Trial Outcomes & Findings for INtervention Study In overweiGHT Patients With COPD (NCT NCT02634268)
NCT ID: NCT02634268
Last Updated: 2022-04-07
Results Overview
distance walked in six minutes
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
684 participants
Primary outcome timeframe
12 months
Results posted on
2022-04-07
Participant Flow
Participants were recruited from 4/28/2017-8/16/2019 from 38 diverse settings across the United States, including rural, urban, and academic medical centers, and Department of Veteran Affairs Health Systems.
Participant milestones
| Measure |
Lifestyle Intervention
Behavioral lifestyle intervention focused on healthy eating and physical activity
Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity
|
Usual Care
Participants continue with usual diet and exercise activities as they desire
|
|---|---|---|
|
Overall Study
STARTED
|
346
|
338
|
|
Overall Study
COMPLETED
|
287
|
291
|
|
Overall Study
NOT COMPLETED
|
59
|
47
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
INtervention Study In overweiGHT Patients With COPD
Baseline characteristics by cohort
| Measure |
Lifestyle Intervention
n=346 Participants
Behavioral lifestyle intervention focused on healthy eating and physical activity
Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity
|
Usual Care
n=338 Participants
Participants continue with usual diet and exercise activities as they desire
|
Total
n=684 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.0 years
STANDARD_DEVIATION 8.2 • n=99 Participants
|
66.9 years
STANDARD_DEVIATION 7.7 • n=107 Participants
|
67.0 years
STANDARD_DEVIATION 8.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
142 Participants
n=99 Participants
|
140 Participants
n=107 Participants
|
282 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
204 Participants
n=99 Participants
|
198 Participants
n=107 Participants
|
402 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
337 Participants
n=99 Participants
|
333 Participants
n=107 Participants
|
670 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
67 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
267 Participants
n=99 Participants
|
260 Participants
n=107 Participants
|
527 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.
distance walked in six minutes
Outcome measures
| Measure |
Lifestyle Intervention
n=346 Participants
Behavioral lifestyle intervention focused on healthy eating and physical activity
Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity
|
Usual Care
n=338 Participants
Participants continue with usual diet and exercise activities as they desire
|
|---|---|---|
|
Six Minute Walk Test
|
1071.0 feet
Standard Deviation 354.1
|
1005.9 feet
Standard Deviation 339.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.
Shortness of breath: scores range from 0 (nothing at all) to 10 (very, very severe).
Outcome measures
| Measure |
Lifestyle Intervention
n=346 Participants
Behavioral lifestyle intervention focused on healthy eating and physical activity
Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity
|
Usual Care
n=338 Participants
Participants continue with usual diet and exercise activities as they desire
|
|---|---|---|
|
Modified Borg Scale
|
2.7 units on a scale
Standard Deviation 1.9
|
3.2 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.
body weight
Outcome measures
| Measure |
Lifestyle Intervention
n=346 Participants
Behavioral lifestyle intervention focused on healthy eating and physical activity
Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity
|
Usual Care
n=338 Participants
Participants continue with usual diet and exercise activities as they desire
|
|---|---|---|
|
Weight
|
91.0 kilograms
Standard Deviation 17.7
|
93.7 kilograms
Standard Deviation 17.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.
scores range from 0-100 with higher scores reflecting better health
Outcome measures
| Measure |
Lifestyle Intervention
n=346 Participants
Behavioral lifestyle intervention focused on healthy eating and physical activity
Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity
|
Usual Care
n=338 Participants
Participants continue with usual diet and exercise activities as they desire
|
|---|---|---|
|
Short Form 12 Health Survey (SF-12) Physical Component Score (PCS)
|
39.7 score on a scale
Standard Deviation 8.5
|
37.5 score on a scale
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: 12-monthsPopulation: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.
scores range from 0-100 with higher scores reflecting better health
Outcome measures
| Measure |
Lifestyle Intervention
n=346 Participants
Behavioral lifestyle intervention focused on healthy eating and physical activity
Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity
|
Usual Care
n=338 Participants
Participants continue with usual diet and exercise activities as they desire
|
|---|---|---|
|
Short Form 12 Health Survey (SF-12) Mental Component Score (MCS)
|
51.7 score on a scale
Standard Deviation 9.7
|
51.4 score on a scale
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.
This measure uses non-laboratory-based measures (sex, age, body mass index, systolic blood pressure, use of antihypertensive treatment, smoking status, and diabetes status) to yield a score (cardiovascular disease points) representing 10-year risk of having a cardiovascular problem. Low scores (minimum of -2 for women, -3 for men) indicate low risk. Scores of 21 or higher indicate high risk (30% risk or higher).
