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

NCT06893146 | Not Yet Recruiting

• 1 other identifier: PI 778
• Study Type: interventional
• Target: 169
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type 2 Diabetes; Sedentary Behaviors

Keywords

Diabetes; Sedentary lifestyle; Sedentary behavior; quality of life

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Physical activity level

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

• Quality of life in people with diabetes

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

Other Outcomes (23)

• Clinical characteristics

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

• Clinical characteristics

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

• Clinical characteristics

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

Study Arms (2)

Intervention group

EXPERIMENTAL

This group will receive face-to-face group and individual visits and telephone calls.

Behavioral: Reduction of Sedentary Behavior

Control group

ACTIVE COMPARATOR

The control grup will receive every two months written information on healthy lifestyle habits by e-mail.

Behavioral: Educational support

Interventions

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.

Intervention group

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of La Rioja: lead

Related Publications (1)

• Sainz-Prado R, Sainz-Prado A, Andrade-Gomez E, Rodriguez-Roca B. Quasi-experimental controlled study protocol to reduce sedentary lifestyle in patients with type 2 diabetes. PLoS One. 2025 Sep 16;20(9):e0330393. doi: 10.1371/journal.pone.0330393. eCollection 2025.

  PMID: 40956797 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Sedentary Behavior; Diabetes Mellitus

Interventions

Training Support

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Financial Support; Economics; Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 25, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-03