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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 31, 2026 → Dec 31, 2027
See other at-risk trials from Linkoeping University

Record History

  1. Primary and study completion pushed from Dec 31, 2026 to Dec 31, 2027 Recruitment opened · Study sites: 0 to 1 · Start date changed from estimate of Sep 15, 2025 to Oct 13, 2025v5 Show 3 more changesShow less
    • Recruitment opened
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 15, 2025 to Oct 13, 2025
  2. Start date: May 1, 2025 to Sep 15, 2025 Secondary endpoints: details revised at 1 of 7 entriesv4 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 7 entries
  3. Re-verified, no change to tracked fieldsv3
  4. Study description shortened, about 176 wordsv2 See this version in full on ClinicalTrials.gov ↗
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06881277
Lead Sponsor Linkoeping University
Conditions Postpartum
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov