Trial Outcomes & Findings for Physical Activity and Healthy Eating Among Young Adult Cancer Survivors (NCT NCT05887401)
NCT ID: NCT05887401
Last Updated: 2025-12-24
Results Overview
Number of participants who agreed to participate divided by the number of months of recruitment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
End of study enrollment period (7 months).
Results posted on
2025-12-24
Participant Flow
Recruitment occurred from October 2023 and April 2024; remote recruitment across the continental United States. 220 individuals completed the online screening survey; 83 were initially eligible; out of those, 11 completed informed consent but were ineligible due to no longer being interested in participating or incomplete baseline measurement procedures, and 72 completed informed consent and all baseline assessment procedures and were randomized and enrolled in the study.
Individuals who signed informed consent and then completed all baseline measurement procedures (online surveys and remote weight measurements) and remained eligible were considered enrolled and were randomized to 1 of 16 conditions.
Participant milestones
| Measure |
Condition 1
Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 2
Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 3
Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 4
Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 5
Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 6
Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 7
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 8
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 9
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 10
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 11
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 12
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 13
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 14
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 15
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 16
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
4
|
4
|
3
|
4
|
6
|
4
|
2
|
5
|
5
|
5
|
6
|
7
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
3
|
2
|
3
|
4
|
6
|
4
|
1
|
3
|
3
|
4
|
6
|
7
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
2
|
0
|
0
|
0
|
0
|
1
|
2
|
2
|
1
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Condition 1
Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 2
Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 3
Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 4
Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 5
Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 6
Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 7
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 8
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 9
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 10
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 11
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 12
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 13
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 14
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 15
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 16
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
2
|
0
|
0
|
0
|
0
|
1
|
1
|
2
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Physical Activity and Healthy Eating Among Young Adult Cancer Survivors
Baseline characteristics by cohort
| Measure |
Condition 14
n=7 Participants
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 15
n=4 Participants
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 16
n=4 Participants
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Total
n=72 Participants
Total of all reporting groups
|
Condition 1
n=4 Participants
Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 2
n=5 Participants
Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 3
n=4 Participants
Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 4
n=4 Participants
Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 5
n=3 Participants
Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 6
n=4 Participants
Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 7
n=6 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 8
n=4 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 9
n=2 Participants
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 10
n=5 Participants
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 11
n=5 Participants
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 12
n=5 Participants
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 13
n=6 Participants
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.6 years
STANDARD_DEVIATION 2.82 • n=13 Participants
|
29.4 years
STANDARD_DEVIATION 5.56 • n=12 Participants
|
33.5 years
STANDARD_DEVIATION 3.45 • n=13 Participants
|
33.5 years
STANDARD_DEVIATION 5.2 • n=205 Participants
|
34.2 years
STANDARD_DEVIATION 1.81 • n=30 Participants
|
34.1 years
STANDARD_DEVIATION 6.15 • n=30 Participants
|
29.2 years
STANDARD_DEVIATION 7.36 • n=60 Participants
|
31.2 years
STANDARD_DEVIATION 8.13 • n=219 Participants
|
38.6 years
STANDARD_DEVIATION 1.18 • n=880 Participants
|
34.5 years
STANDARD_DEVIATION 8.07 • n=5449 Participants
|
34.8 years
STANDARD_DEVIATION 3.14 • n=391 Participants
|
34.1 years
STANDARD_DEVIATION 5.77 • n=9 Participants
|
34.2 years
STANDARD_DEVIATION 0.92 • n=3 Participants
|
35.2 years
STANDARD_DEVIATION 4.03 • n=87 Participants
|
31.6 years
STANDARD_DEVIATION 7.06 • n=13 Participants
|
31.8 years
STANDARD_DEVIATION 5.34 • n=13 Participants
|
32.2 years
STANDARD_DEVIATION 5.48 • n=13 Participants
|
|
Sex/Gender, Customized
Sex · Female
|
5 Participants
n=13 Participants
|
4 Participants
n=12 Participants
|
4 Participants
n=13 Participants
|
62 Participants
n=205 Participants
|
4 Participants
n=30 Participants
|
4 Participants
n=30 Participants
|
4 Participants
n=60 Participants
|
3 Participants
n=219 Participants
|
2 Participants
n=880 Participants
|
4 Participants
n=5449 Participants
|
5 Participants
n=391 Participants
|
3 Participants
n=9 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=87 Participants
|
5 Participants
n=13 Participants
|
4 Participants
n=13 Participants
|
5 Participants
n=13 Participants
|
|
Sex/Gender, Customized
Sex · Male
|
2 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
10 Participants
n=205 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=219 Participants
|
1 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
1 Participants
n=391 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=87 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=87 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=13 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
2 Participants
n=205 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=87 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=87 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
2 Participants
