Trial Outcomes & Findings for Genetic Risk and Health Coaching for Type 2 Diabetes and Coronary Heart Disease (NCT NCT01884545)
NCT ID: NCT01884545
Last Updated: 2018-04-24
Results Overview
Dietary intake as measured by percent energy from fat, adjusted for baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
220 participants
Primary outcome timeframe
12 months
Results posted on
2018-04-24
Participant Flow
220 subjects were consented. Prior to randomization 9 subjects withdrew from the study, 10 were lost to follow up, and 1 did not meet inclusion criteria. 200 participants were randomized.
Participant milestones
| Measure |
Standard Risk Assessment (SRA)
Subjects will receive a standard risk assessment only for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.
Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.
|
SRA Plus Health Coaching (HC)
In addition to the standard risk assessment for CHD and T2D subjects will receive health coaching intervention for 6 months
Health coaching: Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).
Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.
|
SRA Plus Genetic Risk Counseling (GRC)
In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.
Genetic risk counseling: In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.
Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.
|
SRA+HC+GRC
In addition to the standard risk assessment for CHD and T2D subjects will receive genetic risk counseling and health coaching intervention for 6 months.
Health coaching: Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).
Genetic risk counseling: In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.
Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
49
|
49
|
52
|
|
Overall Study
COMPLETED
|
37
|
31
|
35
|
43
|
|
Overall Study
NOT COMPLETED
|
13
|
18
|
14
|
9
|
Reasons for withdrawal
| Measure |
Standard Risk Assessment (SRA)
Subjects will receive a standard risk assessment only for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.
Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.
|
SRA Plus Health Coaching (HC)
In addition to the standard risk assessment for CHD and T2D subjects will receive health coaching intervention for 6 months
Health coaching: Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).
Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.
|
SRA Plus Genetic Risk Counseling (GRC)
In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.
Genetic risk counseling: In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.
Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.
|
SRA+HC+GRC
In addition to the standard risk assessment for CHD and T2D subjects will receive genetic risk counseling and health coaching intervention for 6 months.
Health coaching: Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).
Genetic risk counseling: In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.
Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
4
|
9
|
4
|
|
Overall Study
Patient withdrawn
|
7
|
12
|
5
|
5
|
|
Overall Study
Non-adherence
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Genetic Risk and Health Coaching for Type 2 Diabetes and Coronary Heart Disease
Baseline characteristics by cohort
| Measure |
Standard Risk Assessment (SRA)
n=50 Participants
Subjects will receive a standard risk assessment only for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.
Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.
|
SRA Plus Health Coaching (HC)
n=49 Participants
In addition to the standard risk assessment for CHD and T2D subjects will receive health coaching intervention for 6 months
Health coaching: Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).
Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.
|
SRA Plus Genetic Risk Counseling (GRC)
n=49 Participants
In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.
Genetic risk counseling: In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.
Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.
|
SRA+HC+GRC
n=52 Participants
In addition to the standard risk assessment for CHD and T2D subjects will receive genetic risk counseling and health coaching intervention for 6 months.
Health coaching: Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).
Genetic risk counseling: In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.
Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.16 years
STANDARD_DEVIATION 10.92 • n=5 Participants
|
48.67 years
STANDARD_DEVIATION 12.67 • n=7 Participants
|
48.35 years
STANDARD_DEVIATION 10.51 • n=5 Participants
|
44.85 years
STANDARD_DEVIATION 11.85 • n=4 Participants
|
47.72 years
STANDARD_DEVIATION 11.56 • n=21 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
98 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
102 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
179 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
119 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
200 Participants
n=21 Participants
|
|
Dietary Intake (Percent energy from fat)
|
34.50 percent
STANDARD_DEVIATION 3.60 • n=5 Participants
|
34.87 percent
STANDARD_DEVIATION 3.17 • n=7 Participants
|
34.13 percent
STANDARD_DEVIATION 4.55 • n=5 Participants
|
35.66 percent
STANDARD_DEVIATION 4.91 • n=4 Participants
|
34.81 percent
STANDARD_DEVIATION 4.14 • n=21 Participants
|
|
Dietary Intake (Daily grams of fiber)
|
16.65 grams
STANDARD_DEVIATION 5.82 • n=5 Participants
|
14.94 grams
STANDARD_DEVIATION 5.57 • n=7 Participants
|
15.75 grams
STANDARD_DEVIATION 5.83 • n=5 Participants
|
18.27 grams
STANDARD_DEVIATION 8.68 • n=4 Participants
|
16.46 grams
STANDARD_DEVIATION 6.73 • n=21 Participants
|
|
Physical Activity
Inactive/light intensity activity
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
|
Physical Activity
Moderate/ hard/very hard intensity activity
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
104 Participants
n=21 Participants
|
|
Smoking Status
No
|
45 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
178 Participants
n=21 Participants
|
|
Smoking Status
Yes
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Medication Adherence (Morisky 4)
Low Adherence
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Medication Adherence (Morisky 4)
Medium Adherence
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Medication Adherence (Morisky 4)
High Adherence
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Medication Adherence (Morisky 4)
Not applicable (patient not taking medication)
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Weight
|
85.94 kg
STANDARD_DEVIATION 17.05 • n=5 Participants
|
82.15 kg
STANDARD_DEVIATION 16.75 • n=7 Participants
|
84.96 kg
STANDARD_DEVIATION 20.66 • n=5 Participants
|
89.07 kg
STANDARD_DEVIATION 17.76 • n=4 Participants
|
85.58 kg
STANDARD_DEVIATION 18.15 • n=21 Participants
|
|
Waist Circumference
|
98.86 cm
STANDARD_DEVIATION 10.73 • n=5 Participants
|
98.51 cm
STANDARD_DEVIATION 16.42 • n=7 Participants
|
97.23 cm
STANDARD_DEVIATION 13.50 • n=5 Participants
|
98.56 cm
STANDARD_DEVIATION 12.09 • n=4 Participants
|
98.30 cm
STANDARD_DEVIATION 13.23 • n=21 Participants
|
|
Systolic Blood Pressure
|
128.60 mmHg
STANDARD_DEVIATION 11.06 • n=5 Participants
|
126.41 mmHg
STANDARD_DEVIATION 13.03 • n=7 Participants
|
123.24 mmHg
STANDARD_DEVIATION 10.87 • n=5 Participants
|
128.68 mmHg
STANDARD_DEVIATION 13.30 • n=4 Participants
|
126.77 mmHg
STANDARD_DEVIATION 12.24 • n=21 Participants
|
|
Diastolic Blood Pressure
|
80.78 mmHg
STANDARD_DEVIATION 8.89 • n=5 Participants
|
80.77 mmHg
STANDARD_DEVIATION 10.38 • n=7 Participants
|
78.26 mmHg
STANDARD_DEVIATION 8.36 • n=5 Participants
|
80.62 mmHg
STANDARD_DEVIATION 10.70 • n=4 Participants
|
80.12 mmHg
STANDARD_DEVIATION 9.63 • n=21 Participants
|
|
High-density Lipoprotein (HDL)
|
53.66 mg/dL
STANDARD_DEVIATION 17.15 • n=5 Participants
|
56.45 mg/dL
STANDARD_DEVIATION 18.62 • n=7 Participants
|
49.59 mg/dL
STANDARD_DEVIATION 13.50 • n=5 Participants
|
50.50 mg/dL
STANDARD_DEVIATION 16.41 • n=4 Participants
|
52.53 mg/dL
STANDARD_DEVIATION 16.62 • n=21 Participants
|
|
Low-density Lipoprotein (LDL)
|
133.63 mg/dL
STANDARD_DEVIATION 32.05 • n=5 Participants
|
133.51 mg/dL
STANDARD_DEVIATION 42.40 • n=7 Participants
|
131.94 mg/dL
STANDARD_DEVIATION 32.90 • n=5 Participants
|
136.95 mg/dL
STANDARD_DEVIATION 37.15 • n=4 Participants
|
134.05 mg/dL
STANDARD_DEVIATION 36.12 • n=21 Participants
|
|
Triglycerides
|
176.19 mg/dL
STANDARD_DEVIATION 123.80 • n=5 Participants
|
150.73 mg/dL
STANDARD_DEVIATION 70.53 • n=7 Participants
|
157.35 mg/dL
STANDARD_DEVIATION 87.76 • n=5 Participants
|
156.60 mg/dL
STANDARD_DEVIATION 69.44 • n=4 Participants
|
