Type 2 DiabetesTd2AstNCT05383859
Diet and Physical Activity Program for Type 2 Diabetes Mellitus
A study testing Intervention in people with Type 2 Diabetes, run by University of Oviedo at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Intervention
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
- Dietary and/ or physical activity: face to face plus written material (at baseline)
- 3 months later: motivational phone call.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Intervention |
| Control group (CG) | No intervention | 1. Completing the consent and the pre-intervention questionnaires, anthropometric and HbA1c measurements. 2. Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Change from Baseline physical activity recommendations at 6 months
Secondary outcomes (1)
Change in HbA1c (Mean percentage)
% of HbA1c
Measured: Change from Baseline % of HbA1c at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start1 May 2022
- Primary completion30 Nov 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Collaborators
- Servicio de Salud del Principado de Asturias. Área Sanitaria III
- Responsible party
- Principal investigator, Rubén Martín Payo, University of Oviedo
- Investigators
- Ruben Martin, PhD, Principal investigator, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383859
- Sponsor's protocol ID
- 2022.014
- Acronym
- Td2Ast
- Status last verified
- May 2023
- First submitted
- 31 Mar 2022
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD aren´t be shared
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Primary Care Diet and Physical Activity Educational Program for Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05383859
- Acronym / sponsor ID
- Td2Ast / 2022.014
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Collaborators
- Servicio de Salud del Principado de Asturias. Área Sanitaria III
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (IG) | Experimental | Behavioral: Intervention1. 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. |
| Control group (CG) | No intervention | –1. Completing the consent and the pre-intervention questionnaires, anthropometric and HbA1c measurements. 2. Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention1. Dietary and/ or physical activity: face to face plus written material (at baseline) 2. 3 months later: motivational phone call. | Behavioural | Intervention Group (IG) |
Primary outcome
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 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.
1 secondary outcome
Change in HbA1c (Mean percentage)
Time frame: Change from Baseline % of HbA1c at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No. IPD aren´t be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruben Martin, PhD principal investigator
University of Oviedo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Type 2 Diabetes, run by University of Oviedo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diet recommendations (mean) (time frame: Change from Baseline dietary recommendations at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.