PreDiabetesPREDIBALNCT04328363
Social Prescription and Lifestyles Modification to Reduce Glycemia in People With Prediabetes (PREDIBAL)
A study testing Intervention in people with PreDiabetes, run by University of the Balearic Islands.
Trial summary
This study aims to evaluate the effectiveness and cost-utility of an intervention based on the social prescription of health assets to modify lifestyles and reduce blood glucose values in prediabetic patients in primary care nursing consultations. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- PreDiabetes
- 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
- 232 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to 1 Dec 2022
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fasting basal blood glucose levels between 100 and < 126 mg/dl or HbA1c between 5.7 - 6.4%
Who cannot join
- Patients with T2D or in treatment with oral antidiabetic drugs
- Institutionalized patients
- Terminal illness, dementia or cognitive impairment;
- Pregnancy
- Surgery or hospital admission in the previous 3 months
- Hematological diseases that could interfere in HbA1c determination
- Presence of any condition that limits the participation in the study
- Participation in a clinical trial or receive a social prescription of diet or physical activity.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Social Prescription of Health Assets and Lifestyles Modification by Primary Care Nurses to Reduce Glycemia in People With Prediabetes: PREDIBAL Study -a Cluster-randomized Hybrid Effectiveness-implementation Type II Trial Protocol
This study aims to evaluate the effectiveness and cost-utility of an intervention based on the social prescription of health assets to modify lifestyles and reduce blood glucose values in prediabetic patients in primary care nursing consultations.
Multicentre, controlled and randomized (two different branches) clinical trial with 18 months of follow-up will be performed. The intervention group will receive a social prescription of health assets related to the practice of physical activity and healthy eating patterns in primary care nursing consultation.
Read the detailed description
No pragmatic clinical trial evaluating the effectiveness of prevention interventions has been performed to date. Social prescription is a useful health promotion strategy that facilitates the continuity of individual care. This randomized controlled trial aims to evaluate the effectiveness and cost-utility of an intervention based on the social prescription of health assets to modify lifestyles and reduce blood glucose values in prediabetic patients in primary care nursing consultations. Additional aims are to describe and assess barriers, motivations, and attitudes of patients with low adherence to the intervention and their association with social class and gender.
Methods: Multicentre, controlled and randomized (two different branches) clinical trial with 18 months of follow-up will be performed. The randomization unit will be the primary healthcare center. The study will be conducted by nurses in 12 primary health care centers (PHC) of Mallorca in Spain that will be included and randomly allocated to intervention or control groups. Furthermore, the intervention will be delivered at the PHC level, which is considered the unit of analysis. At least 232 patients (116 per branch) will be recruited. Participants will be aged 25 to 75 years with altered fasting glucose levels (100-125 mg/dl) or with glycosylated hemoglobin (HbA1c) between 5.7 and 6.4%. The intervention will be carried out at three levels: community, group and individually. The intervention group will receive a social prescription of health assets related to the practice of physical activity and healthy eating patterns in primary care nursing consultation for 8 sessions during 12 months of follow-up. The Control group will follow the usual care recommendations. Data will be collected at baseline, 6, 12 and 18 months. Glycaemia, HbA1c, BMI and waist circumference will be measured, as well as the Mediterranean diet adherence (PREDIMED), the physical activity (IPAQ), the cardiovascular risk (REGICOR equation), the quality of life (EuroQoL-5D), the social class, gender, and financial costs.
.
- Conditions
- PreDiabetes
- Being tested
- Intervention
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Social prescription of health assets related to the practice of physical activity and a healthy eating pattern to modify lifestyles.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention will be carried out by primary care nurses over eight visits: baseline visit and follow-up visits which take place 15 days, 1, 2, 4, 6, 9, and 12 months after baseline with a final visit evaluation at 18 months. The intervention will be based on the social prescription of health assets related to the practice of physical activity and a healthy eating pattern to modify lifestyles in people with prediabetes. The content of the intervention proposed is based on the NHS and it will be carried out at three levels (individual, group and community) to facilitate the patient empowerment and promotion of healthy lifestyles with a positive orientation using the community resources. Receives: Behavioral: Intervention |
| Control | No intervention | The Control group will receive routine standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucosa level
The primary outcome will be the percentage of participants reducing at least 4 mg/dl of FPG
Measured: 18 month
Secondary outcomes (1)
Reversion to normal glucose
Percentage of patients who reverse to normal glucose levels
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study startOct 2020 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miquel Bennasar, PhD, Principal investigator, University of balearic islands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328363
- Sponsor's protocol ID
- PREDIBAL
- Acronym
- PREDIBAL
- Status last verified
- Jun 2020
- First submitted
- 27 Mar 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Prescription of Health Assets and Lifestyles Modification by Primary Care Nurses to Reduce Glycemia in People With Prediabetes: PREDIBAL Study -a Cluster-randomized Hybrid Effectiveness-implementation Type II Trial Protocol
- ClinicalTrials.gov ID
- NCT04328363
- Acronym / sponsor ID
- PREDIBAL / PREDIBAL
- Conditions
- PreDiabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 31 Mar 2020 (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.
This study aims to evaluate the effectiveness and cost-utility of an intervention based on the social prescription of health assets to modify lifestyles and reduce blood glucose values in prediabetic patients in primary care nursing consultations.
Multicentre, controlled and randomized (two different branches) clinical trial with 18 months of follow-up will be performed. The intervention group will receive a social prescription of health assets related to the practice of physical activity and healthy eating patterns in primary care nursing consultation.
Detailed description
No pragmatic clinical trial evaluating the effectiveness of prevention interventions has been performed to date. Social prescription is a useful health promotion strategy that facilitates the continuity of individual care. This randomized controlled trial aims to evaluate the effectiveness and cost-utility of an intervention based on the social prescription of health assets to modify lifestyles and reduce blood glucose values in prediabetic patients in primary care nursing consultations. Additional aims are to describe and assess barriers, motivations, and attitudes of patients with low adherence to the intervention and their association with social class and gender.
Methods: Multicentre, controlled and randomized (two different branches) clinical trial with 18 months of follow-up will be performed. The randomization unit will be the primary healthcare center. The study will be conducted by nurses in 12 primary health care centers (PHC) of Mallorca in Spain that will be included and randomly allocated to intervention or control groups. Furthermore, the intervention will be delivered at the PHC level, which is considered the unit of analysis. At least 232 patients (116 per branch) will be recruited. Participants will be aged 25 to 75 years with altered fasting glucose levels (100-125 mg/dl) or with glycosylated hemoglobin (HbA1c) between 5.7 and 6.4%. The intervention will be carried out at three levels: community, group and individually. The intervention group will receive a social prescription of health assets related to the practice of physical activity and healthy eating patterns in primary care nursing consultation for 8 sessions during 12 months of follow-up. The Control group will follow the usual care recommendations. Data will be collected at baseline, 6, 12 and 18 months. Glycaemia, HbA1c, BMI and waist circumference will be measured, as well as the Mediterranean diet adherence (PREDIMED), the physical activity (IPAQ), the cardiovascular risk (REGICOR equation), the quality of life (EuroQoL-5D), the social class, gender, and financial costs.
.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionThe intervention will be carried out by primary care nurses over eight visits: baseline visit and follow-up visits which take place 15 days, 1, 2, 4, 6, 9, and 12 months after baseline with a final visit evaluation at 18 months. The intervention will be based on the social prescription of health assets related to the practice of physical activity and a healthy eating pattern to modify lifestyles in people with prediabetes. The content of the intervention proposed is based on the NHS and it will be carried out at three levels (individual, group and community) to facilitate the patient empowerment and promotion of healthy lifestyles with a positive orientation using the community resources. |
| Control | No intervention | –The Control group will receive routine standard care. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fasting basal blood glucose levels between 100 and < 126 mg/dl or HbA1c between 5.7 - 6.4%
Key exclusion criteria (8 listed)
- Patients with T2D or in treatment with oral antidiabetic drugs
- Institutionalized patients
- Terminal illness, dementia or cognitive impairment;
- Pregnancy
- Surgery or hospital admission in the previous 3 months
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 |
|---|---|---|
| InterventionSocial prescription of health assets related to the practice of physical activity and a healthy eating pattern to modify lifestyles. | Behavioural | Intervention |
Primary outcome
Glucosa level
Time frame: 18 month
The primary outcome will be the percentage of participants reducing at least 4 mg/dl of FPG
1 secondary outcome
Reversion to normal glucose
Time frame: 18 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Miquel Bennasar, PhD principal investigator
University of balearic islands
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with PreDiabetes, run by University of the Balearic Islands.
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 1 inclusion and 8 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 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Aina M Yanez, PhD (+34 971172914, aina.yanez@uib.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucosa level (time frame: 18 month). 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 4 Jun 2020.