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

NCT04328363 | Unknown DMC

• 1 other identifier: PREDIBAL
• Study Type: interventional
• Target: 232
• Locations: 0 countries
• Sites: N/A

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.

Conditions

PreDiabetes

Outcome Measures

Primary Outcomes (1)

• Glucosa level

  The primary outcome will be the percentage of participants reducing at least 4 mg/dl of FPG

  18 month

Secondary Outcomes (1)

• Reversion to normal glucose

  18 month

Study Arms (2)

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.

Behavioral: Intervention

Control

NO INTERVENTION

The Control group will receive routine standard care.

Interventions

Intervention BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the Balearic Islands: lead

MeSH Terms

Conditions

Prediabetic State

Interventions

Methods

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Miquel Bennasar, PhD

  University of balearic islands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aina M Yanez, PhD

CONTACT

+34 971172914; aina.yanez@uib.es

Miquel Bennasar, PhD

CONTACT

+34 971172367; miquel.bennasar@uib.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: March 31, 2020
• Study Start: October 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share