Trial Outcomes & Findings for Coaching Veterans to Healthy Weights and Wellness (NCT NCT00967668)
NCT ID: NCT00967668
Last Updated: 2015-04-24
Results Overview
Expected weight change from baseline to 12 months in kilograms based on linear mixed-effects model using all available data
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
481 participants
Primary outcome timeframe
12 months after enrollment
Results posted on
2015-04-24
Participant Flow
Participant milestones
| Measure |
ASPIRE-Phone Lifestyle Coaching
Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)
Small change approach to improving physical activity and diet: The "Aspire to Lifelong Health" (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle.
|
ASPIRE-Group Lifestyle Coaching
On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)
Small change approach to improving physical activity and diet: The "Aspire to Lifelong Health" (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle.
|
MOVE! Usual Care
Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support
MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care.
|
|---|---|---|---|
|
Overall Study
STARTED
|
162
|
160
|
159
|
|
Overall Study
3-mo Assessment
|
131
|
127
|
115
|
|
Overall Study
Completed Year 1 - 12-mo Assessment
|
120
|
122
|
119
|
|
Overall Study
18-mo Assessment
|
95
|
102
|
92
|
|
Overall Study
COMPLETED
|
91
|
104
|
90
|
|
Overall Study
NOT COMPLETED
|
71
|
56
|
69
|
Reasons for withdrawal
| Measure |
ASPIRE-Phone Lifestyle Coaching
Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)
Small change approach to improving physical activity and diet: The "Aspire to Lifelong Health" (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle.
|
ASPIRE-Group Lifestyle Coaching
On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)
Small change approach to improving physical activity and diet: The "Aspire to Lifelong Health" (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle.
|
MOVE! Usual Care
Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support
MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
13
|
8
|
8
|
|
Overall Study
Death
|
0
|
2
|
4
|
|
Overall Study
Removed due to behavior
|
1
|
1
|
2
|
|
Overall Study
Refused Year 2
|
11
|
6
|
4
|
|
Overall Study
Lost to follow-up at 12-mo
|
27
|
29
|
26
|
|
Overall Study
Lost to Follow-up
|
15
|
9
|
16
|
|
Overall Study
Refused 12-mo assessment
|
3
|
1
|
9
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
Baseline Characteristics
Coaching Veterans to Healthy Weights and Wellness
Baseline characteristics by cohort
| Measure |
ASPIRE-Phone Lifestyle Coaching
n=162 Participants
Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)
Small change approach to improving physical activity and diet: The "Aspire to Lifelong Health" (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates elements from cognitive behavioral therapy, problem-solving therapy, and behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle.
|
ASPIRE-Group Lifestyle Coaching
n=160 Participants
On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)
Small change approach to improving physical activity and diet: The "Aspire to Lifelong Health" (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates elements from cognitive behavioral therapy, problem-solving therapy, and behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle.
|
MOVE! Usual Care
n=159 Participants
Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support
MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care.
|
Total
n=481 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.4 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
54.9 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
54.6 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
409 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
67 participants
n=5 Participants
|
65 participants
n=7 Participants
|
64 participants
n=5 Participants
|
196 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
91 participants
n=5 Participants
|
94 participants
n=7 Participants
|
91 participants
n=5 Participants
|
276 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Education, years
Less than 13
|
38 participants
n=5 Participants
|
34 participants
n=7 Participants
|
36 participants
n=5 Participants
|
108 participants
n=4 Participants
|
|
Education, years
13-15
|
81 participants
n=5 Participants
|
81 participants
n=7 Participants
|
92 participants
n=5 Participants
|
254 participants
n=4 Participants
|
|
Education, years
16 or more
|
40 participants
n=5 Participants
|
42 participants
n=7 Participants
|
26 participants
n=5 Participants
|
108 participants
n=4 Participants
|
|
Education, years
Missing
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Income less than $20k
Income less than $20k
|
55 participants
n=5 Participants
|
70 participants
n=7 Participants
|
71 participants
n=5 Participants
|
196 participants
n=4 Participants
|
|
Income less than $20k
Income $20k or more
|
107 participants
n=5 Participants
|
90 participants
n=7 Participants
|
88 participants
n=5 Participants
|
285 participants
n=4 Participants
|
|
Health-related disability
Yes
|
74 participants
n=5 Participants
|
87 participants
n=7 Participants
|
88 participants
n=5 Participants
|
249 participants
n=4 Participants
|
|
Health-related disability
No
|
88 participants
n=5 Participants
|
73 participants
n=7 Participants
|
71 participants
n=5 Participants
|
232 participants
n=4 Participants
|
|
Charlson Index
|
1.0 units on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
1.2 units on a scale
STANDARD_DEVIATION 1.4 • n=7 Participants
|
1.2 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
1.1 units on a scale
STANDARD_DEVIATION 1.5 • n=4 Participants
|
|
Depression
Yes
|
35 participants
n=5 Participants
|
62 participants
n=7 Participants
|
59 participants
n=5 Participants
|
156 participants
n=4 Participants
|
|
Depression
No
|
127 participants
n=5 Participants
|
98 participants
n=7 Participants
|
100 participants
n=5 Participants
|
325 participants
n=4 Participants
|
|
Diabetes
Yes
|
53 participants
n=5 Participants
|
64 participants
n=7 Participants
|
60 participants
n=5 Participants
|
177 participants
n=4 Participants
|
|
Diabetes
No
|
109 participants
n=5 Participants
|
96 participants
n=7 Participants
|
99 participants
n=5 Participants
|
304 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 months after enrollmentExpected weight change from baseline to 12 months in kilograms based on linear mixed-effects model using all available data
Outcome measures
| Measure |
ASPIRE-Phone Lifestyle Coaching
n=162 Participants
Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)
Small change approach to improving physical activity and diet: The "Aspire to Lifelong Health" (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle.
