- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05590832
The Effect of Smart-Phone Interventional Messages on Gestational Weight Gain
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ordu, Turkey, 52200
- Ordu University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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,
- 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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: İnitiative group
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. |
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.
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No Intervention: Control group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gestational Weight Gain
Time Frame: Total amount of weight gained until 37 weeks of pregnancy
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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.
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Total amount of weight gained until 37 weeks of pregnancy
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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
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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.
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Compliance status of the total weight gained until the 37th week of pregnancy according to the IOM guideline
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Healthy living behavior scale score
Time Frame: at the end of 37th week of pregnancy
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healthy living behavior scale score in pregnant women
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at the end of 37th week of pregnancy
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gy1995
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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