PostpartumNCT06881277
Effectiveness of a Smartphone App (PRIMI) to Promote Healthy Diet and Physical Activity After Pregnancy in Migrant Women
A study testing Mobile phone based intervention in people with Postpartum, run by Linkoeping University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum
- What is being tested?
- Mobile phone based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 13 Oct 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First-generation migrant women
- Given birth ≤ 6 months ago
- Age ≥ 18 years
- Able to receive health-related information in Arabic, Somali, English, or Swedish
Who cannot join
- Swedish-born women
- Age < 18 years
- Given birth > 6 months ago
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Linköping University
Linköping, Östergötland County, 581 83
Pontus Henriksson, PhD, +46701749556, pontus.henriksson@liu.se
Anna Seiterö, PhD, +4613282687, anna.seitero@liu.se
About this study
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.
Read the detailed description
- 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)
- 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.
- Conditions
- Postpartum
- Being tested
- Mobile phone based intervention
- Keywords
- mHealth, app, randomized controlled trial, postpartum, pregnancy, migration, migrant health, diet, physical activity, health literacy
- Medical subject headings
- Alzheimer Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile phone based interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 6 months post-randomization.
Secondary outcomes (7)
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.
Measured: Baseline and 6 months post-randomization.
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.
Measured: Baseline and 6 months post-randomization.
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.
Measured: Baseline and 6 months post-randomization.
eHealth literacy
Measured using the eHealth Literacy Scale (eHEALS). Scores range from 8 to 40, with higher scores indicating higher eHealth literacy.
Measured: Baseline and 6 months post-randomization.
Body mass index (BMI)
Calculated from self-reported weight and height (kg/m²).
Measured: Baseline and 6 months post-randomization.
Self-efficacy
Measured using a questionnaire regarding participants' perceived self-efficacy in having a healthy diet and physical activity. Scores range from 0 (not at all) to 10 (very much), with higher scores indicating greater perceived self-efficacy regarding healthy diet and physical activity.
Measured: Baseline and 6 months post-randomization.
Self-rated health
Assessed using the EQ-5D Visual Analogue Scale (EQ-VAS). The EQ-5D VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Thus, higher scores indicate better self-rated health
Measured: Baseline and 6 months post-randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start13 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PostpartumStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Pontus Henriksson, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881277
- Sponsor's protocol ID
- 2022-06733-01
- Status last verified
- Aug 2026
- First submitted
- 6 Mar 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41106816
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Smartphone App (PRIMI) to Promote Healthy Diet and Physical Activity After Pregnancy in Migrant Women
- ClinicalTrials.gov ID
- NCT06881277
- Acronym / sponsor ID
- 2022-06733-01
- Conditions
- Postpartum
- Keywords
- mHealth, app, randomized controlled trial, postpartum, pregnancy, migration, migrant health, diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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)
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (Access to the PRIMI app + standard care) | Experimental | Behavioral: Mobile phone based interventionParticipants 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 |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First-generation migrant women
- Given birth ≤ 6 months ago
- Age ≥ 18 years
- Able to receive health-related information in Arabic, Somali, English, or Swedish
Key exclusion criteria (3 listed)
- Swedish-born women
- Age < 18 years
- Given birth > 6 months ago
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile phone based interventionThe 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. | Behavioural | Intervention group (Access to the PRIMI app + standard care) |
Primary outcome
Diet quality
Time frame: Baseline and 6 months post-randomization.
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
Time frame: Baseline and 6 months post-randomization.
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.
7 secondary outcomes
Dietary intakes
Time frame: Baseline and 6 months post-randomization.
Physical activity
Time frame: Baseline and 6 months post-randomization.
Health literacy
Time frame: Baseline and 6 months post-randomization.
eHealth literacy
Time frame: Baseline and 6 months post-randomization.
Body mass index (BMI)
Time frame: Baseline and 6 months post-randomization.
Self-efficacy
Time frame: Baseline and 6 months post-randomization.
Self-rated health
Time frame: Baseline and 6 months post-randomization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Derived from this study: PubMed 41106816Seitero 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile phone based intervention in people with Postpartum, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pontus Henriksson, Associate Professor (+46701749556, pontus.henriksson@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet quality (time frame: Baseline and 6 months post-randomization.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06881277, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.