Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542679
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Pregnancy Weight Management Mobile Health App
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development and Testing of a Theory-Based Mobile Health App for Weight Management in Pregnancy A Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed as a single-blind parallel-group randomized controlled trial to develop a mobile health application based on the Information-Motivation-Behavioral Skills IMB Model and Social Cognitive Theory for gestational weight management and to examine the effect of the mobile application on weight management during pregnancy The primary aim is to achieve gestational weight gain following the Institute of Medicine IOM guidelines Secondary aims include improving attitudes towards healthy eating during pregnancy increasing physical activity levels and enhancing maternal pregnancy childbirth and postpartum period and fetal weight etc health outcomes
The hypotheses of the study are as follows
1 H1 Hypothesis The intervention group using the mobile application will have a higher rate of gestational weight gain by IOM guideline recommendations compared to the control group One-tailed H1 hypothesis
2 H1 Hypothesis The intervention group using the mobile application will have a higher score on the healthy eating attitude scale compared to the control group One-tailed H1 hypothesis
3 H1 Hypothesis The intervention group using the mobile application will have a higher level of physical activity compared to the control group One-tailed H1 hypothesis
4 H1 Hypothesis The intervention group will have a higher score on the healthy eating attitude scale after using the mobile application compared to before One-tailed H1 hypothesis
5 H1 Hypothesis The intervention group will have a higher level of physical activity after using the mobile application compared to before One-tailed H1 hypothesis
6 H1 Hypothesis Women with appropriate gestational weight gain will have a lower perinatal risk rate than women with excessive gestational weight gain One-tailed H1 hypothesis
Participant Population
Age between 18-45 years
Singleton pregnancy
Literate in Turkish
Gestational age 12 weeks
Pre-pregnancypregnancy Body Mass Index BMI between 185-399 kgm² normal overweight and obese individuals
Ownership of a smartphone
The hypotheses of the study are as follows
1 H1 Hypothesis The intervention group using the mobile application will have a higher rate of gestational weight gain by IOM guideline recommendations compared to the control group One-tailed H1 hypothesis
2 H1 Hypothesis The intervention group using the mobile application will have a higher score on the healthy eating attitude scale compared to the control group One-tailed H1 hypothesis
3 H1 Hypothesis The intervention group using the mobile application will have a higher level of physical activity compared to the control group One-tailed H1 hypothesis
4 H1 Hypothesis The intervention group will have a higher score on the healthy eating attitude scale after using the mobile application compared to before One-tailed H1 hypothesis
5 H1 Hypothesis The intervention group will have a higher level of physical activity after using the mobile application compared to before One-tailed H1 hypothesis
6 H1 Hypothesis Women with appropriate gestational weight gain will have a lower perinatal risk rate than women with excessive gestational weight gain One-tailed H1 hypothesis
Participant Population
Age between 18-45 years
Singleton pregnancy
Literate in Turkish
Gestational age 12 weeks
Pre-pregnancypregnancy Body Mass Index BMI between 185-399 kgm² normal overweight and obese individuals
Ownership of a smartphone
Detailed Description:
During the data collection phase pregnant women will first fill out the Enrollment Criteria and Preliminary Registration Form to create their records determining included and excluded participants After preliminary tests participants will be divided into intervention and control groups using stratified randomization based on their BMI Participants will be stratified into normal BMI overweight and obese BMI categories Pregnant women who meet the inclusion criteria will be given general information about the study and their written and verbal consent will be obtained Pregnant women will be included in the study by the 12th week of pregnancy andor earlier and after their information and preliminary tests are collected those in the intervention group will start using the mobile application when they reach the 12th week of pregnancy
Data for the study will be collected using the Pregnancy Introduction Form which includes sociodemographic information about the pregnant women the Follow-up Form which includes information from interim and final follow-ups the Healthy Eating Attitude Scale developed to measure the attitude towards healthy eating and the International Physical Activity Questionnaire to determine physical activity levels Interim follow-ups of pregnant women in both groups will be conducted at the 24th week of pregnancy during which the Follow-up Form Healthy Eating Attitude Scale and International Physical Activity Questionnaire will be administered and current weight and height will be recorded Similarly the final follow-up will be conducted during the last prenatal check-up 38th week of pregnancy where the same forms and measurements will be repeated At the end of the study to objectively evaluate participants in the intervention group the User Version of the Mobile Application Rating Scale uMARS will be applied within the first week after birth to evaluate the mobile application