n=205 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=87 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=13 Participants
|
3 Participants
n=12 Participants
|
4 Participants
n=13 Participants
|
60 Participants
n=205 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=60 Participants
|
3 Participants
n=219 Participants
|
3 Participants
n=880 Participants
|
4 Participants
n=5449 Participants
|
5 Participants
n=391 Participants
|
3 Participants
n=9 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=87 Participants
|
5 Participants
n=13 Participants
|
5 Participants
n=13 Participants
|
4 Participants
n=13 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
2 Participants
n=205 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=87 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
6 Participants
n=205 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
1 Participants
n=391 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=87 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=13 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
13 Participants
n=205 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
1 Participants
n=5449 Participants
|
2 Participants
n=391 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=87 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=13 Participants
|
3 Participants
n=12 Participants
|
4 Participants
n=13 Participants
|
57 Participants
n=205 Participants
|
4 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=60 Participants
|
3 Participants
n=219 Participants
|
3 Participants
n=880 Participants
|
3 Participants
n=5449 Participants
|
4 Participants
n=391 Participants
|
3 Participants
n=9 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=87 Participants
|
5 Participants
n=13 Participants
|
5 Participants
n=13 Participants
|
5 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
2 Participants
n=205 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=87 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=13 Participants
|
4 Participants
n=12 Participants
|
4 Participants
n=13 Participants
|
72 Participants
n=205 Participants
|
4 Participants
n=30 Participants
|
5 Participants
n=30 Participants
|
4 Participants
n=60 Participants
|
4 Participants
n=219 Participants
|
3 Participants
n=880 Participants
|
4 Participants
n=5449 Participants
|
6 Participants
n=391 Participants
|
4 Participants
n=9 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=87 Participants
|
5 Participants
n=13 Participants
|
5 Participants
n=13 Participants
|
6 Participants
n=13 Participants
|
|
Weight (lb)
|
180.14 pounds
STANDARD_DEVIATION 31.39 • n=13 Participants
|
156.25 pounds
STANDARD_DEVIATION 39.02 • n=12 Participants
|
173.75 pounds
STANDARD_DEVIATION 28.48 • n=13 Participants
|
174.31 pounds
STANDARD_DEVIATION 40.51 • n=205 Participants
|
163.50 pounds
STANDARD_DEVIATION 24.61 • n=30 Participants
|
179.20 pounds
STANDARD_DEVIATION 60.40 • n=30 Participants
|
136.25 pounds
STANDARD_DEVIATION 18.08 • n=60 Participants
|
168.00 pounds
STANDARD_DEVIATION 36.12 • n=219 Participants
|
167.33 pounds
STANDARD_DEVIATION 8.96 • n=880 Participants
|
174.00 pounds
STANDARD_DEVIATION 8.04 • n=5449 Participants
|
188.33 pounds
STANDARD_DEVIATION 26.27 • n=391 Participants
|
182.00 pounds
STANDARD_DEVIATION 85.12 • n=9 Participants
|
203.50 pounds
STANDARD_DEVIATION 72.83 • n=3 Participants
|
169.60 pounds
STANDARD_DEVIATION 48.28 • n=87 Participants
|
175.80 pounds
STANDARD_DEVIATION 50.31 • n=13 Participants
|
182.60 pounds
STANDARD_DEVIATION 63.87 • n=13 Participants
|
183.17 pounds
STANDARD_DEVIATION 26.07 • n=13 Participants
|
|
Body Mass Index (BMI)
|
28.13 kg/m^2
STANDARD_DEVIATION 4.06 • n=13 Participants
|
26.82 kg/m^2
STANDARD_DEVIATION 7.47 • n=12 Participants
|
26.31 kg/m^2
STANDARD_DEVIATION 6.11 • n=13 Participants
|
28.46 kg/m^2
STANDARD_DEVIATION 7.92 • n=205 Participants
|
26.04 kg/m^2
STANDARD_DEVIATION 6.88 • n=30 Participants
|
29.30 kg/m^2
STANDARD_DEVIATION 9.29 • n=30 Participants
|
21.66 kg/m^2
STANDARD_DEVIATION 2.78 • n=60 Participants
|
26.22 kg/m^2
STANDARD_DEVIATION 6.37 • n=219 Participants
|
26.83 kg/m^2
STANDARD_DEVIATION 1.90 • n=880 Participants
|
29.72 kg/m^2
STANDARD_DEVIATION 2.57 • n=5449 Participants
|
33.01 kg/m^2
STANDARD_DEVIATION 8.74 • n=391 Participants
|
34.84 kg/m^2
STANDARD_DEVIATION 21.55 • n=9 Participants
|
32.33 kg/m^2
STANDARD_DEVIATION 15.22 • n=3 Participants
|
25.20 kg/m^2
STANDARD_DEVIATION 6.67 • n=87 Participants
|
30.49 kg/m^2
STANDARD_DEVIATION 8.37 • n=13 Participants
|
27.24 kg/m^2
STANDARD_DEVIATION 6.52 • n=13 Participants
|
30.24 kg/m^2
STANDARD_DEVIATION 4.22 • n=13 Participants
|
|
Physical Activity (MVPA)
|
203.14 min/wk
STANDARD_DEVIATION 188.81 • n=13 Participants
|
177.75 min/wk
STANDARD_DEVIATION 101.74 • n=12 Participants
|
221.00 min/wk
STANDARD_DEVIATION 27.29 • n=13 Participants
|
181.86 min/wk
STANDARD_DEVIATION 161.93 • n=205 Participants
|
173.25 min/wk
STANDARD_DEVIATION 37.69 • n=30 Participants
|
176.80 min/wk
STANDARD_DEVIATION 247.80 • n=30 Participants
|
73.25 min/wk
STANDARD_DEVIATION 63.89 • n=60 Participants
|
91.75 min/wk
STANDARD_DEVIATION 52.00 • n=219 Participants
|
395.67 min/wk
STANDARD_DEVIATION 143.83 • n=880 Participants
|
184.00 min/wk
STANDARD_DEVIATION 258.98 • n=5449 Participants
|
250.00 min/wk
STANDARD_DEVIATION 218.85 • n=391 Participants
|
200.25 min/wk
STANDARD_DEVIATION 150.93 • n=9 Participants
|
50.50 min/wk
STANDARD_DEVIATION 2.12 • n=3 Participants
|
280.00 min/wk
STANDARD_DEVIATION 195.54 • n=87 Participants
|
124.00 min/wk
STANDARD_DEVIATION 200.22 • n=13 Participants
|
152.00 min/wk
STANDARD_DEVIATION 106.84 • n=13 Participants
|
122.50 min/wk
STANDARD_DEVIATION 104.09 • n=13 Participants
|
|
Diet
|
53.34 Points
STANDARD_DEVIATION 9.96 • n=13 Participants
|
50.02 Points
STANDARD_DEVIATION 7.69 • n=12 Participants
|
48.30 Points
STANDARD_DEVIATION 15.05 • n=13 Participants
|
52.74 Points
STANDARD_DEVIATION 12.58 • n=205 Participants
|
46.55 Points
STANDARD_DEVIATION 15.21 • n=30 Participants
|
56.52 Points
STANDARD_DEVIATION 18.52 • n=30 Participants
|
39.52 Points
STANDARD_DEVIATION 9.13 • n=60 Participants
|
57.93 Points
STANDARD_DEVIATION 12.33 • n=219 Participants
|
64.93 Points
STANDARD_DEVIATION 3.81 • n=880 Participants
|
46.93 Points
STANDARD_DEVIATION 10.16 • n=5449 Participants
|
51.51 Points
STANDARD_DEVIATION 14.45 • n=391 Participants
|
54.26 Points
STANDARD_DEVIATION 12.95 • n=9 Participants
|
66.39 Points
STANDARD_DEVIATION 14.12 • n=3 Participants
|
57.53 Points
STANDARD_DEVIATION 9.58 • n=87 Participants
|
49.33 Points
STANDARD_DEVIATION 12.88 • n=13 Participants
|
54.51 Points
STANDARD_DEVIATION 14.79 • n=13 Participants
|
53.97 Points
STANDARD_DEVIATION 11.88 • n=13 Participants
|
PRIMARY outcome
Timeframe: End of study enrollment period (7 months).Population: Because this measure pertains to the study as a whole, the number of participants is not reported by arm.
Number of participants who agreed to participate divided by the number of months of recruitment.
