Gestational Weight GainNCT06542679
Pregnancy Weight Management Mobile Health App
A study testing Mobile Application in people with Gestational Weight Gain, run by Seda ÇETİN AVCI at 1 site in Turkey (Türkiye).
Trial 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… 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?
- Mobile Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jan 2024to 30 Oct 2024
- 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
- Aged between 18 and 45 years
- Singleton pregnancy
- Able to read and write in Turkish
- Pregnant women with a gestational age ≤ 12 weeks
- Pre-pregnancy/starting BMI between 18.5 and 39.9 kg/m² (including normal weight, overweight, and obese individuals)
- Own a smartphone
Who cannot join
- Having a multiple pregnancy
- Pre-pregnancy/starting BMI <18.5 kg/m² (underweight) or BMI >40 kg/m² (morbidly obese) (due to the need for specialized nutrition/exercise counseling)
- Pregnant following fertility treatment
- Having a diagnosis of diabetes prior to pregnancy
- Having a diagnosis of or a history of eating and nutrition disorders
- Having a history of bariatric surgery
Show all 10Show fewer
- Having diagnosed thyroid disease and/or adrenal disease
- Having a psychiatric illness or history of psychiatric illness
- Having a physical disability
- Pregnant women who do not wish to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Testing of a Theory-Based Mobile Health App for Weight Management in Pregnancy: A Randomized Controlled Trial
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:
Read more
- 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).
- 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).
- 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).
- 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).
- 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).
- 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-pregnancy/pregnancy Body Mass Index (BMI) between 18.5-39.9 kg/m² (normal, overweight, and obese individuals)
- Ownership of a smartphone
Read the 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 and/or 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 Health's 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 Health's 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).
- Conditions
- Gestational Weight Gain
- Being tested
- Mobile Application
- Keywords
- gestational weight gain, mobile application, Theory
- Medical subject headings
- Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile ApplicationBehavioural
A mobile health application based on Social Cognitive Theory (SCT) and the Information-Motivation-Behavioral Skills (IMB) model has been developed. The design of the mobile health application is grounded in SCT, the IMB model, and behavioral change interventions and techniques. The content of the mobile application is based on the 'Healthy Weight Gain Guide for Pregnancy.' The application offers a comprehensive program that provides evidence-based recommendations using self-monitoring, feedback, shaping information, goal setting, planning, and reward techniques for healthy nutrition, physical activity, and optimal gestational weight gain for pregnant women.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group will receive routine care following the Ministry of Health's 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. |
| Intervention Group | Experimental | In addition to the routine care provided according to the Turkish Ministry of Health's Prenatal Care Management Guidelines, the intervention group will receive a mobile application intervention. The intervention (mobile application) will begin at 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. Receives: Behavioral: Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effıcacy and usability of the mobile application on weight management during pregnancy
The primary outcome is to ensure gestational weight management in pregnant women in accordance with the IMB guidelines.
Measured: At 38 weeks
Secondary outcomes (4)
Effect on attitudes towards healthy eating
Percentages of healthy eating of pregnant women will be determined with the Attitudes Towards Healthy Eating Scale.The Attitudes towards Healthy Eating Scale will be employed to assess healthy eating. The scale comprises 21 items. The total score that can be obtained from the scale ranges from 21 to 105. A higher total score indicates a more positive attitude towards healthy eating. A score of 21 indicates a very low attitude, 23-42 a low attitude, 43-63 a moderate attitude, 64-84 a high attitude, and 85-105 an ideal, or optimal, attitude towards healthy eating.
Measured: At 24 and 38 weeks
Effect on physical activity level,
Physical activity levels of pregnant women will be determined with the International Physical Activity Questionnaire (IPAQ).The form comprises seven questions, the responses to which are converted to METs corresponding to basal metabolic rate. The total physical activity score (MET-min/week) is then calculated. According to the criteria established by the International Physical Activity Questionnaire, a score of 600 METs or below is indicative of an inactive (low) level of physical activity, a score between 600 and 3000 METs is indicative of a minimally active (moderately severe) level of physical activity, and a score of over 3000 METs is indicative of a very active (high severe) level of physical activity.
Measured: At 24 and 38 weeks
Effect on maternal health outcomes
The questionnaire will assess the health outcomes of pregnant women until delivery, e.g. gestational diabetes, preeclampsia,caesarean section, etc.Maternal health will not be evaluated using a scale; rather, it will be assessed through the responses provided to the questions included in the questionnaire. The presence of diabetes mellitus, pre-eclampsia, threatened preterm labour, and the mode of delivery will be determined by inquiring about these factors.
Measured: at birth
Effect on fetal health outcomes
The questionnaire will assess the health outcomes of the fetus at birth, e.g. fetal weight.Fetal health will not be assessed with a scale. It will be assessed by the questions in the questionnaire (birth weight and gestational age).
Measured: at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start16 Jan 2024
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Model description
- This study is designed as a single-blind parallel group randomized controlled trial with the aim of developing 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seda ÇETİN AVCI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seda ÇETİN AVCI, Izmir Katip Celebi University
- Investigators
- Zeynep D Zeynep DAŞIKAN, Assoc. Prof., Study director, Ege UniversitySeda Ç ÇETİN AVCI, M.S., Principal investigator, Izmir Katip Çelebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542679
- Sponsor's protocol ID
- 22-8.1T/7
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Whitaker KM, Becker C, Healy H, Wilcox S, Liu J. Women's Report of Health Care Provider Advice and Gestational Weight Gain: A Systematic Review. J Womens Health (Larchmt). 2021 Jan;30(1):73-89. doi: 10.1089/jwh.2019.8223. Epub 2020 Apr 27.