|
ASPIRE-Group Lifestyle Coaching
n=160 Participants
On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)
Small change approach to improving physical activity and diet: The "Aspire to Lifelong Health" (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle.
|
MOVE! Usual Care
n=159 Participants
Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support
MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care.
|
|---|---|---|---|
|
Change in Weight
|
-1.4 Kilograms
Interval -2.4 to -0.5
|
-2.8 Kilograms
Interval -3.8 to -1.9
|
-1.4 Kilograms
Interval -2.3 to -0.4
|
SECONDARY outcome
Timeframe: 24 months after enrollmentPopulation: Includes only individuals who formally consented to participate in the second 12 months of the study.
Expected weight change from baseline to 24 months in kilograms based on linear mixed-effects model using all available data. Statistical analyses methods are the same as for the 12-month outcome.
Outcome measures
| Measure |
ASPIRE-Phone Lifestyle Coaching
n=105 Participants
Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)
Small change approach to improving physical activity and diet: The "Aspire to Lifelong Health" (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle.
|
ASPIRE-Group Lifestyle Coaching
n=115 Participants
On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)
Small change approach to improving physical activity and diet: The "Aspire to Lifelong Health" (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle.
|
MOVE! Usual Care
n=112 Participants
Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support
MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care.
|
|---|---|---|---|
|
Change in Weight
|
-1.91 kilograms
Interval -3.15 to -0.66
|
-1.3 kilograms
Interval -2.47 to -0.12
|
-1.8 kilograms
Interval -3.05 to -0.55
|
Adverse Events
ASPIRE-Phone Lifestyle Coaching
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
ASPIRE-Group Lifestyle Coaching
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
MOVE! Usual Care
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ASPIRE-Phone Lifestyle Coaching
n=162 participants at risk
Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)
Small change approach to improving physical activity and diet: The "Aspire to Lifelong Health" (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle.
|
ASPIRE-Group Lifestyle Coaching
n=160 participants at risk
On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)
Small change approach to improving physical activity and diet: The "Aspire to Lifelong Health" (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle.
|
MOVE! Usual Care
n=159 participants at risk
Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support
MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
sore muscles and joints
|
25.3%
41/162 • Adverse events are reported for the full 2-years of participation of each individual.
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
|
15.0%
24/160 • Adverse events are reported for the full 2-years of participation of each individual.
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
|
6.3%
10/159 • Adverse events are reported for the full 2-years of participation of each individual.
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
|
|
Gastrointestinal disorders
stomach problems
|
1.2%
2/162 • Adverse events are reported for the full 2-years of participation of each individual.
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
|
0.00%
0/160 • Adverse events are reported for the full 2-years of participation of each individual.
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
|
0.00%
0/159 • Adverse events are reported for the full 2-years of participation of each individual.
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
|
|
General disorders
multiple systems or other
|
1.9%
3/162 • Adverse events are reported for the full 2-years of participation of each individual.
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
|
3.8%
6/160 • Adverse events are reported for the full 2-years of participation of each individual.
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
|
0.63%
1/159 • Adverse events are reported for the full 2-years of participation of each individual.
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
|
|
Injury, poisoning and procedural complications
minor injuries while exercising
|
1.9%
3/162 • Adverse events are reported for the full 2-years of participation of each individual.
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
|
3.1%
5/160 • Adverse events are reported for the full 2-years of participation of each individual.
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
|
0.00%
0/159 • Adverse events are reported for the full 2-years of participation of each individual.
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
|
|
Respiratory, thoracic and mediastinal disorders
sinus, breathing
|
0.62%
1/162 • Adverse events are reported for the full 2-years of participation of each individual.
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
|
0.62%
1/160 • Adverse events are reported for the full 2-years of participation of each individual.
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
|
1.3%
2/159 • Adverse events are reported for the full 2-years of participation of each individual.
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
|
|
Skin and subcutaneous tissue disorders
rashes
|
1.2%
2/162 • Adverse events are reported for the full 2-years of participation of each individual.
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
|
3.1%
5/160 • Adverse events are reported for the full 2-years of participation of each individual.
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
|
0.63%
1/159 • Adverse events are reported for the full 2-years of participation of each individual.
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
|
|
Cardiac disorders
low pulse, chest pain
|
0.00%
0/162 • Adverse events are reported for the full 2-years of participation of each individual.
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
|
0.62%
1/160 • Adverse events are reported for the full 2-years of participation of each individual.
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
|
0.63%
1/159 • Adverse events are reported for the full 2-years of participation of each individual.
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
|
|
Endocrine disorders
blood sugar
|
0.00%
0/162 • Adverse events are reported for the full 2-years of participation of each individual.
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
|
2.5%
4/160 • Adverse events are reported for the full 2-years of participation of each individual.
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
|
0.00%
0/159 • Adverse events are reported for the full 2-years of participation of each individual.
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
|
Additional Information
Laura Damschroder
VA Center for Clinical Management Research
Phone: 734-845-3603
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place