Outcome measures
| Measure |
Condition 7
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 8
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 9
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 10
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 11
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 12
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 13
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 14
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 15
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 16
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Simplified Dietary Monitoring (Green)
n=83 Participants
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
|
Simplified Dietary Monitoring (Red)
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach
|
Nutrition Goals (Yes)
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
|
Nutrition Goals (No)
Participants will not be assigned a personalized weekly nutrition goal.
|
Supportive Text Messages (Yes)
Participants will receive up to 5 supportive text messages from the study staff per week.
|
Supportive Text Messages (No)
Participants will not receive supportive text messages.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Accrual Rate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
12 Participants per month
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: End of study enrollment period (7 months).Percentage of consented participants who were randomized.
Outcome measures
| Measure |
Condition 7
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 8
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 9
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 10
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 11
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 12
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 13
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 14
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 15
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 16
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Simplified Dietary Monitoring (Green)
n=83 Participants
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
|
Simplified Dietary Monitoring (Red)
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach
|
Nutrition Goals (Yes)
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
|
Nutrition Goals (No)
Participants will not be assigned a personalized weekly nutrition goal.
|
Supportive Text Messages (Yes)
Participants will receive up to 5 supportive text messages from the study staff per week.
|
Supportive Text Messages (No)
Participants will not receive supportive text messages.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Participation Rate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
72 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 monthsNumber of intervention participants who completed 3-month measures divided by the number randomized to intervention arms.
Outcome measures
| Measure |
Condition 7
n=6 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 8
n=4 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 9
n=2 Participants
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 10
n=5 Participants
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 11
n=5 Participants
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 12
n=5 Participants
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 13
n=6 Participants
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 14
n=7 Participants
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 15
n=4 Participants
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 16
n=4 Participants
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Simplified Dietary Monitoring (Green)
n=4 Participants
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
|
Simplified Dietary Monitoring (Red)
n=5 Participants
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach
|
Nutrition Goals (Yes)
n=4 Participants
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
|
Nutrition Goals (No)
n=4 Participants
Participants will not be assigned a personalized weekly nutrition goal.
|
Supportive Text Messages (Yes)
n=3 Participants
Participants will receive up to 5 supportive text messages from the study staff per week.
|
Supportive Text Messages (No)
n=4 Participants
Participants will not receive supportive text messages.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Retention Rate
|
6 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
6 Participants
|
7 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Among completers of the 12-week questionnaire
1-item measure; a benchmark of 80% of participants answering "somewhat" or "very" satisfied would indicate acceptability
Outcome measures
| Measure |
Condition 7
n=30 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 8
n=30 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 9
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 10
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 11
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 12
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 13
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 14
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 15
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 16
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Simplified Dietary Monitoring (Green)
n=30 Participants
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
|
Simplified Dietary Monitoring (Red)
n=30 Participants
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach
|
Nutrition Goals (Yes)
n=24 Participants
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
|
Nutrition Goals (No)
n=36 Participants
Participants will not be assigned a personalized weekly nutrition goal.
|
Supportive Text Messages (Yes)
n=31 Participants
Participants will receive up to 5 supportive text messages from the study staff per week.
|
Supportive Text Messages (No)
n=29 Participants
Participants will not receive supportive text messages.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Acceptability: How Satisfied Are You Overall With the Program You Received?
|
25 Participants
|
26 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
24 Participants
|
27 Participants
|
20 Participants
|
31 Participants
|
26 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Through study completion, 3 months.Number of days physical activity tracked, as measured by Fitbit.
Outcome measures
| Measure |
Condition 7
n=34 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 8
n=38 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 9
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 10
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 11
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 12
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 13
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 14
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 15
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 16
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Simplified Dietary Monitoring (Green)
n=34 Participants
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
|
Simplified Dietary Monitoring (Red)
n=38 Participants
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach
|
Nutrition Goals (Yes)
n=34 Participants
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
|
Nutrition Goals (No)
n=38 Participants
Participants will not be assigned a personalized weekly nutrition goal.
|
Supportive Text Messages (Yes)
n=36 Participants
Participants will receive up to 5 supportive text messages from the study staff per week.
|
Supportive Text Messages (No)
n=36 Participants
Participants will not receive supportive text messages.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Adherence to Physical Activity Monitoring.
|
81.5 Days
Interval 76.0 to 83.0
|
83 Days
Interval 60.0 to 84.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
81.5 Days
Inter-Quartile Range 21.0 • Interval 65.8 to 84.0
|
70.8 Days
Inter-Quartile Range 21.0 • Interval 66.5 to 83.0
|
79 Days
Inter-Quartile Range 25.1 • Interval 51.0 to 83.0
|
83 Days
Interval 77.2 to 84.0
|
83 Days
Interval 73.2 to 84.0
|
79 Days
Interval 58.8 to 83.2
|
SECONDARY outcome
Timeframe: Through study completion, 3 months.Number of days of complete dietary tracking.
Outcome measures
| Measure |
Condition 7
n=34 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 8
n=38 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 9
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 10
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 11
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 12
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 13
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 14
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 15
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 16
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Simplified Dietary Monitoring (Green)
n=34 Participants
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
|
Simplified Dietary Monitoring (Red)
n=38 Participants
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach
|
Nutrition Goals (Yes)
n=34 Participants
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
|
Nutrition Goals (No)
n=38 Participants
Participants will not be assigned a personalized weekly nutrition goal.
|
Supportive Text Messages (Yes)
n=36 Participants
Participants will receive up to 5 supportive text messages from the study staff per week.
|
Supportive Text Messages (No)
n=36 Participants
Participants will not receive supportive text messages.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Adherence to Diet Self-monitoring
|
48.5 Days
Interval 27.0 to 60.0
|
44.5 Days
Interval 6.75 to 60.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
43 Days
Interval 19.5 to 60.0
|
49.5 Days
Interval 17.0 to 61.5
|
39.5 Days
Interval 9.0 to 60.0
|
52 Days
Interval 27.2 to 59.8
|
52 Days
Interval 27.0 to 69.2
|
35 Days
Interval 8.5 to 57.0
|
SECONDARY outcome
Timeframe: Baseline, 3 months.Population: ITT: all randomized participants using all available MVPA data.
Estimated mean change in MVPA from baseline to 3 months for each of the two levels of each component obtained from intent-to-treat (ITT) linear mixed models of analysis of variance.
