Type 2 DiabetesNCT01813708
Intensive Life-Style Intervention in Type 2 Diabetes Patients
A study testing Intensive Life-Style and Collaborative Education in people with Type 2 Diabetes, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Intensive Life-Style and Collaborative Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2004to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Unidad de Investigación en Epidemiología Clínica, UMAE Hospital de Especialidades, Centro Médico Siglo XXI, IMSS
Mexico City, Mexico City, 06720
About this study
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
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Intensive Life-Style, Collaborative Education
- Keywords
- Type 2 Diabetes, Intensive Life-Style, Collaborative Education, Clinical Trial, Metabolic Control
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Life-StyleBehavioural
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
Collaborative EducationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Collaborative Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease control
Proportion of patients attaining pre-specified goals:
A1c < 7%, LDL cholesterol < 100 mg/dl, blood pressure < 130/80 mmHg.
Measured: 6 months
Secondary outcomes (4)
Body Weight
Body Weight, reduction in abdominal girdle,HDL, Triglycerides
Measured: 6 months
Quality of Life
Quality of life as assessed by the Jacobson Diabetes Quality of Life Measure
Measured: 6 months
Well-Being
Well-being by the 22 item Bradleys Well-Being Questionnaire
Measured: 6 months
Self-Efficacy
Self Efficacy with the Attitudes in Diabetes Questionnaire of Anderson, Funnel, Fitzgerald and Marrero
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startNov 2004
- Primary completionJun 2005
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mireya Gamiochipi Cano, Coordinación de Investigación en Salud, Mexico
- Investigators
- Niels H Wacher, MD, MSc, Study chair, Instituto Mexicano del Seguro SocialMireya Gamiochipi, MSC, Principal investigator, Coordinación de Investigación en Salud, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813708
- Sponsor's protocol ID
- 2003-716-0107
- Status last verified
- Jun 2012
- First submitted
- 18 Jun 2012
- Last updated
- 21 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01813708
- Acronym / sponsor ID
- 2003-716-0107
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Intensive Life-Style, Collaborative Education, Clinical Trial, Metabolic Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- Nov 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 19 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Life-Style Counseling | Experimental | Behavioral: Intensive Life-Style16 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 |
| Collaborative Educational | Active comparator | Behavioral: Collaborative Education16 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Life-Style16 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 | Behavioural | Intensive Life-Style Counseling |
| Collaborative Education16 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 | Behavioural | Collaborative Educational |
Primary outcome
disease control
Time frame: 6 months
Proportion of patients attaining pre-specified goals: A1c < 7%, LDL cholesterol < 100 mg/dl, blood pressure < 130/80 mmHg.
4 secondary outcomes
Body Weight
Time frame: 6 months
Quality of Life
Time frame: 6 months
Well-Being
Time frame: 6 months
Self-Efficacy
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels H Wacher, MD, MSc study chair
Instituto Mexicano del Seguro Social
Mireya Gamiochipi, MSC principal investigator
Coordinación de Investigación en Salud, Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Life-Style and Collaborative Education in people with Type 2 Diabetes, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease control (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2013.