Trial Outcomes & Findings for De Por Vida: A Diabetes Risk Reduction Intervention for Hispanic Women (NCT NCT03113916)
NCT ID: NCT03113916
Last Updated: 2020-09-23
Results Overview
Comparison of body weight trajectories in kilograms between the intervention and usual-care control groups.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
195 participants
Primary outcome timeframe
Baseline, 6, 12, and 18 months
Results posted on
2020-09-23
Participant Flow
Participant milestones
| Measure |
Behavioral Intervention
26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change
Behavioural Lifestyle Intervention: A culturally tailored behavioral intervention.
|
Enhanced Usual Care
Printed materials and usual medical care
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
96
|
|
Overall Study
COMPLETED
|
88
|
84
|
|
Overall Study
NOT COMPLETED
|
11
|
12
|
Reasons for withdrawal
| Measure |
Behavioral Intervention
26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change
Behavioural Lifestyle Intervention: A culturally tailored behavioral intervention.
|
Enhanced Usual Care
Printed materials and usual medical care
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
7
|
|
Overall Study
Pregnancy
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
De Por Vida: A Diabetes Risk Reduction Intervention for Hispanic Women
Baseline characteristics by cohort
| Measure |
Behavioral
n=99 Participants
26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change
Behavioural Lifestyle Intervention: A culturally tailored behavioral intervention.
|
Enhanced Usual Care
n=96 Participants
Printed materials
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 10 • n=5 Participants
|
43 years
STANDARD_DEVIATION 10 • n=7 Participants
|
44 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
99 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
|
Region of Enrollment
United States
|
99 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6, 12, and 18 monthsComparison of body weight trajectories in kilograms between the intervention and usual-care control groups.
Outcome measures
| Measure |
Behavioral
n=99 Participants
26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change
Behavioural Lifestyle Intervention: A culturally tailored behavioral intervention.
|
Enhanced Usual Care
n=96 Participants
Printed materials
|
|---|---|---|
|
Weight in Kilograms
Baseline
|
87.1 kilograms
Interval 83.8 to 90.5
|
86.3 kilograms
Interval 82.9 to 89.7
|
|
Weight in Kilograms
6 Months
|
84.4 kilograms
Interval 81.2 to 87.7
|
85.9 kilograms
Interval 82.6 to 89.2
|
|
Weight in Kilograms
12 Months
|
84.2 kilograms
Interval 81.0 to 87.5
|
85.8 kilograms
Interval 82.5 to 89.2
|
|
Weight in Kilograms
18 Months
|
84.2 kilograms
Interval 80.9 to 87.4
|
85.8 kilograms
Interval 82.5 to 89.1
|
PRIMARY outcome
Timeframe: Baseline, 6, 12, and 18 monthsComparison of waist circumference trajectories in centimeters between the intervention and usual-care control groups.
Outcome measures
| Measure |
Behavioral
n=99 Participants
26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change
Behavioural Lifestyle Intervention: A culturally tailored behavioral intervention.
|
Enhanced Usual Care
n=96 Participants
Printed materials
|
|---|---|---|
|
Waist Circumference in Centimeters
Baseline
|
115.2 centimeters
Interval 112.6 to 117.9
|
115.6 centimeters
Interval 112.8 to 118.2
|
|
Waist Circumference in Centimeters
6 months
|
113.5 centimeters
Interval 110.9 to 116.1
|
114.7 centimeters
Interval 112.1 to 117.4
|
|
Waist Circumference in Centimeters
12 months
|
112.9 centimeters
Interval 110.2 to 115.6
|
114.5 centimeters
Interval 111.7 to 117.2
|
|
Waist Circumference in Centimeters
18 months
|
112.6 centimeters
Interval 109.8 to 115.4
|
114.3 centimeters
Interval 111.5 to 117.1
|
SECONDARY outcome
Timeframe: Baseline, 6, 12 and 18 months from enrollmentPopulation: Analysis limited to data available at different time points (6, 12, 18). As participants were required to come in to the clinic to collect their data it was challenging to get follow up data.