160.24 mg/dL
STANDARD_DEVIATION 90.33 • n=21 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
Dietary intake as measured by percent energy from fat, adjusted for baseline
Outcome measures
| Measure |
Health Coaching
n=75 Participants
Participants who received health coaching
|
Non-Health Coaching
n=71 Participants
Participants who did not receive health coaching
|
Genetic Risk Counseling
n=77 Participants
Patients who received genetic risk counseling
|
Non-Genetic Risk Counseling
n=69 Participants
Patients who did not receive genetic risk counseling
|
|---|---|---|---|---|
|
Dietary Intake as Measured by Percent Energy From Fat
|
33.75 percent energy from fat
Standard Deviation 0.5
|
34.9 percent energy from fat
Standard Deviation 0.5
|
33.72 percent energy from fat
Standard Deviation 0.47
|
35.05 percent energy from fat
Standard Deviation 0.52
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
Dietary intake as measured by daily grams of fiber, adjusted for baseline
Outcome measures
| Measure |
Health Coaching
n=75 Participants
Participants who received health coaching
|
Non-Health Coaching
n=71 Participants
Participants who did not receive health coaching
|
Genetic Risk Counseling
n=77 Participants
Patients who received genetic risk counseling
|
Non-Genetic Risk Counseling
n=69 Participants
Patients who did not receive genetic risk counseling
|
|---|---|---|---|---|
|
Dietary Intake as Measured by Daily Grams of Fiber
|
15.69 grams
Standard Deviation 0.51
|
15.38 grams
Standard Deviation 0.51
|
15.24 grams
Standard Deviation 0.49
|
15.89 grams
Standard Deviation 0.54
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Randomization Arms/Groups were regrouped as pre-specified in the study protocol. Some participants were not analyzed because data were missing.
The Stanford Brief Activity Survey is a 2-item survey that assesses two categories of physical activity - work and leisure. There are five options for degree of activity to choose from in each of the two areas of activity. Activity categories (inactive, light-intensity activity, moderate-intensity activity, hard-intensity activity, and very hard-intensity) are represented in a table of different patterns. Degree of work activity is represented on the vertical axis and degree of leisure activity is represented on the horizontal axis. The overall activity level category is determined by where the two responses intersect.
Outcome measures
| Measure |
Health Coaching
n=72 Participants
Participants who received health coaching
|
Non-Health Coaching
n=72 Participants
Participants who did not receive health coaching
|
Genetic Risk Counseling
n=77 Participants
Patients who received genetic risk counseling
|
Non-Genetic Risk Counseling
n=67 Participants
Patients who did not receive genetic risk counseling
|
|---|---|---|---|---|
|
Physical Activity, as Measured by the Stanford Brief Activity Survey (SBAS)
Inative/light intensity activity
|
25 Participants
|
41 Participants
|
34 Participants
|
32 Participants
|
|
Physical Activity, as Measured by the Stanford Brief Activity Survey (SBAS)
moderate intensity activity
|
30 Participants
|
18 Participants
|
23 Participants
|
25 Participants
|
|
Physical Activity, as Measured by the Stanford Brief Activity Survey (SBAS)
hard/very hard intensity activity
|
17 Participants
|
13 Participants
|
20 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Randomization Arms/Groups were regrouped as pre-specified in the study protocol. Some participants were not analyzed because data were missing.
Outcome measures
| Measure |
Health Coaching
n=69 Participants
Participants who received health coaching
|
Non-Health Coaching
n=66 Participants
Participants who did not receive health coaching
|
Genetic Risk Counseling
n=71 Participants
Patients who received genetic risk counseling
|
Non-Genetic Risk Counseling
n=64 Participants
Patients who did not receive genetic risk counseling
|
|---|---|---|---|---|
|
Smoking Status
Smoked in the last 30 days = No
|
65 Participants
|
63 Participants
|
67 Participants
|
61 Participants
|
|
Smoking Status
Smoked in the last 30 days = Yes
|
4 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
Scores of the MMAS-8 range from 0 to 8. A score below 6 indicates low adherence, a score between 6 \< 8 medium adherence and a score of 8 high adherence.
