Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of an Exercise and Lifestyle Education Program for Diabetics and Prediabetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03914924
Recruitment Status : Active, not recruiting
First Posted : April 16, 2019
Last Update Posted : July 15, 2020
Sponsor:
Collaborators:
Federal University of Minas Gerais
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Lilian Pinto da Silva, Federal University of Juiz de Fora

Brief Summary:
The purpose of this trial is to pragmatically investigate whether participation of diabetics and prediabetics in an Exercise and Lifestyle Education Program (i.e., exercise and education classes) results in better functional capacity, health knowledge and behavior, and cardiometabolic health parameters when compared to Exercise Program (i.e., exercise class only). In addition, the effects of these interventions will be evaluated on other outcomes: quality of life, program adherence, satisfaction about the different tools of Diabetes College and morbidity associated with diabetes in the 6 months follow-up.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Prediabetes Behavioral: Exercise Program Behavioral: Lifestyle Education Program Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly allocated to one of two interventions: Exercise Program (Ex) or Exercise and Lifestyle Education Program (ExLE).
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of an Exercise and Lifestyle Education Program for Brazilian Diabetics and Prediabetics: A Multicenter Randomized Controlled Trial
Actual Study Start Date : January 22, 2020
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Exercise Program
Ex: The participants will be submitted to only exercise sessions for 12 weeks.
Behavioral: Exercise Program

The 12-week program consisting of 16 exercise sessions in a total of supervised and individually prescribed aerobic and muscle-strengthening exercise of approximately 60 minutes duration. The exercise sessions will be delivered as follow:

  • 4 weeks - supervised exercise sessions 2x / week
  • 8 weeks - supervised exercise sessions 1x / week

In addition, they will receive counseling for unsupervised exercise sessions in their community, to accumulate a minimum of 150 min/week.


Experimental: Exercise and Lifestyle Education Program
ExLE: The participants will be submitted to exercise sessions and education classes for 12 weeks.
Behavioral: Exercise Program

The 12-week program consisting of 16 exercise sessions in a total of supervised and individually prescribed aerobic and muscle-strengthening exercise of approximately 60 minutes duration. The exercise sessions will be delivered as follow:

  • 4 weeks - supervised exercise sessions 2x / week
  • 8 weeks - supervised exercise sessions 1x / week

In addition, they will receive counseling for unsupervised exercise sessions in their community, to accumulate a minimum of 150 min/week.


Behavioral: Lifestyle Education Program

The 12-week program consisting of 18 education classes of 30 minutes duration delivery by a health educator team. Participants receive a comprehensive education workbook to accompany the sessions, containing 20 chapters. The classes will be delivered as follow:

  • initial class to program introduction
  • 4 weeks - education classes 2x / week
  • 8 weeks - education classes 1x / week
  • final class to program graduation




Primary Outcome Measures :
  1. Functional Capacity [ Time Frame: Change from Baseline Functional Capacity at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment) ]
    This outcome will be measured by the Incremental Shuttle Walk Test (ISWT) distance.


Secondary Outcome Measures :
  1. Health Behavior: health literacy [ Time Frame: Change from Baseline health literacy at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment) ]
    This outcome will be measured by the Newest Vital Sign (NVS) tool score. This is a six-item toll regarding the information found on an accompanying nutrition label. Each correct response is worth one point with a total of six points possible. Scores equal or greater than four are evidence of adequate health literacy whereas scores below four are evidence of inadequate health literacy.

  2. Health Behavior: pedometer-determined physical activity [ Time Frame: Change from Baseline physical activity at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment) ]
    This outcome will be measured from the total number of steps recorded by a pedometer during consecutive 7 days. For analysis of this outcome, the total number of steps recorded will be divided for seven in order to obtain the average number of steps/day for each participant. The level of physical activity will be classified from the average of steps/day, as follow: sedentary (<5000 steps/day); low active (5000-7499 steps/day); somewhat active (7500-9999 steps/day); active (≥10 000 steps/day) and highly active (>12 500 steps/day).

  3. Health Behavior: exercise self-efficacy [ Time Frame: Change from Baseline Exercise Self-efficacy at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment) ]
    This outcome will be measured by Bandura's Exercise Self-efficacy Scale scores. Exercise self-efficacy is defined as participants' confidence in their ability to exercise regularly (most days of the week). This tool measures exercise self-efficacy using an 18-item scale and ranges from 0 to 100 and the higher the score the better the exercise self-efficacy.

