Motivational Interviewing to Address Freshman Weight Gain

• Sponsor: Auburn University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04130386
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.7
• Patients Per Site Per Month: 5.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Motivational Interviewing	Behavioral: Motivational Interviewing; Behavioral: e-education	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Assigned to either motivational interviewing or e-education.Assigned to either motivational interviewing or e-education.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Motivational Interviewing to Address Freshman Weight Gain
• Actual Study Start Date: Jan 10, 2020
• Actual Primary Completion Date: Aug 31, 2020
• Actual Study Completion Date: Aug 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Motivational Interviewing Participants assigned to this arm will complete three MI sessions over 10 weeks.	Behavioral: Motivational Interviewing; 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.	Behavioral: e-education; Participants receiving e-education

Outcome Measures

Primary Outcome Measures

1. changes in fat mass [12 and 28 weeks]

   changes in fat mass measured in KG by a iDXA scan

2. Changes in lean mass [12 and 28 weeks]

   changes in lean mass measured in KG by a iDXA scan

3. Physical Activity [12 and 28 weeks]

   Changes in minutes of moderate to vigorous physical activity measured by an accelerometer.

4. Changes in the number of servings of Fruit and Vegetables [12 and 28 weeks]

   Changes in fruit and vegetable consumption measured in servings per day

5. Changes in Autonomous motivation [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.

Secondary Outcome Measures

1. Experience with MI [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 20 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Classified as a college freshman and 18 years of age.

2. Low risk for medical complications from exercise (as determined by physical activity readiness questionnaire (PARQ+).

3. Neither currently engaging in exercise nor consistently exercising over the last three months (2 days per week or less).

4. Be considered overweight based on BMI (BMI at or above 25)

5. Not pregnant.

Exclusion Criteria:

• Those that do not meet inclusion criteria.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Kinesiology	Auburn	Alabama	United States	36849

Sponsors and Collaborators

• Auburn University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Danielle D Wadsworth, Associate Professor, Auburn University
• ClinicalTrials.gov Identifier: NCT04130386
• Other Study ID Numbers: AuburnU-MI college freshman
• First Posted: Oct 17, 2019
• Last Update Posted: Feb 12, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Weight Gain

Study Results

No Results Posted as of Feb 12, 2021