Condition category
Pregnancy and Childbirth
Date applied
19/10/2020
Date assigned
21/10/2020
Last edited
20/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

Publication citations

Additional files

Editorial Notes

20/10/2020: Trial's existence confirmed by Korea University Institutional Review Board.