Outcome measures
| Measure |
Condition 7
n=34 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 8
n=38 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 9
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 10
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 11
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 12
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 13
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 14
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 15
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 16
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Simplified Dietary Monitoring (Green)
n=34 Participants
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
|
Simplified Dietary Monitoring (Red)
n=38 Participants
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach
|
Nutrition Goals (Yes)
n=34 Participants
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
|
Nutrition Goals (No)
n=38 Participants
Participants will not be assigned a personalized weekly nutrition goal.
|
Supportive Text Messages (Yes)
n=36 Participants
Participants will receive up to 5 supportive text messages from the study staff per week.
|
Supportive Text Messages (No)
n=36 Participants
Participants will not receive supportive text messages.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Moderate-to-vigorous Physical Activity (Objective)
|
69.23 min/wk
Interval -20.61 to 159.06
|
53.67 min/wk
Interval -33.31 to 140.65
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
52.78 min/wk
Interval -36.06 to 141.62
|
70.12 min/wk
Interval -16.1 to 156.33
|
69.70 min/wk
Interval -24.96 to 164.35
|
53.20 min/wk
Interval -28.21 to 134.61
|
75.94 min/wk
Interval -13.61 to 165.48
|
46.96 min/wk
Interval -40.23 to 134.16
|
SECONDARY outcome
Timeframe: Baseline, 3 months.Population: ITT: all randomized participants using all PPAQ data.
Change in physical activity from baseline to 3 months as measured using the Paffenbarger Physical Activity Questionnaire (PPAQ). The PPAQ assesses the amount of planned and lifestyle associated physical activity performed during a typical week. The PPAQ consists of three components: (1) stair climbing, (2) walking, and (3) sports and recreation. Participants report the frequency and duration of physical activity in the past week. PA Activities were classified as light, moderate, and vigorous based on their metabolic equivalent (MET) value and commonly used cut points. Moderate and vigorous activities were combined for self-reported minutes per week of MVPA. Range is 0 - no theoretical maximum.
Outcome measures
| Measure |
Condition 7
n=34 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 8
n=38 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 9
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 10
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 11
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 12
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 13
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 14
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 15
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 16
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Simplified Dietary Monitoring (Green)
n=34 Participants
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
|
Simplified Dietary Monitoring (Red)
n=38 Participants
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach
|
Nutrition Goals (Yes)
n=34 Participants
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
|
Nutrition Goals (No)
n=38 Participants
Participants will not be assigned a personalized weekly nutrition goal.
|
Supportive Text Messages (Yes)
n=36 Participants
Participants will receive up to 5 supportive text messages from the study staff per week.
|
Supportive Text Messages (No)
n=36 Participants
Participants will not receive supportive text messages.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Moderate-to-vigorous Physical Activity (Self-report)
|
58.67 min/wk
Interval 5.67 to 111.68
|
31.06 min/wk
Interval -19.7 to 81.81
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
55.60 min/wk
Interval 3.13 to 108.07
|
34.13 min/wk
Interval -17.03 to 85.29
|
50.97 min/wk
Interval -4.77 to 106.71
|
38.76 min/wk
Interval -9.53 to 87.05
|
47.36 min/wk
Interval -3.83 to 98.55
|
42.37 min/wk
Interval -10.18 to 94.92
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: ITT: all randomized participants using all available ASA24 data.
Dietary intake will be defined as the change in HEI score as measured by the NCI's Automated Self-Administered 24-hour (ASA 24-hour) dietary recalls from baseline to 3 months.The HEI consists of 13 component scores, including: total fruit, whole fruit, total protein foods, total vegetables, greens and beans, whole grains, dairy, seafood and plant proteins, fatty acids, sodium, refined grains, added sugars, and saturated fats. The summation of the 13 component scores ranges from 0 to 100, with higher scores indicating closer compliance with the Dietary Guidelines for Americans. Estimated mean change in HEI from baseline to 3 months for each of the two levels of each component obtained from intent-to-treat (ITT) linear mixed models of analysis of variance.
Outcome measures
| Measure |
Condition 7
n=34 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 8
n=38 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 9
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 10
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 11
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 12
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 13
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 14
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 15
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 16
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Simplified Dietary Monitoring (Green)
n=34 Participants
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
|
Simplified Dietary Monitoring (Red)
n=38 Participants
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach
|
Nutrition Goals (Yes)
n=34 Participants
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
|
Nutrition Goals (No)
n=38 Participants
Participants will not be assigned a personalized weekly nutrition goal.
|
Supportive Text Messages (Yes)
n=36 Participants
Participants will receive up to 5 supportive text messages from the study staff per week.
|
Supportive Text Messages (No)
n=36 Participants
Participants will not receive supportive text messages.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dietary Intake: Healthy Eating Index (HEI)
|
3.38 Points
Interval -1.04 to 7.8
|
1.59 Points
Interval -2.71 to 5.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.66 Points
Interval 0.29 to 9.02
|
0.32 Points
Interval -4.01 to 4.64
|
4.65 Points
Interval -0.05 to 9.35
|
0.32 Points
Interval -3.69 to 4.34
|
1.85 Points
Interval -2.39 to 6.09
|
3.13 Points
Interval -1.36 to 7.61
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: ITT: all randomized participants using all available weights.
Estimated mean weight change in kg from baseline to 3 months. More negative values of weight change indicate greater weight loss (3-month weight - baseline weight).
Outcome measures
| Measure |
Condition 7
n=34 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 8
n=38 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 9
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 10
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 11
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 12
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 13
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 14
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 15
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 16
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Simplified Dietary Monitoring (Green)
n=34 Participants
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
|
Simplified Dietary Monitoring (Red)
n=38 Participants
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach
|
Nutrition Goals (Yes)
n=34 Participants
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
|
Nutrition Goals (No)
n=38 Participants
Participants will not be assigned a personalized weekly nutrition goal.
|
Supportive Text Messages (Yes)
n=36 Participants
Participants will receive up to 5 supportive text messages from the study staff per week.
|
Supportive Text Messages (No)
n=36 Participants
Participants will not receive supportive text messages.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Weight (kg)
|
-2.23 pounds
Interval -4.28 to -0.18
|
-1.63 pounds
Interval -3.55 to 0.29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-1.47 pounds
Interval -3.44 to 0.51
|
-2.39 pounds
Interval -4.38 to -0.4
|
-1.26 pounds
Interval -3.4 to 0.87
|
-2.60 pounds
Interval -4.43 to -0.76
|
-2.32 pounds
Interval -4.27 to -0.36
|
-1.54 pounds
Interval -3.56 to 0.48
|
SECONDARY outcome
Timeframe: Baseline, 3 MonthsPopulation: All randomized were characterized by Frailty Status (Robust, Prefrail, Frail) at baseline and 3-months. At 3 months, NA = insufficient data for classification based on missing data.
The FRAIL Questionnaire includes five components that assess: 1) self-reported fatigue (PROMIS Fatigue Short form), 2) weight loss, 3) comorbidities (11 items from University of North Carolina Health Registry Comorbidity Assessment), 4) difficulty with ambulation (1 item from PROMIS Physical Function Short Form), and 5) ability to overcome resistance (1 item from PROMIS Physical Function)). The number of positive responses for these components is summed to create the FRAIL index (range 0-5) and characterized as "Frailty Status"; 0-1: robust, 2: prefrail, and 3+: frail. Changes in Frailty Status from baseline to 3 months will be assessed.
