JMIR Publications

ABSTRACT

Background:

Migrant health, including reproductive health, is an important public health priority. The postpartum period is a critical window for establishing healthy behaviors that can impact long-term health. Mobile health (mHealth) interventions offer a scalable solution, but existing tools are often not culturally or linguistically adapted for diverse populations. To the best of our knowledge, no previous study has evaluated the effectiveness of a culturally adapted mHealth intervention delivered after childbirth, targeting health behaviors in migrant women.

Objective:

The PRIMI trial will determine the effectiveness of a smartphone app (the PRIMI app) on the primary outcomes: diet quality and moderate-to-vigorous physical activity, and the secondary outcomes: health literacy, body mass index, self-efficacy, and self-rated health in first-generation migrant women after childbirth. The PRIMI app, developed within the PRIMI project, is compatible with both Android and iOS. It contains weekly changing themes focusing on physical activity, diet, and health literacy, throughout a 6-month intervention period. The app integrates behavior change techniques such as feedback and monitoring, goal-setting, and instructions on how to perform the behavior. The app's language can be switched between four common languages: Arabic, Somali, English, and Swedish, and all textual content can be accessed through audio files for listening.

Methods:

A 2-arm randomized controlled trial will be conducted to examine the effectiveness of the PRIMI app. First-generation migrant women who have given birth within the past 6 months, are aged 18 years or older, and who prefer to receive health-related information in any of the provided languages are eligible to participate in the study, and will be recruited through healthcare services in Sweden. The women will be randomized to the control group (standard care, e.g., parental guidance and support within child healthcare) or the intervention group (PRIMI app + standard care) in a 1:1 ratio. A total of 200 women (100 per group) will be included in the study. A waitlist-controlled strategy will be applied, so that women in the control group will receive the PRIMI app after the follow-up measurement at 6 months. Outcomes will be assessed at baseline and at the 6-month follow-up. All procedures have been approved by the Swedish Ethical Review Authority (reference numbers: 2022-06733-01 and 2024-00135-02).

Results:

Recruitment of study participants is planned to begin on September 1st, 2025. We anticipate completing recruitment in 2026 and that the results of the PRIMI trial will be available in 2027.

Conclusions:

This study will provide novel evidence on the effectiveness of the PRIMI app to promote healthy behaviors and support postpartum health among migrant women. This is highly relevant given the lack of previous comparable studies and the urgent need for tailored postpartum interventions in migrant populations. Clinical Trial: The trial was prospectively registered on March 11, 2025, in ClinicalTrials.gov (identifier: NCT06881277). No participants were enrolled before trial registration and submission of the study protocol.