Comparison of hemoglobin HbA1c trajectories between the intervention and usual-care control groups. Because of the severe kurtosis and skewness present in this outcome, a transformation (using the inverse cube, or 1/HbAlc%\^3) was undertaken to better meet the assumptions of the analysis. Thus, the trajectory differences between arms were formally tested using the inverse cube of HbA1c, and back transforming the least square mean estimates from this model will not result in the least square means in the original metric. We performed a sensitivity analysis using the untransformed HbA1c, and that model exhibited poorer model fit. We can present the crude, observed means, or the least square means from the model using the untransformed HbA1c if it is of greater priority to have more direct interpretability of the HbA1c values than using the model that better meets the statistical assumptions.
Outcome measures
| Measure |
Behavioral
n=99 Participants
26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change
Behavioural Lifestyle Intervention: A culturally tailored behavioral intervention.
|
Enhanced Usual Care
n=96 Participants
Printed materials
|
|---|---|---|
|
Hemoglobin HbA1c % (Transformed Using the Inverse Cube, or 1/HbAlc%^3)
Baseline
|
.00448 inverse cube of HbA1c percentage
Interval 0.00413 to 0.00483
|
.00445 inverse cube of HbA1c percentage
Interval 0.0041 to 0.00481
|
|
Hemoglobin HbA1c % (Transformed Using the Inverse Cube, or 1/HbAlc%^3)
6 Months
|
.00445 inverse cube of HbA1c percentage
Interval 0.0041 to 0.0048
|
.00439 inverse cube of HbA1c percentage
Interval 0.00404 to 0.00474
|
|
Hemoglobin HbA1c % (Transformed Using the Inverse Cube, or 1/HbAlc%^3)
12 months
|
.00437 inverse cube of HbA1c percentage
Interval 0.00402 to 0.00472
|
.00423 inverse cube of HbA1c percentage
Interval 0.00388 to 0.00458
|
|
Hemoglobin HbA1c % (Transformed Using the Inverse Cube, or 1/HbAlc%^3)
18 months
|
.00424 inverse cube of HbA1c percentage
Interval 0.00388 to 0.00461
|
.00397 inverse cube of HbA1c percentage
Interval 0.0036 to 0.00434
|
SECONDARY outcome
Timeframe: Baseline, 6, 12, and 18 monthsComparison of fasting blood glucose trajectories between the intervention and usual-care control groups. Because of the severe kurtosis and skewness present in this outcome, a transformation (using the inverse square, or 1/fasting blood glucose in mg/dl\^2) was undertaken to better meet the assumptions of the analysis. Thus, the trajectory differences between arms were formally tested using the inverse square of fasting blood glucose, and back transforming the least square mean estimates from this model will not result in the least square means in the original metric. We performed a sensitivity analysis using the untransformed fasting blood glucose, and that model exhibited poorer model fit. We can present the crude, observed means, or the least square means from the model using the untransformed fasting blood glucose if it is of greater priority to have more direct interpretability of the fasting blood glucose values than using the model that better meets the statistical assumptions.
Outcome measures
| Measure |
Behavioral
n=99 Participants
26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change
Behavioural Lifestyle Intervention: A culturally tailored behavioral intervention.
