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

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.

Study Overview

• Status: Unknown
• Conditions: PreDiabetes
• Intervention / Treatment: Behavioral: Intervention

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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• Study Type: Interventional
• Enrollment (Anticipated): 232
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aina M Yanez, PhD; Phone Number: +34 971172914; Email: aina.yanez@uib.es
• Study Contact Backup: Name: Miquel Bennasar, PhD; Phone Number: +34 971172367; Email: miquel.bennasar@uib.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Intervention; Social prescription of health assets related to the practice of physical activity and a healthy eating pattern to modify lifestyles.
No Intervention: Control; The Control group will receive routine standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucosa level	The primary outcome will be the percentage of participants reducing at least 4 mg/dl of FPG	18 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reversion to normal glucose	Percentage of patients who reverse to normal glucose levels	18 month

Collaborators and Investigators

• Sponsor: University of the Balearic Islands
• Investigators: Principal Investigator: Miquel Bennasar, PhD, University of Balearic Islands

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 27, 2020
• First Submitted That Met QC Criteria: March 27, 2020
• First Posted (Actual): March 31, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: PREDIBAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No