Motivational InterviewingNCT04130386
Motivational Interviewing to Address Freshman Weight Gain
A study testing Motivational Interviewing and e-education in people with Motivational Interviewing, run by Auburn University at 1 site in United States.
Trial summary
The purpose of the study is to determine the effect of Motivational Interviewing and e-health education on body composition and psychological outcomes. After baseline testing, participants will be randomly assigned to a motivational interviewing or e-health education group for a 10-week intervention. Read more about this study
- Who is it for?
- Ages 18 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Motivational Interviewing
- What is being tested?
- Motivational Interviewing and e-education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2020to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 20 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Classified as a college freshman and 18 years of age.
- Low risk for medical complications from exercise (as determined by physical activity readiness questionnaire (PARQ+).
- Neither currently engaging in exercise nor consistently exercising over the last three months (2 days per week or less).
- Be considered overweight based on BMI (BMI at or above 25)
- Not pregnant.
Who cannot join
- Those that do not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to determine the effect of Motivational Interviewing and e-health education on body composition and psychological outcomes. After baseline testing, participants will be randomly assigned to a motivational interviewing or e-health education group for a 10-week intervention. Variables of interest include: body composition, physical activity, food consumption and self-determination theory constructs.
- Conditions
- Motivational Interviewing
- Being tested
- Motivational Interviewing, e-education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
Participants receiving MI
e-educationBehavioural
Participants receiving e-education
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing | Experimental | Participants assigned to this arm will complete three MI sessions over 10 weeks. Receives: Behavioral: Motivational Interviewing |
| E-education | Active comparator | The e-education group receives three educational modules lasting approximately 10 minutes each over a period of 10 weeks. Receives: Behavioral: e-education |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in fat mass
changes in fat mass measured in KG by a iDXA scan
Measured: 12 and 28 weeks
Changes in lean mass
changes in lean mass measured in KG by a iDXA scan
Measured: 12 and 28 weeks
Physical Activity
Changes in minutes of moderate to vigorous physical activity measured by an accelerometer.
Measured: 12 and 28 weeks
Changes in the number of servings of Fruit and Vegetables
Changes in fruit and vegetable consumption measured in servings per day
Measured: 12 and 28 weeks
Changes in Autonomous motivation
Changes in Autonomous motivation will be assessed with the Exercise Regulation Questionnaire (BREQ-3). The score range for each subscale is 0-16. A higher score for each subscales represents higher levels of motivation for external, introjected, identified and integrated forms of motivation.
Measured: 12 and 28 weeks
Secondary outcomes (1)
Experience with MI
Participants experience with the MI intervention will be assessed with the Health care climate questionnaire. This scale measures perceived autonomous support. The score ranges from 15-105, with higher scores associated with higher levels of perceived autonomy support.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start10 Jan 2020
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Motivational InterviewingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assigned to either motivational interviewing or e-education.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle D Wadsworth, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130386
- Sponsor's protocol ID
- AuburnU-MI college freshman
- Status last verified
- Feb 2021
- First submitted
- 1 Oct 2019
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Publications
Suire KB, Kavookjian J, Strunk K, Wadsworth DD. Motivational interviewing for weight management among college students during COVID-19: An exploratory randomized controlled trial. Obes Pillars. 2023 Dec 26;9:100097. doi: 10.1016/j.obpill.2023.100097. eCollection 2024 Mar.
PubMed 38268522
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing to Address Freshman Weight Gain
- ClinicalTrials.gov ID
- NCT04130386
- Acronym / sponsor ID
- AuburnU-MI college freshman
- Conditions
- Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the effect of Motivational Interviewing and e-health education on body composition and psychological outcomes. After baseline testing, participants will be randomly assigned to a motivational interviewing or e-health education group for a 10-week intervention. Variables of interest include: body composition, physical activity, food consumption and self-determination theory constructs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Assigned to either motivational interviewing or e-education.
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Behavioral: Motivational InterviewingParticipants assigned to this arm will complete three MI sessions over 10 weeks. |
| E-education | Active comparator | Behavioral: e-educationThe e-education group receives three educational modules lasting approximately 10 minutes each over a period of 10 weeks. |
Who may qualify
- Ages
- 18 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Classified as a college freshman and 18 years of age.
- Low risk for medical complications from exercise (as determined by physical activity readiness questionnaire (PARQ+).
- Neither currently engaging in exercise nor consistently exercising over the last three months (2 days per week or less).
- Be considered overweight based on BMI (BMI at or above 25)
- Not pregnant.
Key exclusion criteria (1 listed)
- Those that do not meet inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingParticipants receiving MI | Behavioural | Motivational Interviewing |
| e-educationParticipants receiving e-education | Behavioural | E-education |
Primary outcome
changes in fat mass
Time frame: 12 and 28 weeks
changes in fat mass measured in KG by a iDXA scan
Changes in lean mass
Time frame: 12 and 28 weeks
changes in lean mass measured in KG by a iDXA scan
Physical Activity
Time frame: 12 and 28 weeks
Changes in minutes of moderate to vigorous physical activity measured by an accelerometer.
Changes in the number of servings of Fruit and Vegetables
Time frame: 12 and 28 weeks
Changes in fruit and vegetable consumption measured in servings per day
Changes in Autonomous motivation
Time frame: 12 and 28 weeks
Changes in Autonomous motivation will be assessed with the Exercise Regulation Questionnaire (BREQ-3). The score range for each subscale is 0-16. A higher score for each subscales represents higher levels of motivation for external, introjected, identified and integrated forms of motivation.
1 secondary outcome
Experience with MI
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Derived from this study: PubMed 38268522Suire KB, Kavookjian J, Strunk K, Wadsworth DD. Motivational interviewing for weight management among college students during COVID-19: An exploratory randomized controlled trial. Obes Pillars. 2023 Dec 26;9:100097. doi: 10.1016/j.obpill.2023.100097. eCollection 2024 Mar.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and e-education in people with Motivational Interviewing, run by Auburn University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in fat mass (time frame: 12 and 28 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04130386, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.