NCT00425269

Brief Summary

Immigrants from South Asia in Norway have a high prevalence of type 2 diabetes and conditions related to the metabolic syndrome. It has been documented that these conditions may be prevented by changes in lifestyle. No previous intervention studies on immigrants with focus on diet and physical activity have been carried out in Norway. This project concerns a randomized controlled trial with intervention to change diet and physical activity in 200 high risk female Pakistani immigrants living in Oslo. The intervention will be evaluated both in terms of outcome and process.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

July 21, 2014

Completed
Last Updated

July 21, 2014

Status Verified

April 1, 2014

Enrollment Period

2.4 years

First QC Date

January 19, 2007

Results QC Date

April 11, 2014

Last Update Submit

June 24, 2014

Conditions

Metabolic SyndromeType 2 Diabetes

Keywords

lifestyle interventionType 2 DiabetesMetabolic syndromePakistani womendietary changePhysical activityNorway

Outcome Measures

Primary Outcomes (4)

  • The Fasting Plasma Glucose Value, Baseline

    baseline

  • Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline

    baseline

  • The Fasting Plasma Glucose, Post-test

    post-test

  • Plasma Glucose, 2-h, Post-test

    post-test

Secondary Outcomes (32)

  • HbA1c, Baseline

    baseline

  • C-peptide, 0-h, Baseline

    baseline

  • C-peptid, 2-h, Baseline

    baseline

  • Insulin, 0-h, Baseline

    baseline

  • Insulin, 2-h, Baseline

    baseline

  • +27 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group was divided into nine subgroups of ten to twelve women who were offered six educational sessions, each lasting 2 h, during a 7 +- 1-month period. The main focus was on the physiological importance of blood glucose and its regulation by diet and physical activity, and on knowledge about the Pakistani lifestyle in Pakistan and Norway

Behavioral: lifestyle intervention (diet and physical activity)

Control

NO INTERVENTION

One lesson recieved after post-test

Interventions

lifestyle intervention (diet and physical activity)BEHAVIORAL

The intervention will include a combination of individual counselling group sessions. The intervention groups will be divided into subgroups of 10-12 subjects. Each group will have 10 group sessions on diet/lifestyle in the 6 months the intervention period lasts, and will additionally have the possibility to join a culturally adapted exercise program of low intensity twice a week.

Intervention

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Risk score developed by Ramachandran et al for Asian Indians:
  • BMI, waist circumference, family history of diabetes and sedentary physical activity

You may not qualify if:

  • Type 1 diabetes.
  • Positive auto antibodies.
  • Diagnosis of type 2 diabetes more than 6 months.
  • Medication for type 2 diabetes.
  • Pregnancy at intervention start.
  • Suffering from heart attack or stroke the last 3 months.
  • Already participating in organised physical exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary Health Care Health Center

Oslo, Holmlia, Oslo, 1255, Norway

Location

MeSH Terms

Conditions

Metabolic SyndromeDiabetes Mellitus, Type 2Motor Activity

Interventions

DietExercise

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Victoria Telle Hjellset
Organization
University of Oslo
t.v.t.hjellset@medisin.uio.no
0047 22 85 06 12

Study Officials

  • Gerd Holmboe-Ottesen, Dr. Philos.

    University of Oslo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 19, 2007

First Posted

January 22, 2007

Study Start

April 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

July 21, 2014

Results First Posted

July 21, 2014

Record last verified: 2014-04

Locations

NO(1)