|
Enhanced Usual Care
n=96 Participants
Printed materials
|
|---|---|---|
|
Fasting Blood Glucose (Fbg; Transformed Using the Inverse Square, or 1/Fbg in mg/dl^2 )
Baseline
|
.0000699 inverse square of fbg mg/dl
Interval 0.0000645 to 0.0000753
|
.0000668 inverse square of fbg mg/dl
Interval 0.0000614 to 0.0000723
|
|
Fasting Blood Glucose (Fbg; Transformed Using the Inverse Square, or 1/Fbg in mg/dl^2 )
6 months
|
.0000699 inverse square of fbg mg/dl
Interval 0.0000645 to 0.0000752
|
.000067 inverse square of fbg mg/dl
Interval 0.0000615 to 0.0000724
|
|
Fasting Blood Glucose (Fbg; Transformed Using the Inverse Square, or 1/Fbg in mg/dl^2 )
12 months
|
.0000695 inverse square of fbg mg/dl
Interval 0.0000641 to 0.0000748
|
.0000676 inverse square of fbg mg/dl
Interval 0.0000622 to 0.000073
|
|
Fasting Blood Glucose (Fbg; Transformed Using the Inverse Square, or 1/Fbg in mg/dl^2 )
18 months
|
.0000685 inverse square of fbg mg/dl
Interval 0.0000617 to 0.0000752
|
.0000692 inverse square of fbg mg/dl
Interval 0.0000625 to 0.000076
|
SECONDARY outcome
Timeframe: Baseline, 6, 12, and 18 monthsComparison of total cholesterol trajectories between the intervention and usual-care control groups.
Outcome measures
| Measure |
Behavioral
n=99 Participants
26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change
Behavioural Lifestyle Intervention: A culturally tailored behavioral intervention.
|
Enhanced Usual Care
n=95 Participants
Printed materials
|
|---|---|---|
|
Total Cholesterol
Baseline
|
195.6 mg/dl
Interval 188.0 to 203.2
|
191.9 mg/dl
Interval 184.1 to 199.7
|
|
Total Cholesterol
6 months
|
199.5 mg/dl
Interval 192.3 to 206.7
|
193.8 mg/dl
Interval 186.5 to 201.1
|
|
Total Cholesterol
12 months
|
203.5 mg/dl
Interval 195.8 to 211.2
|
195.6 mg/dl
Interval 187.9 to 203.4
|
|
Total Cholesterol
18 months
|
207.4 mg/dl
Interval 198.4 to 216.5
|
197.5 mg/dl
Interval 188.5 to 206.5
|
SECONDARY outcome
Timeframe: Baseline, 6, 12, and 18 monthsComparison of number fruit servings per day trajectories between the intervention and usual-care control groups. Because of the severe kurtosis and skewness present in this outcome, a transformation (using the natural log) was undertaken to better meet the assumptions of the analysis. Thus, the trajectory differences between arms were formally tested using the log of the number of fruit servings per day, and back transforming the least square mean estimates from this model will not result in the least square means in the original metric. We performed a sensitivity analysis using the untransformed number of fruit servings per day, and that model exhibited poorer model fit. We can present the crude, observed means, or the least square means from the model using the untransformed number of fruit servings per day if it is of greater priority to have more direct interpretability of the # of fruit servings per day values than using the model that better meets the statistical assumptions.
Outcome measures
| Measure |
Behavioral
n=98 Participants
26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change
Behavioural Lifestyle Intervention: A culturally tailored behavioral intervention.
|
Enhanced Usual Care
n=96 Participants
Printed materials
|
|---|---|---|
|
Number of Fruit Servings Per Day (Transformed Using the Natural Log)
Baseline
|
.637 natural log of fruit servings per day
Interval 0.41 to 0.795
|
.511 natural log of fruit servings per day
Interval 0.352 to 0.671
|
|
Number of Fruit Servings Per Day (Transformed Using the Natural Log)
6 months
|
.522 natural log of fruit servings per day
Interval 0.395 to 0.649
|
.483 natural log of fruit servings per day
Interval 0.355 to 0.612
|
|
Number of Fruit Servings Per Day (Transformed Using the Natural Log)
12 months
|
.406 natural log of fruit servings per day
Interval 0.271 to 0.542
|
.456 natural log of fruit servings per day
Interval 0.319 to 0.594
|
|
Number of Fruit Servings Per Day (Transformed Using the Natural Log)
18 months
|
.291 natural log of fruit servings per day
Interval 0.113 to 0.469
|
.423 natural log of fruit servings per day
Interval 0.25 to 0.608
|
SECONDARY outcome
Timeframe: Baseline, 6, 12, and 18 monthsComparison of the number of kilocalories trajectories between the intervention and usual-care control groups.
