NCT04578067

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

September 30, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

May 27, 2021

Status Verified

May 1, 2021

Enrollment Period

1.9 years

First QC Date

September 29, 2020

Last Update Submit

May 26, 2021

Conditions

Body Weight ChangesPhysical ActivityBlood GlucoseCholesterol, Elevated

Outcome Measures

Primary Outcomes (1)

  • Change in body weight in kilograms

    Difference in weight change between intervention and control group

    1 year

Secondary Outcomes (6)

  • Change in sedentary time (min/day)

    1 year

  • Change moderately intense physical activity (min/day)

    1 year

  • Change blood pressure

    1 year

  • Change the blood concentration of HbA1c (mmol/mol)

    1 year

  • Change the blood concentration of cholesterol (total, LDL and HDL) (mmol/L)

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

culturally tailored intervention package on changes in lifestyle-habits

Behavioral: Lifestyle intervention

Control

NO INTERVENTION

Interventions

Lifestyle interventionBEHAVIORAL

on physical activity and healthier eating

Intervention

Eligibility Criteria

Age20 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Madar

Oslo, 0318, Norway

RECRUITING

Related Publications (2)

  • 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.

    PMID: 40197263DERIVED

  • Bohler 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.

    PMID: 38766513DERIVED

MeSH Terms

Conditions

Body Weight ChangesMotor ActivityHypercholesterolemia

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Ahmed A Madar, PhD

CONTACT

+4799486552a.a.madar@medisin.uio.no

Haakon E Meyer, PhD MD

CONTACT

h.e.meyer@medisin.uio.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster intervenrion trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 8, 2020

Study Start

September 30, 2020

Primary Completion

August 31, 2022

Study Completion

December 30, 2023

Last Updated

May 27, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Data protection legislation makes it difficult to share individual data from this study which is limited to approx. 200 participants

Locations

NO(1)