NCT07003971

Brief Summary

The aim of this study is to examine the effectiveness of a programme to improve healthy lifestyle behaviours based on the Health Belief Model to be offered through Instagram, a social media platform. For this purpose, it is aimed to produce content containing accurate and evidence-based information for pregnant women on social media, to ensure that pregnant women can access the right information quickly and easily, to adopt healthy lifestyle behaviours, to test the effectiveness of the social media platform for the adoption of healthy lifestyle behaviours and to contribute to the formation of a healthier family and society in the long term. In addition, this study is aimed to create a model for the midwifery profession to benefit from the new opportunities created by internet technology outside the clinical field in service delivery. The population of the study will consist of women with primiparous pregnancies in the first and second trimester. Women who agree to participate in the study will be randomly assigned to the experimental and control groups. In addition to routine care and counselling, pregnant women in the experimental group will receive support for developing healthy lifestyle behaviours through Instagram, while the control group will receive only standard pregnancy care and counselling services approved by the Ministry of Health. General Hypothesis of the Study: H1: The Healthy Lifestyle Behaviours development programme offered through the social media platform Instagram is effective in providing a positive development on healthy lifestyle behaviours in pregnant women.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Sep 2025May 2026

First Submitted

Initial submission to the registry

May 3, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

September 2, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

7 months

First QC Date

May 3, 2025

Last Update Submit

May 26, 2025

Conditions

Keywords

pregnant women, pregnancy, social media, healthy lifestyle

Outcome Measures

Primary Outcomes (3)

  • Developing healthy lifestyle behaviours in pregnant women

    To ensure the formation of healthy lifestyle behaviours in pregnant women It was developed by Walker et al. (1996) and adapted into Turkish by Bahar et al. (2008). Scale; Health Responsibility (3,9,15,21,27,33,39,45,51), Physical Activity (4,10,16,22,28,34,40,46), Nutrition (2,8,14,20,26,32,38,44,50), Spiritual Development (6,12,18,24,30,36,42,48, 52), Interpersonal Relationships (1,7,13,19,25,25,31,37,43,49), Stress Management (5,11,17,23,29,35,41,47). The scale was used to measure healthy lifestyle behaviors and validity and reliability studies were conducted. The Cronbach Alpha coefficient of the scale is .92 and has a high degree of reliability. The reliability coefficients of the sub-dimensions of the scale were found to be; Health responsibility .77, Physical Activity .79, Nutrition .68, Spiritual Development .79, Interpersonal Relations .80, Stress Management .64. Increasing scores in the total scale and sub-dimensions indicate a positive attitude towards healthy lifestyle beh

    8 weeks

  • Pregnant women who participate in a program to improve healthy lifestyle behaviors offered through Instagram will have better sleep quality.

    Since there is no section evaluating sleep in the Healthy Lifestyle Behaviors Scale, it was found appropriate to use a separate scale. The DSM-5 Sleep Disorder Scale was developed to measure the severity of sleep problems according to DSM-5 criteria (Yu et al. 2012; Yüzeren et al. 2017; https://www.psychiatry.org). The scale, also known as PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disorder Scale Short Form, is a well-structured measurement tool (Yüzeren et al. 2017; Ravyts et al. 2021) and has been used in pregnant women (Haas et al. 2016; Bei et al. 2019). The validity and reliability study of the DSM-5 Sleep Disorder Scale Turkish Form (PROMIS-Sleep Disorder Scale-Short Form) (ANNEX-6), which is planned to be used in this study, was conducted by Yüzeren et al. in 2017. The scale, which is suitable for adults, is filled out by taking into account the sleep patterns and quality of people between the ages of 18-75 in the last seven days.

    8 weeks

  • Pregnant women who participate in a program to improve healthy lifestyle behaviors offered through the Instagram platform may have a more positive attitude towards endocrine disruptors.

    Endocrine Disruptors Attitude Scale (EDAS): Since the Healthy Lifestyle Behaviors Scale does not have a section evaluating the attitude towards endocrine disruptors, it was found appropriate to use a separate scale. The scale was developed by Miral et al (2022) to determine adults' attitudes towards endocrine disruptors and consists of 21 items. The endocrine disruptors attitude scale has two sub-dimensions: consumer behavior and nutrition and hygiene. The consumer behavior sub-dimension consists of 11 items in total, including items numbered 1,2,7,8,9,9,10,10,11,12,12,13,18,21. The nutrition and hygiene sub-dimension consists of 10 items in total, including items numbered 3,4,5,6,14,15,16,17,19,20. The scale was prepared as a five-point Likert-type scale as "Strongly agree", "Agree", "Neutral", "Disagree", "Strongly disagree". There are no reverse items in the scale. The highest score to be obtained from the scale, which has no cut-off value, is 105 and the lowest score is 21.

    8 weeks

Study Arms (2)

social media participants

EXPERIMENTAL

In addition to routine care and counseling, pregnant women in the experimental group will be offered support to develop healthy lifestyle behaviors through Instagram. * Creating and naming the Instagram account for the presentation of the programme planned to create Healthy Lifestyle Behaviours, * Creating programme contents for developing Healthy Lifestyle Behaviours, * Transferring the content prepared to develop Healthy Lifestyle Behaviours to the Instagram platform, * Sharing the training on developing Healthy Lifestyle Behaviours with pregnant women in the experimental group via Instagram and trying to create these behaviours in pregnant women, * It is planned to reveal the effect of the content aimed at developing Healthy Lifestyle Behaviours on the acquisition of healthy living habits of pregnant women by presenting them through Instagram with a randomised controlled study.

Behavioral: counselling

Control

OTHER

The control group will not be trained in Instagram, but will be provided with standardised medical care established by the Turkish Ministry of Health during the follow-up period.

Other: Control

Interventions

counsellingBEHAVIORAL

After the participants in the experimental group signed the 'Informed Consent Form', the Instagram addresses actively used by the pregnant women participating in the study will be taken, the Instagram account created by the researcher will be shared with the pregnant women in the experimental group, the participants will be ensured to follow the Instagram address created by the researcher and join the Instagram DM group. After the participation to the platform is completed, the visibility of the participants in the account will be checked. After the visibility of all participants is ensured, pre-tests created in Google Forms and uploaded to WhatsApp and Instagram DM group will be applied.

social media participants
ControlOTHER

After the 'Informed Consent Form' is signed by the pregnant women in the control group, the telephone numbers of the participants will be taken and recorded in the directory. Participants will also be asked to save the researcher's phone number. After being registered in the phone book, questionnaires and scales will be shared via WhatsApp and asked to answer the pre-tests prepared in Google Forms. Pregnant women who answer will be asked to return with a WhatsApp message in the form of 'I answered' or 'I sent'. The control group will not be trained on Instagram, but will be provided with standardised medical care established by the Turkish Ministry of Health during the follow-up period.

Control

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe group to be trained during their pregnancy consists of women.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • First and second trimester pregnancy
  • years old
  • With a singleton pregnancy
  • Able to use web and mobile devices
  • Has an account of the determined social media platform and actively uses it
  • Can read and write Turkish

You may not qualify if:

  • Has a psychiatric problem that prevents communication
  • Have a serious pre-pregnancy condition (heart disease, kidney disease or other chronic disease)
  • Previously used a similar programme or app to change healthy lifestyle habits
  • Risky pregnancies (heart disease, kidney disease or other chronic diseases)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • Stephenson J, Heslehurst N, Hall J, Schoenaker DAJM, Hutchinson J, Cade JE, Poston L, Barrett G, Crozier SR, Barker M, Kumaran K, Yajnik CS, Baird J, Mishra GD. Before the beginning: nutrition and lifestyle in the preconception period and its importance for future health. Lancet. 2018 May 5;391(10132):1830-1841. doi: 10.1016/S0140-6736(18)30311-8. Epub 2018 Apr 16.

    PMID: 29673873BACKGROUND
  • Oli N, Vaidya A, Pahkala K, Eiben G, Krettek A. Knowledge, attitude and practice on diet and physical activity among mothers with young children in the Jhaukhel-Duwakot Health Demographic Surveillance Site, Nepal. PLoS One. 2018 Jul 9;13(7):e0200329. doi: 10.1371/journal.pone.0200329. eCollection 2018.

    PMID: 29985946BACKGROUND
  • Katenga-Kaunda LZ, Kamudoni PR, Holmboe-Ottesen G, Fjeld HE, Mdala I, Shi Z, Iversen PO. Enhancing nutrition knowledge and dietary diversity among rural pregnant women in Malawi: a randomized controlled trial. BMC Pregnancy Childbirth. 2021 Sep 22;21(1):644. doi: 10.1186/s12884-021-04117-5.

    PMID: 34551744BACKGROUND
  • Hojeij B, Schoenmakers S, Willemsen S, van Rossem L, Dinnyes A, Rousian M, Steegers-Theunissen RP. The Effect of an eHealth Coaching Program (Smarter Pregnancy) on Attitudes and Practices Toward Periconception Lifestyle Behaviors in Women Attempting Pregnancy: Prospective Study. J Med Internet Res. 2023 Jan 31;25:e39321. doi: 10.2196/39321.

    PMID: 36719733BACKGROUND

Related Links

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Neslihan Özcan, Prof. Dr.

    Istanbul Univercity-Cerrahpasa

    STUDY DIRECTOR

Central Study Contacts

Özlem Taş, PhD. Candidate

CONTACT

Neslihan Özcan, Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The research will be conducted in a prospective pre-test, post-test randomised controlled experimental research design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

May 3, 2025

First Posted

June 4, 2025

Study Start

September 2, 2025

Primary Completion

April 1, 2026

Study Completion (Estimated)

May 30, 2026

Last Updated

June 4, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations