- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07506343
SDT-Based Intervention for Exercise Motivation in Female Students (No acronym use)
Study Protocol for a Randomized Controlled Trial of a Self-determination Theory-Based Psychoeducational Intervention to Enhance Autonomous Motivation for Exercise in Female University Students
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Patricia Ruiz-Bravo, PA and Sport Sciences
- Phone Number: 1939 +34917091400
- Email: p.ruiz.prof@ufv.es
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female sex
- Age between 18 and 25 years
- Enrolled in Health Sciences programs (Physical Activity and Sport Sciences, Physiotherapy, Human Nutrition and Dietetics, Nursing) at Universidad Francisco de Vitoria
- Provision of written informed consent
Exclusion Criteria:
- Current or previous diagnosis of an eating disorder
- Failure to complete baseline or post-intervention questionnaires
- Identification of an eating disorder after enrollment, which triggers referral according to the well-being protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Participants in the intervention group will attend a six-session psychoeducational program, delivered weekly in small groups.
|
Participants in the experimental group will receive a face-to-face psychoeducational program grounded in Self-Determination Theory. The intervention consists of six 60-minute weekly group workshops (up to 15 participants per group). Sessions include autonomy-supportive communication, competence-building activities, functionality-oriented body image content, experiential tasks, and guided reflection. Facilitators are trained professionals in exercise science and psychonutrition who follow a standardized session guide. Intervention fidelity is monitored using session checklists. Workshop content progresses through: Awareness of motivational quality Personal values and self-endorsed goals Competence and flexible planning Functionality-oriented body appreciation Social support and supportive relational climate Maintenance of behavior change and coping with setbacks |
|
No Intervention: Control Group
Participants assigned to the control group will remain on the wait-list during the intervention and follow-up periods and will not receive any specific intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
RAI continuous score
Time Frame: Assessed at three time points: baseline (Day 0), immediately after the 6-week intervention (post-intervention), and at 6-week follow-up.
|
Measured using the Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3). The Relative Autonomy Index (RAI) was calculated by weighting the six regulation subscales (Amotivation -3, External -2, Introjected -1, Identified +1, Integrated +2, Intrinsic +3) and summing the weighted mean scores. Higher (positive) scores indicate more autonomous forms of motivation, whereas lower (negative) scores reflect more controlled forms of regulation. Because the RAI is computed from mean subscale scores, its theoretical limits depend on the 0-4 response scale and the weighting structure; for typical BREQ-3 scoring, values fall approximately between -12 and +12. |
Assessed at three time points: baseline (Day 0), immediately after the 6-week intervention (post-intervention), and at 6-week follow-up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Autonomy, competence, relatedness (satisfaction subscales)
Time Frame: Assessed at three time points: baseline (Day 0), immediately after the 6-week intervention (post-intervention), and at 6-week follow-up.
|
Measured using the Basic Psychological Need Satisfaction and Frustration Scale (BPNSFS). This instrument assesses both satisfaction and frustration of the three basic psychological needs, autonomy, competence, and relatedness, within the framework of Self-Determination Theory. Items are rated on a 5-point Likert scale ranging from 1 (not at all true) to 5 (completely true). Subscale scores were computed as the mean of the corresponding items, resulting in scores ranging from 1 to 5 for each dimension. Higher scores on the satisfaction subscales indicate greater need satisfaction, whereas higher scores on the frustration subscales reflect greater need frustration. The scale demonstrates a six-factor structure, comprising autonomy, competence, and relatedness satisfaction and frustration dimensions. |
Assessed at three time points: baseline (Day 0), immediately after the 6-week intervention (post-intervention), and at 6-week follow-up.
|
|
Weekly MET-minutes
Time Frame: Assessed at three time points: baseline (Day 0), immediately after the 6-week intervention (post-intervention), and at 6-week follow-up.
