse event data was collected over the 6-month intervention period.
|
0.00%
0/75 • For each participant, adverse event data was collected over the 6-month intervention period.
|
|
Gastrointestinal disorders
Surgery
|
0.00%
0/75 • For each participant, adverse event data was collected over the 6-month intervention period.
|
1.3%
1/75 • Number of events 1 • For each participant, adverse event data was collected over the 6-month intervention period.
|
|
Eye disorders
Surgery
|
0.00%
0/75 • For each participant, adverse event data was collected over the 6-month intervention period.
|
1.3%
1/75 • Number of events 1 • For each participant, adverse event data was collected over the 6-month intervention period.
|
Additional Information
Dr. Kirsten Dorans, Assistant Professor, Department of Epidemiology
Tulane University School of Public Health and Tropical Medicine
Phone: 15049880883
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place