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

NCT ID: NCT06893146

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2026-07-31

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.

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.

Conditions

Type 2 Diabetes; Sedentary Behaviors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Reduction of Sedentary Behavior

Intervention Type: 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.

Control group

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

Group Type: ACTIVE_COMPARATOR

Educational support

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of La Rioja

OTHER

Sponsor Role: lead

Responsible Party

Raquel Sainz Prado

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 40956797 (View on PubMed)

Other Identifiers

PI 778

Identifier Type: -

Identifier Source: org_study_id