Trial Outcomes & Findings for Motivational Interviewing to Promote Healthy Behaviours in Young Adults (NCT NCT05264740)
NCT ID: NCT05264740
Last Updated: 2025-05-18
Results Overview
% of eligible participants who are recruited from all those who contact the research team to learn about the study
COMPLETED
NA
101 participants
At recruitment, over 6 months.
2025-05-18
Participant Flow
Participant milestones
| Measure |
Motivational Interviewing
Motivational interviewing: The intervention group will receive motivational interviewing sessions with a trained study team member plus educational material
|
no Motivational Interviewing
Educational materials: The control group will receive educational material only.
|
|---|---|---|
|
Baseline
STARTED
|
52
|
49
|
|
Baseline
COMPLETED
|
52
|
48
|
|
Baseline
NOT COMPLETED
|
0
|
1
|
|
Follow Up 1
STARTED
|
52
|
48
|
|
Follow Up 1
COMPLETED
|
51
|
46
|
|
Follow Up 1
NOT COMPLETED
|
1
|
2
|
|
Follow Up 2
STARTED
|
51
|
46
|
|
Follow Up 2
COMPLETED
|
50
|
42
|
|
Follow Up 2
NOT COMPLETED
|
1
|
4
|
|
Follow Up 3
STARTED
|
50
|
42
|
|
Follow Up 3
COMPLETED
|
43
|
38
|
|
Follow Up 3
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
| Measure |
Motivational Interviewing
Motivational interviewing: The intervention group will receive motivational interviewing sessions with a trained study team member plus educational material
|
no Motivational Interviewing
Educational materials: The control group will receive educational material only.
|
|---|---|---|
|
Baseline
Withdrawal by Subject
|
0
|
1
|
|
Follow Up 1
Lost to Follow-up
|
1
|
1
|
|
Follow Up 1
Withdrawal by Subject
|
0
|
1
|
|
Follow Up 2
Lost to Follow-up
|
1
|
4
|
|
Follow Up 3
Lost to Follow-up
|
7
|
4
|
Baseline Characteristics
Motivational Interviewing to Promote Healthy Behaviours in Young Adults
Baseline characteristics by cohort
| Measure |
Motivational Interviewing
n=52 Participants
Motivational interviewing: The intervention group will receive motivational interviewing sessions with a trained study team member plus educational material
|
no Motivational Interviewing
n=48 Participants
Educational materials: The control group will receive educational material only.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.8 years
STANDARD_DEVIATION 3.49 • n=99 Participants
|
23 years
STANDARD_DEVIATION 3.61 • n=107 Participants
|
22.2 years
STANDARD_DEVIATION 3.56 • n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Southeast Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
South Asian
|
18 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
10 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Body Mass Index
|
24.6 kg/m²
STANDARD_DEVIATION 4.43 • n=99 Participants
|
25.6 kg/m²
STANDARD_DEVIATION 5.27 • n=107 Participants
|
25.1 kg/m²
STANDARD_DEVIATION 4.85 • n=206 Participants
|
PRIMARY outcome
Timeframe: At recruitment, over 6 months.% of eligible participants who are recruited from all those who contact the research team to learn about the study
Outcome measures
| Measure |
Recruitment
n=118 Participants
All participants screened for eligibility.
|
no Motivational Interviewing
Educational materials: The control group will receive educational material only.
|
|---|---|---|
|
Recruitment Rate
|
101 Participants
|
—
|
PRIMARY outcome
Timeframe: from 0 to 6 months% of participants who complete 6-month follow-up
Outcome measures
| Measure |
Recruitment
n=52 Participants
All participants screened for eligibility.
|
no Motivational Interviewing
n=49 Participants
Educational materials: The control group will receive educational material only.
|
|---|---|---|
|
Retention Rate
|
43 participants
|
38 participants
|
PRIMARY outcome
Timeframe: At 6 monthsNumber of participants with no missing data on clinical outcomes
Outcome measures
| Measure |
Recruitment
n=52 Participants
All participants screened for eligibility.
|
no Motivational Interviewing
n=49 Participants
Educational materials: The control group will receive educational material only.
|
|---|---|---|
|
Data Completion
|
48 Participants
|
45 Participants
|
PRIMARY outcome
Timeframe: At 6 monthsPopulation: All participants who completed the study.
Satisfaction was measured using a single-item question: "How satisfied are you with this research study?" Responses were collected on a 5-point Likert scale with the following options: 1. = Highly Dissatisfied 2. = Dissatisfied 3. = Neither Satisfied nor Dissatisfied 4. = Satisfied 5. = Highly Satisfied Mean scores were calculated, with higher scores indicating greater satisfaction.
