Type 2 Diabetes
Conditions
Keywords
diabetes mellitus, physical activity, sedentary behavior, exercise intervention
Brief summary
This behavioral intervention study aims to assess physical activity levels and sedentary behavior among individuals with diabetes. It will compare the effectiveness of standard interventions against informational sessions on the benefits of physical activity for achieving changes in behavior and improving quality of life while reducing reliance on healthcare services. Participants will be divided into 3 groups: one receiving standard care from the diabetology service; one attending three theoretical motor counseling sessions; another engaging in three theoretical motor counseling sessions plus practical counseling supervised by kinesiologist. The primary objective is to evaluate physical activity levels at 6 and 12 months post-intervention. Secondary objectives include assessing sedentary time, health status, anthropometric measurements, blood pressure, barriers to engaging in physical activity, motivation levels, dietary habits, readiness for lifestyle changes, perceived quality of life, and functional capacities.
Detailed description
A total of 123 participants, all voluntary and at no cost, will be recruited from the Diabetology clinics of the Complex Structure of Endocrinology and Metabolic Diseases in Perugia. The recruitment process will employ a randomized, non-blinded methodology, enabling the formation of three distinct groups for comparison. Group 1 will consist of 41 people who have been diagnosed with diabetes mellitus for a minimum of three months. This cohort will receive standard medical care, which encompasses routine monitoring and management of their condition. Alongside this, participants will complete questionnaires designed to assess their health status and lifestyle, as well as undergo evaluations of their functional abilities, which may include tests of strength, mobility, and overall physical capacity. Importantly, members of this group will not receive specific recommendations for engaging in daily physical activity from healthcare providers or kinesiologists. Instead, the guidance provided will be solely theoretical, with no practical motor counseling offered to enhance their physical activity levels. Group 2 will similarly include 41 people meeting the same three-month diagnostic criteria for diabetes mellitus. These participants will also benefit from standard care, complete questionnaires, and undergo assessments of their functional abilities. However, a key distinction for Group 2 is the provision of recommendations for daily physical activity from both healthcare professionals and kinesiologists. While this group will receive theoretical guidance on the importance of physical activity, they will not receive practical motor counseling to help them implement these recommendations in their daily lives. Group 3 will feature another set of 41 people, again fulfilling the condition of having a diabetes mellitus diagnosis for no less than three months. In addition to receiving the same standard care, questionnaire administration, and assessments of functional capabilities, participants in this group will also receive recommendations for daily physical activity from their healthcare and kinesiology teams. What sets Group 3 apart is the inclusion of 24 biweekly sessions focused on practical motor counseling, where individuals will engage in structured physical activity programs. This component is designed to provide hands-on, practical guidance that enables participants to actively incorporate physical exercise into their routines, aiming to enhance their overall health and functional abilities. Through this detailed approach, the study aims to explore the impact of differing levels of prescribed physical activity and support on the functional outcomes of individuals living with diabetes mellitus, contributing valuable insights to the management practices in diabetic care.
Interventions
BEHAVIORALTheoretical Counseling on Physical Activity (TCPA)
Participant wil be involved in: * Routine assessments: Anthropometric (weight, height, waist circumference) and hematobiochemical parameters (e.g., glycemic and lipid profiles), and systolic and diastolic blood pressure. * General information + administration of the IPAQ, PACE, Barriers, Mediterranean Diet, and Quality of Life questionnaires. * Body Composition Assessment: BMI, fat mass (FM), fat free mass (FFM), muscle mass, total body water (TBW) and basal metabolism rate (BMR). * Non-diagnostic assessment of functional abilities: submaximal tests of strength, muscular endurance, and flexibility. * Only 3 sessions (1 per month) of TCPA: the Kinesiologist will inform the patient about the guidelines and the various types of PA, as well as their dose-dependent effects.
BEHAVIORALStandard Care + Theoretical Counseling on Physical Activity (TCPA) + Practical Counseling on Physical Activity (PCPA)
Participant wil be involved in: * Routine assessments: Anthropometric (weight, height, waist circumference) and hematobiochemical parameters (e.g., glycemic and lipid profiles), and systolic and diastolic blood pressure. * General information + administration of the IPAQ, PACE, Barriers, Mediterranean Diet, and Quality of Life questionnaires. * Body Composition Assessment: BMI, fat mass (FM), fat free mass (FFM), muscle mass, total body water (TBW) and basal metabolism rate (BMR). * Non-diagnostic assessment of functional abilities: submaximal tests of strength, muscular endurance, and flexibility. * Only 3 sessions (1 per month) of TCPA: the Kinesiologist will inform the patient about the guidelines and the various types of PA, as well as their dose-dependent effects. * PCPA: supervised mixed physical activity program (cardiovascular + resistance) lasting 3 months, with 2 sessions per week.
