Body ImageNo acronym useNCT07506343
SDT-Based Intervention for Exercise Motivation in Female Students
A study of Body Image and Physical Activity, run by Universidad Francisco de Vitoria.
Trial summary
Physical inactivity, maladaptive exercise motives, and body image concerns are highly prevalent among young adult women and are associated with reduced psychological well-being and increased risk for disordered eating. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Image, Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Physical inactivity, maladaptive exercise motives, and body image concerns are highly prevalent among young adult women and are associated with reduced psychological well-being and increased risk for disordered eating. This study protocol describes a randomized controlled trial designed to evaluate a multi-component psychoeducational intervention integrating Self-Determination Theory principles with functionality-oriented body image strategies to enhance autonomous motivation for exercise and promote psychological well-being among female university students. Female Health Sciences students aged 18-25 will be randomly allocated (1:1) to an experimental or control group following baseline assessment, and outcomes will be evaluated at baseline, post-intervention, and six-week follow-up. The six-session face-to-face intervention incorporates autonomy-supportive communication, competence-building activities, meaningful rationales, choice provision, and supportive relational climates, combined with functionality-based body image content. The primary outcome is autonomous motivation for exercise (BREQ-3; Relative Autonomy Index), and secondary outcomes include basic psychological need satisfaction and frustration, physical activity levels, positive body image, and eating disorder risk. Linear mixed-effects models will be used under an intention-to-treat approach, and mediation analyses will test whether changes in psychological need satisfaction underlie improvements in motivational quality. The intervention is expected to promote healthier motivational regulation, increase physical activity engagement, strengthen positive body image, and reduce maladaptive exercise drivers. Findings aim to inform scalable, theory-driven preventive strategies for improving health and well-being among young women in university settings.
- Conditions
- Body Image, Physical Activity
- Being tested
- Experimental group will receive a face-to-face psychoeducational program grounded in Self-Determination Theory. Control group will no receive any psychoeducational program
- Keywords
- SDT theory, Gender gap, ED risk
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group will receive a face-to-face psychoeducational program grounded in Self-Determination Theory. Control group will no receive any psychoeducational programBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in the intervention group will attend a six-session psychoeducational program, delivered weekly in small groups. Receives: Behavioral: Experimental group will receive a face-to-face psychoeducational program grounded in Self-Determination Theory. Control group will no receive any psychoeducational program |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
RAI continuous score
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.
Measured: Assessed at three time points: baseline (Day 0), immediately after the 6-week intervention (post-intervention), and at 6-week follow-up.
Secondary outcomes (4)
Autonomy, competence, relatedness (satisfaction subscales)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Assessed at three time points: baseline (Day 0), immediately after the 6-week intervention (post-intervention), and at 6-week follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start1 Oct 2026 (estimated)
- Primary completion20 Feb 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body ImageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study design is a randomized controlled trial (RCT) (1:1 ratio), including an experimental group receiving a multicomponent psychoeducational intervention and a control group. Assessments take place at baseline, post-intervention, and six-week follow-up. The design allows evaluation of intervention effectiveness and examination of changes over time.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Francisco de Vitoria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Ruiz Bravo, Universidad Francisco de Vitoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506343
- Sponsor's protocol ID
- UFV2026-22
- Acronym
- No acronym use
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The treatment of personal data will strictly comply with Regulation (EU) 2016/679 (General Data Protection Regulation, GDPR), ensuring the reconciliation of the right to data protection with the freedom of scientific research.
Publications
Garcia-Merino S, Ruiz-Bravo P, Diaz Urena G. 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. PLoS One. 2026 Aug 7;21(8):e0355374. doi: 10.1371/journal.pone.0355374. eCollection 2026.
PubMed 42566404
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07506343
- Acronym / sponsor ID
- No acronym use / UFV2026-22
- Conditions
- Body Image, Physical Activity
- Keywords
- SDT theory, Gender gap, ED risk
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Physical inactivity, maladaptive exercise motives, and body image concerns are highly prevalent among young adult women and are associated with reduced psychological well-being and increased risk for disordered eating. This study protocol describes a randomized controlled trial designed to evaluate a multi-component psychoeducational intervention integrating Self-Determination Theory principles with functionality-oriented body image strategies to enhance autonomous motivation for exercise and promote psychological well-being among female university students. Female Health Sciences students aged 18-25 will be randomly allocated (1:1) to an experimental or control group following baseline assessment, and outcomes will be evaluated at baseline, post-intervention, and six-week follow-up. The six-session face-to-face intervention incorporates autonomy-supportive communication, competence-building activities, meaningful rationales, choice provision, and supportive relational climates, combined with functionality-based body image content. The primary outcome is autonomous motivation for exercise (BREQ-3; Relative Autonomy Index), and secondary outcomes include basic psychological need satisfaction and frustration, physical activity levels, positive body image, and eating disorder risk. Linear mixed-effects models will be used under an intention-to-treat approach, and mediation analyses will test whether changes in psychological need satisfaction underlie improvements in motivational quality. The intervention is expected to promote healthier motivational regulation, increase physical activity engagement, strengthen positive body image, and reduce maladaptive exercise drivers. Findings aim to inform scalable, theory-driven preventive strategies for improving health and well-being among young women in university settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study design is a randomized controlled trial (RCT) (1:1 ratio), including an experimental group receiving a multicomponent psychoeducational intervention and a control group. Assessments take place at baseline, post-intervention, and six-week follow-up. The design allows evaluation of intervention effectiveness and examination of changes over time.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Experimental group will receive a face-to-face psychoeducational program grounded in Self-Determination Theory. Control group will no receive any psychoeducational programParticipants in the intervention group will attend a six-session psychoeducational program, delivered weekly in small groups. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental group will receive a face-to-face psychoeducational program grounded in Self-Determination Theory. Control group will no receive any psychoeducational programParticipants 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 | Behavioural | Intervention Group |
Primary outcome
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Derived from this study: PubMed 42566404Garcia-Merino S, Ruiz-Bravo P, Diaz Urena G. 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. PLoS One. 2026 Aug 7;21(8):e0355374. doi: 10.1371/journal.pone.0355374. eCollection 2026.
- Individual participant dataSharing planned: No. The treatment of personal data will strictly comply with Regulation (EU) 2016/679 (General Data Protection Regulation, GDPR), ensuring the reconciliation of the right to data protection with the freedom of scientific research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study of Body Image and Physical Activity, run by Universidad Francisco de Vitoria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia Ruiz-Bravo, PA and Sport Sciences (+34917091400 ext. 1939, p.ruiz.prof@ufv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07506343, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.