Outcome measures
| Measure |
Behavioral
n=98 Participants
26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change
Behavioural Lifestyle Intervention: A culturally tailored behavioral intervention.
|
Enhanced Usual Care
n=96 Participants
Printed materials
|
|---|---|---|
|
Number of Kilocalories
Baseline
|
1546 kilocalories
Interval 1435.0 to 1658.0
|
1431 kilocalories
Interval 1319.0 to 1544.0
|
|
Number of Kilocalories
6 months
|
1381 kilocalories
Interval 1289.0 to 1473.0
|
1333 kilocalories
Interval 1240.0 to 1426.0
|
|
Number of Kilocalories
12 months
|
1215 kilocalories
Interval 1117.0 to 1313.0
|
1234 kilocalories
Interval 1135.0 to 1333.0
|
|
Number of Kilocalories
18 months
|
1049 kilocalories
Interval 924.0 to 1175.0
|
1135 kilocalories
Interval 1009.0 to 1261.0
|
SECONDARY outcome
Timeframe: Baseline, 6, 12, and 18 monthsComparison of the sugar intake in grams trajectories between the intervention and usual-care control groups.
Outcome measures
| Measure |
Behavioral
n=98 Participants
26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change
Behavioural Lifestyle Intervention: A culturally tailored behavioral intervention.
|
Enhanced Usual Care
n=96 Participants
Printed materials
|
|---|---|---|
|
Sugar Intake in Grams
Baseline
|
79.9 grams
Interval 72.5 to 87.3
|
72.6 grams
Interval 65.2 to 80.1
|
|
Sugar Intake in Grams
6 months
|
70.2 grams
Interval 64.1 to 76.3
|
66.7 grams
Interval 60.5 to 72.9
|
|
Sugar Intake in Grams
12 months
|
60.5 grams
Interval 54.1 to 67.0
|
60.8 grams
Interval 54.2 to 67.3
|
|
Sugar Intake in Grams
18 months
|
50.8 grams
Interval 42.5 to 59.1
|
54.8 grams
Interval 46.4 to 63.2
|
SECONDARY outcome
Timeframe: Baseline, 6, 12, and 18 monthsComparison of the dietary fiber intake in grams trajectories between the intervention and usual-care control groups. Because of the severe kurtosis and skewness present in this outcome, a transformation (using the natural log) was undertaken to better meet the assumptions of the analysis. Thus, the trajectory differences between arms were formally tested using the log of the dietary fiber intake in grams and back transforming the least square mean estimates from this model will not result in the least square means in the original metric. We performed a sensitivity analysis using the untransformed dietary fiber intake in grams, and that model exhibited poorer model fit. We can present the crude, observed means, or the least square means from the model using the untransformed dietary fiber intake in grams if it is of greater priority to have more direct interpretability of the dietary fiber intake in grams values than using the model that better meets the statistical assumptions.
Outcome measures
| Measure |
Behavioral
n=98 Participants
26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change
Behavioural Lifestyle Intervention: A culturally tailored behavioral intervention.
