Intensive Life-Style Intervention in Type 2 Diabetes Patients

NCT01813708 | Completed DMC

• 1 other identifier: 2003-716-0107
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Type 2 Diabetes

Keywords

Type 2 Diabetes; Intensive Life-Style; Collaborative Education; Clinical Trial; Metabolic Control

Outcome Measures

Primary Outcomes (1)

• disease control

  Proportion of patients attaining pre-specified goals: A1c \< 7%, LDL cholesterol \< 100 mg/dl, blood pressure \< 130/80 mmHg.

  6 months

Secondary Outcomes (4)

• Body Weight

  6 months

• Quality of Life

  6 months

• Well-Being

  6 months

• Self-Efficacy

  6 months

Study Arms (2)

Intensive Life-Style Counseling

EXPERIMENTAL

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: Intensive Life-Style

Collaborative Educational

ACTIVE COMPARATOR

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

Behavioral: Collaborative Education

Interventions

Intensive Life-Style BEHAVIORAL

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

Intensive Life-Style Counseling

Collaborative Education BEHAVIORAL

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

Collaborative Educational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes (ADA criteria) diagnosed during the last 3 years. Without chronic complications, negative urine ketone tests, current in their dues to IMSS, A1c \> 7%, and BMI \> 25. No age limits.

You may not qualify if:

• Psychosis or personality disorders, other illnesses thought to be fatal in 6 months or less (e.g. AIDS, liver Cirrhosis, etc), unable to read and write, and currently taking other drugs that impair blood glucose metabolism, such as glucocorticoids.
• Patients unable to perform physical activity because of other neurological, orthopedic or rheumatological conditions, patients on drug treatment for depression or obesity.
• Patients with alcohol or other drug dependencies, and being a relative of a patient already included in the study.

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

Unidad de Investigación en Epidemiología Clínica, UMAE Hospital de Especialidades, Centro Médico Siglo XXI, IMSS

Mexico City, Mexico City, 06720, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Niels H Wacher, MD, MSc

  Instituto Mexicano del Seguro Social

  STUDY CHAIR

• Mireya Gamiochipi, MSC

  Coordinación de Investigación en Salud, Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: June 18, 2012
• First Posted: March 19, 2013
• Study Start: November 1, 2004
• Primary Completion: June 1, 2005
• Study Completion: December 1, 2007
• Last Updated: March 21, 2013

Record last verified: 2012-06

Locations

ME (1)