Social Prescription and Lifestyles Modification to Reduce Glycemia in People With Prediabetes (PREDIBAL)

NCT ID: NCT04328363

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-31
• Study Completion Date: 2022-12-01

Brief 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.

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.

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Conditions

PreDiabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Intervention

Intervention Type: BEHAVIORAL

Social prescription of health assets related to the practice of physical activity and a healthy eating pattern to modify lifestyles.

Control

The Control group will receive routine standard care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intervention

Social prescription of health assets related to the practice of physical activity and a healthy eating pattern to modify lifestyles.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Fasting basal blood glucose levels between 100 and < 126 mg/dl or HbA1c between 5.7 - 6.4%

Exclusion Criteria

• 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of the Balearic Islands

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miquel Bennasar, PhD

Role: PRINCIPAL_INVESTIGATOR

University of balearic islands

Central Contacts

Aina M Yanez, PhD

Role: CONTACT

aina.yanez@uib.es

+34 971172914

Miquel Bennasar, PhD

Role: CONTACT

miquel.bennasar@uib.es

+34 971172367

Other Identifiers

PREDIBAL

Identifier Type: -

Identifier Source: org_study_id