Outcome measures
| Measure |
Condition 7
n=34 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 8
n=38 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 9
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 10
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 11
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 12
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 13
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 14
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 15
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 16
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Simplified Dietary Monitoring (Green)
n=34 Participants
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
|
Simplified Dietary Monitoring (Red)
n=38 Participants
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach
|
Nutrition Goals (Yes)
n=34 Participants
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
|
Nutrition Goals (No)
n=38 Participants
Participants will not be assigned a personalized weekly nutrition goal.
|
Supportive Text Messages (Yes)
n=36 Participants
Participants will receive up to 5 supportive text messages from the study staff per week.
|
Supportive Text Messages (No)
n=36 Participants
Participants will not receive supportive text messages.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Fried Physical Frailty : FRAIL Index
Baseline Frailty Status · Robust
|
32 Participants
|
36 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
34 Participants
|
34 Participants
|
32 Participants
|
36 Participants
|
35 Participants
|
33 Participants
|
|
Fried Physical Frailty : FRAIL Index
Baseline Frailty Status · Prefrail
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Fried Physical Frailty : FRAIL Index
Baseline Frailty Status · Frail
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Fried Physical Frailty : FRAIL Index
Baseline Frailty Status · NA
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Fried Physical Frailty : FRAIL Index
3-Month Frailty Status · Robust
|
27 Participants
|
27 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
29 Participants
|
25 Participants
|
22 Participants
|
32 Participants
|
27 Participants
|
27 Participants
|
|
Fried Physical Frailty : FRAIL Index
3-Month Frailty Status · Prefrail
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
|
Fried Physical Frailty : FRAIL Index
3-Month Frailty Status · Frail
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Fried Physical Frailty : FRAIL Index
3-Month Frailty Status · NA
|
4 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
|
7 Participants
|
10 Participants
|
1 Participants
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Participants who completed the PROMIS measures at 3 months.
Changes in health-related quality of life from baseline to 3 months as measured using the Adolescent and Young Adult (AYA) PROMIS PRO Core Battery. These measures assess relevant HRQoL domains for AYA cancer survivors that are most likely to be impacted during and after cancer treatment. The AYA PRO Core battery includes the following PROMIS short forms: depression, anxiety, fatigue, physical function, pain interference, emotional support, and cognitive function. For each measure, each question has five responses ranging in value from 1 to 5, which are summed to find the total raw score. Total raw scores are translated to a T-score, standardized with a population mean of 50 and a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured.
Outcome measures
| Measure |
Condition 7
n=30 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 8
n=31 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 9
n=61 Participants
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 10
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 11
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 12
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 13
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 14
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 15
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 16
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Simplified Dietary Monitoring (Green)
n=30 Participants
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
|
Simplified Dietary Monitoring (Red)
n=31 Participants
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach
|
Nutrition Goals (Yes)
n=24 Participants
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
|
Nutrition Goals (No)
n=37 Participants
Participants will not be assigned a personalized weekly nutrition goal.
|
Supportive Text Messages (Yes)
n=32 Participants
Participants will receive up to 5 supportive text messages from the study staff per week.
|
Supportive Text Messages (No)
n=29 Participants
Participants will not receive supportive text messages.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Health-related Quality of Life: AYA PROMIS PRO Core Battery
Fatigue (PROMIS v1.0-Fatigue Short form 4a)
|
-2.64 T-score
Standard Deviation 10.8
|
-2.22 T-score
Standard Deviation 8.14
|
-2.42 T-score
Standard Deviation 9.46
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-4.26 T-score
Standard Deviation 9.64
|
-0.65 T-score
Standard Deviation 9.08
|
-3.28 T-score
Standard Deviation 7.34
|
-1.87 T-score
Standard Deviation 10.7
|
-3.45 T-score
Standard Deviation 9.67
|
-1.29 T-score
Standard Deviation 9.26
|
|
Health-related Quality of Life: AYA PROMIS PRO Core Battery
Depressive Symptoms (PROMIS v1.0-Depression Short Form 4a)
|
-1.70 T-score
Standard Deviation 7.71
|
1.42 T-score
Standard Deviation 7.71
|
-0.11 T-score
Standard Deviation 7.81
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.68 T-score
Standard Deviation 9.19
|
-1.85 T-score
Standard Deviation 5.83
|
1.72 T-score
Standard Deviation 9.87
|
-1.3 T-score
Standard Deviation 5.97
|
1.75 T-score
Standard Deviation 9.01
|
-2.17 T-score
Standard Deviation 5.68
|
|
Health-related Quality of Life: AYA PROMIS PRO Core Battery
Anxiety (PROMIS v1.0-Emotional Distress Anxiety Short Form 4a)
|
-1.41 T-score
Standard Deviation 8.89
|
-1.23 T-score
Standard Deviation 6.45
|
-1.32 T-score
Standard Deviation 7.68
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-1.50 T-score
Standard Deviation 7.53
|
-1.14 T-score
Standard Deviation 7.95
|
-0.83 T-score
Standard Deviation 9.24
|
-1.63 T-score
Standard Deviation 6.51
|
-1.76 T-score
Standard Deviation 6.28
|
-0.83 T-score
Standard Deviation 9.07
|
|
Health-related Quality of Life: AYA PROMIS PRO Core Battery
Physical Function (PROMIS v2.0 Physical Function Short Form 4a)
|
1.55 T-score
Standard Deviation 5.14
|
0.15 T-score
Standard Deviation 6.83
|
0.84 T-score
Standard Deviation 6.05
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.08 T-score
Standard Deviation 5.29
|
0.60 T-score
Standard Deviation 6.79
|
-0.86 T-score
Standard Deviation 6.28
|
1.94 T-score
Standard Deviation 5.71
|
0.25 T-score
Standard Deviation 4.78
|
1.49 T-score
Standard Deviation 7.23
|
|
Health-related Quality of Life: AYA PROMIS PRO Core Battery
Pain Interference (PROMIS v1.1 Pain Interference Short Form 4a)
|
1.85 T-score
Standard Deviation 4.92
|
4.12 T-score
Standard Deviation 6.98
|
3.00 T-score
Standard Deviation 6.11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3.37 T-score
Standard Deviation 6.12
|
2.65 T-score
Standard Deviation 6.19
|
3.30 T-score
Standard Deviation 5.45
|
2.81 T-score
Standard Deviation 6.57
|
3.16 T-score
Standard Deviation 6.61
|
2.83 T-score
Standard Deviation 5.62
|
|
Health-related Quality of Life: AYA PROMIS PRO Core Battery
Emotional Support (PROMIS v2.0 Emotional Support Short Form 4a)
|
-0.08 T-score
Standard Deviation 5.90
|
-1.91 T-score
Standard Deviation 5.93
|
-1.01 T-score
Standard Deviation 5.94
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-2.06 T-score
Standard Deviation 6.22
|
-0.003 T-score
Standard Deviation 5.57
|
-1.33 T-score
Standard Deviation 6.05
|
-0.81 T-score
Standard Deviation 5.94
|
-2.42 T-score
Standard Deviation 6.67
|
0.54 T-score
Standard Deviation 4.64
|
|
Health-related Quality of Life: AYA PROMIS PRO Core Battery
Cognitive Function (PROMIS v2.0 Cognitive Function Short Form 4a)
|
2.81 T-score
Standard Deviation 9.03
|
1.53 T-score
Standard Deviation 5.79
|
2.16 T-score
Standard Deviation 7.52
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.86 T-score
Standard Deviation 8.67
|
1.48 T-score
Standard Deviation 6.30
|
3.30 T-score
Standard Deviation 7.56
|
1.41 T-score
Standard Deviation 7.51
|
1.18 T-score
Standard Deviation 7.10
|
3.24 T-score
Standard Deviation 7.95
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Participants who completed the PROMIS measures at 3 months.
