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

NCT ID: NCT06871059

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2028-03-31

Brief Summary

The ALADIM trial is a hybrid type II effectiveness-implementation cluster-randomized controlled, parallel, two arm, superiority trial. The clusters consist of 10 Primary Care Centers (PCCs) of Mallorca (Balearic Islands, Spain), which are randomly assigned to either the intervention or the control group in a 1:1 ratio. The intervention group (5 PCCs) receives training and supporting material to facilitate the implementation of the adapted DPP and effectively deliver the program over a 12-month period. The control group (5 PCCs) continues providing usual care, in line with standard healthcare practices. Effectiveness outcomes are assessed at participant level according to a cluster-randomized controlled design with data collection at baseline, 6-month and 12-month during the intervention period, and at 18-month follow-up to evaluate mid-term effects post-intervention. Implementation outcomes are assessed at PCC level throughout the study period. Prior to the hybrid trial, the DPP will be culturally and contextually adapted to the Spanish Primary Care setting.

The DPP will be culturally adapted using the Intervention Mapping ADAPT (IM-ADAPT) approach. Simultaneously, the implementation strategy will be designed using the Implementation Mapping approach.

Detailed Description

Alongside type 2 diabetes (T2D), prediabetes prevalence is also rising, placing a significant burden on public health systems, individuals, and their families.

Promoting a healthy lifestyle that includes regular physical activity, a healthy diet, smoking cessation, and achieving and maintaining a healthy body weight can effectively prevent or delay T2D onset. Major diabetes prevention trials, such as the Diabetes Prevention Program (DPP) in the United States, have demonstrated that intensive lifestyle interventions can significantly reduce T2D risk in individuals with prediabetes.However, despite strong evidence supporting the effectiveness of lifestyle interventions, and international guidelines recommending screening and referral of at-risk individuals, the global impact of scaling up diabetes prevention in real-world healthcare practice remains insufficient, most probably due to systemic (organization and leadership) and individual (healthcare professionals) barriers hindering effective implementation.

The ALADIM study aims to evaluate the effectiveness and implementation of an adapted DPP in Spanish Primary Care Centers (PCCs), using a hybrid type 2 approach. This approach addresses the gap between efficacy and effectiveness studies, providing clinically valid results while accelerating the translation of research into practice. The IM-ADAPT approach will guide the DPP adaptation to the Spanish Primary Care setting, while Implementation Mapping will inform the development, refinement, and evaluation of the implementation strategy.

Conditions

Prediabetes

Study Design

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

Study Groups

Adapted Diabetes Prevention Program

12-month group-based behavioural program on lifestyle changes

Group Type: EXPERIMENTAL

Adapted Diabetes Prevention Program

Intervention Type: BEHAVIORAL

Participants assigned to this group will participate in a group-based behavioural change program to improve diet and increase physical activity levels during 12 months.

Usual care

Usual care according to national guidelines

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

Participants assigned to this groups will receive usual care according to national guidelines

Interventions

Adapted Diabetes Prevention Program

Participants assigned to this group will participate in a group-based behavioural change program to improve diet and increase physical activity levels during 12 months.

Intervention Type: BEHAVIORAL

Usual Care

Participants assigned to this groups will receive usual care according to national guidelines

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

University of the Balearic Islands

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miquel Bennasar-Veny, PhD

Role: PRINCIPAL_INVESTIGATOR

University of the Baleric Islands

Locations

Gerència d'Atenció Primària de Mallorca

Palma de Mallorca, Balearic Islands, Spain

Countries

Spain

Central Contacts

Miquel Bennasar-Veny, PhD

Role: CONTACT

miquel.bennasar@uib.es

+34 971172367

Facility Contacts

Miquel Bennasar-Veny, PhD

Role: primary

miquel.bennasar@uib.es

+34 971172367

References

Bennasar-Veny M, Abbate M, Colom-Rossello M, Capitan-Moyano L, Hernandez-Bermudez IC, Ricci-Cabello I, Yanez AM, Fernandez ME; ALADIM investigators. Impact of an adapted diabetes prevention program in a spanish primary care setting: protocol for a type II hybrid effectiveness-implementation cluster-randomized trial (ALADIM). Implement Sci. 2025 Jun 2;20(1):27. doi: 10.1186/s13012-025-01438-3.

Reference Type: DERIVED

PMID: 40457444 (View on PubMed)

Other Identifiers

PI23/01625

Identifier Type: -

Identifier Source: org_study_id