Diet and Physical Activity Program for Type 2 Diabetes Mellitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Intervention

Intervention Type BEHAVIORAL

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

Control group (CG)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No