Changes in health-related quality of life from baseline to 3 months as measured using the Adolescent and Young Adult (AYA) PROMIS PRO Core Battery. Pain intensity was assessed with the 1-tiem PROMIS v1.0 pain intensity 1a, "In the past 7 days, how would you rate your pain on average?" Scored 0-10 from no pain to the worst imaginable pain.
Outcome measures
| Measure |
Condition 7
n=30 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 8
n=31 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 9
n=61 Participants
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 10
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 11
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 12
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 13
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 14
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 15
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 16
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Simplified Dietary Monitoring (Green)
n=30 Participants
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
|
Simplified Dietary Monitoring (Red)
n=31 Participants
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach
|
Nutrition Goals (Yes)
n=24 Participants
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
|
Nutrition Goals (No)
n=37 Participants
Participants will not be assigned a personalized weekly nutrition goal.
|
Supportive Text Messages (Yes)
n=32 Participants
Participants will receive up to 5 supportive text messages from the study staff per week.
|
Supportive Text Messages (No)
n=29 Participants
Participants will not receive supportive text messages.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Health-related Quality of Life: AYA PROMIS PRO Core Battery (Pain Intensity)
|
0.37 Score on scale
Standard Deviation 1.81
|
0.68 Score on scale
Standard Deviation 1.72
|
0.53 Score on scale
Standard Deviation 1.76
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.7 Score on scale
Standard Deviation 2.12
|
0.36 Score on scale
Standard Deviation 1.33
|
0.54 Score on scale
Standard Deviation 1.47
|
0.51 Score on scale
Standard Deviation 1.94
|
0.44 Score on scale
Standard Deviation 1.54
|
0.62 Score on scale
Standard Deviation 1.99
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Participants who completed the Perceived Competence Scales for Nutrition and Diet at 3 months
Changes in perceived competence from baseline to 3 months as measured using the Perceived Competence Scale. The Scale measures perceived competence for diet (4 items) and physical activity (4 items). Items are rated on a 7-point Likert scale (1 = not at all true, 7 = very true), and include items such as "I feel confident in my ability to maintain a healthy diet." Scores are summed for the items in the subscale (diet and physical activity) and the range for each subscale is 4 - 28. Greater values indicate higher levels of perceived competence for engaging in positive diet and physical activity behaviors. Scores are summed for the items in each subscale separately (diet and physical activity). Outcomes are change in perceived competence for diet and change in perceived competence.
Outcome measures
| Measure |
Condition 7
n=30 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 8
n=31 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 9
n=61 Participants
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 10
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 11
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 12
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 13
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 14
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 15
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 16
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Simplified Dietary Monitoring (Green)
n=30 Participants
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
|
Simplified Dietary Monitoring (Red)
n=31 Participants
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach
|
Nutrition Goals (Yes)
n=24 Participants
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
|
Nutrition Goals (No)
n=37 Participants
Participants will not be assigned a personalized weekly nutrition goal.
|
Supportive Text Messages (Yes)
n=32 Participants
Participants will receive up to 5 supportive text messages from the study staff per week.
|
Supportive Text Messages (No)
n=29 Participants
Participants will not receive supportive text messages.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Competence for Exercise and Nutrition
Perceived Competence for Exercise
|
0.9 Score on scale
Standard Deviation 5.51
|
-1.90 Score on scale
Standard Deviation 4.74
|
-0.53 Score on scale
Standard Deviation 5.28
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.6 Score on scale
Standard Deviation 6.15
|
-1.61 Score on scale
Standard Deviation 4.09
|
-1.38 Score on scale
Standard Deviation 5.52
|
0.027 Score on scale
Standard Deviation 5.12
|
-1.28 Score on scale
Standard Deviation 5.13
|
0.31 Score on scale
Standard Deviation 5.41
|
|
Competence for Exercise and Nutrition
Perceived Competence for Nutrition
|
1.53 Score on scale
Standard Deviation 3.14
|
-0.42 Score on scale
Standard Deviation 4.20
|
0.54 Score on scale
Standard Deviation 3.81
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.13 Score on scale
Standard Deviation 4.49
|
-0.03 Score on scale
Standard Deviation 2.98
|
0.54 Score on scale
Standard Deviation 4.53
|
0.54 Score on scale
Standard Deviation 3.34
|
0.28 Score on scale
Standard Deviation 4.11
|
0.83 Score on scale
Standard Deviation 3.51
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Participants who completed the Self-efficacy Scale for Exercise and Diet at 3 months.
Changes in self-efficacy from baseline to 3 months as measured using the Nutrition and Physical Activity Self-Efficacy Scale, a 10-items measured on a 4-point Likert scale that assesses an individual's confidence (where where 1 is 'very uncertain' to 4 'very certain') with in their ability to eat healthy foods (5 items) and exercise (5 items) in the presence of barriers. Self-efficacy for each behavior is calculated as the sum of the 5 Likert-type responses with a range of 5-20 for each subscale. Higher values indicate higher levels of self-efficacy for the behavior. Outcomes are changes in self-eficacy for exercise and self-efficacy for nutrition from baseline to 3 months.
