Effectiveness, Implementation and Spillover Effects of a Culturally Adapted DPP in Spanish Primary Care Centers (ALADIM)
Effectiveness, Implementation and Spillover Effects of a Culturally Adapted Diabetes Prevention Program in Spanish Primary Care Centers: a Cluster Randomized Hybrid Type II Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Miquel Bennasar-Veny, PhD
- Phone Number: +34 971172367
- Email: miquel.bennasar@uib.es
Study Locations
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Balearic Islands
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Palma De Mallorca, Balearic Islands, Spain, 07002
- Gerència d'Atenció Primària de Mallorca
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Contact:
- Miquel Bennasar-Veny, PhD
- Phone Number: +34 971172367
- Email: miquel.bennasar@uib.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Adapted Diabetes Prevention Program
12-month group-based behavioural program on lifestyle changes
|
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.
|
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Active Comparator: Usual care
Usual care according to national guidelines
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Participants assigned to this groups will receive usual care according to national guidelines
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight
Time Frame: Baseline, 6 and 12 months
|
Change in body weight at 6 and 12 months versus baseline
|
Baseline, 6 and 12 months
|
|
Implementation fidelity
Time Frame: Throughout the implementation period (from baseline to 12 months)
|
Degree to which the adapted DPP is delivered as intended.
|
Throughout the implementation period (from baseline to 12 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
-1, 6 and 18 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Miquel Bennasar-Veny, PhD, University of the Baleric Islands
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI23/01625
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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