Sponsors
Centro Universitario Ricerca Interdipartimentale Attivita' Motoria
Azienda Ospedaliera di Perugia
University of Perugia, Faculty of Medicine, Department of Internal Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Controlled, Randomized, non-blinded, intervention study
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of T2DM of at least 3 months; * age between 25 and 80 years; * engagement in insufficient PA (\< 150 minutes per week of moderate-intensity PA, according to WHO guidelines); * ability to walk independently; * 18.5 \< BMI (kg/m²) \< 40.
Exclusion criteria
* the presence of severe cardiovascular, neurological, or musculoskeletal conditions that contraindicate PA; * refusal or inability to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total weekly physical activity time | At the time of enrollment and follow-up (6 and 12 months). | Total physical activity (PA) time in a week, expressed in min/week. It result from the sum of time spent in moderate-intensity PA + time spent in vigorous-intensity PA + time spent in walking. This measure will be assessed using the International Physical Activity Questionnaire and Actigraphy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total weekly walking physical activity time | At the time of enrollment and follow-up (6 and 12 months). | Total physical activity (PA) time in a week, expressed in min/week, spent in walking. This measure will be assessed using the International Physical Activity Questionnaire and Actigraphy. |
| Total weekly moderate physical activity time | At the time of enrollment and follow-up (6 and 12 months). | Total physical activity (PA) time in a week, expressed in min/week, spent in moderate-intensity PA. This measure will be assessed using the International Physical Activity Questionnaire and Actigraphy. |
| Total weekly vigorous physical activity time | At the time of enrollment and follow-up (6 and 12 months). | Total physical activity (PA) time in a week, expressed in min/week, spent in vigorous-intensity PA. This measure will be assessed using the International Physical Activity Questionnaire and Actigraphy. |
| Sedentary time | At the time of enrollment and follow-up (6 and 12 months). | Daily time spent in sedentary activities (defined as activities with a energy expenditure \<1.5 Metabolic Equivalent of Task-hours). This measure will be assessed using the International Physical Activity Questionnaire and Actigraphy. |
| Age | At the time of enrollment. | Number of years of patients |
| Body weight | At the time of enrollment and follow-up (6 and 12 months). | Weight (kg) assessed using a calibrate medical scale |
| Height | At the enrollment, and during follow up (6 and 12 months) | Height (m) assessed using a medical stadiometer. |
| Waist circumference | At the enrollment, and during follow up (6 and 12 months) | Waist circumference (cm) will be measured using a medical tape |
| Body mass index (BMI) | At the time of enrollment and follow-up (6 and 12 months). | Body mass index (kg/m2) will be calculated as weight (kg) divided by the square of height (meters). |
| Fasting glucose | At the enrollment, and during follow up (6 and 12 months) | Blood glucose value expressed in mg/dl |
| Glycated hemoglobin (HbA1c) | At the enrollment, and during follow up (6 and 12 months) | Mean of blood glucose in the last three months, expressed in percentage |
| Total blood cholesterol value | At the enrollment, and during follow up (6 and 12 months) | Total cholesterol value in blood, expressed in mg/dL |
| Serum Glutamic-Oxaloacetic Transaminase (SGOT) and Serum Glutamic-Pyruvic Transaminase (SGPT) | At the enrollment, and during follow up (6 and 12 months) | SGOT and SGPT blood values |
| Creatinine | At the enrollment, and during follow up (6 and 12 months) | creatinine blood values, expresseg in mg/dL |
| Blood pressure | At the enrollment, and during follow up (6 and 12 months) | Systolic and diastolic blood pressure (mmHg) values will be measured with a digital column sphygmomanometer for professional blood pressure measurement. |
| Stages of Change | At the time of enrollment and follow-up (6 and 12 months). | Stages of Change will be studied using an eight point item questionnaire specifically used for exercise, developed as part of the PACE (Patient-centered Assessment and Counseling for Activity) project. It is based on the Transthetic Model of Prochaska and Di Clemente and helps understand where a person is with respect to physical activity. |
| Barriers to physical activity | At time of enrollment and follow up (6 and 12 months). | This is a 32-item instrument used to identify specific barriers to adherence and maintenance physical activity. Items are grouped into key categories that influence behavior: personal barriers (e.g., laziness, lack of motivation, tiredness, feelings of shame); physical/health barriers (e.g., pain, fear of injury, feeling too fat); environmental/external barriers (e.g., weather conditions, lack of safe places, traffic); social/economic barriers (lack of family support, excessive costs). The list of barriers comes from integrating the "PACE" protocol adapted for diabetic or obese people . |
| Adherence to the Mediterranean diet | At time of enrollment and follow up (6 and 12 months). | Eating habits and adherence to the principles of the Mediterranean diet will be assessed by administering the 14-Item Mediterranean Diet Assessment Tool questionnaire. |