Outcome measures
| Measure |
Condition 7
n=30 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 8
n=31 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 9
n=61 Participants
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 10
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 11
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 12
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 13
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 14
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 15
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 16
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Simplified Dietary Monitoring (Green)
n=30 Participants
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
|
Simplified Dietary Monitoring (Red)
n=31 Participants
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach
|
Nutrition Goals (Yes)
n=24 Participants
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
|
Nutrition Goals (No)
n=37 Participants
Participants will not be assigned a personalized weekly nutrition goal.
|
Supportive Text Messages (Yes)
n=32 Participants
Participants will receive up to 5 supportive text messages from the study staff per week.
|
Supportive Text Messages (No)
n=29 Participants
Participants will not receive supportive text messages.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Self-efficacy for Exercise and Nutrition
Self-efficacy for Exercise
|
-0.27 Score on scale
Standard Deviation 2.72
|
0.03 Score on scale
Standard Deviation 3.59
|
-0.12 Score on scale
Standard Deviation 3.17
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-0.3 Score on scale
Standard Deviation 3.80
|
0.06 Score on scale
Standard Deviation 2.46
|
0.58 Score on scale
Standard Deviation 3.71
|
-0.57 Score on scale
Standard Deviation 2.72
|
0 Score on scale
Standard Deviation 3.34
|
-0.24 Score on scale
Standard Deviation 3.02
|
|
Self-efficacy for Exercise and Nutrition
Self-efficacy for Nutrition
|
0.53 Score on scale
Standard Deviation 2.43
|
0.58 Score on scale
Standard Deviation 3.01
|
0.56 Score on scale
Standard Deviation 2.72
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.73 Score on scale
Standard Deviation 2.94
|
0.39 Score on scale
Standard Deviation 2.53
|
0.71 Score on scale
Standard Deviation 2.74
|
0.46 Score on scale
Standard Deviation 2.73
|
1.25 Score on scale
Standard Deviation 2.83
|
-0.21 Score on scale
Standard Deviation 2.41
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Participants who completed the Treatment Self-Regulation Questionnaire (TSRQ) for Exercise and Diet at 3 months.
Changes in self-regulation from baseline to 3 months as measured using the Treatment Self-Regulation Questionnaire (TSRQ). The TSRQ assesses autonomous and controlled motivation for making changes in diet (15 items) and physical activity (15 items). Ratings are on a 7-point Likert scale indicating agreement with statements regarding motivation for behavior change. Examples item: "Because I feel that I want to take responsibility for my own health" answered on a scale of 1 (not at all true) to 7 (very true)." Calculating the scores for the sub-scales will consist of averaging the items on that subscale. Responses to the items within the subscale are averaged with the range of scores being 1 to 7. Higher values on each subscale indicate greater levels of that type of motivation. Outcomes are changes in autonomous and controlled motivation for exercise and diet at 3 months.
Outcome measures
| Measure |
Condition 7
n=30 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 8
n=31 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 9
n=61 Participants
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 10
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 11
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 12
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 13
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 14
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 15
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 16
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Simplified Dietary Monitoring (Green)
n=30 Participants
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
|
Simplified Dietary Monitoring (Red)
n=31 Participants
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach
|
Nutrition Goals (Yes)
n=24 Participants
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
|
Nutrition Goals (No)
n=37 Participants
Participants will not be assigned a personalized weekly nutrition goal.
|
Supportive Text Messages (Yes)
n=32 Participants
Participants will receive up to 5 supportive text messages from the study staff per week.
|
Supportive Text Messages (No)
n=29 Participants
Participants will not receive supportive text messages.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Self-Regulation for Exercise and Nutrition
Autonomous Motivation for Exercise
|
-0.04 Score on scale
Standard Deviation 0.76
|
-0.11 Score on scale
Standard Deviation 0.85
|
-0.07 Score on scale
Standard Deviation 0.80
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-0.06 Score on scale
Standard Deviation 0.85
|
-0.09 Score on scale
Standard Deviation 0.761
|
-0.17 Score on scale
Standard Deviation 0.87
|
-0.014 Score on scale
Standard Deviation 0.76
|
0.04 Score on scale
Standard Deviation 0.88
|
-0.20 Score on scale
Standard Deviation 0.70
|
|
Self-Regulation for Exercise and Nutrition
Autonomous Motivation for Diet
|
-0.03 Score on scale
Standard Deviation 0.53
|
-0.02 Score on scale
Standard Deviation 1.0
|
-0.02 Score on scale
Standard Deviation 0.80
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-0.07 Score on scale
Standard Deviation 0.88
|
0.02 Score on scale
Standard Deviation 0.71
|
-0.11 Score on scale
Standard Deviation 0.89
|
0.04 Score on scale
Standard Deviation 0.74
|
-0.05 Score on scale
Standard Deviation 1.01
|
0.006 Score on scale
Standard Deviation 0.48
|
|
Self-Regulation for Exercise and Nutrition
Externally Controlled Motivation for Exercise
|
0.44 Score on scale
Standard Deviation 0.82
|
-0.07 Score on scale
Standard Deviation 0.88
|
0.19 Score on scale
Standard Deviation 0.88
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-0.01 Score on scale
Standard Deviation 0.61
|
0.38 Score on scale
Standard Deviation 1.05
|
0.05 Score on scale
Standard Deviation 1.04
|
0.28 Score on scale
Standard Deviation 0.76
|
0.14 Score on scale
Standard Deviation 0.95
|
0.24 Score on scale
Standard Deviation 0.81
|
|
Self-Regulation for Exercise and Nutrition
Externally Controlled Motivation for Diet
|
0.12 Score on scale
Standard Deviation 0.80
|
0.15 Score on scale
Standard Deviation 1.10
|
0.14 Score on scale
Standard Deviation 0.96
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Score on scale
Standard Deviation 0.96
|
0.27 Score on scale
Standard Deviation 0.95
|
-0.13 Score on scale
Standard Deviation 0.89
|
0.31 Score on scale
Standard Deviation 0.97
|
0.03 Score on scale
Standard Deviation 1.12
|
0.26 Score on scale
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Participants who completed the Virtual Care Climate Questionnaire (VCCQ) at 3 months.
Changes in perceived autonomy support from baseline to 3 months as measured using the Virtual Care Climate Questionnaire (VCCQ) a 15-item measure of perceived support for autonomy provided by the study team in a virtual care setting. Ratings are on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). Responses are averaged with a range of 1 to 7. Higher scores indicate a higher level of perceived autonomy support in a virtual setting.
