Pregnancy Weight Management Mobile Health App

NCT06542679 | Active Not Recruiting

• 1 other identifier: 22-8.1T/7
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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:

• 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

Conditions

Gestational Weight Gain

Keywords

gestational weight gain; mobile application; Theory

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Effect on attitudes towards healthy eating

  At 24 and 38 weeks

• Effect on physical activity level,

  At 24 and 38 weeks

• Effect on maternal health outcomes

  at birth

• Effect on fetal health outcomes

  at birth

Study Arms (2)

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.

Behavioral: Mobile Application

Interventions

Mobile Application BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seda ÇETİN AVCI: lead

Study Sites (1)

Izmir Katip Çelebi University

Izmir, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 32343926 RESULT

• 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.

  PMID: 33953614 RESULT

• 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.

  PMID: 33481513 RESULT

• Cetin Avci S, Dasikan Z. A theory-based mobile health application for gestational weight management: Protocol for a randomized controlled trial. Technol Health Care. 2025 Nov 7:9287329251388165. doi: 10.1177/09287329251388165. Online ahead of print.

  PMID: 41204072 DERIVED

MeSH Terms

Conditions

Gestational Weight Gain

Condition Hierarchy (Ancestors)

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

Study Officials

• Zeynep D Zeynep DAŞIKAN, Assoc. Prof.

  Ege University

  STUDY DIRECTOR

• Seda Ç ÇETİN AVCI, M.S.

  Izmir Katip Çelebi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The planned study will be a single-blind trial. Due to the nature of the study, blinding of the researcher will not be possible, but participant blinding and statistician blinding will be implemented. During the data analysis phase, the statistical unit will perform the analyses without knowing which data belong to the intervention group and which belong to the control group. This will ensure the blinding of the statistician.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher assistant

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 7, 2024
• Study Start: January 16, 2024
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)