NCT01749176

Brief Summary

Randomized controlled trial testing the efficacy of a text messaging intervention in a low income, low health literacy group of Latino patients. Project Dulce 2.0 (PD 2.0) will address barriers to participation in health education classes, increasing adherence to treatment and medications and improving diabetes self management behaviors and skills. Two community clinic organizations that provide services to a large proportion of Latino patients with type 2 diabetes will participate to randomize 200 patients into one of 2 arms: standard diabetes management care (control) only or text messaging and standard care. Comparisons between groups will evaluate clinical, behavioral and psychosocial outcomes. Intervention: Standard Care and Text Messaging. All participants will receive standard diabetes care provided by primary care providers at the clinic. Of the 100 that are randomized to the intervention arm will be given instructions on how the text messaging component will be addressed throughout the duration of the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

1.9 years

First QC Date

December 11, 2012

Last Update Submit

November 17, 2014

Conditions

Diabetes

Keywords

High risk Latino patients with diabetes

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    6 months

Study Arms (2)

SMS texting intervention

EXPERIMENTAL

Behavioral text messages will be sent at random times throughout the week reagarding Healthy nutrition tips, benefits of physical activity, benefits of medication adherence and requests to check blood sugar and send back results.

Behavioral: SMS texting intervention

Control-Usual Care

PLACEBO COMPARATOR

Participants will continue to receive their usual care in their primary care home. They will return at months 3 and 6 to conduct behavioral and laboratory assessments to compare results with the intervention group.

Behavioral: Control-Usual Care

Interventions

SMS texting interventionBEHAVIORAL
SMS texting intervention
Control-Usual CareBEHAVIORAL
Control-Usual Care

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18-75,
  • Type 2 DM,
  • Enrolled at community health center,
  • Latino ethnicity,
  • non Project Dulce participant,
  • HbA1c\>/= 8%, must be able to read

You may not qualify if:

  • Have a severe illness precluding frequent visits to the clinic,
  • have a severe medical condition, poor mental function or any other reason to expect patient difficulty in complying with the requirements of the study, any history of malignancy, except subjects who have been disease-free for \>10 years, or whose only malignancy has been basal or squamous cell skin carcinoma,
  • patients who have a creatinine level greater than 3.5,
  • any history of drug or alcohol abuse within 12 months prior to the study,
  • those who are not a permanent resident in the area.
  • Patients who are not willing to use a cell phone with texting capability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neighborhood Health

Escondido, California, United States

Location

Related Publications (1)

  • Fortmann AL, Gallo LC, Garcia MI, Taleb M, Euyoque JA, Clark T, Skidmore J, Ruiz M, Dharkar-Surber S, Schultz J, Philis-Tsimikas A. Dulce Digital: An mHealth SMS-Based Intervention Improves Glycemic Control in Hispanics With Type 2 Diabetes. Diabetes Care. 2017 Oct;40(10):1349-1355. doi: 10.2337/dc17-0230. Epub 2017 Jun 9.

    PMID: 28600309DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Athena Philis-Tsimikas, MD

    Scripps Whittier Diabetes Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Corporate Vice President

Study Record Dates

First Submitted

December 11, 2012

First Posted

December 13, 2012

Study Start

October 1, 2012

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

US(1)