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Pregnancy Weight Management Mobile Health App

NCT06542679 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-08-09

No results posted yet for this study

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

Conditions

  • Gestational Weight Gain

Interventions

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.

Sponsors & Collaborators

  • Seda ÇETİN AVCI

    lead OTHER

Principal Investigators

  • Zeynep D Zeynep DAŞIKAN, Assoc. Prof. · Ege University

  • Seda Ç ÇETİN AVCI, M.S. · Izmir Katip Çelebi University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-16
Primary Completion
2024-10-30
Completion
2024-10-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06542679 on ClinicalTrials.gov