Trial Outcomes & Findings for Balanced Lifestyle for Undergraduate Excellence - Mobile (Project BLUEM) (NCT NCT04105725)
NCT ID: NCT04105725
Last Updated: 2022-06-14
Results Overview
Change in past-month typical weekly alcohol use
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
Baseline, 3-month follow-up
Results posted on
2022-06-14
Participant Flow
Participant milestones
| Measure |
BMI+Substance-Free Activity Session
Two 50-minute text messaging sessions that discuss alcohol use and experiences related to alcohol use, as well as the individual's college, career, and personal goals. Additionally, there are 4 weeks of 20-30-minute booster text messaging sessions (once a week) that return to the individual's goals and progress.
Brief Motivational Intervention+Substance-Free Activity Session: A dialogue with the individual of their own experiences with alcohol use and related problems, as well as academic/career goals and personal interests.
|
Alcohol + Nutrition Education Session
Two 50-minute text messaging sessions the provide information on alcohol and nutrition. Additionally, there are 4 weeks of 20-30-minute booster text messaging sessions (once a week) that provide additional information and review previous information about alcohol use and nutrition.
Alcohol + Nutrition Education Session: Education on alcohol, alcohol metabolism in the body, and alcohol overdose, as well as education on food groups and recommendations for a balanced diet.
|
|---|---|---|
|
Primary Intervention
STARTED
|
37
|
29
|
|
Primary Intervention
COMPLETED
|
37
|
26
|
|
Primary Intervention
NOT COMPLETED
|
0
|
3
|
|
Mini-Session Week 1
STARTED
|
37
|
26
|
|
Mini-Session Week 1
COMPLETED
|
36
|
25
|
|
Mini-Session Week 1
NOT COMPLETED
|
1
|
1
|
|
Mini-Session Week 2
STARTED
|
37
|
26
|
|
Mini-Session Week 2
COMPLETED
|
34
|
22
|
|
Mini-Session Week 2
NOT COMPLETED
|
3
|
4
|
|
Mini-Session Week 3
STARTED
|
37
|
26
|
|
Mini-Session Week 3
COMPLETED
|
34
|
22
|
|
Mini-Session Week 3
NOT COMPLETED
|
3
|
4
|
|
Mini-Session Week 4
STARTED
|
37
|
26
|
|
Mini-Session Week 4
COMPLETED
|
35
|
21
|
|
Mini-Session Week 4
NOT COMPLETED
|
2
|
5
|
|
Post-Intervention Survey
STARTED
|
37
|
26
|
|
Post-Intervention Survey
COMPLETED
|
33
|
18
|
|
Post-Intervention Survey
NOT COMPLETED
|
4
|
8
|
|
3-Month Follow-up Survey
STARTED
|
37
|
26
|
|
3-Month Follow-up Survey
COMPLETED
|
33
|
22
|
|
3-Month Follow-up Survey
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
BMI+Substance-Free Activity Session
Two 50-minute text messaging sessions that discuss alcohol use and experiences related to alcohol use, as well as the individual's college, career, and personal goals. Additionally, there are 4 weeks of 20-30-minute booster text messaging sessions (once a week) that return to the individual's goals and progress.
Brief Motivational Intervention+Substance-Free Activity Session: A dialogue with the individual of their own experiences with alcohol use and related problems, as well as academic/career goals and personal interests.
|
Alcohol + Nutrition Education Session
Two 50-minute text messaging sessions the provide information on alcohol and nutrition. Additionally, there are 4 weeks of 20-30-minute booster text messaging sessions (once a week) that provide additional information and review previous information about alcohol use and nutrition.
Alcohol + Nutrition Education Session: Education on alcohol, alcohol metabolism in the body, and alcohol overdose, as well as education on food groups and recommendations for a balanced diet.
|
|---|---|---|
|
Primary Intervention
Lost to Follow-up
|
0
|
2
|
|
Primary Intervention
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Balanced Lifestyle for Undergraduate Excellence - Mobile (Project BLUEM)
Baseline characteristics by cohort
| Measure |
BMI+Substance-Free Activity Session
n=37 Participants
Two 50-minute text messaging sessions that discuss alcohol use and experiences related to alcohol use, as well as the individual's college, career, and personal goals. Additionally, there are 4 weeks of 20-30-minute booster text messaging sessions (once a week) that return to the individual's goals and progress.
Brief Motivational Intervention+Substance-Free Activity Session: A dialogue with the individual of their own experiences with alcohol use and related problems, as well as academic/career goals and personal interests.
|
Alcohol + Nutrition Education Session
n=29 Participants
Two 50-minute text messaging sessions the provide information on alcohol and nutrition. Additionally, there are 4 weeks of 20-30-minute booster text messaging sessions (once a week) that provide additional information and review previous information about alcohol use and nutrition.
