NCT01207349

Brief Summary

Three hundred and ninety height diabetic patients were educated during a week of hospitalisation (nutritional and physical-activity advices). After that, they were randomized in two groups : frequent follow-up (each three month) by educational nurses and dieteticians, versus no follow-up (control group). All patients were evaluated one year after their inclusion,by HbA1c (primary outcome), anthropometry, other cardiovascular risk factors, nutritionnal and physical-activity behaviours.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
398

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2002

Typical duration for all trials

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

August 1, 2002

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2010

Completed
Last Updated

December 4, 2025

Status Verified

January 1, 2012

Enrollment Period

2.3 years

First QC Date

September 14, 2010

Last Update Submit

November 26, 2025

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetesSecondary preventionPhysical activityNutritional educationHbA1cReunion islanddiabetic patients, both female and male, age >=18 years, able to practise a physical activity, in Saint Pierre (GHSR) and Saint Denis (CHD)

Outcome Measures

Primary Outcomes (1)

  • %HbA1c

    measure of % HbA1c at inclusion and at one year and comparison between intervention and control groups

    at inclusion and at one year

Secondary Outcomes (1)

  • anthropometry

    at inclusion and at one year

Study Arms (2)

close follow-up by nurse

close follow-up by nurse : patients were visited each tree months

Behavioral: Secondary prevention intervention trial

standard follow up

stantdard follow up at one year

Behavioral: standard follow up

Interventions

standard follow upBEHAVIORAL
standard follow up
Secondary prevention intervention trialBEHAVIORAL

Close follow-up by nurses, exercise physiologist and dieteticians

Also known as: Rédia-prev2
close follow-up by nurse

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

type 2 diabetic patients

You may qualify if:

  • type 2 diabetes patient aged \>=18 years

You may not qualify if:

  • incapacity to a moderate physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GHSR

Saint-Pierre, La Réunion, 97448, France

Location

Related Publications (1)

  • Debussche X, Rollot O, Le Pommelet C, Fianu A, Le Moullec N, Regnier C, Boyer MC, Cogne M, Bakiri F, Schwager JC, Favier F. Quarterly individual outpatients lifestyle counseling after initial inpatients education on type 2 diabetes: the REDIA Prev-2 randomized controlled trial in Reunion Island. Diabetes Metab. 2012 Feb;38(1):46-53. doi: 10.1016/j.diabet.2011.07.002. Epub 2011 Oct 24.

    PMID: 22030240RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Jean-Claude Schwager, MD

    GHSR

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2010

First Posted

September 22, 2010

Study Start

August 1, 2002

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

December 4, 2025

Record last verified: 2012-01

Locations

FR(1)