|
Enhanced Usual Care
n=96 Participants
Printed materials
|
|---|---|---|
|
Dietary Fiber Intake in Grams (Transformed Using the Natural Log)
Baseline
|
3.15 natural log of fiber intake in grams
Interval 3.06 to 3.24
|
3.01 natural log of fiber intake in grams
Interval 2.92 to 3.1
|
|
Dietary Fiber Intake in Grams (Transformed Using the Natural Log)
6 months
|
2.87 natural log of fiber intake in grams
Interval 2.8 to 2.95
|
2.90 natural log of fiber intake in grams
Interval 2.83 to 2.98
|
|
Dietary Fiber Intake in Grams (Transformed Using the Natural Log)
12 months
|
2.87 natural log of fiber intake in grams
Interval 2.79 to 2.94
|
2.90 natural log of fiber intake in grams
Interval 2.83 to 2.98
|
|
Dietary Fiber Intake in Grams (Transformed Using the Natural Log)
18 months
|
2.87 natural log of fiber intake in grams
Interval 2.79 to 2.94
|
2.90 natural log of fiber intake in grams
Interval 2.83 to 2.98
|
SECONDARY outcome
Timeframe: Baseline, 6, 12, and 18 monthsComparison of the saturated fat intake as percentage of total energy intake trajectories between the intervention and usual-care control groups.
Outcome measures
| Measure |
Behavioral
n=98 Participants
26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change
Behavioural Lifestyle Intervention: A culturally tailored behavioral intervention.
|
Enhanced Usual Care
n=96 Participants
Printed materials
|
|---|---|---|
|
Saturated Fat Intake as Percentage of Total Energy Intake
6 months
|
8.80 Percentage of total energy
Interval 8.45 to 9.15
|
8.98 Percentage of total energy
Interval 8.63 to 9.33
|
|
Saturated Fat Intake as Percentage of Total Energy Intake
Baseline
|
9.13 Percentage of total energy
Interval 8.72 to 9.55
|
9.40 Percentage of total energy
Interval 8.98 to 9.82
|
|
Saturated Fat Intake as Percentage of Total Energy Intake
12 months
|
8.47 Percentage of total energy
Interval 8.09 to 8.85
|
8.56 Percentage of total energy
Interval 8.18 to 8.94
|
|
Saturated Fat Intake as Percentage of Total Energy Intake
18 months
|
8.14 Percentage of total energy
Interval 7.66 to 8.62
|
8.14 Percentage of total energy
Interval 7.65 to 8.62
|
SECONDARY outcome
Timeframe: Baseline, 6, 12, and 18 monthsComparison of the dietary intake of the number of vegetable servings per day trajectories between the intervention and usual-care control groups. Because of the severe kurtosis and skewness present in this outcome, a transformation (using the natural log) was undertaken to better meet the assumptions of the analysis. Thus, the trajectory differences between arms were formally tested using the log of the number of vegetable servings per day, and back transforming the least square mean estimates from this model will not result in the least square means in the original metric. We performed a sensitivity analysis using the untransformed outcome, and that model exhibited poorer model fit. We can present the crude, observed means, or the least square means from the model using the untransformed number of vegetable servings per day if it is of greater priority to have more direct interpretability of the outcome values than using the model that better meets the statistical assumptions.
Outcome measures
| Measure |
Behavioral
n=98 Participants
26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change
Behavioural Lifestyle Intervention: A culturally tailored behavioral intervention.
|
Enhanced Usual Care
n=96 Participants
Printed materials
|
|---|---|---|
|
Number of Vegetable Servings Per Day (Transformed Using the Natural Log)
Baseline
|
1.37 natural log of vegetable servings / day
Interval 1.25 to 1.5
|
1.27 natural log of vegetable servings / day
Interval 1.15 to 1.4
|
|
Number of Vegetable Servings Per Day (Transformed Using the Natural Log)
6 months
|
1.30 natural log of vegetable servings / day
Interval 1.2 to 1.4
|
1.20 natural log of vegetable servings / day
Interval 1.1 to 1.3
|
|
Number of Vegetable Servings Per Day (Transformed Using the Natural Log)
12 months
|
1.22 natural log of vegetable servings / day
Interval 1.12 to 1.33
|
1.13 natural log of vegetable servings / day
Interval 1.02 to 1.24
|
|
Number of Vegetable Servings Per Day (Transformed Using the Natural Log)
18 months
|
1.15 natural log of vegetable servings / day
Interval 1.01 to 1.29
|
1.05 natural log of vegetable servings / day
Interval 0.91 to 1.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsAverage cost per participant of the De Por Vida intervention and enhanced usual care
Outcome measures
| Measure |
Behavioral
n=99 Participants
26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change
Behavioural Lifestyle Intervention: A culturally tailored behavioral intervention.
