Clinical trial NCT06893146: Clinical Trial to Reduce Sedentary Lifestyle in Patients with Type 2 Diabetes
Official title: Clinical Trial Protocol to Reduce Sedentary Lifestyle in Patients with Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Sedentary Behaviors
Keywords: Diabetes
Sedentary lifestyle
Sedentary behavior
quality of life
Lead sponsor: University of La Rioja
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 clinical trial 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.

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.

Primary outcomes:
measure: Level of sedentary lifestyle
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: Level of sedentary lifestyle
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: State of motivation to change
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Secondary outcomes:
measure: Physical activity level
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: Quality of life in people with diabetes
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Other outcomes:
measure: Clinical characteristics
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: Clinical characteristics
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: Clinical characteristics
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: Clinical characteristics
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: Clinical characteristics
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: Clinical characteristics
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: Clinical characteristics
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: Clinical characteristics
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: Clinical characteristics
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: Clinical characteristics
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: Clinical characteristics
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: Clinical characteristics
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: Clinical characteristics
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: Clinical characteristics
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: Clinical characteristics
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: Clinical characteristics
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: Clinical characteristics
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: Clinical characteristics
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: Blood pressure
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: Anthropometric data
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: Anthropometric data
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: Anthropometric data
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
measure: Anthropometric data
timeFrame: At baseline, and at 3, 6 and 12 months after the initiation of the intervention
Locations:
Study officials:
References: