Evaluation of a Primary Type 2 Diabetes Prevention Programme (PREDIAS)

Forschungsinstitut der Diabetes Akademie Mergentheim

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus

Treatments: Behavioral: Control; Behavioral: PREDIAS

Study type: Interventional

Funder types: Other

Identifiers

NCT00707447

FIDAM 006-04

Details and patient eligibility

About

A type 2 diabetes prevention programme, named PREDIAS was developed. It consists of 12 lessons delivered as group sessions. Die efficacy of PREDIAS was studied in a randomized controlled study with 12 month follow up. Control group received written information about diabetes risk. Primary outcome variable was weight reduction at 12 months follow up. Secondary variables were impact of the intervention on glycemic parameters, lipids, eating and exercise behavior and other metabolic risk factors

Full description

The PREDIAS programme was developed based on the interventions used in the Diabetes Prevention Study (DPS, Finland) and the Diabetes Prevention Programme (DPP; USA). The main purpose of PREDIAS was to develop a prevention programme delivered as a group programme to improve cost-benefit ration of diabetes prevention programmes.

Enrollment: 182 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• impaired fasting glucose and/or
• impaired glucose tolerance
• overweight (BMI > 26 kg/m²)

Exclusion criteria

• type 2 diabetes
• severe illness (cancer diagnosis, stroke or myocardial infarction in the last 12 months)
• diagnosis of a current mental disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups, including a placebo group

1/Control

Placebo Comparator group

Description:

Control group received written information about diabetes risks with instructions about healthy eating and increasing physical exercise

Treatment:

Behavioral: Control

2/PREDIAS

Experimental group

Description:

Intervention consists of a group programme (PREDIAS) aiming at modification of lifestyle

Treatment:

Behavioral: PREDIAS