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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 visi
• Поведенческое 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.

Первичные конечные точки

• Level of sedentary lifestyle [Срок оценки: At baseline, and at 3, 6 and 12 months after the initiation of the intervention]
• Level of sedentary lifestyle [Срок оценки: At baseline, and at 3, 6 and 12 months after the initiation of the intervention]
• State of motivation to change [Срок оценки: At baseline, and at 3, 6 and 12 months after the initiation of the intervention]

Вторичные конечные точки (2)

• Physical activity level [Срок оценки: At baseline, and at 3, 6 and 12 months after the initiation of the intervention]
• Quality of life in people with diabetes [Срок оценки: At baseline, and at 3, 6 and 12 months after the initiation of the intervention]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT06893146 · PI 778

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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