Outcome measures
| Measure |
Recruitment
n=43 Participants
All participants screened for eligibility.
|
no Motivational Interviewing
n=38 Participants
Educational materials: The control group will receive educational material only.
|
|---|---|---|
|
Study Satisfaction
|
3.8 units on a scale
Standard Deviation 1.02
|
3.9 units on a scale
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: Change from 0 to 6 monthsPopulation: Discrepancy in Overall Number Analyzed due to missing data.
Change in BMI from baseline to 6-month follow-up
Outcome measures
| Measure |
Recruitment
n=46 Participants
All participants screened for eligibility.
|
no Motivational Interviewing
n=42 Participants
Educational materials: The control group will receive educational material only.
|
|---|---|---|
|
Body Mass Index (BMI) Change
|
-0.3 kg/m²
Standard Deviation 0.89
|
-0.5 kg/m²
Standard Deviation 1.52
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: Data from the IPAQ were available for 81 participants. Two participants in the control group had missing responses for the vigorous activity question, and two had missing responses for the moderate activity question. All participants in the intervention group completed both items.
Minutes per day from activity trackers and International Physical Activity Questionnaire (IPAQ).Participants self-reported the number of days per week they engaged in moderate and vigorous physical activity using items adapted from the International Physical Activity Questionnaire (IPAQ). Responses ranged from 0 to 7 days per week for each activity type.
Outcome measures
| Measure |
Recruitment
n=44 Participants
All participants screened for eligibility.
|
no Motivational Interviewing
n=37 Participants
Educational materials: The control group will receive educational material only.
|
|---|---|---|
|
Physical Activity
Vigorous activity (0 days)
|
14 Participants
|
12 Participants
|
|
Physical Activity
Vigorous activity (1-3 days)
|
19 Participants
|
19 Participants
|
|
Physical Activity
Vigorous activity (4-6 days)
|
11 Participants
|
6 Participants
|
|
Physical Activity
Vigorous activity (7 days)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: Data on sedentary behavior were available for 82 participants. One participant in the control group did not complete the ISAT, while all participants in the intervention group provided complete data.
Measured per day from activity trackers and questionnaire. Sedentary behaviour was assessed using the International Sedentary Assessment Tool (ISAT).
Outcome measures
| Measure |
Recruitment
n=44 Participants
All participants screened for eligibility.
|
no Motivational Interviewing
n=38 Participants
Educational materials: The control group will receive educational material only.
|
|---|---|---|
|
Sedentary Time
Sitting (pastime) (hrs)
|
5 hours
Interval 3.0 to 7.4
|
4 hours
Interval 2.6 to 6.0
|
|
Sedentary Time
Driving (hrs)
|
1 hours
Interval 0.5 to 2.0
|
1 hours
Interval 0.5 to 2.0
|
|
Sedentary Time
Sitting (full day) (hrs)
|
7.9 hours
Interval 5.0 to 10.0
|
8 hours
Interval 6.0 to 9.9
|
SECONDARY outcome
Timeframe: At 6 monthsMeasured from National Cancer Institute's Dietary Screener Questionnaire. Items from the National Cancer Institute's Dietary Screener Questionnaire (DSQ), which asked participants how often they consumed fruit over the past month. Responses ranged from "Never" to "More than once a day" and were reported separately for each item as frequency categories (n, %).
Outcome measures
| Measure |
Recruitment
n=43 Participants
All participants screened for eligibility.
|
no Motivational Interviewing
n=37 Participants
Educational materials: The control group will receive educational material only.
|
|---|---|---|
|
Nutrition
<1 time per week
|
6 Participants
|
7 Participants
|
|
Nutrition
1-5 times/week
|
25 Participants
|
20 Participants
|
|
Nutrition
≥1 time/day
|
12 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: Discrepancy in number analyzed due to missing data.
Depressive Symptoms- defined by the Center for Epidemiologic Studies Depression Scale (CES-D). \>=10 indicating presence of depressive symptoms, \<10 no depressive symptoms.
Outcome measures
| Measure |
Recruitment
n=44 Participants
All participants screened for eligibility.
|
no Motivational Interviewing
n=39 Participants
Educational materials: The control group will receive educational material only.
|
|---|---|---|
|
Mental Health
Yes (>=10)
|
23 Participants
|
20 Participants
|
|
Mental Health
No (<10)
|
21 Participants
|
19 Participants
|
Adverse Events
Motivational Interviewing
no Motivational Interviewing
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