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

PreDiabetes Clinical Trial

— PREDIBAL  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04328363
• Other study ID #: PREDIBAL
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: June 2020
• Source: University of the Balearic Islands
• Contact: Aina M Yanez, PhD
• Phone: +34 971172914
• Email: aina.yanez[@]uib.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 232
• Est. completion date: December 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of the Balearic Islands

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucosa level	The primary outcome will be the percentage of participants reducing at least 4 mg/dl of FPG	18 month
Secondary	Reversion to normal glucose	Percentage of patients who reverse to normal glucose levels	18 month