Alcohol + Nutrition Education Session: Education on alcohol, alcohol metabolism in the body, and alcohol overdose, as well as education on food groups and recommendations for a balanced diet.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.19 years
STANDARD_DEVIATION 1.63 • n=99 Participants
|
19.66 years
STANDARD_DEVIATION 1.67 • n=107 Participants
|
19.95 years
STANDARD_DEVIATION 1.66 • n=206 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=99 Participants
|
29 participants
n=107 Participants
|
66 participants
n=206 Participants
|
|
Daily Drinking Questionnaire
|
4.30 heavy drinking episodes (past month)
STANDARD_DEVIATION 3.66 • n=99 Participants
|
4.59 heavy drinking episodes (past month)
STANDARD_DEVIATION 3.55 • n=107 Participants
|
4.42 heavy drinking episodes (past month)
STANDARD_DEVIATION 3.59 • n=206 Participants
|
|
Brief Young Adult Alcohol Consequences Questionnaire
|
8.57 # of consequences endorsed (past month)
STANDARD_DEVIATION 5.63 • n=99 Participants
|
8.28 # of consequences endorsed (past month)
STANDARD_DEVIATION 5.69 • n=107 Participants
|
8.44 # of consequences endorsed (past month)
STANDARD_DEVIATION 5.62 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3-month follow-upChange in past-month typical weekly alcohol use
Outcome measures
| Measure |
BMI+Substance-Free Activity Session
n=31 Participants
Two 50-minute text messaging sessions that discuss alcohol use and experiences related to alcohol use, as well as the individual's college, career, and personal goals. Additionally, there are 4 weeks of 20-30-minute booster text messaging sessions (once a week) that return to the individual's goals and progress.
Brief Motivational Intervention+Substance-Free Activity Session: A dialogue with the individual of their own experiences with alcohol use and related problems, as well as academic/career goals and personal interests.
|
Alcohol + Nutrition Education Session
n=20 Participants
Two 50-minute text messaging sessions the provide information on alcohol and nutrition. Additionally, there are 4 weeks of 20-30-minute booster text messaging sessions (once a week) that provide additional information and review previous information about alcohol use and nutrition.
Alcohol + Nutrition Education Session: Education on alcohol, alcohol metabolism in the body, and alcohol overdose, as well as education on food groups and recommendations for a balanced diet.
|
|---|---|---|
|
Daily Drinking Questionnaire
|
7.43 drinks per week
Standard Error 0.85
|
8.11 drinks per week
Standard Error 1.50
|
PRIMARY outcome
Timeframe: Baseline, 3-month follow-upChange in past-month heavy drinking episodes
Outcome measures
| Measure |
BMI+Substance-Free Activity Session
n=31 Participants
Two 50-minute text messaging sessions that discuss alcohol use and experiences related to alcohol use, as well as the individual's college, career, and personal goals. Additionally, there are 4 weeks of 20-30-minute booster text messaging sessions (once a week) that return to the individual's goals and progress.
Brief Motivational Intervention+Substance-Free Activity Session: A dialogue with the individual of their own experiences with alcohol use and related problems, as well as academic/career goals and personal interests.
|
Alcohol + Nutrition Education Session
n=20 Participants
Two 50-minute text messaging sessions the provide information on alcohol and nutrition. Additionally, there are 4 weeks of 20-30-minute booster text messaging sessions (once a week) that provide additional information and review previous information about alcohol use and nutrition.
Alcohol + Nutrition Education Session: Education on alcohol, alcohol metabolism in the body, and alcohol overdose, as well as education on food groups and recommendations for a balanced diet.
|
|---|---|---|
|
Heavy Episodic (Binge) Drinking
|
2.73 past month heavy drinking episodes
Standard Error 0.54
|
4.04 past month heavy drinking episodes
Standard Error 0.83
|
PRIMARY outcome
Timeframe: Baseline, 3-month follow-upChange in past-month alcohol-related problems
Outcome measures
| Measure |
BMI+Substance-Free Activity Session
n=31 Participants
Two 50-minute text messaging sessions that discuss alcohol use and experiences related to alcohol use, as well as the individual's college, career, and personal goals. Additionally, there are 4 weeks of 20-30-minute booster text messaging sessions (once a week) that return to the individual's goals and progress.
Brief Motivational Intervention+Substance-Free Activity Session: A dialogue with the individual of their own experiences with alcohol use and related problems, as well as academic/career goals and personal interests.
|
Alcohol + Nutrition Education Session
n=19 Participants
Two 50-minute text messaging sessions the provide information on alcohol and nutrition. Additionally, there are 4 weeks of 20-30-minute booster text messaging sessions (once a week) that provide additional information and review previous information about alcohol use and nutrition.
Alcohol + Nutrition Education Session: Education on alcohol, alcohol metabolism in the body, and alcohol overdose, as well as education on food groups and recommendations for a balanced diet.
|
|---|---|---|
|
Brief Young Adult Alcohol Consequences Questionnaire
|
5.89 past month alcohol-related problems
Standard Error 0.89
|
5.13 past month alcohol-related problems
Standard Error 0.89
|
SECONDARY outcome
Timeframe: Baseline, 5-week follow-up, 3-month follow-upChange in substance-free reinforcement
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 1-week follow-up, 2-week follow-up, 3-week follow-up, 4-week follow-up, 5-week follow-up, 3-month follow-upChange in delay discounting
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 1-week follow-up, 2-week follow-up, 3-week follow-up, 4-week follow-up, 5-week follow-up, 3-month follow-upChange in reinforcing efficacy (reward value) of alcohol
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 1-week follow-up, 2-week follow-up, 3-week follow-up, 4-week follow-up, 5-week follow-up, 3-month follow-upChange in substance-free reinforcement
Outcome measures
Outcome data not reported
Adverse Events
BMI+Substance-Free Activity Session
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Alcohol + Nutrition Education Session
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place