|
Enhanced Usual Care
n=96 Participants
Printed materials
|
|---|---|---|
|
Average Program Cost Per Participant
|
360.68 Dollars
Standard Deviation 63.01
|
0 Dollars
Standard Deviation 0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-intervention for 12 monthsNumber of participants recruited
Outcome measures
| Measure |
Behavioral
n=30 Participants
26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change
Behavioural Lifestyle Intervention: A culturally tailored behavioral intervention.
|
Enhanced Usual Care
Printed materials
|
|---|---|---|
|
Recruit Participants for Sustainability Phase
|
30 Participants
|
—
|
Adverse Events
Behavioral
Serious events: 5 serious events
Other events: 64 other events
Deaths: 0 deaths
Enhanced Usual Care
Serious events: 2 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Behavioral
n=102 participants at risk
26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change
Behavioural Lifestyle Intervention: A culturally tailored behavioral intervention.
|
Enhanced Usual Care
n=98 participants at risk
Printed materials
|
|---|---|---|
|
Gastrointestinal disorders
Cholecystectomy
|
2.0%
2/102 • Number of events 2 • Adverse event data was collected at 6, 12 and 18 month assessment follow up time points.
When an event was reported by a participant, study staff collected information on a form that asked for details about the event, and about ER, hospital and urgent care visits since the last assessment. An endocrinologist, blinded to study arm, then assessed whether the event was likely or unlikely to be study related and were monitored/assessed without regard to a specific Adverse Event Term and categorized after assessment. All events were reviewed by an independent safety monitor.
|
1.0%
1/98 • Number of events 1 • Adverse event data was collected at 6, 12 and 18 month assessment follow up time points.
When an event was reported by a participant, study staff collected information on a form that asked for details about the event, and about ER, hospital and urgent care visits since the last assessment. An endocrinologist, blinded to study arm, then assessed whether the event was likely or unlikely to be study related and were monitored/assessed without regard to a specific Adverse Event Term and categorized after assessment. All events were reviewed by an independent safety monitor.
|
|
Infections and infestations
Infection
|
0.98%
1/102 • Number of events 1 • Adverse event data was collected at 6, 12 and 18 month assessment follow up time points.
When an event was reported by a participant, study staff collected information on a form that asked for details about the event, and about ER, hospital and urgent care visits since the last assessment. An endocrinologist, blinded to study arm, then assessed whether the event was likely or unlikely to be study related and were monitored/assessed without regard to a specific Adverse Event Term and categorized after assessment. All events were reviewed by an independent safety monitor.
|
1.0%
1/98 • Number of events 1 • Adverse event data was collected at 6, 12 and 18 month assessment follow up time points.
When an event was reported by a participant, study staff collected information on a form that asked for details about the event, and about ER, hospital and urgent care visits since the last assessment. An endocrinologist, blinded to study arm, then assessed whether the event was likely or unlikely to be study related and were monitored/assessed without regard to a specific Adverse Event Term and categorized after assessment. All events were reviewed by an independent safety monitor.
|
|
Nervous system disorders
Neurological
|
0.98%
1/102 • Number of events 1 • Adverse event data was collected at 6, 12 and 18 month assessment follow up time points.
When an event was reported by a participant, study staff collected information on a form that asked for details about the event, and about ER, hospital and urgent care visits since the last assessment. An endocrinologist, blinded to study arm, then assessed whether the event was likely or unlikely to be study related and were monitored/assessed without regard to a specific Adverse Event Term and categorized after assessment. All events were reviewed by an independent safety monitor.
|
0.00%
0/98 • Adverse event data was collected at 6, 12 and 18 month assessment follow up time points.