PubMed 32343926Tinius R, Duchette C, Beasley S, Blankenship M, Schoenberg N. Obstetric Patients and Healthcare Providers Perspectives to Inform Mobile App Design for Physical Activity and Weight Control During Pregnancy and Postpartum in a Rural Setting. Int J Womens Health. 2021 Apr 29;13:405-432. doi: 10.2147/IJWH.S296310. eCollection 2021.
PubMed 33953614Syed H, Slayman T, DuChene Thoma K. ACOG Committee Opinion No. 804: Physical Activity and Exercise During Pregnancy and the Postpartum Period. Obstet Gynecol. 2021 Feb 1;137(2):375-376. doi: 10.1097/AOG.0000000000004266. No abstract available.
PubMed 33481513Cetin Avci S, Dasikan Z. A theory-based mobile health application for gestational weight management: Protocol for a randomized controlled trial. Technol Health Care. 2026 Jul;34(4):489-500. doi: 10.1177/09287329251388165. Epub 2025 Nov 7.
PubMed 41204072
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Testing of a Theory-Based Mobile Health App for Weight Management in Pregnancy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06542679
- Acronym / sponsor ID
- 22-8.1T/7
- Conditions
- Gestational Weight Gain
- Keywords
- gestational weight gain, mobile application, Theory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Seda ÇETİN AVCIUniversity, hospital or other
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 7 Aug 2024 (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.
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:
- 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).
- 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).
- 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).
- 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).
- 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).
- 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-pregnancy/pregnancy Body Mass Index (BMI) between 18.5-39.9 kg/m² (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 and/or 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 Health's 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 Health's 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is designed as a single-blind parallel group randomized controlled trial with the aim of developing 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group will receive routine care following the Ministry of Health's 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. |
| Intervention Group | Experimental | Behavioral: Mobile ApplicationIn addition to the routine care provided according to the Turkish Ministry of Health's Prenatal Care Management Guidelines, the intervention group will receive a mobile application intervention. The intervention (mobile application) will begin at 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged between 18 and 45 years
- Singleton pregnancy
- Able to read and write in Turkish
- Pregnant women with a gestational age ≤ 12 weeks
- Pre-pregnancy/starting BMI between 18.5 and 39.9 kg/m² (including normal weight, overweight, and obese individuals)
Key exclusion criteria (10 listed)
- Having a multiple pregnancy
- Pre-pregnancy/starting BMI <18.5 kg/m² (underweight) or BMI >40 kg/m² (morbidly obese) (due to the need for specialized nutrition/exercise counseling)
- Pregnant following fertility treatment
- Having a diagnosis of diabetes prior to pregnancy
- Having a diagnosis of or a history of eating and nutrition disorders
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 |
|---|---|---|
| Mobile ApplicationA mobile health application based on Social Cognitive Theory (SCT) and the Information-Motivation-Behavioral Skills (IMB) model has been developed. The design of the mobile health application is grounded in SCT, the IMB model, and behavioral change interventions and techniques. The content of the mobile application is based on the 'Healthy Weight Gain Guide for Pregnancy.' The application offers a comprehensive program that provides evidence-based recommendations using self-monitoring, feedback, shaping information, goal setting, planning, and reward techniques for healthy nutrition, physical activity, and optimal gestational weight gain for pregnant women. | Behavioural | Intervention Group |
Primary outcome
Effıcacy and usability of the mobile application on weight management during pregnancy
Time frame: At 38 weeks
The primary outcome is to ensure gestational weight management in pregnant women in accordance with the IMB guidelines.
4 secondary outcomes
Effect on attitudes towards healthy eating
Time frame: At 24 and 38 weeks
Effect on physical activity level,
Time frame: At 24 and 38 weeks
Effect on maternal health outcomes
Time frame: at birth
Effect on fetal health outcomes
Time frame: at birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Results publication: PubMed 32343926Whitaker KM, Becker C, Healy H, Wilcox S, Liu J. Women's Report of Health Care Provider Advice and Gestational Weight Gain: A Systematic Review. J Womens Health (Larchmt). 2021 Jan;30(1):73-89. doi: 10.1089/jwh.2019.8223. Epub 2020 Apr 27.
- Results publication: PubMed 33953614Tinius R, Duchette C, Beasley S, Blankenship M, Schoenberg N. Obstetric Patients and Healthcare Providers Perspectives to Inform Mobile App Design for Physical Activity and Weight Control During Pregnancy and Postpartum in a Rural Setting. Int J Womens Health. 2021 Apr 29;13:405-432. doi: 10.2147/IJWH.S296310. eCollection 2021.
- Results publication: PubMed 33481513Syed H, Slayman T, DuChene Thoma K. ACOG Committee Opinion No. 804: Physical Activity and Exercise During Pregnancy and the Postpartum Period. Obstet Gynecol. 2021 Feb 1;137(2):375-376. doi: 10.1097/AOG.0000000000004266. No abstract available.
- Derived from this study: PubMed 41204072Cetin Avci S, Dasikan Z. A theory-based mobile health application for gestational weight management: Protocol for a randomized controlled trial. Technol Health Care. 2026 Jul;34(4):489-500. doi: 10.1177/09287329251388165. Epub 2025 Nov 7.
- 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.
Zeynep D Zeynep DAŞIKAN, Assoc. Prof. study director
Ege University
Seda Ç ÇETİN AVCI, M.S. principal investigator
Izmir Katip Çelebi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Application in people with Gestational Weight Gain, run by Seda ÇETİN AVCI 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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 9 Aug 2024. 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?
Results are not available in the source record.
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?
Effıcacy and usability of the mobile application on weight management during pregnancy (time frame: At 38 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06542679, which also lists 4 linked publications.
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 9 Aug 2024.