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

NCT06881277 | Not Yet Recruiting

• 1 other identifier: 2022-06733-01
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postpartum

Keywords

mHealth; app; randomized controlled trial; postpartum; pregnancy; migration; migrant health; diet; physical activity; health literacy

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and 6 months post-randomization.

• 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.

  Baseline and 6 months post-randomization.

Secondary Outcomes (7)

• Dietary intakes

  Baseline and 6 months post-randomization.

• Physical activity

  Baseline and 6 months post-randomization.

• Health literacy

  Baseline and 6 months post-randomization.

• eHealth literacy

  Baseline and 6 months post-randomization.

• Body mass index (BMI)

  Baseline and 6 months post-randomization.

Study Arms (2)

Intervention group (Access to the PRIMI app + standard care)

EXPERIMENTAL

Participants randomized to the intervention group will receive standard postpartum care plus access to the PRIMI app for 6 months. The PRIMI app is a mobile health (mHealth) intervention designed to promote healthy dietary habits, physical activity, and health literacy among migrant women after pregnancy

Behavioral: Mobile phone based intervention

Control group (standard care)

NO INTERVENTION

Participants in the control group will receive standard postpartum care. After the six-month follow-up, they will be granted access to the PRIMI app (wait-list control).

Interventions

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.

Intervention group (Access to the PRIMI app + standard care)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Linkoeping University: lead

Related Publications (1)

• Seitero A, Shirvanifar M, Jubran Leksell M, Rydfjord M, Al-Saedi B, Salah Ahmed A, Gharakhani Bahar T, Berglind D, Henriksson H, H Ahlqvist V, Wangdahl J, Mussener U, Henriksson P. A Smartphone App (PRIMI) to Promote Healthy Diet, Physical Activity, and Health Literacy After Childbirth Among Migrant Women: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 17;14:e79277. doi: 10.2196/79277.

  PMID: 41106816 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Motor Activity

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Central Study Contacts

Pontus Henriksson, Associate Professor

CONTACT

+46701749556; pontus.henriksson@liu.se

Anna Seiterö, Dr.

CONTACT

+4613282687; anna.seitero@liu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 18, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share