The Effect of Smart-Phone Interventional Messages on Gestational Weight Gain

NCT05590832 | Completed

• 1 other identifier: Gy1995
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Gestational Weight Gain

Keywords

pregnancy; gestational weight gain; weight gain during pregnancy; healthy eating; physical exercise

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  at the end of 37th week of pregnancy

Study Arms (2)

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.

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.

Interventions

Activity of Whatsapp messages BEHAVIORAL

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.

İnitiative group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: It is a study conducted with pregnant women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ordu University: lead
• Ege University: collaborator

Study Sites (1)

Ordu University

Ordu, 52200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gestational Weight Gain; Motor Activity

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The individuals included in the study were first stratified according to their BMI classes (normal, preobese, obese). Then, the BMI classes were included in the experimental and control groups in a balanced way by block randomisation method. Within each stratum, randomisation lists were generated with the help of "The random sorting randomization algorithm" (Maximum Allowable Deviation = 10%) PASS 11.0 software (NCSS LLC, Kaysville, UT). In total, participants were randomly assigned to experimental and control groups of 51 participants each.The study was completed with 96 pregnant women
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Gizem Yıldız (Master Student)

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 21, 2022
• Study Start: June 15, 2022
• Primary Completion: September 17, 2022
• Study Completion: December 30, 2022
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)