Pregnancy Weight Management Mobile Health App

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:

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

Study Overview

• Status: Active, not recruiting
• Conditions: Gestational Weight Gain
• Intervention / Treatment: Behavioral: Mobile Application

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 Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey
    • Izmir Katip Çelebi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; 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.
Experimental: Intervention Group; 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.	Behavioral: Mobile Application; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Seda ÇETİN AVCI
• Investigators: Study Director: Zeynep D Zeynep DAŞIKAN, Assoc. Prof., Ege University; Principal Investigator: Seda Ç ÇETİN AVCI, M.S., Izmir Katip Çelebi University

Publications and helpful links

General 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.
• Tinius 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.
• Syed 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2024
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: gestational weight gain; mobile application; Theory
• Additional Relevant MeSH Terms: Body Weight Changes; Body Weight; Weight Gain; Gestational Weight Gain
• Other Study ID Numbers: 22-8.1T/7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No