Diet and Physical Activity Program for Type 2 Diabetes Mellitus (Td2Ast)

May 14, 2023 updated by: Rubén Martín Payo, University of Oviedo

Effectiveness of a Primary Care Diet and Physical Activity Educational Program for Patients With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • University of Oviedo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group (IG)
  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.
Behavioral: Intervention
  1. Dietary and/ or physical activity: face to face plus written material (at baseline)
  2. 3 months later: motivational phone call.
No Intervention: Control group (CG)
  1. Completing the consent and the pre-intervention questionnaires, anthropometric and HbA1c measurements.
  2. Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Change from Baseline dietary recommendations at 6 months
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.
Change from Baseline physical activity recommendations at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c (Mean percentage)
Time Frame: Change from Baseline % of HbA1c at 6 months
% of HbA1c
Change from Baseline % of HbA1c at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oviedo

Collaborators

Servicio de Salud del Principado de Asturias. Área Sanitaria III

Investigators

  • Principal Investigator: Ruben Martin, PhD, University of Oviedo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

March 31, 2022

First Submitted That Met QC Criteria

May 16, 2022

First Posted (Actual)

May 20, 2022

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 14, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022.014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD aren´t be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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