Clinical trial NCT06881277: Effectiveness of a Smartphone App (PRIMI) to Promote Healthy Diet and Physical Activity After Pregnancy in Migrant Women
Official title: Effectiveness of a Smartphone App (PRIMI) to Promote Healthy Diet and Physical Activity After Pregnancy in Migrant Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postpartum
Keywords: mHealth
app
randomized controlled trial
postpartum
pregnancy
migration
migrant health
diet
physical activity
health literacy
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2025-03-18
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 1. BACKGROUND

   International migrants represent a growing population in Sweden and many European countries. Currently, approximately 25% of women of childbearing age in Sweden have migrated (hereafter referred to as "migrant women"). Evidence suggests that migrant women face a higher risk of adverse health outcomes during and after pregnancy. Thus, improving migrant health, including reproductive health, is a public health priority. The period after pregnancy presents a critical opportunity to promote healthy dietary habits, physical activity, and body weight. However, there is a lack of lifestyle interventions after pregnancy tailored specifically for migrant women. Mobile health (mHealth) interventions are potentially effective in this regard, given that mobile phones are widely accessible across different socioeconomic groups. Previous research has demonstrated the potential of mHealth interventions to improve diet and physical activity. However, no previous study has evaluated the effectiveness of an mHealth intervention on health behaviors and body weight among migrant women after pregnancy.

   The PRIMI project (Promoting Reproductive Health In MIgrant Women) aims to address this gap by assessing the effectiveness of a smartphone app to support healthy behaviors after pregnancy in migrant women. The PRIMI trial will evaluate the effectiveness of a smartphone app (PRIMI app) on: i) Diet quality (primary outcome) ii) Moderate-to-vigorous physical activity (primary outcome) iii) Health literacy (secondary outcome) iv) Body mass index (BMI) (secondary outcome) v) Self-efficacy (secondary outcome) vi) Self-rated health (secondary outcome)
2. METHODS

2.1 Study Design

The PRIMI trial is a 6-month, two-arm randomized controlled trial (RCT) with a 1:1 allocation ratio. The intervention group will receive standard postpartum care plus access to the PRIMI app for six months. The control group will receive standard postpartum care and will gain access to the PRIMI app after the six-month follow-up (wait-list control design). The study follows the SPIRIT 2013 guidelines and will be reported according to the CONSORT-EHEALTH checklist.

2.2 Eligibility and Recruitment

Participants will be recruited through maternal and child healthcare services across Sweden. If recruitment is slow, additional strategies, such as outreach through non-governmental organizations, community associations, and social media, will be considered.

2.3 Randomization and Blinding

Participants will be randomly assigned to the intervention or control group using a 1:1 allocation ratio. Allocation will be concealed.

2.4 The PRIMI app

The PRIMI app consists of a 6-month structured program with weekly themes, goal-setting features, self-monitoring tools, and an extensive library of recipes, exercise videos, and behavior change support. The intervention is based on social cognitive theory and incorporates behavior change techniques such as shaping knowledge, feedback and monitoring, and goal setting. The app provides culturally adapted dietary and physical activity guidelines based on current recommendations and includes multimedia elements (e.g., images, audio, and video) for accessibility.

Eligibility criteria: Inclusion Criteria:

* First-generation migrant women
* Given birth ≤ 6 months ago
* Age ≥ 18 years
* Able to receive health-related information in Arabic, Somali, English, or Swedish

Exclusion Criteria:

* Swedish-born women
* Age \< 18 years
* Given birth \> 6 months ago

Primary outcomes:
measure: Diet quality
timeFrame: Baseline and 6 months post-randomization.
measure: Moderate-to-vigorous physical activity
timeFrame: Baseline and 6 months post-randomization.
Secondary outcomes:
measure: Dietary intakes
timeFrame: Baseline and 6 months post-randomization.
measure: Physical activity
timeFrame: Baseline and 6 months post-randomization.
measure: Health literacy
timeFrame: Baseline and 6 months post-randomization.
measure: eHealth literacy
timeFrame: Baseline and 6 months post-randomization.
measure: Body mass index (BMI)
timeFrame: Baseline and 6 months post-randomization.
measure: Self-efficacy
timeFrame: Baseline and 6 months post-randomization.
measure: Self-rated health
timeFrame: Baseline and 6 months post-randomization.
Other outcomes:
Locations:
Study officials:
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