Outcome measures
| Measure |
Condition 7
n=30 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 8
n=30 Participants
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 9
n=60 Participants
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 10
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 11
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 12
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 13
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 14
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 15
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 16
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Simplified Dietary Monitoring (Green)
n=30 Participants
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
|
Simplified Dietary Monitoring (Red)
n=30 Participants
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach
|
Nutrition Goals (Yes)
n=24 Participants
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
|
Nutrition Goals (No)
n=36 Participants
Participants will not be assigned a personalized weekly nutrition goal.
|
Supportive Text Messages (Yes)
n=31 Participants
Participants will receive up to 5 supportive text messages from the study staff per week.
|
Supportive Text Messages (No)
n=29 Participants
Participants will not receive supportive text messages.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Autonomy Support
|
5.07 Score on scale
Standard Deviation 1.18
|
4.75 Score on scale
Standard Deviation 0.98
|
4.91 Score on scale
Standard Deviation 1.09
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.98 Score on scale
Standard Deviation 1.06
|
4.84 Score on scale
Standard Deviation 1.13
|
4.59 Score on scale
Standard Deviation 0.89
|
5.12 Score on scale
Standard Deviation 1.16
|
4.97 Score on scale
Standard Deviation 1.24
|
4.85 Score on scale
Standard Deviation 0.92
|
Adverse Events
Condition 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Condition 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Condition 3
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Condition 5
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Condition 6
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Condition 7
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Condition 8
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Condition 9
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Condition 10
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Condition 11
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Condition 12
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Condition 13
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Condition 14
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Condition 15
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Condition 16
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Condition 1
n=4 participants at risk
Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 2
n=5 participants at risk
Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 3
n=4 participants at risk
Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 4
n=4 participants at risk
Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 5
n=3 participants at risk
Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 6
n=4 participants at risk
Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 7
n=6 participants at risk
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 8
n=4 participants at risk
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 9
n=2 participants at risk
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 10
n=5 participants at risk
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 11
n=5 participants at risk
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 12
n=5 participants at risk
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 13
n=6 participants at risk
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 14
n=7 participants at risk
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 15
n=4 participants at risk
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 16
n=4 participants at risk
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Bowel Obstruction
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
25.0%
1/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/3 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/2 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/7 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
Other adverse events
| Measure |
Condition 1
n=4 participants at risk
Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 2
n=5 participants at risk
Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 3
n=4 participants at risk
Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 4
n=4 participants at risk
Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 5
n=3 participants at risk
Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 6
n=4 participants at risk
Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 7
n=6 participants at risk
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 8
n=4 participants at risk
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 9
n=2 participants at risk
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 10
n=5 participants at risk
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 11
n=5 participants at risk
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 12
n=5 participants at risk
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
Condition 13
n=6 participants at risk
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
|
Condition 14
n=7 participants at risk
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
|
Condition 15
n=4 participants at risk
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
|
Condition 16
n=4 participants at risk
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
PVCs
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/3 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/2 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
20.0%
1/5 • Number of events 1 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/7 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
|
Injury, poisoning and procedural complications
Motor vehicle accident
|
0.00%
0/4 • Up to 3 months
|
20.0%
1/5 • Number of events 1 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/3 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/2 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/7 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
|
Musculoskeletal and connective tissue disorders
Throbbing back and hip pain
|
0.00%
0/4 • Up to 3 months
|
20.0%
1/5 • Number of events 1 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/3 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/2 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/7 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
25.0%
1/4 • Number of events 1 • Up to 3 months
|
0.00%
0/3 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/2 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/7 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
|
Musculoskeletal and connective tissue disorders
Tendonitis in shoulder
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
25.0%
1/4 • Number of events 1 • Up to 3 months
|
0.00%
0/3 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/2 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/7 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
|
Musculoskeletal and connective tissue disorders
Stress injury in tibia
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/3 • Up to 3 months
|
25.0%
1/4 • Number of events 1 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/2 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/7 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
|
General disorders
Bruised/cracked rib from bronchitis
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/3 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/2 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/7 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
25.0%
1/4 • Number of events 1 • Up to 3 months
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/3 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/2 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
28.6%
2/7 • Number of events 2 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
|
General disorders
Headaches and neck pain
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/3 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/2 • Up to 3 months
|
20.0%
1/5 • Number of events 1 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/7 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
|
Musculoskeletal and connective tissue disorders
Pulled out lower back, neck, and shoulder pain
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/3 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
16.7%
1/6 • Number of events 1 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/2 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/7 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
|
Blood and lymphatic system disorders
Lymphadema flare
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/3 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/2 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
20.0%
1/5 • Number of events 1 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/7 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
|
Reproductive system and breast disorders
Debilitating menstrual cramps
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/3 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/2 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
20.0%
1/5 • Number of events 1 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/7 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
|
Musculoskeletal and connective tissue disorders
Tweaked IT band
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
33.3%
1/3 • Number of events 1 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/2 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/7 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
|
Nervous system disorders
Migraine
|
25.0%
1/4 • Number of events 1 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/3 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/2 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/7 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
25.0%
1/4 • Number of events 1 • Up to 3 months
|
|
Musculoskeletal and connective tissue disorders
Bruised hip
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/3 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/2 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
14.3%
1/7 • Number of events 1 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
|
Musculoskeletal and connective tissue disorders
Twisted ankle
|
25.0%
1/4 • Number of events 1 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/3 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/2 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/7 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus infection/sinusitis
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/3 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
25.0%
1/4 • Number of events 1 • Up to 3 months
|
0.00%
0/2 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/7 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Covid, cold, flu, viral illness
|
25.0%
1/4 • Number of events 1 • Up to 3 months
|
20.0%
1/5 • Number of events 1 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
25.0%
1/4 • Number of events 1 • Up to 3 months
|
33.3%
1/3 • Number of events 1 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
25.0%
1/4 • Number of events 1 • Up to 3 months
|
50.0%
1/2 • Number of events 1 • Up to 3 months
|
40.0%
2/5 • Number of events 2 • Up to 3 months
|
20.0%
1/5 • Number of events 1 • Up to 3 months
|
40.0%
2/5 • Number of events 2 • Up to 3 months
|
50.0%
3/6 • Number of events 3 • Up to 3 months
|
14.3%
1/7 • Number of events 1 • Up to 3 months
|
25.0%
1/4 • Number of events 1 • Up to 3 months
|
50.0%
2/4 • Number of events 2 • Up to 3 months
|
|
Cardiac disorders
Low blood pressure
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/3 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
25.0%
1/4 • Number of events 1 • Up to 3 months
|
0.00%
0/2 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/7 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
|
Cardiac disorders
Racing heartbeat
|
0.00%
0/4 • Up to 3 months
|
20.0%
1/5 • Number of events 1 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/3 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/2 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/5 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
0.00%
0/7 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
0.00%
0/4 • Up to 3 months
|
Additional Information
Dr. Erin Coffman
University of North Carolina at Chapel Hill
Phone: 9195254677
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place