About this trial
The PRIMI trial (Promoting Reproductive health In MIgrant women) is a randomized controlled trial evaluating the effectiveness of a smartphone app designed to promote a healthy diet, physical activity, and health literacy among first-generation migrant women after pregnancy. The study will recruit 200 women within six months after pregnancy and randomize them into an intervention group, receiving access to the PRIMI app for six months, or a wait-list control group. The primary outcomes are diet quality and moderate-to-vigorous physical activity, while secondary outcomes include health literacy, body mass index, self-efficacy, and self-rated health. The intervention is expected to provide accessible and culturally tailored support to improve postpartum health behaviors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
First-generation migrant women
Given birth ≤ 6 months ago
Age ≥ 18 years
Able to receive health-related information in Arabic, Somali, English, or Swedish
Disqualifiers
Swedish-born women
Age < 18 years
Given birth > 6 months ago
Trial design
Parallel
Treatments tested in this trial
Mobile phone based intervention
BehavioralThe PRIMI intervention is a 6-month smartphone-based digital health program designed to promote a healthy diet and physical activity among migrant women after pregnancy.
Treatment groups
Trial outcomes
Primary outcomes
Diet quality
Assessed using a modified version of the Swedish National Board of Health and Welfare's dietary survey. A composite dietary quality score will be created based on intakes of: i) vegetables, ii) fruits and berries, iii) sweet beverages, and iv) sweet and savory snacks.
Moderate-to-vigorous physical activity
Assessed via self-reported time spent in moderate and vigorous physical activity per day using a modified version of the physical activity questions in the Swedish National Board of Health and Welfare's survey.
Secondary outcomes
Dietary intakes
Assessed using a modified version of the Swedish National Board of Health and Welfare's dietary survey. In addition to the composite diet quality score, we will examine the effectiveness of the PRIMI app on the four key indicators individually: i) vegetables, ii) fruit and berries, iii) sweet beverages, iv) sweet and savory snacks.
Physical activity
Assessed using a modified version of the physical activity questions in the Swedish National Board of Health and Welfare's survey. Beyond analyzing the effects on moderate-to-vigorous physical activity, we will also assess moderate and vigorous physical activity separately.
Health literacy
Measured using the Health Literacy Survey Questionnaire-16 (HLS-Q16). Scores range from 16 to 64, with higher scores indicating higher health literacy.
eHealth literacy
Measured using the eHealth Literacy Scale (eHEALS). Scores range from 8 to 40, with higher scores indicating higher eHealth literacy.
Sponsors and contacts
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