|
Physical activity was assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). This instrument evaluates the frequency (days per week) and duration (minutes per day) of walking, moderate-intensity, and vigorous-intensity physical activity performed during the previous 7 days. Total physical activity was expressed in metabolic equivalent minutes per week (MET-min/week), following the official IPAQ scoring protocol. MET-min/week values were obtained by multiplying the assigned MET coefficient of each activity category by the corresponding minutes and days: walking (3.3 METs), moderate-intensity activity (4.0 METs), and vigorous-intensity activity (8.0 METs), and summing the results across all categories. Total scores range from 0 MET-min/week to theoretically unbounded values, depending on the volume of physical activity accumulated. Higher scores indicate higher levels of physical activity. |
Assessed at three time points: baseline (Day 0), immediately after the 6-week intervention (post-intervention), and at 6-week follow-up.
|
|
BAS-2 total score
Time Frame: Assessed at three time points: baseline (Day 0), immediately after the 6-week intervention (post-intervention), and at 6-week follow-up.
|
Body appreciation was assessed using the Body Appreciation Scale-2 (BAS-2), a 10-item measure of positive body image.
Items are rated on a 5-point Likert scale ranging from 1 (never) to 5 (always).
Scores were computed as the mean of all items, resulting in a total score ranging from 1 to 5. Higher scores indicate greater body appreciation, reflecting acceptance, respect, and positive attitudes toward one's body.
The BAS-2 has demonstrated strong psychometric properties and a robust unidimensional factor structure across different populations.
|
Assessed at three time points: baseline (Day 0), immediately after the 6-week intervention (post-intervention), and at 6-week follow-up.
|
|
EAT-26 total score
Time Frame: Assessed at three time points: baseline (Day 0), immediately after the 6-week intervention (post-intervention), and at 6-week follow-up.
|
Disordered eating attitudes were assessed using the Eating Attitudes Test-26 (EAT-26).
The instrument consists of 26 items assessing symptoms and concerns characteristic of eating disorders.
Items are scored on a 6-point Likert scale, which is recoded into a 4-point scale ranging from 0 to 3 (Always = 3, Usually = 2, Often = 1, and Sometimes/Rarely/Never = 0), following standard scoring procedures.
Total scores are obtained by summing all items, resulting in a range from 0 to 78.
Higher scores indicate greater eating-related concerns and a higher risk of disordered eating.
A total score of 20 or higher is commonly used as a screening cut-off indicating elevated risk and the potential need for further clinical evaluation.
|
Assessed at three time points: baseline (Day 0), immediately after the 6-week intervention (post-intervention), and at 6-week follow-up.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UFV2026-22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Physical Activity
-
Muğla Sıtkı Koçman UniversityEge UniversityCompletedPhysical Activity | Physical Activity Behavior | Physical Activity LevelsTurkey
-
Istinye UniversityCompletedPhysical Activity | Youth | Physical Activity Barriers | Physical Activity FacilitatorsTurkey
-
Universidad Pedagogica Nacional, ColombiaEnrolling by invitationPhysical Activity | Running | Running Performance | Running Endurance | Physical Activity in Adults | Physical Activity IntensityColombia
-
Istanbul Kültür UniversityWithdrawnPhysical Activity Level | Physical Activity Awareness
-
University of ManitobaResearch ManitobaCompletedPhysical Activity | Physical Activity Self-Definition
-
Odense University HospitalUniversity of Southern DenmarkRecruitingQuality of Life | Physical Activity | Physical Disability | Physical Function | ParticipationDenmark
-
Universidade do PortoActive, not recruitingPhysical Activity | Physical Fitness | Well BeingPortugal
-
Firat UniversityNot yet recruitingUniversity Students | Physical Activity Level | Postural Awareness | Physical Activity AttitudeTurkey
-
Assistance Publique - Hôpitaux de ParisTerminatedPhysical Activity | Physical DisabilityFrance
-
University of Colorado, DenverCompletedPhysical Activity | Physical ImpairmentUnited States
Clinical Trials on Experimental group will receive a face-to-face psychoeducational program grounded in Self-Determination Theory. Control group will no receive any psychoeducational program
-
Henry Ford Health SystemNational Heart, Lung, and Blood Institute (NHLBI); University of Michigan; Augusta...Completed
-
Cairo UniversityRecruitingPatients with Lower Extremity Burn | Postural Stability, Depressive Symptoms and Anxiety in Patients with Lower Extremity BurnEgypt