Body Weight ChangesNCT04578067
Empowering Immigrant Women for Active and Healthy Lifestyle
A study testing Lifestyle intervention in people with Body Weight Changes and Physical Activity, run by University of Oslo at 1 site in Norway.
Trial summary
The study will include overweight and obese otherwise healthy women, recruited from two main borough in Oslo with the highest population of Somali origin. The study comprises two phases: A 12-months controlled trial where the participants in the intervention borough will be compared to participants in the control… Read more about this study
- Who is it for?
- Ages 20 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight Changes, Physical Activity, Blood Glucose
- What is being tested?
- Lifestyle 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 siteNorway
- Study dates
- 30 Sep 2020to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women living in the two boroughs in Oslo with Somali background (born in Somali regions or women born in Norway by two Somali parents), aged 20-67 years
- Being overweight or obese (BMI ≥27 kg/m2)
- Not planning to move away from the recruitment area within the next 2 years
- Not physically active on a regular basis
- Willing and able to participate in all aspects of the study
- Must be capable and willing to sign written informed consent and thumb-print for illiterate participants -
Who cannot join
- Currently pregnant
- Participating in a formal exercise or weight loss programme
- Suffering from serious bone or joint problems or difficulty walking
- Having known chronic diseases such as diabetes, cancer and uncontrolled hypo- or hyperthyroidism
- Suffering from other illnesses or being on medications that may affect weight loss
- Suffering from eating disorders
- Planning to be out of town for more than 6 weeks in the next 12 months
Trial locations and contacts
1 site in 1 country.
Haakon E Meyer, PhD MD contact
Norway1 site, 1 recruiting
- Recruiting
Ahmed Madar
Oslo, 0318
Ahmed Madar, PHD, +4722850634, a.a.madar@medisin.uio.no
Haakon Meyer, PHD, h.e.m@medisin.uio.no
About this study
Official title: Økt Fysisk Aktivitet og Sunnere Livsstil Hos Innvandrer Kvinner (ASLI)
The study will include overweight and obese otherwise healthy women, recruited from two main borough in Oslo with the highest population of Somali origin. The study comprises two phases: A 12-months controlled trial where the participants in the intervention borough will be compared to participants in the control borough. This is followed by a 12-months maintaining phase for the intervention borough where the control group will be given the same intervention as the intervention group received during the first 12-months.
Read the detailed description
Through a research-based intervention program, the overall goal of this project is to promote immigrant health by improving, evolving and adapting a preventive healthcare in the municipality. There is social inequalities and geographical differences in health in Norway. Immigrant women struggle more with overweight and obesity than ethnic Norwegian women, and immigrant women have an increased susceptibility for diabetes and other lifestyle related diseases. In this study, we will measure the effect of a culturally tailored intervention package (physical activity and nutrition) on weight reduction, and cardio-metabolic outcomes, among overweight and obese Somali women. The study will include women (aged 20-67 years) recruited from two boroughs in Oslo with the highest population of Somali origin.
The intervention program composes a 12-month controlled trial. The core component of the program is to counsel and empower women through individual counseling and group education sessions with emphasis on physical activities and the creation of an enabling environment. The goal is that the participants become more physically active, less sedentary, eat healthy, and maintain these changes long term.
All main analysis will be done at data collected at the one-year follow up. In addition, the control group in intervention phase will after the completion of the one-year follow up be given the same intervention as the intervention group.
User involvement is included in the development, planning, implementation and dissemination of the program results. The program will produce evidence, relevant for policy-makers and stakeholders locally and globally, of how to improve health and nutrition strategies towards immigrants and minorities. The program represents a collaboration between Oslo municipality, the University of Oslo and the Norwegian School of Sport Sciences.
- Being tested
- Lifestyle intervention
- Medical subject headings
- Body Weight Changes, Motor Activity, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionBehavioural
on physical activity and healthier eating
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | culturally tailored intervention package on changes in lifestyle-habits Receives: Behavioral: Lifestyle intervention |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight in kilograms
Difference in weight change between intervention and control group
Measured: 1 year
Secondary outcomes (6)
Change in sedentary time (min/day)
As measured by ActivePal
Measured: 1 year
Change moderately intense physical activity (min/day)
As measured by ActivePal
Measured: 1 year
Change blood pressure
as measured by automatic blood pressure measuring device
Measured: 1 year
Change the blood concentration of HbA1c (mmol/mol)
measured by blood tests
Measured: 1 year
Change the blood concentration of cholesterol (total, LDL and HDL) (mmol/L)
measured by blood tests
Measured: 1 year
Change the blood concentration of triglycerides (mmol/L)
measured by blood tests
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start30 Sep 2020
- Primary completion31 Aug 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Body Weight ChangesStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cluster intervenrion trial
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo Municipality, Norwegian School of Sport Sciences
- Responsible party
- Principal investigator, Ahmed A. Madar, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578067
- Sponsor's protocol ID
- 724880 NSD
- Other IDs
- 296558/H40
- Status last verified
- May 2021
- First submitted
- 29 Sep 2020
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data protection legislation makes it difficult to share individual data from this study which is limited to approx. 200 participants
Publications
Andersen E, Bohler L, Leirbakk MJ, Cabral D, Wedegren MC, Wieland ML, Meyer HE, Madar AA. Effects of a lifestyle programme on accelerometer-measured physical activity level and sedentary time on overweight and obese women of Somali background living in Norway. BMC Public Health. 2025 Apr 7;25(1):1310. doi: 10.1186/s12889-025-22475-z.
