Clinical trial NCT04578067: Empowering Immigrant Women for Active and Healthy Lifestyle
Official title: Økt Fysisk Aktivitet og Sunnere Livsstil Hos Innvandrer Kvinner (ASLI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Body Weight Changes
Physical Activity
Blood Glucose
Cholesterol, Elevated
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Oslo Municipality
name: Norwegian School of Sport Sciences
First posted: 2020-10-08
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster intervenrion trial
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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 -

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in body weight in kilograms
timeFrame: 1 year
Secondary outcomes:
measure: Change in sedentary time (min/day)
timeFrame: 1 year
measure: Change moderately intense physical activity (min/day)
timeFrame: 1 year
measure: Change blood pressure
timeFrame: 1 year
measure: Change the blood concentration of HbA1c (mmol/mol)
timeFrame: 1 year
measure: Change the blood concentration of cholesterol (total, LDL and HDL) (mmol/L)
timeFrame: 1 year
measure: Change the blood concentration of triglycerides (mmol/L)
timeFrame: 1 year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Ahmed Madar
Study officials:
References: