CClinicalTrials.gg
CompletedNCT04033016Updated Jul 26, 2019

Use of Motivational Interviewing for Promotion of Physical Activity During Pregnancy

An interventional study of motivational interviewing and online social media intervention in Physical Activity, sponsored by University of Belgrade. Completed at 1 site in Serbia. Open to female participants. Per ClinicalTrials.gov, last updated 2019-07-26.

Sponsored by University of Belgrade · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Jan 2018, registered Jul 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
188
Allocation
Randomized
Sex
Female
01

Study summary

We conducted a randomized control trial to assess the differences in the increase in PA among pregnant women who were included in the online social media intervention (Facebook group), the combination of online social media intervention and MI (Facebook and MI group) and control group. The study was conducted from January 2018 to April 2019 at the Clinic for Gynecology and Obstetrics, Clinical Centre of Serbia and Institute of Social Medicine, Medical Faculty, University of Belgrade. The women were approached after the prenatal screening at the 12th week of gestation. The intervention lasted through the second trimester. The reassessment was done at the end of the second trimester. The final analysis included 134 women.

Read the detailed description

The study was designed as a randomized controlled clinical trial and was conducted from January of 2018 to April 2019, at the Clinic for Gynaecology and Obstetrics, Clinical Centre of Serbia, Belgrade and the Institute for Social Medicine, Medical Faculty, University of Belgrade. The study compared the physical activity in the second trimester of pregnancy of the pregnant women who were included in the intervention groups (Facebook group and Facebook and MI group) and pregnant women from the control group. The intervention lasted for three months (from 12th till 28th week of gestation).

Total of 227 women were approached after the double test screening at the end of the first trimester (12th week of gestation). All women without medical or obstetric contraindications for physical activity were included in the study.

Baseline questionnaire consisted of 85 questions divided into five sections: social characteristics (age, place of residence, marital status, education, employment status, self-rated health, self-perceived financial status), anthropometric characteristics (height, weight, waist circumference), pregnancy and lifestyle characteristics (planning a pregnancy, symptoms present during the first trimester, and diet), and physical activity (leisure-time physical activity in the period of three months before pregnancy and physical activity during the first trimester).

At the baseline level, participants filled in the questionnaire and anthropometric measures were recorded. Anthropometric measures, height, weight and waist circumference, were measured by one of the researchers. Randomization was done after the initial baseline measurements. The follow-up measurement was done three months after the baseline, and all participants were asked to fill in the questionnaire which referred to physical activity in the second trimester.

The intervention involved social media intervention and Motivational interviewing.

Facebook group was specially designed for purposes of intervention and was administered by the research team. It was used to motivate the participants to be more physically active. The intervention used a hybrid approach. Motivation was done through health promotion campaign with motivational messages and pictures, journal articles, questions with the aim to spark a discussion on barriers or possibilities for physical activity ('What is your favourite form of physical activity?', 'Do you think that physical activity is safe during pregnancy?', 'Would you like to be more active during pregnancy?', etc). Facebook discussion group used a participatory approach and all members were allowed to post motivational messages or questions for their peers. The reports and photos from organized events (walking, yoga) were also posted regularly, so all participants could follow the level of participation of others. The research team shared information on free sports activities for pregnant women in multiple sports centres in Belgrade, as well as, specially organized events (walking around the lake, yoga).

Women who were randomized in the MI group went through two sessions of MI with the principal researcher. The first MI session was scheduled in the week after the inclusion in the study and the second was after 10-14 days. Each session lasted between 30 and 45 minutes. The principal researcher, who conducted the MI went to certified international training in MI.

02

Conditions studied

  • Physical Activity
03

In context

Lead sponsor

University of Belgrade is the lead sponsor of 70 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Women without medical or obstetric contraindication for physical activity during pregnancy.

Exclusion criteria

Exclusion Criteria:

  • known medical or obstetric contraindication for physical activity during pregnancy;
  • heavy smoking (>20 cigarettes per day)
  • mental inability to understand and fill in the questionnaire.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
188 participants (actual)

Study arms

  • Experimental
    Facebook and motivational interviewing group

    Women from this group were included in social media intervention and in two sessions of motivational interviewing.

    Behavioral: motivational interviewing · Behavioral: online social media intervention

  • Experimental
    Facebook only group

    Women from this group were included in the social media intervention only.

    Behavioral: online social media intervention

  • No intervention
    control group

    women from this group only received the information on the benefits of physical activity during pregnancy.

Interventions

  • Behavioralmotivational interviewing

    Motivational interviewing (MI) is a contemporary form of advisory support, which is often used for behavioral change. During the motivational interviewing educated health professional leads the counseling session by asking questions on lifestyle, attitude towards the behavioral change, and factors pro and against the change. During the MI the focus is on the patient/ client, his/her own perception of their health, understanding the reasons for current behavioral patterns, and encouragement to assess these patterns.

  • Behavioralonline social media intervention

    Facebook group was specially designed for purposes of intervention and was administered by the research team. It was used to motivate the participants to be more physically active. The intervention used hybrid approach, with health promotion campaign with motivational messages and pictures, journal articles, questions with the aim to spark a discussion on barriers or possibilities for physical activity and participatory approach (all members were allowed to post motivational messages or questions for their peers).

06

What researchers measure

Primary outcomes

  1. Leisure time physical activity in second trimester

    leisure time physical activity is expressed in MET-minutes/week, which is a measure of energy expenditure.

    Time frame: 3 months

07

Study locations

1 site
  • Clinical Center of Serbia, Clinic for Gynecology and Obstetrics
    Belgrade, 11000, Serbia
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04033016
Lead sponsor
University of Belgrade
Responsible party
Todorovic Jovana (teaching assistant, University of Belgrade) — Principal investigator
First posted
Jul 25, 2019
Start date
Jan 11, 2018
Primary completion
Oct 15, 2018
Completion
Apr 30, 2019
Last update
Jul 26, 2019

Study contacts

Jovana S Todorovic, MD
principal investigator · University of Belgrade, Faculty of Medicine, Institute of Social Medicine
Miroslava Gojnic-Dugalic, MD, PhD
study chair · Clinical Center of Serbia, Clinic for Gynecology and Obstetrics

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion