UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059102 |
|---|---|
| Receipt number | R000067605 |
| Scientific Title | Pilot study protocol to increase resistance to peer pressure in tobacco use among nursing students (T-RESIST) |
| Date of disclosure of the study information | 2025/09/17 |
| Last modified on | 2025/09/17 02:01:32 |
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Basic information
Public title
T-RESIST: Program to Help Nursing Students Resist Peer Pressure and Avoid Tobacco Use
Acronym
T-RESIST: Teaching Resistance to Peer Pressure in Tobacco Use
Scientific Title
Pilot study protocol to increase resistance to peer pressure in tobacco use among nursing students (T-RESIST)
Scientific Title:Acronym
Resistance to peer pressure in tobacco use among nursing students (T-RESIST)
Region
| North America |
Condition
Condition
Prevention of tobacco use in young adults
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective is to evaluate the acceptability and feasibility of the intervention for application in academic settings.
Basic objectives2
Others
Basic objectives -Others
The secondary objective is to determine whether participation in the intervention produces changes in self-esteem, emotional dependence, social skills, and susceptibility to peer pressure for tobacco use.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Feasibility and acceptability of the T-RESIST intervention, assessed through quantitative indicators (recruitment rate, participation/acceptance rate, retention rate, completion rate, and follow-up rate) and qualitative evaluation (focus group interview guide exploring motivation, satisfaction, and perceived usefulness).
Time Frame: Baseline (pre-intervention), during the sessions (weeks 1-4), immediately post-intervention (week 4), and 6-month follow-up.
Key secondary outcomes
In addition to the primary outcome, secondary outcomes will assess preliminary effects of the T-RESIST intervention on psychosocial factors related to peer pressure and tobacco use.
Peer Pressure Resistance, measured by the Peer Pressure Resistance Scale for Conventional Cigarette Use in University Students.
Time Frame: Baseline, post-intervention (week 4), and 6-month follow-up.
Self-esteem, measured by the Coopersmith Self-Esteem Inventory.
Time Frame: Baseline, post-intervention (week 4), and 6-month follow-up.
Social Skills, measured by the Social Skills Inventory.
Time Frame: Baseline, post-intervention (week 4), and 6-month follow-up.
Emotional Dependence on Friendships, measured by the Emotional Dependence Scale.
Time Frame: Baseline, post-intervention (week 4), and 6-month follow-up.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The T-RESIST intervention will be delivered in groups, consisting of four active sessions plus two evaluation sessions (pre-test and post-test), each lasting 50 minutes. The sessions will focus on strategies to recognize and cope with peer pressure, enhance self-esteem to resist peer influence, reduce emotional dependence on friendships, and develop social skills to avoid yielding to pressure for the sake of group acceptance. At the end of the sessions, evaluations will be conducted through games, activities, and group logs.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Undergraduate nursing students aged 18 years or older, whether they are conventional cigarette smokers, who agree to participate and provide written informed consent.
Key exclusion criteria
Students with any condition that prevents them from performing the cognitive or physical activities required during the intervention.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | David |
| Middle name | Zepeta |
| Last name | Hernandez |
Organization
Veracruzana University
Division name
Faculty of Nursing
Zip code
93340
Address
Blvd. Lazaro Cardenas 801, Morelos, Poza Rica de Hidalgo, Veracruz, Mexico
TEL
+527828245700
dzepeta@uv.mx
Public contact
Name of contact person
| 1st name | David |
| Middle name | Zepeta |
| Last name | Hernandez |
Organization
Veracruzana University
Division name
Faculty of Nursing
Zip code
93340
Address
Blvd. Lazaro Cardenas 801, Morelos, Poza Rica de Hidalgo, Veracruz, Mexico
TEL
+527828245700
Homepage URL
https://www.uv.mx/pozarica/enfermeria/
dzepeta@uv.mx
Sponsor or person
Institute
The Veracruzana University, Poza Rica, Veracruz, Mexico, is the sponsor of this study.
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Nursing, Veracruzana University.
Address
Blvd. Lazaro Cardenas 801, Morelos, Poza Rica de Hidalgo, Veracruz, Mexico.
Tel
+528728245700
erdelangel@uv.mx
Secondary IDs
Secondary IDs
YES
Study ID_1
P-ME-02-2025B
Org. issuing International ID_1
Faculty of Nursing, Universidad Veracruzana - Research Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Second follow-up-date: 3 may 2026
Management information
Registered date
| 2025 | Year | 09 | Month | 17 | Day |
Last modified on
| 2025 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067605