| Measures of patient's health-related quality of life | At time of enrollment and follow up (6 and 12 months). | The 36-Item Short Form Survey (SF-36) evaluates eight health domains (physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health), providing scores for both physical and mental health functioning. Each item is scored on a 0 to 100 range: a lower score indicates higher impairment and a higher score indicates better health. |
| Self-Care, Usual Activities quality of life, and health status | At time of enrollment and follow up (6 and 12 months). | Movement Ability, Personal Care, usual Activities (i.e. Work, Study, Home), Pain or Discomfort, and Anxiety or Depression will be assessed using the EuroQol-5Dimensions-3levels questionnaire. For each dimensions, participants will choose between 3 levels of severity (indicated by numbers 1= No problems; 2=Some / Moderate problems; 3=Extreme problems / Inability to perform the action). Finally, the EQ-VAS will be used to ask participants about health status over the past year. This questionnaire is usually accompanied by a Visual Analog Scale (VAS), a sort of "thermometer" graduated from 0 to 100 on which the patient is asked to mark how they rate their health today. |
| Hand Grip Strength | At time of enrollment and follow up (6 and 12 months). | The Hand Grip Strength will be measured with DynX ® dynamometer. |
| Dynamic muscle strength | At time of enrollment and follow up (6 and 12 months). | Dynamic muscle strength will be assessed by estimating one repetition maximum by submaximal upper and lower limb strength tests, performed at natural load or with the aid of isotonic machines, using Brzycki's 1-RM prediction equation. |
| Aerobic capacity | At the time of enrolment and at 6 and 12 months | Aerobic capacity will be estimated using the 6 Minutes Walking Test. |
| Total High-Density Lipoprotein (HDL) values | At the enrollment, and during follow up (6 and 12 months) | Total HDL values in blood, expressed in mg/dL |
| Total Low-Density Lipoprotein (LDL) values | At the enrollment, and during follow up (6 and 12 months) | Total LDL values in blood, expressed in mg/dL |
| Triglycerides values | At the time of enrollment and follow-up (6 and 12 months). | Triglycerides value in blood, expressed as mg/dL |
| Fat mass value | At time of enrollment and follow up (6 and 12 months). | Body fat mass, expressed in kg, assessed using an impedance platform (Tanita Body Composition Analyzer BC-420MA; Tokyo, Japan). |
| Fat free mass value | At time of enrollment and follow up (6 and 12 months). | Body fat free mass, expressed in kg, assessed using an impedance platform (Tanita Body Composition Analyzer BC-420MA; Tokyo, Japan). |
| Muscle mass value | At time of enrollment and follow up (6 and 12 months). | Muscle mass, expressed in kg, assessed using an impedance platform (Tanita Body Composition Analyzer BC-420MA; Tokyo, Japan). |
| Total body water value | At time of enrollment and follow up (6 and 12 months). | Total body water, expressed in percentage, assessed using an impedance platform (Tanita Body Composition Analyzer BC-420MA; Tokyo, Japan). |
| Basal metabolism value | At time of enrollment and follow up (6 and 12 months). | Basal metabolism rate, expressed in kcal, assessed using an impedance platform (Tanita Body Composition Analyzer BC-420MA; Tokyo, Japan). |
| Fat mass percentage | At time of enrollment and follow up (6 and 12 months). | Fat mass percentage assessed using an air plethysmograph (BOD POD® Composition System; COSMED, Albano Laziale, Italy). |
| Fat free mass percentage | At time of enrollment and follow up (6 and 12 months). | Fat free mass percentage assessed using an air plethysmograph (BOD POD® Composition System; COSMED, Albano Laziale, Italy). |
| Total Sleep Time | At the time of enrollment and follow-up (6 and 12 months). | Total Sleep Time, expressed in minutes, measured with the help of portable accelerometers of the ActiGraph Wearable Devices - wGT3X-BT type. |
| Sleep Efficiency percentage | At the time of enrollment and follow-up (6 and 12 months). | Sleep Efficiency is a a ratio, expressed as a percentage, representing the proportion of time spent asleep relative to the total time spent in bed. It is calculated as (Total Sleep Time / Time in Bed) × 100. Higher values indicate more consolidated and restorative sleep. It will be measured with the help of portable accelerometers of the ActiGraph Wearable Devices - wGT3X-BT type. |
| Wake After Sleep Onset | At the time of enrollment and follow-up (6 and 12 months). | Wake After Sleep Onset is the total amount of time spent awake after initially falling asleep, until the final awakening. It reflects the degree of sleep fragmentation during the night. It will be measured with the help of portable accelerometers of the ActiGraph Wearable Devices - wGT3X-BT type. |
| Sleep Onset Latency time | At the time of enrollment and follow-up (6 and 12 months). | Sleep Onset Latency, expressed in minutes, is the time it takes to transition from full wakefulness to sleep after lying down. Longer latency may indicate difficulty initiating sleep. It will be measured with the help of portable accelerometers of the ActiGraph Wearable Devices - wGT3X-BT type. |
| Sleep Fragmentation Index | At the time of enrollment and follow-up (6 and 12 months). | Sleep Fragmentation Index is an index that measures the frequency of sleep-wake transitions, expressed as a percentage. It will be measured with the help of portable accelerometers of the ActiGraph Wearable Devices - wGT3X-BT type. |
Countries
Italy
Contacts
CONTACTCarmine G Fanelli, Prof.
CONTACTRoberto Pippi, PhD
Outcome results
None listed