Effectiveness of a Smartphone App (PRIMI) to Promote Healthy Diet and Physical Activity After Pregnancy in Migrant Women

ConditionPostpartum
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLinkoeping University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Mobile phone based intervention

    Behavioral

    The 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

200 Participants
are divided into 2 treatment groups
Group A: Intervention group (Access to the PRIMI app + standard care)Experimental treatment 1 intervention
Group B: Control group (standard care)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 6 months post-randomization.
2

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.

Time frame
Baseline and 6 months post-randomization.

Secondary outcomes

1

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.

Time frame
Baseline and 6 months post-randomization.
2

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.

Time frame
Baseline and 6 months post-randomization.
3

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.

Time frame
Baseline and 6 months post-randomization.
4

eHealth literacy

Measured using the eHealth Literacy Scale (eHEALS). Scores range from 8 to 40, with higher scores indicating higher eHealth literacy.

Time frame
Baseline and 6 months post-randomization.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.