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Intensive Life-Style Intervention in Type 2 Diabetes Patients

NCT01813708 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2013-03-21

No results posted yet for this study

Summary

200 type 2 diabetes patients will be randomly submitted to an intensive life-style or a collaborative educational programmes by means of random numbers list. The intervention will be conducted by certified nutritionists or certified diabetes educators, previously trained in behavioural modification and in self-care techniques. The intervention will last 16 weekly sessions and A1c, LDL cholesterol, blood pressure will be measured as main variables. Furthermore, body weight and abdominal girth, other lipids (HDL cholesterol, triglycerides),and physical activity, quality of life, psychological well-being and self-efficacy will be measured with specific questionnaires for up to 6 months.

Conditions

Interventions

BEHAVIORAL

Intensive Life-Style

16 weekly sessions conducted by certified nutritionists certified in behavioural modification, and self-care techniques, including self-monitoring, healthy nutrition, physical activity, problem solving, relapse prevention, self-reinforcement, long-term motivation, and stress management

BEHAVIORAL

Collaborative Education

16 weekly sessions conducted by certified diabetes educators including: diabetes knowledge, nutrition, exercise, goal establishment in diabetes, problem solving, relapse prevention, self-monitoring, family and sexuality in diabetes, emotional management in diabetes, and stress management. Patients established their own goals

Sponsors & Collaborators

  • Coordinación de Investigación en Salud, Mexico

    lead OTHER_GOV

Principal Investigators

  • Niels H Wacher, MD, MSc · Instituto Mexicano del Seguro Social

  • Mireya Gamiochipi, MSC · Coordinación de Investigación en Salud, Mexico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2005-06-30
Completion
2007-12-31

Countries

  • Mexico

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01813708 on ClinicalTrials.gov