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Effectiveness of Whatsapp Messages in Gestational Weight Gain

Primary Purpose

Gestational Weight Gain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Activity of Whatsapp messages
Sponsored by
T.C. ORDU ÜNİVERSİTESİ
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Weight Gain focused on measuring pregnancy, gestational weight gain, weight gain during pregnancy, healthy eating, physical exercise

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Ordu UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

İnitiative group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Healthy living behavior scale score
healthy living behavior scale score in pregnant women

Secondary Outcome Measures

Full Information

First Posted
October 17, 2022
Last Updated
October 20, 2022
Sponsor
T.C. ORDU ÜNİVERSİTESİ
Collaborators
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT05590832
Brief Title
Effectiveness of Whatsapp Messages in Gestational Weight Gain
Official Title
Effectiveness of Whatsapp Messages in Ensuring Proper Gestational Weight Gain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
October 17, 2022 (Actual)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
T.C. ORDU ÜNİVERSİTESİ
Collaborators
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Obesity has become an epidemic all over the world. As a result of the Turkey Demographic and Health Survey (TDHS) conducted in our country in 2018, 29% of women were found to be overweight and 30% were obese. It has been determined that there is a major relationship between maternal obesity and excessive gestational weight gain (GWG) . In the prevention of maternal obesity; In 2009, the American Institute of Medicine (IOM) presented the recommendations of the American Institute of Medicine (IOM) according to the pregnancy-onset body mass index (BMI) groups in order to prevent excessive gestational weight gain (GKA) of women and to reduce the negative health consequences that may develop in the mother and baby. According to the pre-pregnancy BMI published by the American Institute of Medicine (IOM), the intended weight gain during pregnancy has also been adopted by ACOG . In recent studies; According to the recommendations of the IOM guideline of 2009, it has been determined that 43%-73% of women have excessive WHA . In societies where the prevalence of maternal obesity is rapidly increasing, weight management strategies focus especially on pregnancy and postpartum period . Pregnancy period; This is the best time for women to make an effort to develop healthy lifestyle behaviors. A combination of effective weight control interventions, healthy eating, increased physical activity, and behavioral therapy is used to prevent excessive SCA during pregnancy. While these interventions are sent in face-to-face formats; some individuals may perceive attending these sessions as a burden, possibly limiting pre-program participation. Computer and internet technology offers innovative and alternative distribution channels that can appeal to people looking for more comfortable and anonymous environments. Computer and Internet-based programs can be acceptable and successful if structured similarly to personal treatment programs . As a result; Rapid increases in internet access have become a viable and logical situation for health intervention. Based on all this, are the interventions for healthy eating and physical activity via whatsapp, an online phone application that is widely used by everyone today, effective in appropriate gestational weight gain? Based on this question, the research was planned.
Detailed Description
Study; investigates the effectiveness of WhatsApp, an online phone application, by using motivational interviewing techniques in providing appropriate gestational weight gain in pregnant women. This experimental type study will be conducted with pregnant women who are registered in Ordu University Training and Research Hospital, Obstetrics and Gynecology Polyclinic, and who meet the research criteria. According to studies in the literature, it is stated that 30-40% of pregnant women adhere to the IOM guideline recommendation . At the beginning of the study, the rate of those who adhered to the IOM weight gain guide was accepted as 40% and it was aimed to increase this rate from 40 to 70% with messages containing internet and whatsapp. At the beginning of the study, at the significance level of alpha = 0.05, the sample size required to achieve 80% power was determined as 48 pregnant women for each group and a total of 96 women. After the pregnant women who are suitable for the study are determined, the consent form, the Individual Identification Form, the Scale of Healthy Life Behaviors in Pregnants, the Physical Activity Questionnaire in Pregnancy, and the Weight Monitoring Chart to be used in the research will be filled using the face-to-face interview technique. At the first meeting, women's height and pregnancy starting weight will be recorded and BMI will be calculated. For women who do not remember their initial pregnancy weight, pregnancy- puerperal follow-up forms will be used and weight measurements up to the first 10 weeks of pregnancy will be discussed. Filling out the forms will take an average of 10-15 minutes. Collection of research data; determination of pregnant women suitable for the study, randomization phase, intervention and follow-up phases. The pre-test data of all pregnant women who participated in the study at first were simultaneously 12-18. will be collected at the week of pregnancy and then randomization will be done. After the determination of the women participating in the study and the collection of pre-test data, randomization will be made by drawing lots. In addition, randomization will be ensured by ensuring homogeneity between the BMI status of the women in the intervention and control groups. Information messages about healthy nutrition and physical activity will be sent to the intervention group pregnant women via whatsapp. The study will continue 3 times a week until the 37th week and once a week after the 37th week. In order to remind the control group once a month for routine prenatal care and to prevent them from leaving the study. message will be sent. Pre-test data of intervention and control groups 12-18. and post-test data will be collected at 36-38 weeks of gestation. For data analysis; The analysis of the data obtained in the research will be done with the statistical package program. Descriptive statistics in data analysis (socio-demographic characteristics of pregnant women and their spouses, family characteristics, pregnancy/obstetric characteristics); will be displayed as numbers and percentages. Kruskal-Wallis analysis of variance in order to determine the relationship between the mean BMI levels of pregnant women and their age groups, education levels, education levels of their spouses, income status, number of children, gestational week, pregnancy planning status, pre-pregnancy BMI, number of receiving antenatal care during pregnancy, Then, it will be analyzed using the Tukey HSD test and Tamhane 2 test, which are "post hoc" multiple comparison methods. Again, BMI levels of pregnant women will be evaluated by analysis of variance (ANOVA) in order to determine the relationship between their average score and the duration of marriage, their spouse's occupation, the place where they live most, and the number of pregnancies, and then the Tukey HSD test and Tamhane 2 test, which are "post hoc" multiple comparison methods.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Weight Gain
Keywords
pregnancy, gestational weight gain, weight gain during pregnancy, healthy eating, physical exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
96 pregnant women who met the criteria for inclusion in the study and volunteered to participate in the study were divided into control and intervention groups by the statistical unit, using the randomization technique, using a simple random numbers table. Randomization was achieved by ensuring homogeneity between the BMI status of the women in the intervention and control groups.
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
İnitiative group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Activity of Whatsapp messages
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gestational Weight Gain
Description
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.
Time Frame
Total amount of weight gained until 37 weeks of pregnancy
Title
Appropriate GWG ratios with IOM guideline
Description
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.
Time Frame
Compliance status of the total weight gained until the 37th week of pregnancy according to the IOM guideline
Title
Healthy living behavior scale score
Description
healthy living behavior scale score in pregnant women
Time Frame
at the end of 37th week of pregnancy

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
It is a study conducted with pregnant women.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ordu University
City
Ordu
ZIP/Postal Code
52200
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gizem Yıldız, Res.Assist.
Phone
04522265200
Ext
6409
Email
gizemg.2795@gmail.com
First Name & Middle Initial & Last Name & Degree
Gizem Yıldız, Res.Assist.
First Name & Middle Initial & Last Name & Degree
Zeynep Dasikan, Assc.Prof.

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Whatsapp Messages in Gestational Weight Gain

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