  4. Health Behavior: medication adherence [ Time Frame: Change from Baseline Medication adherence at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment) ]
    This outcome will be assessed by self-report in the collection of clinical data. The medications in use and dosage will be recorded and 5 questions will be asked about the regular use of medicines with "yes" or "no" response options. The higher the number of affirmative answers, the better the participant adherence. In addition, a Likert Scale (1 to 5) will be applied to assess the participant's perception of adherence to drug treatment. The higher the reported value, the higher the adherence.

  5. Cardiometabolic Health Parameter: glycemic control [ Time Frame: Change from Baseline blood sugar level at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment) ]
    This outcome will be measured by the blood sugar level.

  6. Cardiometabolic Health Parameter: body weight control [ Time Frame: Change from Baseline BMI and waist circumference at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment) ]
    This outcome will be measured by the body mass index (BMI - kg/m2) and the waist circumference.

  7. Cardiometabolic Health Parameter: cardiac autonomic control [ Time Frame: Change from Baseline Cardiac autonomic control at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment) ]
    This outcome will be measured by heart rate variability (HRV) indexes.

  8. Health Knowledge [ Time Frame: Change from Baseline Disease-related knowledge at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment). ]
    This outcome will be measured by the score obtained in the Diabetes Knowledge Questionnaire (DATE-Q), tool self-administered consisting of 20 true/false statements covering 5 areas of Diabetes knowledge and based on the Diabetes College. The score of this questionnaire ranges from 0 to 20 and the higher the score the better the knowledge about the disease.


Other Outcome Measures:
  1. Quality of life level [ Time Frame: Change from Baseline Quality of life at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment) ]
    Quality of life level will be evaluated using the the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). This questionnaire assesses 8 physical and mental health domains: Physical Functioning, Social Functioning, Role-Physical, Bodily Pain, Mental Health, Role-Emotional,Vitality and General Health. For each domain, item scores are coded, summed, and transformed, with final values (expressed as a percentage) ranging from 0 (worst health) to 100 (best health).

  2. Satisfaction about the learning tools of Diabetes College: 11- questions survey score [ Time Frame: 12 weeks (post-intervention assessment) only to group 2 (Exercise and Lifestyle Education Program). ]
    This outcome will be measured by 11- questions survey score, developed by the researchers.

  3. Adherence program [ Time Frame: 12 weeks (post-intervention assessment). ]
    This outcome will be measured by the number of sessions attended in the program for each participant.

  4. Morbidity associated with diabetes [ Time Frame: 6 months after post-intervention assessment (follow-up assessment). ]
    This outcome will be assessed through the participant's record during the 6-month follow-up regarding the following parameters: number of hospitalizations associated with diabetes, the occurrence of acute complications and diagnoses of chronic complications of diabetes.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (> 18 years old);
  • Clinical and laboratory diagnosis of Prediabetes or Diabetes Mellitus (type 1 or type 2);
  • Clinical compensation (glycemic control);
  • No cognitive limitation (score ≥ 4 in the six-item screener);
  • No confirmed diagnosis of cardiovascular diseases such as unstable coronary artery disease (CAD), heart failure; use of a pacemaker and/or implantable cardioverter-defibrillator (ICD), intermittent claudication; no recent cardiovascular event or cardiac surgery (≤ 6 months);
  • Participants not currently enrolled in a structured physical exercise program that follows diabetes guidelines.

Exclusion Criteria:

  • Clinical decompensation that contraindicates the performance of physical exercises (not glycemic control);
  • Physical and/or mental limitations that will prevent the participant to perform physical exercises and/or understanding of educational content;
  • Complex ventricular arrhythmias (i.e., atrial flutter or atrial fibrillation, multiple atrial or ventricular ectopy, and atrioventricular or ventricular block.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914924


Locations
Layout table for location information
Brazil
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 31270-901
Hospital Universitário da UFJF
Juiz de Fora, Minas Gerais, Brazil, 36038330
Sponsors and Collaborators
Federal University of Juiz de Fora
Federal University of Minas Gerais
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
Layout table for investigator information
Principal Investigator: Lilian P da Silva, PhD University Federal of Juiz de Fora
Additional Information:
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Lilian Pinto da Silva, Professor, Principal Investigator, Federal University of Juiz de Fora
ClinicalTrials.gov Identifier: NCT03914924    
Other Study ID Numbers: DiabetesCollegeBrazil
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lilian Pinto da Silva, Federal University of Juiz de Fora:
Diabetes Mellitus
Exercise
Health Education
Patient Education
Randomized Controlled Trial
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases