Physical ActivityNCT04033016
Use of Motivational Interviewing for Promotion of Physical Activity During Pregnancy
A study testing motivational interviewing and online social media intervention in people with Physical Activity, run by University of Belgrade at 1 site in Serbia.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Physical Activity
- What is being tested?
- motivational interviewing and online social media intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteSerbia
- Study dates
- 11 Jan 2018to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women without medical or obstetric contraindication for physical activity during pregnancy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Clinical Center of Serbia, Clinic for Gynecology and Obstetrics
Belgrade, 11000
About this study
Official title: The Influence of Motivational Public Health Intervention for Improvement of Physical Activity During Pregnancy
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.
- Conditions
- Physical Activity
- Being tested
- motivational interviewing, online social media intervention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational interviewingBehavioural
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.
online social media interventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Facebook and motivational interviewing group | Experimental | Women from this group were included in social media intervention and in two sessions of motivational interviewing. Receives: Behavioral: motivational interviewing; Behavioral: online social media intervention |
| Facebook only group | Experimental | Women from this group were included in the social media intervention only. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leisure time physical activity in second trimester
leisure time physical activity is expressed in MET-minutes/week, which is a measure of energy expenditure.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start11 Jan 2018
- Primary completion15 Oct 2018
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todorovic Jovana, University of Belgrade
- Investigators
- Jovana S Todorovic, MD, Principal investigator, University of Belgrade, Faculty of Medicine, Institute of Social MedicineMiroslava Gojnic-Dugalic, MD, PhD, Study chair, Clinical Center of Serbia, Clinic for Gynecology and Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033016
- Sponsor's protocol ID
- MI and pregnancy PA
- Status last verified
- Jul 2019
- First submitted
- 23 Jul 2019
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Motivational Public Health Intervention for Improvement of Physical Activity During Pregnancy
- ClinicalTrials.gov ID
- NCT04033016
- Acronym / sponsor ID
- MI and pregnancy PA
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 25 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Facebook and motivational interviewing group | Experimental | Behavioral: motivational interviewing, Behavioral: online social media interventionWomen from this group were included in social media intervention and in two sessions of motivational interviewing. |
| Facebook only group | Experimental | Behavioral: online social media interventionWomen from this group were included in the social media intervention only. |
| control group | No intervention | –women from this group only received the information on the benefits of physical activity during pregnancy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women without medical or obstetric contraindication for physical activity during pregnancy.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| motivational interviewingMotivational 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. | Behavioural | Facebook and motivational interviewing group |
| online social media interventionFacebook 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). | Behavioural | Facebook and motivational interviewing group, Facebook only group |
Primary outcome
Leisure time physical activity in second trimester
Time frame: 3 months
leisure time physical activity is expressed in MET-minutes/week, which is a measure of energy expenditure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motivational interviewing and online social media intervention in people with Physical Activity, run by University of Belgrade at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leisure time physical activity in second trimester (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.