Plain English Summary
Background and study aims
Young adult women might face reproductive health issues without being aware of them and tend to lack preventive health behavior. Therefore, in order to promote the reproductive health of young adult women, it is important to identify the stage of their health behavior and to develop a program that can induce behavior change. The aim of this study is to develop a reproductive health promotion program based on the Precaution Adoption Process Model (PAPM) for young adult women and to evaluate its effects.
Who can participate?
Healthy young adult women volunteers aged 18-25, women who had coitus in the last 3 months and had partners, and women in Stages 1, 2, and 3 of the PAPM for reproductive health via an online survey
What does the study involve?
The reproductive health promotion program developed in this study is strategically applied to each stage of the PAPM (Stages 1, 2, and 3). For Stage 1 participants in the intervention group, the program consists of strategies such as lectures, providing periodic information, small group discussions, Q&A sessions, and practical training. For Stage 2 participants in the intervention group, the program includes the strategies of stage 1 and additionally consists of strategies such as case experience using videos and individual counselling using the 5 Rs. For Stage 3 participants in the intervention group, the program includes the strategies of stage 1 and additionally consists of strategies such as individual counselling using the 5 As and providing tailored information according to the individual’s needs. The program is replaced with educational material for the control group. In both groups, the total duration of the intervention is 8 weeks and the outcomes are measured at three times: baseline, 1 week after the seminar and 1 week after completion of the interventions.
What are the possible benefits and risks of participating?
As possible benefits of participating, participants will play an active role in their own health care. Also, by contributing to this research, they can help in many other ways. However, the participants should also consider the following risks: participating in the program may cause unpleasant feelings or the intervention may not be effective for participants.
Where is the study run from?
Korea University (Korea, South)
When is the study starting and how long is it expected to run for?
May 2017 to November 2018
Who is funding the study?
The Health Fellowship Foundation (Korea, South)
Who is the main contact?
Inhae Cho
sexyinhae@korea.ac.kr
Trial website
Contact information
Type
Public
Primary contact
Dr Inhae Cho
ORCID ID
http://orcid.org/0000-0003-2256-5064
Contact details
College of Nursing
Korea University
145 Anam-ro
Seongbuk-ku
Seoul
02841
Korea
South
+82 (0)10 7106 8014
sexyinhae@korea.ac.kr
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
1
Study information
Scientific title
Development and evaluation of a reproductive health promotion program based on the Precaution Adoption Process Model for young adult women
Acronym
Study hypothesis
1. There will be differences in variables of the primary outcome (reproductive health-promoting behavior, rate of contraception use) between the intervention group who were provided with the reproductive health promotion program and the control group.
2. There will be differences in variables of the secondary outcome (reproductive health knowledge, reproductive health belief, reproductive health motivation, reproductive health self-efficacy) between the intervention group who were provided with the reproductive health promotion program and the control group.
Ethics approval
Approved 18/12/2017, Korea University Institutional Review Board (145 Anam-ro, Seongbuk-gu, Seoul, 02841, Korea; +82 (0)2 3290 1137; kuirb@korea.ac.kr), ref: 1040548-KU-IRB-17-169-A-3
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Condition
Reproductive health
Intervention
After conducting a preliminary, experimental investigation procedure, the program for promoting reproductive health based on the PAPM was applied step by step to the intervention group, and the program was replaced with educational material for the control group. The random allocation sequence was conducted with a 1:1 ratio using a computer-generated program (https://www.randomizer.org/) after the pretest.
The program is a tailored program whereby each stage of the PAPM (Stages 1, 2, and 3) is outlined, using components of the Information-Motivation-Behavioral skills model. The program comprises intervention strategies, such as lectures; periodic information and information tailored to individuals’ needs; small group discussions; question and answer sessions (Q&A); individual counselling; case experience using videos; and practical training.
The total duration of the intervention is 8 weeks. Outcomes are measured at three timepoints: T0 indicates the baseline, T1 indicates 1 week after the seminar (2 weeks after baseline) and T2 indicates within 1 week after completion of the interventions (8 weeks after baseline).
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Reproductive health-promoting behavior measured using self-reported questionnaire via online survey at T0 (baseline), T1(2 weeks after baseline), and T3 (after completion of intervention/8 weeks after baseline)
2. Rate of contraception use measured using self-reported questionnaire via online survey at T0, T3
Outcomes are measured at three timepoints: T0 indicates the baseline, T1 indicates 1 week after the seminar (2 weeks after baseline) and T2 indicates within 1 week after completion of the interventions (8 weeks after baseline).
Secondary outcome measures
1. Reproductive health knowledge measured using self-reported questionnaire via online survey at T0, T1, T3
2. Reproductive health belief measured using self-reported questionnaire via online survey at T0, T1, T3
3. Reproductive health motivation measured using self-reported questionnaire via online survey at T0, T1, T3
4. Reproductive health self-efficacy measured using self-reported questionnaire via online survey at T0, T1, T3
Outcomes are measured at three timepoints: T0 indicates the baseline, T1 indicates 1 week after the seminar (2 weeks after baseline) and T2 indicates within 1 week after completion of the interventions (8 weeks after baseline).
Overall trial start date
24/05/2017
Overall trial end date
05/11/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Young adult women aged between 18 and 25
2. Women who had coitus in the last 3 months and had partners
Phase 2 of the study:
3. Women in Stages 1, 2, and 3 of the PAPM for reproductive health via an online survey
Participant type
Healthy volunteer
Age group
Adult
Gender
Female
Target number of participants
The desired sample size for repeated ANOVA was 26 per study group. Considering the expected dropout rate, 30 participants were needed per group.
Total final enrolment
60
Participant exclusion criteria
Women in Stages 4, 5, and 6 of the PAPM for reproductive health
Recruitment start date
26/12/2017
Recruitment end date
13/04/2018
Locations
Countries of recruitment
Korea, South
Trial participating centre
Korea University
145 Anam-ro, Seongbuk-gu
Seoul
02841
Korea, South
Sponsor information
Organisation
Korea University
Sponsor details
College of Nursing
145 Anam-ro
Sungbuk-gu
Seoul
02841
Korea
South
+82 (0)2 3290 4910
webmaster@korea.ac.kr
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Health Fellowship Foundation (Korea, South)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/12/2022
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list