Protocol for a Quasi-experimental Controlled Study to Reduce Sedentary Lifestyle in Patients With Type 2 Diabetes

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of La Rioja

About this trial

The prevalence of diabetes has increased worldwide, making it the most prevalent metabolic disorder. Physical inactivity contributes to the progression of this disease and aggravates other comorbidities, such as obesity and cardiovascular disease. Beneficial strategies aimed at promotion and healthy aging, oriented to decrease sedentary behavior, are necessary to obtain desirable metabolic effects and improve the quality of life of people with diabetes.

The objective is to examine, through a clinical trial, the effect of decreasing sedentary time and increasing motivation to adopt an active lifestyle on different clinical, anthropometric and biochemical parameters in patients diagnosed with type 2 diabetes mellitus.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of type 2 diabetes mellitus

18 years of age or older

Minimal physical fitness

Disqualifiers

Medical contraindication

Pregnant women

Recent surgical interventions limiting mobility

Patients currently undergoing oncological treatment or less than one year since the end of treatment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Reduction of Sedentary Behavior

    Behavioral

    The intervention group will receive an intervention that will include two group sessions, bimonthly phone calls and a face-to-face visit with the study nurse. Phone calls will be made every two months using motivational interviewing techniques with the aim of educating on habits and behaviors that reduce sedentary lifestyles, addressing needs and concerns on an individual basis, and enhancing patients motivation, well-being and quality of life. The same purpose is served by the face-to-face visit that will be conducted in the third month of the study. The study's interventions have a personalized approach, which considers individual preferences and needs to consolidate the new habits acquired in the long term. The active intervention has a duration of 6 months and will be carried out by nursing professionals.

  • Educational support

    Behavioral

    Every two months, this group will receive detailed written information about healthy lifestyle habits via email, emphasizing the importance of maintaining an active lifestyle. Additionally, they will be provided with standard educational material on the management of type 2 diabetes.

Treatment groups

169 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Level of sedentary lifestyle

The level of sedentary lifestyle will be measured with the use of accelerometers. The model used in our study is ActiTrainer.

Time frame
At baseline, and at 3, 6 and 12 months after the initiation of the intervention
2

Level of sedentary lifestyle

The level of sedentary lifestyle will be measured with the questionnaire validated in Spanish Sedentary Behavior Questionnaire. This instrument measures the time spent on sedentary behaviors from the moment the person wakes up until they go to bed, performed during weekdays and weekends. Responses are provided on numerical scales, and then the total number of hours dedicated to each activity is summed up. Higher scores indicate more time spent in sedentary activities.

Time frame
At baseline, and at 3, 6 and 12 months after the initiation of the intervention
3

State of motivation to change

Measured by the Transtheoretical Model of Physical Exercise Change Questionnaire. This questionnaire identifies the stage of the Transtheoretical Model of Change in which a person stands regarding their willingness to engage in physical exercise. It consists of two tables: one for those who do not exercise regularly, with items about reasons for not exercising, and another for those who do, with reasons for exercising. Responses are rated on a scale from 1 (strongly disagree) to 5 (strongly agree). The measurement is based on the average scores for each stage of the model. Higher scores indicate a greater readiness to engage in physical activity (better outcome in terms of behavior change).

Time frame
At baseline, and at 3, 6 and 12 months after the initiation of the intervention

Secondary outcomes

1

Physical activity level

To measure the level of physical activity, the short, self-administered format of the "International Physical Activity Questionnaire" will be used. Questions are asked about the time spent on activity over the past 7 days, distinguishing between vigorous activities, walking, or sitting. Results are calculated in minutes per week by multiplying the number of days by the duration of the activity in minutes, obtaining a weekly value for each category. A person is considered inactive if they do not meet the recommended threshold of 150 minutes of moderate physical activity per week. They are classified as sufficiently active if they reach 150 minutes of moderate or 75 minutes of vigorous activity per week, and very active if they exceed 300 minutes of moderate or 150 minutes of vigorous activity per week, as recommended by the WHO.

Time frame
At baseline, and at 3, 6 and 12 months after the initiation of the intervention
2

Quality of life in people with diabetes

The validated Spanish version of the Diabetes Quality of Life Questionnaire (DQoL) will be used. Participants rate the items on a 5-point Likert scale, where 1 represents "strongly disagree" and 5 represents "strongly agree." Other items are rated from 1 ("very satisfied") to 5 ("very dissatisfied"). The scores are quantified, with higher scores indicating better quality of life, while lower scores suggest a greater negative impact of diabetes on the patient's life.

Time frame
At baseline, and at 3, 6 and 12 months after the initiation of the intervention

Other outcomes

1

Clinical characteristics

Levels of glucose: mg/dL (milligrams per deciliter).

Time frame
At baseline, and at 3, 6 and 12 months after the initiation of the intervention
2

Clinical characteristics

Glycosylated hemoglobin (HbA1c): % (percentage).

Time frame
At baseline, and at 3, 6 and 12 months after the initiation of the intervention
3

Clinical characteristics

Homeostasis model assessment-insulin resistance (HOMA-IR): Dimensionless unit.

Time frame
At baseline, and at 3, 6 and 12 months after the initiation of the intervention
4

Clinical characteristics

Total cholesterol: mg/dL (milligrams per deciliter).

Time frame
At baseline, and at 3, 6 and 12 months after the initiation of the intervention

Locations

This trial has no locations.

Sponsors and contacts

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