When an event was reported by a participant, study staff collected information on a form that asked for details about the event, and about ER, hospital and urgent care visits since the last assessment. An endocrinologist, blinded to study arm, then assessed whether the event was likely or unlikely to be study related and were monitored/assessed without regard to a specific Adverse Event Term and categorized after assessment. All events were reviewed by an independent safety monitor.
|
|
Reproductive system and breast disorders
Gynecological
|
0.98%
1/102 • Number of events 1 • Adverse event data was collected at 6, 12 and 18 month assessment follow up time points.
When an event was reported by a participant, study staff collected information on a form that asked for details about the event, and about ER, hospital and urgent care visits since the last assessment. An endocrinologist, blinded to study arm, then assessed whether the event was likely or unlikely to be study related and were monitored/assessed without regard to a specific Adverse Event Term and categorized after assessment. All events were reviewed by an independent safety monitor.
|
0.00%
0/98 • Adverse event data was collected at 6, 12 and 18 month assessment follow up time points.
When an event was reported by a participant, study staff collected information on a form that asked for details about the event, and about ER, hospital and urgent care visits since the last assessment. An endocrinologist, blinded to study arm, then assessed whether the event was likely or unlikely to be study related and were monitored/assessed without regard to a specific Adverse Event Term and categorized after assessment. All events were reviewed by an independent safety monitor.
|
Other adverse events
| Measure |
Behavioral
n=102 participants at risk
26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change
Behavioural Lifestyle Intervention: A culturally tailored behavioral intervention.
|
Enhanced Usual Care
n=98 participants at risk
Printed materials
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal
|
6.9%
7/102 • Number of events 7 • Adverse event data was collected at 6, 12 and 18 month assessment follow up time points.
When an event was reported by a participant, study staff collected information on a form that asked for details about the event, and about ER, hospital and urgent care visits since the last assessment. An endocrinologist, blinded to study arm, then assessed whether the event was likely or unlikely to be study related and were monitored/assessed without regard to a specific Adverse Event Term and categorized after assessment. All events were reviewed by an independent safety monitor.
|
9.2%
9/98 • Number of events 9 • Adverse event data was collected at 6, 12 and 18 month assessment follow up time points.
When an event was reported by a participant, study staff collected information on a form that asked for details about the event, and about ER, hospital and urgent care visits since the last assessment. An endocrinologist, blinded to study arm, then assessed whether the event was likely or unlikely to be study related and were monitored/assessed without regard to a specific Adverse Event Term and categorized after assessment. All events were reviewed by an independent safety monitor.
|
|
Endocrine disorders
Hypoglycemia (Expected)
|
11.8%
12/102 • Number of events 12 • Adverse event data was collected at 6, 12 and 18 month assessment follow up time points.
When an event was reported by a participant, study staff collected information on a form that asked for details about the event, and about ER, hospital and urgent care visits since the last assessment. An endocrinologist, blinded to study arm, then assessed whether the event was likely or unlikely to be study related and were monitored/assessed without regard to a specific Adverse Event Term and categorized after assessment. All events were reviewed by an independent safety monitor.
|
11.2%
11/98 • Number of events 11 • Adverse event data was collected at 6, 12 and 18 month assessment follow up time points.
When an event was reported by a participant, study staff collected information on a form that asked for details about the event, and about ER, hospital and urgent care visits since the last assessment. An endocrinologist, blinded to study arm, then assessed whether the event was likely or unlikely to be study related and were monitored/assessed without regard to a specific Adverse Event Term and categorized after assessment. All events were reviewed by an independent safety monitor.
|
|
Infections and infestations
Infection
|
8.8%
9/102 • Number of events 9 • Adverse event data was collected at 6, 12 and 18 month assessment follow up time points.