Outcome measures
| Measure |
Health Coaching
n=75 Participants
Participants who received health coaching
|
Non-Health Coaching
n=71 Participants
Participants who did not receive health coaching
|
Genetic Risk Counseling
n=77 Participants
Patients who received genetic risk counseling
|
Non-Genetic Risk Counseling
n=69 Participants
Patients who did not receive genetic risk counseling
|
|---|---|---|---|---|
|
Medication Adherence as Measured by Morisky Adherence Survey MMAS8
|
6.66 units on a scale
Standard Deviation 0.19
|
6.59 units on a scale
Standard Deviation 0.18
|
6.79 units on a scale
Standard Deviation 0.17
|
6.43 units on a scale
Standard Deviation 0.19
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
Weight in kg
Outcome measures
| Measure |
Health Coaching
n=75 Participants
Participants who received health coaching
|
Non-Health Coaching
n=71 Participants
Participants who did not receive health coaching
|
Genetic Risk Counseling
n=77 Participants
Patients who received genetic risk counseling
|
Non-Genetic Risk Counseling
n=69 Participants
Patients who did not receive genetic risk counseling
|
|---|---|---|---|---|
|
Weight
|
86.61 kg
Standard Deviation 0.43
|
86.76 kg
Standard Deviation 0.45
|
86.77 kg
Standard Deviation 0.43
|
86.59 kg
Standard Deviation 0.45
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
Waist circumference in cm
Outcome measures
| Measure |
Health Coaching
n=75 Participants
Participants who received health coaching
|
Non-Health Coaching
n=71 Participants
Participants who did not receive health coaching
|
Genetic Risk Counseling
n=77 Participants
Patients who received genetic risk counseling
|
Non-Genetic Risk Counseling
n=69 Participants
Patients who did not receive genetic risk counseling
|
|---|---|---|---|---|
|
Waist Circumference
|
97.43 cm
Standard Deviation 0.63
|
96.9 cm
Standard Deviation 0.64
|
97.29 cm
Standard Deviation 0.62
|
97.04 cm
Standard Deviation 0.65
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
Systolic blood pressure in mmHg
Outcome measures
| Measure |
Health Coaching
n=75 Participants
Participants who received health coaching
|
Non-Health Coaching
n=71 Participants
Participants who did not receive health coaching
|
Genetic Risk Counseling
n=77 Participants
Patients who received genetic risk counseling
|
Non-Genetic Risk Counseling
n=69 Participants
Patients who did not receive genetic risk counseling
|
|---|---|---|---|---|
|
Systolic Blood Pressure
|
124.47 mmHg
Standard Deviation 1.21
|
127.05 mmHg
Standard Deviation 1.25
|
124.71 mmHg
Standard Deviation 1.2
|
126.83 mmHg
Standard Deviation 1.26
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
Diastolic blood pressure in mmHg
Outcome measures
| Measure |
Health Coaching
n=75 Participants
Participants who received health coaching
|
Non-Health Coaching
n=71 Participants
Participants who did not receive health coaching
|
Genetic Risk Counseling
n=77 Participants
Patients who received genetic risk counseling
|
Non-Genetic Risk Counseling
n=69 Participants
Patients who did not receive genetic risk counseling
|
|---|---|---|---|---|
|
Diastolic Blood Pressure
|
79.79 mmHg
Standard Deviation 0.95
|
79.38 mmHg
Standard Deviation 0.98
|
79.59 mmHg
Standard Deviation 0.95
|
79.59 mmHg
Standard Deviation 0.99
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
High-density lipoprotein (HDL) in mg/dL
Outcome measures
| Measure |
Health Coaching
n=75 Participants
Participants who received health coaching
|
Non-Health Coaching
n=71 Participants
Participants who did not receive health coaching
|
Genetic Risk Counseling
n=77 Participants
Patients who received genetic risk counseling
|
Non-Genetic Risk Counseling
n=69 Participants
Patients who did not receive genetic risk counseling
|
|---|---|---|---|---|
|
High-density Lipoprotein (HDL)
|
54.27 mg/dL
Standard Deviation 0.93
|
53.3 mg/dL
Standard Deviation 0.96
|
53.02 mg/dL
Standard Deviation 0.93
|
54.67 mg/dL
Standard Deviation 0.99
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
Low-density lipoprotein (LDL) in mg/dL
Outcome measures
| Measure |
Health Coaching
n=75 Participants
Participants who received health coaching
|
Non-Health Coaching
n=71 Participants
Participants who did not receive health coaching
|
Genetic Risk Counseling
n=77 Participants
Patients who received genetic risk counseling
|
Non-Genetic Risk Counseling
n=69 Participants
Patients who did not receive genetic risk counseling
|
|---|---|---|---|---|
|
Low-density Lipoprotein (LDL)
|
128.62 mg/dL
Standard Deviation 3.5
|
122.42 mg/dL
Standard Deviation 3.6
|
125.33 mg/dL
Standard Deviation 3.47
|
125.93 mg/dL
Standard Deviation 3.68
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
Triglycerides in mg/dL
Outcome measures
| Measure |
Health Coaching
n=75 Participants
Participants who received health coaching
|
Non-Health Coaching
n=71 Participants
Participants who did not receive health coaching
|
Genetic Risk Counseling
n=77 Participants
Patients who received genetic risk counseling
|
Non-Genetic Risk Counseling
n=69 Participants
Patients who did not receive genetic risk counseling
|
|---|---|---|---|---|
|
Triglycerides
|
149.34 mg/dL
Standard Deviation 6.67
|
135.36 mg/dL
Standard Deviation 6.87
|
148.3 mg/dL
Standard Deviation 6.59
|
136.09 mg/dL
Standard Deviation 7
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
Adjusted for baseline
Outcome measures
| Measure |
Health Coaching
n=75 Participants
Participants who received health coaching
|
Non-Health Coaching
n=71 Participants
Participants who did not receive health coaching
|
Genetic Risk Counseling
n=77 Participants
Patients who received genetic risk counseling
|
Non-Genetic Risk Counseling
n=69 Participants
Patients who did not receive genetic risk counseling
|
|---|---|---|---|---|
|
Fasting Blood Glucose
|
99.62 mg/dL
Standard Deviation 1.54
|
100.64 mg/dL
Standard Deviation 1.42
|
100.13 mg/dL
Standard Deviation 1.44
|
100.23 mg/dL
Standard Deviation 1.56
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
Outcome measures
| Measure |
Health Coaching
n=75 Participants
Participants who received health coaching
|
Non-Health Coaching
n=71 Participants
Participants who did not receive health coaching
|
Genetic Risk Counseling
n=77 Participants
Patients who received genetic risk counseling
|
Non-Genetic Risk Counseling
n=69 Participants
Patients who did not receive genetic risk counseling
|
|---|---|---|---|---|
|
Body Mass Index (BMI)
|
28.97 kg/m2
Standard Deviation 0.25
|
29.4 kg/m2
Standard Deviation 0.25
|
29.22 kg/m2
Standard Deviation 0.25
|
29.14 kg/m2
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
Adjusted for baseline
Outcome measures
| Measure |
Health Coaching
n=75 Participants
Participants who received health coaching
|
Non-Health Coaching
n=71 Participants
Participants who did not receive health coaching
|
Genetic Risk Counseling
n=77 Participants
Patients who received genetic risk counseling
|
Non-Genetic Risk Counseling
n=69 Participants
Patients who did not receive genetic risk counseling
|
|---|---|---|---|---|
|
Total Cholesterol
|
212.86 mg/dL
Standard Deviation 4.01
|
202.39 mg/dL
Standard Deviation 4.1
|
207.07 mg/dL
Standard Deviation 3.99
|
208.51 mg/dL
Standard Deviation 4.27
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data only collected on active duty participants as part of their annual assessment. Randomization Arms/Groups were regrouped as pre-specified in the study protocol.
