- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04130386
Motivational Interviewing to Address Freshman Weight Gain
February 11, 2021 updated by: Danielle D Wadsworth, Auburn University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Alabama
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Auburn, Alabama, United States, 36849
- School of Kinesiology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 20 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Those that do not meet inclusion criteria.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Motivational Interviewing
Participants assigned to this arm will complete three MI sessions over 10 weeks.
|
Participants receiving MI
|
Active Comparator: E-education
The e-education group receives three educational modules lasting approximately 10 minutes each over a period of 10 weeks.
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Participants receiving e-education
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in fat mass
Time Frame: 12 and 28 weeks
|
changes in fat mass measured in KG by a iDXA scan
|
12 and 28 weeks
|
Changes in lean mass
Time Frame: 12 and 28 weeks
|
changes in lean mass measured in KG by a iDXA scan
|
12 and 28 weeks
|
Physical Activity
Time Frame: 12 and 28 weeks
|
Changes in minutes of moderate to vigorous physical activity measured by an accelerometer.
|
12 and 28 weeks
|
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
|
12 and 28 weeks
|
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.
|
12 and 28 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Experience with MI
Time Frame: 12 weeks
|
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.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2020
Primary Completion (Actual)
August 31, 2020
Study Completion (Actual)
August 31, 2020
Study Registration Dates
First Submitted
October 1, 2019
First Submitted That Met QC Criteria
October 16, 2019
First Posted (Actual)
October 17, 2019
Study Record Updates
Last Update Posted (Actual)
February 12, 2021
Last Update Submitted That Met QC Criteria
February 11, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AuburnU-MI college freshman
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
There is not a plan to make IPD available
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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