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

NCT06871059 | Not Yet Recruiting

• 1 other identifier: PI23/01625
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Prediabetes

Keywords

Diabetes Prevention Program; Prediabetes; Type 2 diabetes; Lifestyle; Disease prevention; Diet; Physical activity

Outcome Measures

Primary Outcomes (2)

• Weight

  Change in body weight at 6 and 12 months versus baseline

  Baseline, 6 and 12 months

• Implementation fidelity

  Degree to which the adapted DPP is delivered as intended.

  Throughout the implementation period (from baseline to 12 months)

Secondary Outcomes (1)

• Spill-over effect

  -1, 6 and 18 months

Study Arms (2)

Adapted Diabetes Prevention Program

EXPERIMENTAL

12-month group-based behavioural program on lifestyle changes

Behavioral: Adapted Diabetes Prevention Program

Usual care

ACTIVE COMPARATOR

Usual care according to national guidelines

Behavioral: Usual Care

Interventions

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.

Adapted Diabetes Prevention Program

Usual Care BEHAVIORAL

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

Usual care

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the Balearic Islands: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Gerència d'Atenció Primària de Mallorca

Palma de Mallorca, Balearic Islands, 07002, Spain

Location

Related Publications (1)

• 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.

  PMID: 40457444 DERIVED

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus, Type 2; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Miquel Bennasar-Veny, PhD

  University of the Baleric Islands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miquel Bennasar-Veny, 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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 11, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)