Diet and Physical Activity Program for Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

— Td2Ast  

Official title:

Effectiveness of a Primary Care Diet and Physical Activity Educational Program for Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05383859
• Other study ID #: 2022.014
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2023
• Source: University of Oviedo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An individualized educational intervention are going to be developed. Its based on the COM-B model, designed and applied by Primary Care nursing professionals for patients with type 2 diabetes mellitus. Its expected that participants, after a 6 month intervention, face to face and telephone, will improve their adherence to healthy behaviors related to diet and physical activity, their quality of life and the glycosylated hemoglobin figures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: March 31, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be cared for by one of the nurses participating in the research team
• Ability to complete the questionnaire
• Sign the informed consent
• Keep the Primary care health center during till the end of the research

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Intervention
Dietary and/ or physical activity: face to face plus written material (at baseline) 3 months later: motivational phone call.

Locations

Country	Name	City	State
Spain	University of Oviedo	Oviedo	Asturias

Sponsors (2)

Lead Sponsor	Collaborator
University of Oviedo	Servicio de Salud del Principado de Asturias. Área Sanitaria III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Diet recommendations (mean)	Compliance with dietary recommendations. We are going to use the Motiva.Diaf DM2 questionnaire. Includes 8 questions for dietary adherence. Response in dichotomous option 0 (do not follow the recommendation) or 1 (follow the recommendation). Total score range from 0 (worst dietary compliance) to 8 (best dietary compliance).	Change from Baseline dietary recommendations at 6 months
Primary	Change in Physical activity recommendations (mean)	Compliance with physical activity recommendations. We are going to use the Motiva.Diaf DM2 questionnaire. Includes 4 questions for physical activity recommendations. Response in dichotomous option 0 (do not follow the recommendation) or 1 (follow the recommendation). Total score range from 0 (worst dietary compliance) to 4 (best dietary compliance).; Result: mean number of recommendations followed.	Change from Baseline physical activity recommendations at 6 months
Secondary	Change in HbA1c (Mean percentage)	% of HbA1c	Change from Baseline % of HbA1c at 6 months