When an event was reported by a participant, study staff collected information on a form that asked for details about the event, and about ER, hospital and urgent care visits since the last assessment. An endocrinologist, blinded to study arm, then assessed whether the event was likely or unlikely to be study related and were monitored/assessed without regard to a specific Adverse Event Term and categorized after assessment. All events were reviewed by an independent safety monitor.
|
17.3%
17/98 • Number of events 17 • Adverse event data was collected at 6, 12 and 18 month assessment follow up time points.
When an event was reported by a participant, study staff collected information on a form that asked for details about the event, and about ER, hospital and urgent care visits since the last assessment. An endocrinologist, blinded to study arm, then assessed whether the event was likely or unlikely to be study related and were monitored/assessed without regard to a specific Adverse Event Term and categorized after assessment. All events were reviewed by an independent safety monitor.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
23.5%
24/102 • Number of events 24 • Adverse event data was collected at 6, 12 and 18 month assessment follow up time points.
When an event was reported by a participant, study staff collected information on a form that asked for details about the event, and about ER, hospital and urgent care visits since the last assessment. An endocrinologist, blinded to study arm, then assessed whether the event was likely or unlikely to be study related and were monitored/assessed without regard to a specific Adverse Event Term and categorized after assessment. All events were reviewed by an independent safety monitor.
|
12.2%
12/98 • Number of events 12 • Adverse event data was collected at 6, 12 and 18 month assessment follow up time points.
When an event was reported by a participant, study staff collected information on a form that asked for details about the event, and about ER, hospital and urgent care visits since the last assessment. An endocrinologist, blinded to study arm, then assessed whether the event was likely or unlikely to be study related and were monitored/assessed without regard to a specific Adverse Event Term and categorized after assessment. All events were reviewed by an independent safety monitor.
|
|
Nervous system disorders
Neurological
|
5.9%
6/102 • Number of events 6 • Adverse event data was collected at 6, 12 and 18 month assessment follow up time points.
When an event was reported by a participant, study staff collected information on a form that asked for details about the event, and about ER, hospital and urgent care visits since the last assessment. An endocrinologist, blinded to study arm, then assessed whether the event was likely or unlikely to be study related and were monitored/assessed without regard to a specific Adverse Event Term and categorized after assessment. All events were reviewed by an independent safety monitor.
|
3.1%
3/98 • Number of events 3 • Adverse event data was collected at 6, 12 and 18 month assessment follow up time points.
When an event was reported by a participant, study staff collected information on a form that asked for details about the event, and about ER, hospital and urgent care visits since the last assessment. An endocrinologist, blinded to study arm, then assessed whether the event was likely or unlikely to be study related and were monitored/assessed without regard to a specific Adverse Event Term and categorized after assessment. All events were reviewed by an independent safety monitor.
|
|
Renal and urinary disorders
Urological
|
5.9%
6/102 • Number of events 6 • Adverse event data was collected at 6, 12 and 18 month assessment follow up time points.
When an event was reported by a participant, study staff collected information on a form that asked for details about the event, and about ER, hospital and urgent care visits since the last assessment. An endocrinologist, blinded to study arm, then assessed whether the event was likely or unlikely to be study related and were monitored/assessed without regard to a specific Adverse Event Term and categorized after assessment. All events were reviewed by an independent safety monitor.
|
0.00%
0/98 • Adverse event data was collected at 6, 12 and 18 month assessment follow up time points.
When an event was reported by a participant, study staff collected information on a form that asked for details about the event, and about ER, hospital and urgent care visits since the last assessment. An endocrinologist, blinded to study arm, then assessed whether the event was likely or unlikely to be study related and were monitored/assessed without regard to a specific Adverse Event Term and categorized after assessment. All events were reviewed by an independent safety monitor.
|
Additional Information
Nangel Lindberg
Kaiser Permanente Center for Health Research
Phone: 503 528 3961
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place