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NCT Number: NCT06871059

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gerència d'Atenció Primària de Mallorca

Palma de Mallorca, Balearic Islands, 07002, Spain

Location contact

Miquel Bennasar-Veny, PhD

CONTACT

[email protected]

+34 971172367

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adapted diabetes prevention program

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

Behavioral

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

Primary outcomes

  1. Weight

    Time frame: Baseline, 6 and 12 months

    Change in body weight at 6 and 12 months versus baseline

  2. Implementation fidelity

    Time frame: Throughout the implementation period (from baseline to 12 months)

    Degree to which the adapted DPP is delivered as intended.

Secondary outcomes

  1. Spill-over effect

    Time frame: -1, 6 and 18 months

    Change in the percentage of individuals with prediabetes receiving lifestyle advice from their healthcare professional.

Study contacts

Contact information is provided by the study sponsor or research team.

Miquel Bennasar-Veny, PhD

CONTACT

[email protected]

+34 971172367

Sponsors and collaborators

Lead sponsor

University of the Balearic Islands

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

Effectiveness, Implementation and Spillover Effects of a Culturally Adapted Diabetes Prevention Program in Spanish Primary Care Centers: a Cluster Randomized Hybrid Type II Trial

Acronym: ALADIM

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 11, 2025
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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