Outcome measures
| Measure |
Lifestyle Intervention
n=345 Participants
Behavioral lifestyle intervention focused on healthy eating and physical activity
Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity
|
Usual Care
n=338 Participants
Participants continue with usual diet and exercise activities as they desire
|
|---|---|---|
|
Non-laboratory Framingham Risk Score
|
15.0 score on a scale
Standard Deviation 3.0
|
15.4 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12-months; see Statistical Analysis 1 for those results.
cardiovascular disease risk
Outcome measures
| Measure |
Lifestyle Intervention
n=346 Participants
Behavioral lifestyle intervention focused on healthy eating and physical activity
Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity
|
Usual Care
n=338 Participants
Participants continue with usual diet and exercise activities as they desire
|
|---|---|---|
|
Waist Circumference
|
111.3 centimeters
Standard Deviation 12.9
|
113.1 centimeters
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.
indicator of cardiovascular disease risk; higher values indicate higher risk
Outcome measures
| Measure |
Lifestyle Intervention
n=346 Participants
Behavioral lifestyle intervention focused on healthy eating and physical activity
Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity
|
Usual Care
n=338 Participants
Participants continue with usual diet and exercise activities as they desire
|
|---|---|---|
|
Systolic Blood Pressure
|
129.5 mmHg
Standard Deviation 17.2
|
128.8 mmHg
Standard Deviation 16.2
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.
cardiovascular disease risk
Outcome measures
| Measure |
Lifestyle Intervention
n=346 Participants
Behavioral lifestyle intervention focused on healthy eating and physical activity
Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity
|
Usual Care
n=338 Participants
Participants continue with usual diet and exercise activities as they desire
|
|---|---|---|
|
Body Mass Index (BMI)
|
31.9 kg/m^2
Standard Deviation 5.0
|
32.7 kg/m^2
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.
Designed to measure respiratory health quality of life in patients with COPD, providing a total score and three subscale scores assessing: (1) symptoms (frequency and severity), (2) activities that cause or are limited by breathlessness and (3) Impact (social functioning and psychological disturbances resulting from COPD). Each score ranges from 0-100, with higher scores indicating more limitations.
Outcome measures
| Measure |
Lifestyle Intervention
n=346 Participants
Behavioral lifestyle intervention focused on healthy eating and physical activity
Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity
|
Usual Care
n=338 Participants
Participants continue with usual diet and exercise activities as they desire
|
|---|---|---|
|
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Symptom Component Score
|
52.6 score on a scale
Standard Deviation 21.9
|
54.9 score on a scale
Standard Deviation 20.8
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.
Designed to measure respiratory health quality of life in patients with COPD, providing a total score and three subscale scores assessing: (1) symptoms (frequency and severity), (2) activities that cause or are limited by breathlessness and (3) Impact (social functioning and psychological disturbances resulting from COPD). Each score ranges from 0-100, with higher scores indicating more limitations.
Outcome measures
| Measure |
Lifestyle Intervention
n=346 Participants
Behavioral lifestyle intervention focused on healthy eating and physical activity
Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity
|
Usual Care
n=338 Participants
Participants continue with usual diet and exercise activities as they desire
|
|---|---|---|
|
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Activity Component Score
|
58.9 score on a scale
Standard Deviation 25.8
|
63.3 score on a scale
Standard Deviation 25.3
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.
Designed to measure respiratory health quality of life in patients with COPD, providing a total score and three subscale scores assessing: (1) symptoms (frequency and severity), (2) activities that cause or are limited by breathlessness and (3) Impact (social functioning and psychological disturbances resulting from COPD). Each score ranges from 0-100, with higher scores indicating more limitations.
Outcome measures
| Measure |
Lifestyle Intervention
n=346 Participants
Behavioral lifestyle intervention focused on healthy eating and physical activity
Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity
|
Usual Care
n=338 Participants
Participants continue with usual diet and exercise activities as they desire
|
|---|---|---|
|
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Impact Component Score
|
29.2 score on a scale
Standard Deviation 20.1
|
32.8 score on a scale
Standard Deviation 21.5
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.
Designed to measure respiratory health quality of life in patients with COPD, providing a total score and three subscale scores assessing: (1) symptoms (frequency and severity), (2) activities that cause or are limited by breathlessness and (3) Impact (social functioning and psychological disturbances resulting from COPD). Each score ranges from 0-100, with higher scores indicating more limitations.
