Diet and Physical Activity Program for Type 2 Diabetes Mellitus

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05383859

Acronym

Td2Ast

Enrollment

208

Registered

2022-05-20

Start date

2022-05-01

Completion date

2023-03-31

Last updated

2023-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

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.

Interventions

BEHAVIORALIntervention

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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).
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.

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026