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Dulce Wireless Tijuana: Impact of the project Dulce TM and mobile technology on metabolic outcomes, quality of life and behaviors

Dulce Wireless Tijuana: A randomized controlled trial studying the impact of the project Dulce TM and mobile technology on metabolic outcomes, quality of life and behaviors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN28210329
Enrollment
300
Registered
2014-04-17
Start date
2011-01-11
Completion date
Unknown
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Type 2 Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

The DWT study randomly assigned patients to the following three arms: 1. Project Dulce TM intervention only (PD) 2. Project Dulce + Technology Enhanced intervention(PD-
culturally appropriate designed videos and educational materials uploaded to patients? cell phones. Patients were encouraged to watch these videos and materials as they pleased in order to clarify the

Sponsors

Mexican Social Security Institute (Instituto Mexicano del Seguro Social) (Mexico)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults 18-75 years old 2. Diabetes Mellitus type 2 3. Glycated haemoglobin (HbA1c) =8% 4. No current insulin use 5. Member or holder of IMSS clinic 27 insurance

Exclusion criteria

Exclusion criteria: 1. Patients without insurance to IMSS UMF No. 27 2. Pregnant women 3. Patients without physical or mental capacity to attend clinic visits and self-care classes for reasons beyond diabetes

Design outcomes

Primary

MeasureTime frame
Hb A1C measured using metabolic tests at baseline, fourth and tenth month

Secondary

MeasureTime frame
1. Quality of life (QoL) is evaluated using the Diabetes 39 instrument . This instrument has been validated in Spanish and in Mexico by Juan Manuel Lopez-Carmona and Raymundo Rodriguez-Moctezuma. 2. Lifestyles (LS) are evaluated using the IMEVID instrument (Instrument to measure lifestyle of type 2 diabetes mellitus patients). This instrument has been validated in Spanish and in Mexico by Juan Manuel Lopez-Carmona et.al. 3. Self efficacy is evaluated using the instrument Spanish Diabetes Self-Eficacy. This instrument was prepared by Stanford Patient Education Research Center and was adapted to Spanish. 4. Depression measured by the PHQ9 instrument at baseline and the tenth month. This instrument is developed by Spitzer et.al. and has been validated to Spanish. 5. Diabetes knowledge evaluated using the Diabetes Knowledge Questionnaire 24. This instrument was develop and validated to Spanish by Alexandra A. Gracia, et.al. (The Starr County Diabetes Education Study) 6. Total cholesterol, HDL, LDL and triglycerides measured at baseline, fourth and tenth month

Countries

Mexico

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026