Diet and Physical Activity Program for Type 2 Diabetes Mellitus

NCT05383859 | Completed

• 1 other identifier: 2022.014
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Change in HbA1c (Mean percentage)

  Change from Baseline % of HbA1c at 6 months

Study Arms (2)

Intervention Group (IG)

EXPERIMENTAL

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

Control group (CG)

NO INTERVENTION

1. Completing the consent and the pre-intervention questionnaires, anthropometric and HbA1c measurements. 2. Usual care

Interventions

Intervention BEHAVIORAL

1. Dietary and/ or physical activity: face to face plus written material (at baseline) 2. 3 months later: motivational phone call.

Intervention Group (IG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Oviedo: lead
• Servicio de Salud del Principado de Asturias. Área Sanitaria III: collaborator

Study Sites (1)

University of Oviedo

Oviedo, Principality of Asturias, 33006, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Methods

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Ruben Martin, PhD

  University of Oviedo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Researcher, PhD

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: May 20, 2022
• Study Start: May 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: March 31, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)