Intensive Life-Style Intervention in Type 2 Diabetes Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mireya Gamiochipi Cano, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier:
NCT01813708
First received: June 18, 2012
Last updated: March 20, 2013
Last verified: June 2012
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Behavioral: Intensive Life-Style
Behavioral: Collaborative Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: The Effectiveness of an Intensive Life-Style Intervention Compared to an Collaborative Educational Intervention On Metabolic Control, and Its Impact on Weight, Physical Activity, Quality of Life, Self-Efficacy in Type 2 Diabetes Patients

Resource links provided by NLM:


Further study details as provided by Coordinación de Investigación en Salud, Mexico:

Primary Outcome Measures:
  • disease control [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Proportion of patients attaining pre-specified goals:

    A1c < 7%, LDL cholesterol < 100 mg/dl, blood pressure < 130/80 mmHg.



Secondary Outcome Measures:
  • Body Weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Body Weight, reduction in abdominal girdle,HDL, Triglycerides

  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Quality of life as assessed by the Jacobson Diabetes Quality of Life Measure

  • Well-Being [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Well-being by the 22 item Bradleys Well-Being Questionnaire

  • Self-Efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Self Efficacy with the Attitudes in Diabetes Questionnaire of Anderson, Funnel, Fitzgerald and Marrero


Enrollment: 200
Study Start Date: November 2004
Study Completion Date: December 2007
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive Life-Style Counseling
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
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
Active Comparator: Collaborative Educational
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
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

Detailed Description:

Two interventions will be compared for metabolic control (A1c, LDL Cholesterol, and blood pressure). Additional measures will include: body weight abdominal girdle, other lipids (HDL cholesterol, triglycerides);and physical activity, quality of life, psychological well-being and self-efficacy will be measured with specific questionnaires.

Inclusion criteria are: 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.

Exclusion criteria: 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.

Patients will be randomly assigned to either intervention and will not be told to which intervention he/she was assigned.

The Intensive intervention is structured in 16 sessions to be held every week for groups of up to 15 patients in family medicine clinics in Mexico City. This includes healthy nutrition and physical activity plus behavioural modification techniques; the treatment goals will be instituted by the case manager (lowering body weight by 5% 10%, and increasing physical activity to 150 minutes/week).

The Educational Collaborative group will attend 16 weekly sessions where nutritional and physical activity will also be discussed, along with knowledge about diabetes and its treatment. Behavioural modification techniques are included in the curricula but the treatment goals will be selected by the patients themselves.

Blood samples will be drawn from an antecubital vein before the program starts and every 3 months thereafter. Measurements will include: A1c, glucose, total cholesterol, LDL, HDL cholesterol and triglycerides. Furthermore, body weight and abdominal girdle will be measured by a trained nurse observer who does not know the patient's group allocation. Questionnaires for physical activity, quality of life, psychological well-being and self-efficacy will be answered by patients every 3 months.

The statistical analysis will be conducted as an intention-to-treat analysis, and will include comparison of proportions of patients attaining treatment goals, adjusted by age, sex, BMI, and base-line values with logistic regression; continuous variables will be analyzed with Analysis of Covariance.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01813708

Locations
Mexico
Unidad de Investigación en Epidemiología Clínica, UMAE Hospital de Especialidades, Centro Médico Siglo XXI, IMSS
Mexico City, Distrito Federal, Mexico, 06720
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Investigators
Study Chair: Niels H Wacher, MD, MSc Instituto Mexicano del Seguro Social
Principal Investigator: Mireya Gamiochipi, MSC Coordinación de Investigación en Salud, Mexico
  More Information

No publications provided

Responsible Party: Mireya Gamiochipi Cano, MSc, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT01813708     History of Changes
Other Study ID Numbers: 2003-716-0107
Study First Received: June 18, 2012
Last Updated: March 20, 2013
Health Authority: Mexico: Secretaria de Salud

Keywords provided by Coordinación de Investigación en Salud, Mexico:
Type 2 Diabetes
Intensive Life-Style
Collaborative Education
Clinical Trial
Metabolic Control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 20, 2014