Last annual fitness exam result, collected as pass or fail
Outcome measures
| Measure |
Health Coaching
n=22 Participants
Participants who received health coaching
|
Non-Health Coaching
n=6 Participants
Participants who did not receive health coaching
|
Genetic Risk Counseling
n=18 Participants
Patients who received genetic risk counseling
|
Non-Genetic Risk Counseling
n=10 Participants
Patients who did not receive genetic risk counseling
|
|---|---|---|---|---|
|
AF Composite Fitness Scores
Fail
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
AF Composite Fitness Scores
Pass
|
22 Participants
|
5 Participants
|
17 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: risk score data was only collected and calculated at baseline
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: risk score data was only collected and calculated at baseline
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
Investigator developed questions assessing level of personal perceived risk, fear, anger, worry regarding CHD risk. The consequences subscale ranges from 6-30. Higher scores on the consequences represent strongly held beliefs about negative consequences of the illness. The personal control subscale ranges from 6-30 and the treatment control subscale ranges from 2-10. Higher scores on the personal control and treatment control represent positive beliefs about the controllability of the illness. The emotional representations scores range from 6-30. Higher score indicates higher levels of worry or anxiety about risk of illness.
Outcome measures
| Measure |
Health Coaching
n=75 Participants
Participants who received health coaching
|
Non-Health Coaching
n=71 Participants
Participants who did not receive health coaching
|
Genetic Risk Counseling
n=77 Participants
Patients who received genetic risk counseling
|
Non-Genetic Risk Counseling
n=69 Participants
Patients who did not receive genetic risk counseling
|
|---|---|---|---|---|
|
Perceived Risk for Coronary Heart Disease (CHD)
Consequences subscale
|
23.35 units on a scale
Standard Deviation 0.53
|
23.55 units on a scale
Standard Deviation 0.53
|
24.03 units on a scale
Standard Deviation 0.52
|
22.83 units on a scale
Standard Deviation 0.53
|
|
Perceived Risk for Coronary Heart Disease (CHD)
Personal control
|
25.44 units on a scale
Standard Deviation 0.38
|
24.42 units on a scale
Standard Deviation 0.39
|
25.15 units on a scale
Standard Deviation 0.38
|
24.62 units on a scale
Standard Deviation 0.39
|
|
Perceived Risk for Coronary Heart Disease (CHD)
Treatment control
|
8.44 units on a scale
Standard Deviation 0.13
|
8.21 units on a scale
Standard Deviation 0.13
|
8.39 units on a scale
Standard Deviation 0.12
|
8.23 units on a scale
Standard Deviation 0.13
|
|
Perceived Risk for Coronary Heart Disease (CHD)
Emotional representations
|
13.54 units on a scale
Standard Deviation 0.37
|
14.15 units on a scale
Standard Deviation 0.37
|
13.68 units on a scale
Standard Deviation 0.36
|
14 units on a scale
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
Investigator developed questions assessing level of personal perceived risk, fear, anger, worry regarding T2D risk. The consequences subscale ranges from 6-30. Higher scores on the consequences represent strongly held beliefs about negative consequences of the illness. The personal control subscale ranges from 6-30 and the treatment control subscale ranges from 2-10. Higher scores on the personal control and treatment control represent positive beliefs about the controllability of the illness. The emotional representations scores range from 6-30. Higher score indicates higher levels of worry or anxiety about risk of illness.
Outcome measures
| Measure |
Health Coaching
n=75 Participants
Participants who received health coaching
|
Non-Health Coaching
n=71 Participants
Participants who did not receive health coaching
|
Genetic Risk Counseling
n=77 Participants
Patients who received genetic risk counseling
|
Non-Genetic Risk Counseling
n=69 Participants
Patients who did not receive genetic risk counseling
|
|---|---|---|---|---|
|
Perceived Risk for Type 2 Diabetes (T2D)
Personal control
|
24.79 units on a scale
Standard Deviation 0.36
|
24.55 units on a scale
Standard Deviation 0.36
|
25.14 units on a scale
Standard Deviation 0.35
|
24.28 units on a scale
Standard Deviation 0.36
|
|
Perceived Risk for Type 2 Diabetes (T2D)
Emotional representations
|
13.23 units on a scale
Standard Deviation 0.36
|
14.66 units on a scale
Standard Deviation 0.37
|
13.75 units on a scale
Standard Deviation 0.37
|
14.18 units on a scale
Standard Deviation 0.37
|
|
Perceived Risk for Type 2 Diabetes (T2D)
Consequences subscale
|
22.05 units on a scale
Standard Deviation 0.55
|
21.79 units on a scale
Standard Deviation 0.56
|
22.32 units on a scale
Standard Deviation 0.54
|
21.63 units on a scale
Standard Deviation 0.56
|
|
Perceived Risk for Type 2 Diabetes (T2D)
Treatment control
|
8.37 units on a scale
Standard Deviation 0.14
|
8.18 units on a scale
Standard Deviation 0.14
|
8.35 units on a scale
Standard Deviation 0.13
|
8.2 units on a scale
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
Patient activation is the degree to which patients accept an active role in their healthcare, and have the knowledge, skills and confidence to take care of their health. When scored as a continuous variable, the range is from 0 to 100, with higher numbers indicating greater levels of patient activation.
Outcome measures
| Measure |
Health Coaching
n=75 Participants
Participants who received health coaching
|
Non-Health Coaching
n=71 Participants
Participants who did not receive health coaching
|
Genetic Risk Counseling
n=77 Participants
Patients who received genetic risk counseling
|
Non-Genetic Risk Counseling
n=69 Participants
Patients who did not receive genetic risk counseling
|
|---|---|---|---|---|
|
Patient Activation Score
|
73.13 units on a scale
Standard Deviation 1.5
|
70.95 units on a scale
Standard Deviation 1.53
|
72.3 units on a scale
Standard Deviation 1.45
|
71.51 units on a scale
Standard Deviation 1.55
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
These evidence-based questions are validated and based upon the Transtheoretical Model and assess an individual's readiness to make behavioral change in 5 health behavior domains (dietary intake, exercise, weight loss, smoking cessation, and medication adherence).
Outcome measures
| Measure |
Health Coaching
n=75 Participants
Participants who received health coaching
|
Non-Health Coaching
n=71 Participants
Participants who did not receive health coaching
|
Genetic Risk Counseling
n=77 Participants
Patients who received genetic risk counseling
|
Non-Genetic Risk Counseling
n=69 Participants
Patients who did not receive genetic risk counseling
|
|---|---|---|---|---|
|
Stages of Change
Weight reduction: Action
|
47 Participants
|
43 Participants
|
53 Participants
|
37 Participants
|
|
Stages of Change
Exercise behavior: Contemplation
|
9 Participants
|
16 Participants
|
10 Participants
|
15 Participants
|
|
Stages of Change
Smoking behavior: Preparation
|
3 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Stages of Change
Smoking behavior: Action
|
4 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
|
Stages of Change
Healthier eating behavior: Pre-contemplation
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Stages of Change
Healthier eating behavior: Contemplation
|
8 Participants
|
9 Participants
|
9 Participants
|
8 Participants
|
|
Stages of Change
Healthier eating behavior: Preparation
|
6 Participants
|
7 Participants
|
8 Participants
|
5 Participants
|
|
Stages of Change
Stress behavior: Contemplation
|
9 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
|
Stages of Change
Stress behavior: Preparation
|
8 Participants
|
4 Participants
|
8 Participants
|
4 Participants
|
|
Stages of Change
Stress behavior: Action
|
27 Participants
|
23 Participants
|
22 Participants
|
28 Participants
|
|
Stages of Change
Stress behavior: Maintenance
|
24 Participants
|
34 Participants
|
33 Participants
|
25 Participants
|
|
Stages of Change
Weight reduction: Pre-contemplation
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Stages of Change
Weight reduction: Contemplation
|
8 Participants
|
10 Participants
|
8 Participants
|
10 Participants
|
|
Stages of Change
Weight reduction: Preparation
|
4 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
|
Stages of Change
Weight reduction: Maintenance
|
10 Participants
|
11 Participants
|
8 Participants
|
13 Participants
|
|
Stages of Change
Exercise behavior: Pre-contemplation
|
2 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Stages of Change
Exercise Behavior: Preparation
|
15 Participants
|
20 Participants
|
18 Participants
|
17 Participants
|
|
Stages of Change
Exercise Behavior: Action
|
29 Participants
|
23 Participants
|
26 Participants
|
26 Participants
|
|
Stages of Change
Exercise Behavior: Maintenance
|
20 Participants
|
13 Participants
|
21 Participants
|
12 Participants
|
|
Stages of Change
Smoking behavior: Pre-contemplation
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Stages of Change
Smoking behavior: Contemplation
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Stages of Change
Healthier eating behavior: Action
|
41 Participants
|
44 Participants
|
41 Participants
|
44 Participants
|
|
Stages of Change
Healthier eating behavior: Maintenance
|
13 Participants
|
11 Participants
|
13 Participants
|
11 Participants
|
|
Stages of Change
Stress behavior: Pre-contemplation
|
7 Participants
|
4 Participants
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
The Beck Depression Inventory is a 21-item measure that assesses self-reported symptoms of depression. It has been heavily used in research linking depression to heart disease. Scores range from 0-63, with 0 = minimal depression and 63 = severe depression.
