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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

101 participants

Primary outcome timeframe

At recruitment, over 6 months.

Results posted on

2025-05-18

Participant Flow

Participant milestones

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

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

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

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

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 months

Number of participants with no missing data on clinical outcomes

Outcome measures

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 months

Population: 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

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 months

Population: Discrepancy in Overall Number Analyzed due to missing data.

Change in BMI from baseline to 6-month follow-up

Outcome measures

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 months

Population: 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

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 months

Population: 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

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 months

Measured 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

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 months

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

no Motivational Interviewing

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

Dr. Laura Anderson

McMaster University

Phone: N/a

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place