Healthy LifestyleNCT05714852
Promotion of Healthy Eating Behaviors in Type 2 Diabetes Patients
A study testing Healthy eating in people with Healthy Lifestyle and Diabetes, run by University of Valencia at 1 site in Spain.
Trial summary
Intervention designed to promote healthy eating in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Healthy Lifestyle, Diabetes
- What is being tested?
- Healthy eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2023to 10 Feb 2026
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age
- Type 2 diabetes
- Poor dietary habits
Who cannot join
- Micro and macro-vascular complications
- Poor glycemic control
- Food allergy
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University hospital valencia
Valencia, 46010
Antonio cano sanchez, 629308479, antonio.cano@uv.es
About this study
Intervention designed to promote healthy eating in patients with type 2 diabetes.
- Conditions
- Healthy Lifestyle, Diabetes
- Being tested
- Healthy eating
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy eatingBehavioural
Promotion of healthy eating
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Healthy eating |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma triglycerides
Plasma triglycerides (mmol/L) assessed using chemistry kits on an analyzer platform
Measured: Before - 16 weeks
Change in blood glucose
Plasma blood glucose (mmol/L) assessed using chemistry kits on an analyzer platform
Measured: Before - 16 weeks
Secondary outcomes (1)
Change in waist circumference
Waist circumference in cm assessed using steel tape
Measured: Before - 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start15 Feb 2023
- Primary completion10 Feb 2025 (estimated)
- Study completion10 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy LifestyleStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714852
- Sponsor's protocol ID
- Valencia Hospital Clínico
- Status last verified
- Jan 2023
- First submitted
- 26 Jan 2023
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Promotion of Healthy Eating Behaviors in Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT05714852
- Acronym / sponsor ID
- Valencia Hospital Clínico
- Conditions
- Healthy Lifestyle, Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 10 Feb 2025 (estimated)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 6 Feb 2023 (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.
Intervention designed to promote healthy eating in patients with type 2 diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Healthy eating |
| Control | No intervention | – |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age
- Type 2 diabetes
- Poor dietary habits
Key exclusion criteria (3 listed)
- Micro and macro-vascular complications
- Poor glycemic control
- Food allergy
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 |
|---|---|---|
| Healthy eatingPromotion of healthy eating | Behavioural | Intervention |
Primary outcome
Change in plasma triglycerides
Time frame: Before - 16 weeks
Plasma triglycerides (mmol/L) assessed using chemistry kits on an analyzer platform
Change in blood glucose
Time frame: Before - 16 weeks
Plasma blood glucose (mmol/L) assessed using chemistry kits on an analyzer platform
1 secondary outcome
Change in waist circumference
Time frame: Before - 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
Related trials for Healthy Lifestyle
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
Active, not recruiting
Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception
Overweight and Obesity, Pregnancy Complications
Recruiting
LIfestyle MEtabotype Study B (LIME-B)
Nutritional and Metabolic Diseases, Prediabetes
Recruiting
Implementation of a Multiple Intervention to Promote Healthy Lifestyles in Patients With Depression
Major Depressive Disorder (MDD)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy eating in people with Healthy Lifestyle and Diabetes, run by University of Valencia 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 3 inclusion and 3 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Cano (0034 629308479, antonio.cano@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma triglycerides (time frame: Before - 16 weeks). 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.