NCT07506343

Brief 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. 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.

Trial Health

65
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Trial Health Score

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

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Oct 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

March 23, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

March 23, 2026

Last Update Submit

March 27, 2026

Conditions

Keywords

SDT theoryGender gapED risk

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    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

    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

    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

    Assessed at three time points: baseline (Day 0), immediately after the 6-week intervention (post-intervention), and at 6-week follow-up.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in the intervention group will attend a six-session psychoeducational program, delivered weekly in small groups.

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.

Interventions

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

Intervention Group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Patricia Ruiz-Bravo, PA and Sport Sciences

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the psychoeducational intervention, participants and intervention facilitators cannot be blinded to group allocation. Their awareness of assignment is unavoidable and does not compromise intervention delivery. However, outcome assessment and data analysis will be blinded. All raw datasets will be exported using participant identification codes with group allocation removed. The researcher responsible for data analysis will receive a dataset in which participants are identified only by anonymized numeric codes, and the allocation variable will be masked until all primary analyses have been completed. No member of the enrolment team, facilitators, or participants will have access to the randomization sequence. The independent researcher managing the allocation will not participate in data analysis. This procedure ensures that outcome assessors and data analysts remain fully blinded and cannot infer group assignment during processing, modelling, or interpretation, t
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer and Principal Investigator

Study Record Dates

First Submitted

March 23, 2026

First Posted

April 1, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

February 20, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.