PubMed 40197263Bohler L, Meyer HE, Stigum H, Leirbakk MJ, Cabral D, Wedegren MC, Andersen E, Wieland ML, Madar AA. A controlled weight loss intervention study among women of Somali background in Norway. J Migr Health. 2024 May 4;9:100231. doi: 10.1016/j.jmh.2024.100231. eCollection 2024.
PubMed 38766513
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Økt Fysisk Aktivitet og Sunnere Livsstil Hos Innvandrer Kvinner (ASLI)
- ClinicalTrials.gov ID
- NCT04578067
- Acronym / sponsor ID
- 724880 NSD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Oslo Municipality, Norwegian School of Sport Sciences
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 8 Oct 2020 (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 study will include overweight and obese otherwise healthy women, recruited from two main borough in Oslo with the highest population of Somali origin. The study comprises two phases: A 12-months controlled trial where the participants in the intervention borough will be compared to participants in the control borough. This is followed by a 12-months maintaining phase for the intervention borough where the control group will be given the same intervention as the intervention group received during the first 12-months.
Detailed description
Through a research-based intervention program, the overall goal of this project is to promote immigrant health by improving, evolving and adapting a preventive healthcare in the municipality. There is social inequalities and geographical differences in health in Norway. Immigrant women struggle more with overweight and obesity than ethnic Norwegian women, and immigrant women have an increased susceptibility for diabetes and other lifestyle related diseases. In this study, we will measure the effect of a culturally tailored intervention package (physical activity and nutrition) on weight reduction, and cardio-metabolic outcomes, among overweight and obese Somali women. The study will include women (aged 20-67 years) recruited from two boroughs in Oslo with the highest population of Somali origin.
The intervention program composes a 12-month controlled trial. The core component of the program is to counsel and empower women through individual counseling and group education sessions with emphasis on physical activities and the creation of an enabling environment. The goal is that the participants become more physically active, less sedentary, eat healthy, and maintain these changes long term.
All main analysis will be done at data collected at the one-year follow up. In addition, the control group in intervention phase will after the completion of the one-year follow up be given the same intervention as the intervention group.
User involvement is included in the development, planning, implementation and dissemination of the program results. The program will produce evidence, relevant for policy-makers and stakeholders locally and globally, of how to improve health and nutrition strategies towards immigrants and minorities. The program represents a collaboration between Oslo municipality, the University of Oslo and the Norwegian School of Sport Sciences.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster intervenrion trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Lifestyle interventionculturally tailored intervention package on changes in lifestyle-habits |
| Control | No intervention | – |
Who may qualify
- Ages
- 20 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women living in the two boroughs in Oslo with Somali background (born in Somali regions or women born in Norway by two Somali parents), aged 20-67 years
- Being overweight or obese (BMI ≥27 kg/m2)
- Not planning to move away from the recruitment area within the next 2 years
- Not physically active on a regular basis
- Willing and able to participate in all aspects of the study
Key exclusion criteria (7 listed)
- Currently pregnant
- Participating in a formal exercise or weight loss programme
- Suffering from serious bone or joint problems or difficulty walking
- Having known chronic diseases such as diabetes, cancer and uncontrolled hypo- or hyperthyroidism
- Suffering from other illnesses or being on medications that may affect weight loss
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 |
|---|---|---|
| Lifestyle interventionon physical activity and healthier eating | Behavioural | Intervention |
Primary outcome
Change in body weight in kilograms
Time frame: 1 year
Difference in weight change between intervention and control group
6 secondary outcomes
Change in sedentary time (min/day)
Time frame: 1 year
Change moderately intense physical activity (min/day)
Time frame: 1 year
Change blood pressure
Time frame: 1 year
Change the blood concentration of HbA1c (mmol/mol)
Time frame: 1 year
Change the blood concentration of cholesterol (total, LDL and HDL) (mmol/L)
Time frame: 1 year
Change the blood concentration of triglycerides (mmol/L)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Derived from this study: PubMed 40197263Andersen E, Bohler L, Leirbakk MJ, Cabral D, Wedegren MC, Wieland ML, Meyer HE, Madar AA. Effects of a lifestyle programme on accelerometer-measured physical activity level and sedentary time on overweight and obese women of Somali background living in Norway. BMC Public Health. 2025 Apr 7;25(1):1310. doi: 10.1186/s12889-025-22475-z.
- Derived from this study: PubMed 38766513Bohler L, Meyer HE, Stigum H, Leirbakk MJ, Cabral D, Wedegren MC, Andersen E, Wieland ML, Madar AA. A controlled weight loss intervention study among women of Somali background in Norway. J Migr Health. 2024 May 4;9:100231. doi: 10.1016/j.jmh.2024.100231. eCollection 2024.
- Individual participant dataSharing planned: No. Data protection legislation makes it difficult to share individual data from this study which is limited to approx. 200 participants
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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. This study is not recruiting at the moment.
Haakon E Meyer, PhD MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention in people with Body Weight Changes and Physical Activity, run by University of Oslo at 1 site in Norway.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 27 May 2021. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Madar, PhD (+4799486552, a.a.madar@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight in kilograms (time frame: 1 year). 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 NCT04578067, which also lists 2 linked publications.
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 May 2021.