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Completed

NCT Number: NCT05383859

Diet and Physical Activity Program for Type 2 Diabetes Mellitus

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oviedo

Oviedo, Principality of Asturias, 33006, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

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

Primary outcomes

  1. Change in Diet recommendations (mean)

    Time frame: 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).

  2. Change in Physical activity recommendations (mean)

    Time frame: 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.

Secondary outcomes

  1. Change in HbA1c (Mean percentage)

    Time frame: Change from Baseline % of HbA1c at 6 months

    % of HbA1c

Sponsors and collaborators

Lead sponsor

University of Oviedo

Other

Collaborators

  • Servicio de Salud del Principado de Asturias. Área Sanitaria III

Registry information

Official study title

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

Acronym: Td2Ast

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
May 20, 2022
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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