Empowering Immigrant Women for Active and Healthy Lifestyle

Physical Activity Clinical Trial

Official title:

Økt Fysisk Aktivitet og Sunnere Livsstil Hos Innvandrer Kvinner (ASLI)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04578067
• Other study ID #: 724880 NSD
• Secondary ID: 296558/H40
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2021
• Source: University of Oslo
• Contact: Ahmed A Madar, PhD
• Phone: +4799486552
• Email: a.a.madar[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2023
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 67 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Glucose
• Body Weight
• Body Weight Changes
• Cholesterol, Elevated
• Hypercholesterolemia
• Physical Activity

Intervention

Behavioral:
• Lifestyle intervention
on physical activity and healthier eating

Locations

Country	Name	City	State
Norway	Ahmed Madar	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
University of Oslo	Norwegian School of Sport Sciences, Oslo Municipality

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight in kilograms	Difference in weight change between intervention and control group	1 year
Secondary	Change in sedentary time (min/day)	As measured by ActivePal	1 year
Secondary	Change moderately intense physical activity (min/day)	As measured by ActivePal	1 year
Secondary	Change blood pressure	as measured by automatic blood pressure measuring device	1 year
Secondary	Change the blood concentration of HbA1c (mmol/mol)	measured by blood tests	1 year
Secondary	Change the blood concentration of cholesterol (total, LDL and HDL) (mmol/L)	measured by blood tests	1 year
Secondary	Change the blood concentration of triglycerides (mmol/L)	measured by blood tests	1 year