Gestational Weight GainNCT05590832
The Effect of Smart-Phone Interventional Messages on Gestational Weight Gain
A study testing Activity of Whatsapp messages in people with Gestational Weight Gain, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
Methods: The study is a randomized controlled experimental study. Groups were determined by stratified randomization according to the BMI of the pregnant women. In the study, individual identification form, Healthy Living Behaviors in Pregnancy Scale (HLBPS), and maternal questionnaire were used. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Weight Gain
- What is being tested?
- Activity of Whatsapp messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2022to 30 Dec 2022
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18-45,
- Using Whatsapp,
- Having a smart phone and using the internet,
- At least primary school graduate/literate,
- Does not have any chronic and psychological disorders,
- Having spontaneous pregnancy,
Show all 10Show fewer
- Volunteer to participate in the research,
- Pregnancy below the 16th week of participation in the study,
- Not having any physical disability,
- Pregnant women with low pregnancies with low BMI and not morbidly obese were included in the study.
Who cannot join
- Dropping out of research participation and initiative program,
- Low,
- Giving birth before 37 weeks,
- Having multiple pregnancy,
- Those who did not have a spontaneous pregnancy were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Smart-Phone Interventional Messages on Gestational Weight Gain: A Randomized Controlled Study
Methods: The study is a randomized controlled experimental study. Groups were determined by stratified randomization according to the BMI of the pregnant women. In the study, individual identification form, Healthy Living Behaviors in Pregnancy Scale (HLBPS), and maternal questionnaire were used. The initiative program was carried out via WhatsApp messages on a smartphone. Messages regarding routine prenatal care were sent to the intervention group three times a week, and to the control group once a month, about appropriate weight gain, nutrition, and physical activity via WhatsApp.
Results: The mean gestational weight gain was 13.1±4.3 in the intervention group and 14.6±4.2 in the control group, and no significant difference was found between the groups. According to the IOM guideline, there was a significant difference between the groups in terms of appropriate GWG , while no significant difference was found between excessive GWG.HLBPS scale total score, nutrition and physical activity post-test mean scores increased significantly in the intervention group compared to the control group. In the intervention group, the group/time interaction in the scale total score, nutrition and physical activity scores of the pregnant women who gained appropriate weight according to the IOM guideline was significant, and the intervention was effective.Significant differences were found between the groups in the pretest-posttest score differences in the HLBPS total score, nutrition and physical activity sub-dimensions of the pregnant women.
Conclusion: Healthy nutrition and physical activity short message intervention with a smart phone increased the appropriate gestational weight gain rates of pregnants in the intervention group according to the IOM guideline, and the intervention was effective. However, there was no difference between the groups in terms of excessive gestational weight gain. It is recommended to conduct studies with a high level of evidence, including internet and social media applications, with larger samples.
Read the detailed description
Most of the descriptive characteristics of the intervention and control group pregnant women who participated in the study were homogenously distributed (p>0.05). A significant difference was found only between gestational week and place of residence (p<0.05).The mean total GWG of all pregnant women participating in the study was 13.9±4.3/kg. The mean difference between the intervention (13.1±4.3/kg) and control group (14.6±4.2/kg) pregnant women was 1.5 kg, but no significant difference was found between the groups (p>0.05). The rate of GWG within the limits of IOM guideline recommendations in the intervention group pregnant women (48.9%) was significantly higher than in the control group (22.2%) (p<0.05). Excessive GWG was found to be higher in the control group (68.9%) than in the intervention group (48.9%), but no significant difference was found (p>0.05).In the pre-intervention, pre-test data, pregnancy responsibility, nutrition and physical activity and HLBPS total scores were higher in the intervention group than in the control group (p<0.05). While no significant difference was found between the groups in the post-test scores of the pregnancy responsibility sub-dimension of the intervention/control group pregnant women (p>0.05), a statistically significant difference was found in both intervention (p<0.001) and control groups (p<0.001) in the in-group pre-post comparison. While there was a significant increase in the intra-group nutrition, physical activity sub-dimension and HLBPS total score of the intervention group pregnant women (p<0.001), no significant increase was observed in the control group (p>0.05). In the post-test comparison between groups, nutrition, physical activity sub-dimension score and HLBPS total score increased significantly in the intervention group compared to the control group (p<0.001). While the nutrition sub-dimension score of the intervention group was effective in appropriate GWG, it was not effective in the control group. Physical activity sub-dimension and HLBPS total score were effective in appropriate GWG in both intervention and control groups.