Outcome measures
| Measure |
Lifestyle Intervention
n=346 Participants
Behavioral lifestyle intervention focused on healthy eating and physical activity
Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity
|
Usual Care
n=338 Participants
Participants continue with usual diet and exercise activities as they desire
|
|---|---|---|
|
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Total Score
|
42.4 score on a scale
Standard Deviation 19.5
|
46.1 score on a scale
Standard Deviation 19.8
|
Adverse Events
Lifestyle Intervention
Serious events: 78 serious events
Other events: 95 other events
Deaths: 4 deaths
Usual Care
Serious events: 75 serious events
Other events: 90 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Lifestyle Intervention
n=346 participants at risk
Behavioral lifestyle intervention focused on healthy eating and physical activity
Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity
|
Usual Care
n=338 participants at risk
Participants continue with usual diet and exercise activities as they desire
|
|---|---|---|
|
General disorders
Cardiovascular
|
6.4%
22/346 • Number of events 27 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
5.9%
20/338 • Number of events 27 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Skin and subcutaneous tissue disorders
Dermatological
|
0.58%
2/346 • Number of events 2 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
0.89%
3/338 • Number of events 5 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Gastrointestinal disorders
Gastrointestinal
|
4.0%
14/346 • Number of events 16 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
2.1%
7/338 • Number of events 9 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Blood and lymphatic system disorders
Hematological
|
0.58%
2/346 • Number of events 3 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
0.59%
2/338 • Number of events 2 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Metabolism and nutrition disorders
Metabolic
|
0.58%
2/346 • Number of events 2 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
0.89%
3/338 • Number of events 4 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
2.9%
10/346 • Number of events 10 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
2.1%
7/338 • Number of events 7 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Nervous system disorders
Neurological
|
2.0%
7/346 • Number of events 7 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
2.1%
7/338 • Number of events 8 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Psychiatric disorders
Psychological
|
0.58%
2/346 • Number of events 4 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
0.59%
2/338 • Number of events 2 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Respiratory
|
10.1%
35/346 • Number of events 42 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
10.4%
35/338 • Number of events 50 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Renal and urinary disorders
Renal/Urologic
|
2.0%
7/346 • Number of events 9 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
3.3%
11/338 • Number of events 11 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Hepatobiliary disorders
Hepatobiliary
|
1.2%
4/346 • Number of events 4 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
0.89%
3/338 • Number of events 3 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
|
General disorders
Other
|
3.8%
13/346 • Number of events 14 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
4.1%
14/338 • Number of events 14 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
Other adverse events
| Measure |
Lifestyle Intervention
n=346 participants at risk
Behavioral lifestyle intervention focused on healthy eating and physical activity
Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity
|
Usual Care
n=338 participants at risk
Participants continue with usual diet and exercise activities as they desire
|
|---|---|---|
|
General disorders
Cardiovascular
|
5.8%
20/346 • Number of events 21 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
4.1%
14/338 • Number of events 16 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Skin and subcutaneous tissue disorders
Dermatological
|
3.5%
12/346 • Number of events 15 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
3.3%
11/338 • Number of events 12 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Gastrointestinal disorders
Gastrointestinal
|
1.7%
6/346 • Number of events 6 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
3.0%
10/338 • Number of events 13 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Blood and lymphatic system disorders
Hematological
|
1.7%
6/346 • Number of events 6 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
0.30%
1/338 • Number of events 1 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Metabolism and nutrition disorders
Metabolic
|
1.4%
5/346 • Number of events 5 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
1.2%
4/338 • Number of events 4 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
8.7%
30/346 • Number of events 35 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
7.1%
24/338 • Number of events 29 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Nervous system disorders
Neurological
|
2.0%
7/346 • Number of events 8 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
1.8%
6/338 • Number of events 7 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Psychiatric disorders
Psychological
|
1.2%
4/346 • Number of events 5 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
0.89%
3/338 • Number of events 4 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Respiratory
|
11.0%
38/346 • Number of events 47 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
15.4%
52/338 • Number of events 67 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Renal and urinary disorders
Renal/Urologic
|
0.87%
3/346 • Number of events 4 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
1.5%
5/338 • Number of events 5 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Hepatobiliary disorders
Hepatobiliary
|
0.00%
0/346 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
0.59%
2/338 • Number of events 2 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
|
General disorders
Other
|
4.6%
16/346 • Number of events 19 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
3.0%
10/338 • Number of events 11 • We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse events were monitored without regard to the specific Adverse Event Term.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place