Pregnancy Weight Management Mobile Health App
NCT Number: NCT06542679
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gestational Weight Gain
Interventions: BEHAVIORAL: Mobile Application
Sponsor: Seda ÇETİN AVCI
Sex: FEMALE
Age: ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-01-16
Completion Date: 2024-10-30
Locations: Izmir Katip Çelebi University, İzmir, Turkey

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-pregnancy/pregnancy Body Mass Index (BMI) between 18.5-39.9 kg/m² (normal, overweight, and obese individuals)
* Ownership of a smartphone

Primary Outcome Measures: 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., At 38 weeks
Secondary Outcome Measures: 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., 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., 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., 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)., at birth