Intensive Life-Style Intervention in Type 2 Diabetes Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Intensive Life-Style; Behavioral: Collaborative Education

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Distrito Federal
    • Mexico City, Distrito Federal, Mexico, 06720
      • Unidad de Investigación en Epidemiología Clínica, UMAE Hospital de Especialidades, Centro Médico Siglo XXI, IMSS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease control	Proportion of patients attaining pre-specified goals: A1c < 7%, LDL cholesterol < 100 mg/dl, blood pressure < 130/80 mmHg.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight	Body Weight, reduction in abdominal girdle,HDL, Triglycerides	6 months
Quality of Life	Quality of life as assessed by the Jacobson Diabetes Quality of Life Measure	6 months
Well-Being	Well-being by the 22 item Bradleys Well-Being Questionnaire	6 months
Self-Efficacy	Self Efficacy with the Attitudes in Diabetes Questionnaire of Anderson, Funnel, Fitzgerald and Marrero	6 months

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Primary Completion (Actual): June 1, 2005
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: June 18, 2012
• First Submitted That Met QC Criteria: March 15, 2013
• First Posted (Estimate): March 19, 2013

Study Record Updates

• Last Update Posted (Estimate): March 21, 2013
• Last Update Submitted That Met QC Criteria: March 20, 2013
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Clinical Trial; Metabolic Control; Intensive Life-Style; Collaborative Education
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2003-716-0107