NCT04033016

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2019

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

9 months

First QC Date

July 23, 2019

Last Update Submit

July 25, 2019

Conditions

Outcome Measures

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.

    3 months

Study Arms (3)

Facebook and motivational interviewing group

EXPERIMENTAL

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

Behavioral: motivational interviewingBehavioral: online social media intervention

Facebook only group

EXPERIMENTAL

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

Behavioral: online social media intervention

control group

NO INTERVENTION

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

Interventions

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.

Facebook and motivational interviewing group

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).

Facebook and motivational interviewing groupFacebook only group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Center of Serbia, Clinic for Gynecology and Obstetrics

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jovana S Todorovic, MD

    University of Belgrade, Faculty of Medicine, Institute of Social Medicine

    PRINCIPAL INVESTIGATOR
  • Miroslava Gojnic-Dugalic, MD, PhD

    Clinical Center of Serbia, Clinic for Gynecology and Obstetrics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
teaching assistant

Study Record Dates

First Submitted

July 23, 2019

First Posted

July 25, 2019

Study Start

January 11, 2018

Primary Completion

October 15, 2018

Study Completion

April 30, 2019

Last Updated

July 26, 2019

Record last verified: 2019-07

Locations