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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes; Sedentary Behaviors
• Intervention / Treatment: Behavioral: Reduction of Sedentary Behavior; Behavioral: Educational support

Detailed Description

A quasy-experimental controlled study with a 12-month follow-up will be carried out. The study has been chosen to be conducted as a single-center study for strategic and logistical reasons. A two-arm parallel design will be used. The control group (CG) will receive messages by mail with healthy lifestyle habits, while the intervention group (IG) will receive a behavioral intervention based on lifestyle modification, focusing on reducing sedentary time. These interventions will be directed by the research nurse.

The general objective of the study is to know the effect of decreasing sedentary time and increasing motivation to adopt an active lifestyle of different health-related parameters in patients diagnosed with type 2 diabetes mellitus. Also to provide support and resources for the proper management of diabetes. Likewise, it will be verified that face-to-face interventions and telephone interventions by nursing professionals decrease the sedentary time in the diabetic population and if it means and improvement in clinical, anthropometric and biochemical parameters. Also, to evaluate the quality of life and the degree of motivation aimed at reducing sedentary time and to integrate the reduction of sedentary time in the lifestyle of the participants with practical tools and guidelines adapted to the circumstances.

• Study Type: Interventional
• Enrollment (Estimated): 169
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of type 2 diabetes mellitus
• 18 years of age or older
• Minimal physical fitness

Exclusion Criteria:

• Medical contraindication
• Pregnant women
• Recent surgical interventions limiting mobility
• Patients currently undergoing oncological treatment or less than one year since the end of treatment.
• Suffering from dementia, impairment or a severe cognitive or psychiatric disorder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; This group will receive face-to-face group and individual visits and telephone calls.	Behavioral: Reduction of Sedentary Behavior; 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.
Active Comparator: Control group; The control grup will receive every two months written information on healthy lifestyle habits by e-mail.	Behavioral: Educational support; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
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.	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
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).	At baseline, and at 3, 6 and 12 months after the initiation of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
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.	At baseline, and at 3, 6 and 12 months after the initiation of the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical characteristics	Levels of glucose: mg/dL (milligrams per deciliter).	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Clinical characteristics	Glycosylated hemoglobin (HbA1c): % (percentage).	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Clinical characteristics	Homeostasis model assessment-insulin resistance (HOMA-IR): Dimensionless unit.	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Clinical characteristics	Total cholesterol: mg/dL (milligrams per deciliter).	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Clinical characteristics	High-density lipoprotein cholesterol (HDL-c): mg/dL (milligrams per deciliter).	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Clinical characteristics	Low-density lipoprotein cholesterol (LDL-c): mg/dL (milligrams per deciliter).	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Clinical characteristics	Triglycerides (TG): mg/dL (milligrams per deciliter).	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Clinical characteristics	Aspartate aminotransferase (AST): U/L (units per liter).	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Clinical characteristics	Alanine aminotransferase (ALT): U/L (units per liter).	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Clinical characteristics	Gamma-glutamyl transferase (GGT): U/L (units per liter).	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Clinical characteristics	Creatinine: mg/dL (milligrams per deciliter).	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Clinical characteristics	Urea: mg/dL (milligrams per deciliter.	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Clinical characteristics	Creatinine clearance: mL/min (milliliters per minute).	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Clinical characteristics	Iron: µg/dL (micrograms per deciliter).	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Clinical characteristics	Ferritin: ng/mL (nanograms per milliliter).	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Clinical characteristics	Sodium: mmol/L (millimoles per liter).	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Clinical characteristics	Potassium: mmol/L (millimoles per liter).	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Clinical characteristics	C-reactive protein (CRP): mg/L (milligrams per liter).	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Blood pressure	Measurements will be taken over the brachial artery, after 5 minutes of rest while seated and with the arms resting at heart level. Long-sleeved shirts will be removed for a correct reading and the cuff size must be adequate.	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Anthropometric data	Anthropometric measurements of weight are collected by healthcare personnel using calibrated instruments and clinical standard procedures. Weight will be measured in kilograms (kg).	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Anthropometric data	Anthropometric measurements of height are collected by healthcare personnel using calibrated instruments and clinical standard procedures. Height will be measured in centimeters (cm).	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Anthropometric data	Weight and height will be combined to report the BMI in kg/m².	At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Anthropometric data	Anthropometric measurements of waist-hip circumference are collected by healthcare personnel using calibrated instruments and clinical standard procedures. Waist-hip circumference will be measured in centimeters (cm).	At baseline, and at 3, 6 and 12 months after the initiation of the intervention

Collaborators and Investigators

• Sponsor: University of La Rioja

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes; quality of life; Sedentary lifestyle; Sedentary behavior
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: PI 778

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No