The control group will receive routine care following the Ministry of Healths Prenatal Care Management Guide of the Republic of Turkey To enhance adherence among control group participants weekly antenatal health information unrelated to healthy eating physical activity and weight management will be provided via phone Interim follow-ups will be conducted face-to-face during routine check-ups for OGTT at the 24th week of pregnancy during which the Follow-up Form Healthy Eating Attitude Scale and International Physical Activity Questionnaire-Short Form will be administered and current weights will be measured with a standard simple scale brought by the researcher same scale and recorded The final follow-up will be conducted face-to-face during the last prenatal check-up at the 38th week of pregnancy where the Follow-up Form Healthy Eating Attitude Scale and International Physical Activity Questionnaire-Short Form will be administered again and current weights will be measured with the same scale
In addition to the routine care provided according to the Turkish Ministry of Healths Prenatal Care Management Guidelines the intervention group will receive a mobile application intervention The intervention mobile application will begin in the 12th week of pregnancy Participants in the intervention group will start using the mobile application at the 12th week of pregnancy and continue to use it throughout their pregnancy The content of the mobile application includes information on healthy nutrition and exercise during pregnancy as well as monitoring and notifications Pregnant women will be guided encouraged and monitored for healthy nutrition and exercise through the mobile application
At the 24th week of pregnancy interim assessments will be conducted for the participants in the intervention group These assessments will include the Tracking Form the Attitude Scale Towards Healthy Nutrition and the Short Form of the International Physical Activity Questionnaire administered face-to-face during routine check-ups The current weight of the participants will be measured using a standard scale the same scale brought by the researcher and the data will be recorded
The final assessment for the group will be conducted during the last prenatal check-up at the 38th week of pregnancy where the Tracking Form the Attitude Scale Towards Healthy Nutrition and the Short Form of the International Physical Activity Questionnaire will be administered face-to-face and the current weight will be measured using the same scale
At the end of the study within the first week after childbirth participants in the intervention group will be asked to evaluate the mobile application using the User Version of the Mobile Application Rating Scale uMARS
Data for the study will be collected using the Pregnancy Introduction Form which includes sociodemographic information about the pregnant women the Follow-up Form which includes information from interim and final follow-ups the Healthy Eating Attitude Scale developed to measure the attitude towards healthy eating and the International Physical Activity Questionnaire to determine physical activity levels Interim follow-ups of pregnant women in both groups will be conducted at the 24th week of pregnancy during which the Follow-up Form Healthy Eating Attitude Scale and International Physical Activity Questionnaire will be administered and current weight and height will be recorded Similarly the final follow-up will be conducted during the last prenatal check-up 38th week of pregnancy where the same forms and measurements will be repeated At the end of the study to objectively evaluate participants in the intervention group the User Version of the Mobile Application Rating Scale uMARS will be applied within the first week after birth to evaluate the mobile application
The control group will receive routine care following the Ministry of Healths Prenatal Care Management Guide of the Republic of Turkey To enhance adherence among control group participants weekly antenatal health information unrelated to healthy eating physical activity and weight management will be provided via phone Interim follow-ups will be conducted face-to-face during routine check-ups for OGTT at the 24th week of pregnancy during which the Follow-up Form Healthy Eating Attitude Scale and International Physical Activity Questionnaire-Short Form will be administered and current weights will be measured with a standard simple scale brought by the researcher same scale and recorded The final follow-up will be conducted face-to-face during the last prenatal check-up at the 38th week of pregnancy where the Follow-up Form Healthy Eating Attitude Scale and International Physical Activity Questionnaire-Short Form will be administered again and current weights will be measured with the same scale
In addition to the routine care provided according to the Turkish Ministry of Healths Prenatal Care Management Guidelines the intervention group will receive a mobile application intervention The intervention mobile application will begin in the 12th week of pregnancy Participants in the intervention group will start using the mobile application at the 12th week of pregnancy and continue to use it throughout their pregnancy The content of the mobile application includes information on healthy nutrition and exercise during pregnancy as well as monitoring and notifications Pregnant women will be guided encouraged and monitored for healthy nutrition and exercise through the mobile application
At the 24th week of pregnancy interim assessments will be conducted for the participants in the intervention group These assessments will include the Tracking Form the Attitude Scale Towards Healthy Nutrition and the Short Form of the International Physical Activity Questionnaire administered face-to-face during routine check-ups The current weight of the participants will be measured using a standard scale the same scale brought by the researcher and the data will be recorded
The final assessment for the group will be conducted during the last prenatal check-up at the 38th week of pregnancy where the Tracking Form the Attitude Scale Towards Healthy Nutrition and the Short Form of the International Physical Activity Questionnaire will be administered face-to-face and the current weight will be measured using the same scale
At the end of the study within the first week after childbirth participants in the intervention group will be asked to evaluate the mobile application using the User Version of the Mobile Application Rating Scale uMARS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None