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Empowering Immigrant Women for Active and Healthy Lifestyle

Primary Purpose

Body Weight Changes, Physical Activity, Blood Glucose

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Lifestyle intervention
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Body Weight Changes

Eligibility Criteria

20 Years - 67 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ahmed MadarRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

culturally tailored intervention package on changes in lifestyle-habits

Outcomes

Primary Outcome Measures

Change in body weight in kilograms
Difference in weight change between intervention and control group

Secondary Outcome Measures

Change in sedentary time (min/day)
As measured by ActivePal
Change moderately intense physical activity (min/day)
As measured by ActivePal
Change blood pressure
as measured by automatic blood pressure measuring device
Change the blood concentration of HbA1c (mmol/mol)
measured by blood tests
Change the blood concentration of cholesterol (total, LDL and HDL) (mmol/L)
measured by blood tests
Change the blood concentration of triglycerides (mmol/L)
measured by blood tests

Full Information

First Posted
September 29, 2020
Last Updated
May 26, 2021
Sponsor
University of Oslo
Collaborators
Oslo Municipality, Norwegian School of Sport Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04578067
Brief Title
Empowering Immigrant Women for Active and Healthy Lifestyle
Official Title
Økt Fysisk Aktivitet og Sunnere Livsstil Hos Innvandrer Kvinner (ASLI)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
Oslo Municipality, Norwegian School of Sport Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight Changes, Physical Activity, Blood Glucose, Cholesterol, Elevated

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster intervenrion trial
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
culturally tailored intervention package on changes in lifestyle-habits
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention
Intervention Description
on physical activity and healthier eating
Primary Outcome Measure Information:
Title
Change in body weight in kilograms
Description
Difference in weight change between intervention and control group
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in sedentary time (min/day)
Description
As measured by ActivePal
Time Frame
1 year
Title
Change moderately intense physical activity (min/day)
Description
As measured by ActivePal
Time Frame
1 year
Title
Change blood pressure
Description
as measured by automatic blood pressure measuring device
Time Frame
1 year
Title
Change the blood concentration of HbA1c (mmol/mol)
Description
measured by blood tests
Time Frame
1 year
Title
Change the blood concentration of cholesterol (total, LDL and HDL) (mmol/L)
Description
measured by blood tests
Time Frame
1 year
Title
Change the blood concentration of triglycerides (mmol/L)
Description
measured by blood tests
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed A Madar, PhD
Phone
+4799486552
Email
a.a.madar@medisin.uio.no
First Name & Middle Initial & Last Name or Official Title & Degree
Haakon E Meyer, PhD MD
Email
h.e.meyer@medisin.uio.no
Facility Information:
Facility Name
Ahmed Madar
City
Oslo
ZIP/Postal Code
0318
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Madar, PHD
Phone
+4722850634
Email
a.a.madar@medisin.uio.no
First Name & Middle Initial & Last Name & Degree
Haakon Meyer, PHD
Email
h.e.m@medisin.uio.no

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data protection legislation makes it difficult to share individual data from this study which is limited to approx. 200 participants

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Empowering Immigrant Women for Active and Healthy Lifestyle

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