- Conditions
- Gestational Weight Gain
- Being tested
- Activity of Whatsapp messages
- Keywords
- pregnancy, gestational weight gain, weight gain during pregnancy, healthy eating, physical exercise
- Medical subject headings
- Gestational Weight Gain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity of Whatsapp messagesBehavioural
Informative messages will be sent to the initiative group on Mondays, Wednesdays and Fridays for the first 10 weeks / three times a week (up to the 28th week), and reminder messages will be sent once a week on Wednesdays between the 29th-36th weeks.
| Study group | Role | What they receive |
|---|---|---|
| İnitiative group | Experimental | All pregnant women participating in the study were divided into intervention and control groups by applying randomization. Pre-test data of both groups will be collected before 18th gestational week, and post-test data will be collected after 37th gestational week.
Pregnant women assigned to the initiative group were added to a group established via Whatsapp. Information messages will be sent via Whatsapp on Mondays, Wednesdays and Fridays for the first 10 weeks / three times a week (up to the 28th week), and reminder messages will be sent once a week on Wednesdays between the 29th-36th weeks. When necessary, individual messages will be sent to the pregnant women and special directions will be given according to their weight gain rates. Receives: Behavioral: Activity of Whatsapp messages |
| Control group | No intervention | In the same way, a Whatsapp group will be set up to the control group and messages will be sent once a month about the subjects included in antenatal care up to 37 weeks. Topics included in routine maintenance will be included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational Weight Gain
Gestational weight gain rate in line with IOM guideline, Thanks to the intervention, it is expected that the average weight gain of the pregnant women in the intervention group will be lower than the control group.
Measured: Total amount of weight gained until 37 weeks of pregnancy
Appropriate GWG ratios with IOM guideline
Compliance with the IOM guideline 2009,Thanks to the intervention, it is expected that the pregnant women in the intervention group will have higher rates of appropriate weight gain according to the 2009 IOM guideline compared to the control group.
Measured: Compliance status of the total weight gained until the 37th week of pregnancy according to the IOM guideline
Healthy living behavior scale score
healthy living behavior scale score in pregnant women
Measured: at the end of 37th week of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start15 Jun 2022
- Primary completion17 Sep 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Weight GainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Principal investigator, Gizem Yıldız, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590832
- Sponsor's protocol ID
- Gy1995
- Status last verified
- Nov 2023
- First submitted
- 17 Oct 2022
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Smart-Phone Interventional Messages on Gestational Weight Gain: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05590832
- Acronym / sponsor ID
- Gy1995
- Conditions
- Gestational Weight Gain
- Keywords
- pregnancy, gestational weight gain, weight gain during pregnancy, healthy eating, physical exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 17 Sep 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 21 Oct 2022 (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.
Methods: The study is a randomized controlled experimental study. Groups were determined by stratified randomization according to the BMI of the pregnant women. In the study, individual identification form, Healthy Living Behaviors in Pregnancy Scale (HLBPS), and maternal questionnaire were used. The initiative program was carried out via WhatsApp messages on a smartphone. Messages regarding routine prenatal care were sent to the intervention group three times a week, and to the control group once a month, about appropriate weight gain, nutrition, and physical activity via WhatsApp.
Results: The mean gestational weight gain was 13.1±4.3 in the intervention group and 14.6±4.2 in the control group, and no significant difference was found between the groups. According to the IOM guideline, there was a significant difference between the groups in terms of appropriate GWG , while no significant difference was found between excessive GWG.HLBPS scale total score, nutrition and physical activity post-test mean scores increased significantly in the intervention group compared to the control group. In the intervention group, the group/time interaction in the scale total score, nutrition and physical activity scores of the pregnant women who gained appropriate weight according to the IOM guideline was significant, and the intervention was effective.Significant differences were found between the groups in the pretest-posttest score differences in the HLBPS total score, nutrition and physical activity sub-dimensions of the pregnant women.
Conclusion: Healthy nutrition and physical activity short message intervention with a smart phone increased the appropriate gestational weight gain rates of pregnants in the intervention group according to the IOM guideline, and the intervention was effective. However, there was no difference between the groups in terms of excessive gestational weight gain. It is recommended to conduct studies with a high level of evidence, including internet and social media applications, with larger samples.
Detailed description
Most of the descriptive characteristics of the intervention and control group pregnant women who participated in the study were homogenously distributed (p>0.05). A significant difference was found only between gestational week and place of residence (p<0.05).The mean total GWG of all pregnant women participating in the study was 13.9±4.3/kg. The mean difference between the intervention (13.1±4.3/kg) and control group (14.6±4.2/kg) pregnant women was 1.5 kg, but no significant difference was found between the groups (p>0.05). The rate of GWG within the limits of IOM guideline recommendations in the intervention group pregnant women (48.9%) was significantly higher than in the control group (22.2%) (p<0.05). Excessive GWG was found to be higher in the control group (68.9%) than in the intervention group (48.9%), but no significant difference was found (p>0.05).In the pre-intervention, pre-test data, pregnancy responsibility, nutrition and physical activity and HLBPS total scores were higher in the intervention group than in the control group (p<0.05). While no significant difference was found between the groups in the post-test scores of the pregnancy responsibility sub-dimension of the intervention/control group pregnant women (p>0.05), a statistically significant difference was found in both intervention (p<0.001) and control groups (p<0.001) in the in-group pre-post comparison. While there was a significant increase in the intra-group nutrition, physical activity sub-dimension and HLBPS total score of the intervention group pregnant women (p<0.001), no significant increase was observed in the control group (p>0.05). In the post-test comparison between groups, nutrition, physical activity sub-dimension score and HLBPS total score increased significantly in the intervention group compared to the control group (p<0.001). While the nutrition sub-dimension score of the intervention group was effective in appropriate GWG, it was not effective in the control group. Physical activity sub-dimension and HLBPS total score were effective in appropriate GWG in both intervention and control groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| İnitiative group | Experimental | Behavioral: Activity of Whatsapp messagesAll pregnant women participating in the study were divided into intervention and control groups by applying randomization. Pre-test data of both groups will be collected before 18th gestational week, and post-test data will be collected after 37th gestational week. Pregnant women assigned to the initiative group were added to a group established via Whatsapp. Information messages will be sent via Whatsapp on Mondays, Wednesdays and Fridays for the first 10 weeks / three times a week (up to the 28th week), and reminder messages will be sent once a week on Wednesdays between the 29th-36th weeks. When necessary, individual messages will be sent to the pregnant women and special directions will be given according to their weight gain rates. |
| Control group | No intervention | –In the same way, a Whatsapp group will be set up to the control group and messages will be sent once a month about the subjects included in antenatal care up to 37 weeks. Topics included in routine maintenance will be included. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Between the ages of 18-45,
- Using Whatsapp,
- Having a smart phone and using the internet,
- At least primary school graduate/literate,
- Does not have any chronic and psychological disorders,
Key exclusion criteria (5 listed)
- Dropping out of research participation and initiative program,
- Low,
- Giving birth before 37 weeks,
- Having multiple pregnancy,
- Those who did not have a spontaneous pregnancy were not included in the study.
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 |
|---|---|---|
| Activity of Whatsapp messagesInformative messages will be sent to the initiative group on Mondays, Wednesdays and Fridays for the first 10 weeks / three times a week (up to the 28th week), and reminder messages will be sent once a week on Wednesdays between the 29th-36th weeks. | Behavioural | İnitiative group |
Primary outcome
Gestational Weight Gain
Time frame: Total amount of weight gained until 37 weeks of pregnancy
Gestational weight gain rate in line with IOM guideline, Thanks to the intervention, it is expected that the average weight gain of the pregnant women in the intervention group will be lower than the control group.
Appropriate GWG ratios with IOM guideline
Time frame: Compliance status of the total weight gained until the 37th week of pregnancy according to the IOM guideline
Compliance with the IOM guideline 2009,Thanks to the intervention, it is expected that the pregnant women in the intervention group will have higher rates of appropriate weight gain according to the 2009 IOM guideline compared to the control group.
Healthy living behavior scale score
Time frame: at the end of 37th week of pregnancy
healthy living behavior scale score in pregnant women
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 7 Nov 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity of Whatsapp messages in people with Gestational Weight Gain, run by Ordu University at 1 site in Turkey (Türkiye).
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 10 inclusion and 5 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 7 Nov 2023. 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 Turkey (Türkiye). 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?
Gestational Weight Gain (time frame: Total amount of weight gained until 37 weeks of pregnancy). The study lists 3 primary outcomes in all. 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 7 Nov 2023.