Effectiveness, Implementation and Spillover Effects of a Culturally Adapted DPP in Spanish Primary Care Centers

Launched by UNIVERSITY OF THE BALEARIC ISLANDS · Mar 6, 2025

Keywords

ClinConnect Summary

The ALADIM trial is studying a special program designed to help people with prediabetes, a condition where blood sugar levels are higher than normal but not yet high enough to be called diabetes. This program will be taught in 10 primary care centers in Mallorca, Spain. Five of these centers will receive training and materials to help them deliver the program effectively over 12 months, while the other five will continue providing standard care without the new program. Researchers will measure how well the program works and how easily it can be put into practice by collecting information from participants at the beginning, after 6 months, 12 months, and again 18 months later.

To join this study, participants should be at least 18 years old, have a body mass index (BMI) of 25 or higher (or 23 if they are Asian), and have specific blood sugar levels that indicate prediabetes. However, individuals with diabetes, those taking diabetes medications, or anyone with certain health conditions won't be eligible. Participants can expect to learn more about managing their health and may receive support to help improve their lifestyle. This trial is important because it aims to adapt a proven diabetes prevention program to fit the cultural needs of Spanish speakers, which could ultimately help reduce the risk of developing diabetes in this community.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years; body mass index (BMI) of ≥25 kg/m2 (≥23 kg/m2, if Asian); fasting plasma glucose (FPG) between 1010 and 125 mg/dL, or plasma glucose of 140 to 199 mg/dl measured 2 hours after a 75 g glucose load, or HbA1c between 5.7% and 6.4%, or with a documented history of gestational diabetes mellitus during a previous pregnancy.
• Exclusion Criteria:
• • Previous diagnosis of type 1 or type 2 diabetes; current use of antidiabetic medications; pregnancy at time of enrollment; terminal illness; institutionalization; dementia or significant cognitive impairment; major surgery or hospitalization in the previous 3 months; presence of any medical or psychological condition limiting participation; and concomitant active participation in another clinical trial.