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

University of La Rioja

Status: Not yet enrolling

Conditions: Sedentary Behaviors; Type 2 Diabetes

Treatments: Behavioral: Reduction of Sedentary Behavior; Behavioral: Educational support

Study type: Interventional

Funder types: Other

Identifiers

NCT06893146

PI 778

Details and patient eligibility

About

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.

Full 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.

Enrollment: 169 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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169 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Behavioral: Reduction of Sedentary Behavior

Control group

Active Comparator group

Description:

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

Treatment:

Behavioral: Educational support