Back to resultsMotivational Interviewing to Address Freshman Weight Gain
Primary Purpose
Motivational Interviewing
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
e-education
Sponsored by
About this trial
This is an interventional treatment trial for Motivational Interviewing
Eligibility Criteria
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.
Sites / Locations
- School of Kinesiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Motivational Interviewing
E-education
Arm Description
Participants assigned to this arm will complete three MI sessions over 10 weeks.
The e-education group receives three educational modules lasting approximately 10 minutes each over a period of 10 weeks.
Outcomes
Primary Outcome Measures
changes in fat mass
changes in fat mass measured in KG by a iDXA scan
Changes in lean mass
changes in lean mass measured in KG by a iDXA scan
Physical Activity
Changes in minutes of moderate to vigorous physical activity measured by an accelerometer.
Changes in the number of servings of Fruit and Vegetables
Changes in fruit and vegetable consumption measured in servings per day
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04130386
Brief Title
Motivational Interviewing to Address Freshman Weight Gain
Official Title
Motivational Interviewing to Address Freshman Weight Gain
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Auburn University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. Variables of interest include: body composition, physical activity, food consumption and self-determination theory constructs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motivational Interviewing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Assigned to either motivational interviewing or e-education.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Motivational Interviewing
Arm Type
Experimental
Arm Description
Participants assigned to this arm will complete three MI sessions over 10 weeks.
Arm Title
E-education
Arm Type
Active Comparator
Arm Description
The e-education group receives three educational modules lasting approximately 10 minutes each over a period of 10 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
Participants receiving MI
Intervention Type
Behavioral
Intervention Name(s)
e-education
Intervention Description
Participants receiving e-education
Primary Outcome Measure Information:
Title
changes in fat mass
Description
changes in fat mass measured in KG by a iDXA scan
Time Frame
12 and 28 weeks
Title
Changes in lean mass
Description
changes in lean mass measured in KG by a iDXA scan
Time Frame
12 and 28 weeks
Title
Physical Activity
Description
Changes in minutes of moderate to vigorous physical activity measured by an accelerometer.
Time Frame
12 and 28 weeks
Title
Changes in the number of servings of Fruit and Vegetables
Description
Changes in fruit and vegetable consumption measured in servings per day
Time Frame
12 and 28 weeks
Title
Changes in Autonomous motivation
Description
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.
Time Frame
12 and 28 weeks
Secondary Outcome Measure Information:
Title
Experience with MI
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
School of Kinesiology
City
Auburn
State/Province
Alabama
ZIP/Postal Code
36849
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available
Learn more about this trial
Motivational Interviewing to Address Freshman Weight Gain
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