NCT04130386

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 17, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 10, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

February 12, 2021

Status Verified

February 1, 2021

Enrollment Period

8 months

First QC Date

October 1, 2019

Last Update Submit

February 11, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • changes in fat mass

    changes in fat mass measured in KG by a iDXA scan

    12 and 28 weeks

  • Changes in lean mass

    changes in lean mass measured in KG by a iDXA scan

    12 and 28 weeks

  • Physical Activity

    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

    Changes in fruit and vegetable consumption measured in servings per day

    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.

    12 and 28 weeks

Secondary Outcomes (1)

  • Experience with MI

    12 weeks

Study Arms (2)

Motivational Interviewing

EXPERIMENTAL

Participants assigned to this arm will complete three MI sessions over 10 weeks.

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.

Behavioral: e-education

Interventions

Participants receiving MI

Motivational Interviewing
e-educationBEHAVIORAL

Participants receiving e-education

E-education

Eligibility Criteria

Age18 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Kinesiology

Auburn, Alabama, 36849, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Assigned to either motivational interviewing or e-education.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 1, 2019

First Posted

October 17, 2019

Study Start

January 10, 2020

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

February 12, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available

Locations