Diet and Physical Activity Program for Type 2 Diabetes Mellitus

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Intervention

• Registration Number: NCT05383859
• Lead Sponsor: University of Oviedo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-31
• Study Start: 2022-05-01
• Study First Submitted QC: 2022-05-16
• Study First Posted: 2022-05-20
• Primary Completion: 2022-11-30
• Study Completion: 2023-03-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-14
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group (IG)	Intervention	1. Completing the consent and the pre-intervention questionnaires, anthropometric and HbA1c measurements. 2. Dietary and/ or physical activity: face to face plus written material 3. 3 months later: motivational phone call.

Primary Outcome Measures

Name	Time	Method
Change in Physical activity recommendations (mean)	Change from Baseline physical activity recommendations at 6 months	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 in Diet recommendations (mean)	Change from Baseline dietary recommendations at 6 months	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).

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c (Mean percentage)	Change from Baseline % of HbA1c at 6 months	% of HbA1c

Trial Locations

Locations (1)

University of Oviedo; 🇪🇸 Oviedo, Asturias, Spain