Outcome measures
| Measure |
Health Coaching
n=75 Participants
Participants who received health coaching
|
Non-Health Coaching
n=71 Participants
Participants who did not receive health coaching
|
Genetic Risk Counseling
n=77 Participants
Patients who received genetic risk counseling
|
Non-Genetic Risk Counseling
n=69 Participants
Patients who did not receive genetic risk counseling
|
|---|---|---|---|---|
|
Depression, as Measured by the Beck Depression Inventory (BDI)
|
3.85 units on a scale
Standard Deviation 0.37
|
5.1 units on a scale
Standard Deviation 0.37
|
4.52 units on a scale
Standard Deviation 0.37
|
4.43 units on a scale
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Randomization Arms/Groups were regrouped as pre-specified in the study protocol
The PSS is a 10 item survey assessing feelings and thoughts of stress. Scores range from 0-40 with higher scores indicating higher perceived stress.
Outcome measures
| Measure |
Health Coaching
n=75 Participants
Participants who received health coaching
|
Non-Health Coaching
n=71 Participants
Participants who did not receive health coaching
|
Genetic Risk Counseling
n=77 Participants
Patients who received genetic risk counseling
|
Non-Genetic Risk Counseling
n=69 Participants
Patients who did not receive genetic risk counseling
|
|---|---|---|---|---|
|
Unmanaged Stress as Measured by the Perceived Stress Scale (PSS)
|
10.86 units on a scale
Standard Deviation 0.56
|
11.43 units on a scale
Standard Deviation 0.56
|
11.07 units on a scale
Standard Deviation 0.55
|
11.22 units on a scale
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data is reported for participants who had data available at the 6 month visit. Randomization Arms/Groups were regrouped as pre-specified in the study protocol.
Single item to assess for availability of support person, where No=no support person.
Outcome measures
| Measure |
Health Coaching
n=75 Participants
Participants who received health coaching
|
Non-Health Coaching
n=76 Participants
Participants who did not receive health coaching
|
Genetic Risk Counseling
n=77 Participants
Patients who received genetic risk counseling
|
Non-Genetic Risk Counseling
n=74 Participants
Patients who did not receive genetic risk counseling
|
|---|---|---|---|---|
|
Social Isolation
Social Support=No
|
3 Participants
|
7 Participants
|
8 Participants
|
2 Participants
|
|
Social Isolation
Social Support=Yes
|
72 Participants
|
69 Participants
|
69 Participants
|
72 Participants
|
Adverse Events
Standard Risk Assessment (SRA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SRA Plus Health Coaching (HC)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
SRA Plus Genetic Risk Counseling (GRC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SRA+HC+GRC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Risk Assessment (SRA)
n=50 participants at risk
Subjects will receive a standard risk assessment only for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.
Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.
|
SRA Plus Health Coaching (HC)
n=49 participants at risk
In addition to the standard risk assessment for CHD and T2D subjects will receive health coaching intervention for 6 months
Health coaching: Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).
Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.
|
SRA Plus Genetic Risk Counseling (GRC)
n=49 participants at risk
In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.
Genetic risk counseling: In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.
Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.
|
SRA+HC+GRC
n=52 participants at risk
In addition to the standard risk assessment for CHD and T2D subjects will receive genetic risk counseling and health coaching intervention for 6 months.
Health coaching: Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).
Genetic risk counseling: In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.
Standard risk assessment: Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastric Hemorrhage
|
0.00%
0/50 • date of consent to 12 months
|
2.0%
1/49 • date of consent to 12 months
|
0.00%
0/49 • date of consent to 12 months
|
0.00%
0/52 • date of consent to 12 months
|
Other adverse events
Adverse event data not reported
Additional Information
Allison A. Vorderstrasse, DNSc, APRN, FAAN
NYU Rory Meyers College of Nursing
Phone: 212-998-5786
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place