ISRCTN ISRCTN12556383
DOI https://doi.org/10.1186/ISRCTN12556383
Secondary identifying numbers 1
Submission date
19/10/2020
Registration date
21/10/2020
Last edited
17/11/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Inhae Cho
Public

College of Nursing
Korea University
145 Anam-ro
Seongbuk-ku
Seoul
02841
Korea, South

ORCiD logoORCID ID 0000-0003-2256-5064
Phone +82 (0)10 7106 8014
Email sexyinhae@korea.ac.kr

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Community
Study typePrevention
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleDevelopment and evaluation of a reproductive health promotion program based on the Precaution Adoption Process Model for young adult women
Study objectives1. 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(s)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
Health condition(s) or problem(s) studiedReproductive health
InterventionAfter 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 typeBehavioural
Primary outcome measure1. 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 measures1. 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 study start date24/05/2017
Completion date05/11/2018

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participantsThe desired sample size for repeated ANOVA was 26 per study group. Considering the expected dropout rate, 30 participants were needed per group.
Total final enrolment60
Key inclusion criteria1. 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
Key exclusion criteriaWomen in Stages 4, 5, and 6 of the PAPM for reproductive health
Date of first enrolment26/12/2017
Date of final enrolment13/04/2018

Locations

Countries of recruitment

  • Korea, South

Study participating centre

Korea University
145 Anam-ro, Seongbuk-gu
Seoul
02841
Korea, South

Sponsor information

Korea University
University/education

College of Nursing
145 Anam-ro, Sungbuk-gu
Seoul
02841
Korea, South

Phone +82 (0)2 3290 4910
Email webmaster@korea.ac.kr

Funders

Funder type

Charity

The Health Fellowship Foundation (Korea, South)

No information available

Results and Publications

Intention to publish date31/12/2022
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe data-sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 27/10/2022 17/11/2023 Yes No

Editorial Notes

17/11/2023: Publication reference added.
20/10/2020: Trial's existence confirmed by Korea University Institutional Review Board.