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Diabetes Mellitus, Type 2/Prevention & ControlNCT07837856

Therapeutic Adherence in Type 2 Diabetes

A study testing Group I (WhatsApp) motivational and educational messages delivered periodically and Group II: To implement the SMART method in people with Diabetes Mellitus, Type 2/Prevention & Control and Diabete Type 2, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A quasi-experimental, non-randomized, prospective, longitudinal study comparing the use of WhatsApp messaging versus the SMART technique in patients with type 2 diabetes to improve treatment adherence Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Group I (WhatsApp) motivational and educational messages delivered periodically and Group II: To implement the SMART method
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteMexico
Study dates
30 Nov 2024to 30 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • Patients with type 2 diabetes mellitus.
  • Patients enrolled in UMF 84.
  • Men and women between the ages of 35 and 70.
  • Patients who agree to participate, understand the informed consent form, and sign it.
  • Patients who have a cell phone and the WhatsApp app.

Who cannot join

  • • Patients with type 1 diabetes mellitus.
  • Patients with dementia, schizophrenia, alcoholism, drug addiction, cancer, Parkinson's disease, hearing and vision impairments, and comprehension and language disorders.
  • Pregnant patients.
  • Patients who cannot read or write.
  • Patients who withdraw their consent.
  • Patients who fail to attend laboratory tests, questionnaire administration, or regular medical appointments.
Show all 9Show fewer
  • Patient death.
  • Changes in health insurance enrollment.
  • Loss of health insurance coverage.

Trial locations and contacts

1 site in 1 country.

Mexico1 site
  • Family Medicine Unit No. 84

    Morelia, Michoacán, 58332

Other trials in Mexico

About this study

Official title: WhatsApp Messaging Versus SMART Goal-setting to Improve Therapeutic Adherence in Patients With Type 2 Diabetes in Primary Care: a Quasi-experimental Study

A quasi-experimental, non-randomized, prospective, longitudinal study comparing the use of WhatsApp messaging versus the SMART technique in patients with type 2 diabetes to improve treatment adherence

Read the detailed description

The study included patients with type 2 diabetes who received training on diabetes, lifestyle, and self-management prior to the implementation of reinforcement messages or the use of the SMART technique at a primary care facility in Mexico.

Being tested
Group I (WhatsApp) motivational and educational messages delivered periodically, Group II: To implement the SMART method
Keywords
treatment adherence, polypharmacy, SMART goals, glycemic control., Treatment adherence, polypharmacy, glucose
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2, Treatment Adherence and Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group I (WhatsApp) motivational and educational messages delivered periodicallyOther

    Positive reinforcement messages were sent once every two days for two weeks, then once a week for three weeks

  • Group II: To implement the SMART methodOther

    Group II: To implement the SMART method, the patient was first given an explanation of the concept of a goal or objective, as well as what each of the concepts of the SMART method entails. The participant was then asked to identify a goal that meets the SMART criteria and, above all, is measurable.

Study groups in NCT07837856
Study groupRoleWhat they receive
Group I received WhatsApp messagesExperimentalGroup I: Participants received behavioral training and education on T2D, treatment adherence, and polypharmacy, along with the messages shown below via WhatsApp. Positive reinforcement messages were sent once every two days for two weeks, followed by one per week for three weeks.
Receives: Other: Group I (WhatsApp) motivational and educational messages delivered periodically
Group II underwent the SMART S(Specific), M(Measurable, A(Achievable), R(Relevant), T(TimetechniqueActive comparatorGroup II: To implement the SMART method, the patient was first given an explanation of the concept of a goal or objective, as well as what each of the concepts of the SMART method entails. The participant was then asked to identify a goal that meets the SMART criteria and, above all, is measurable.
Receives: Other: Group II: To implement the SMART method

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Therapeutic adherence

    According to the Morisky-Green questionnaire: Good >8 points, Fair 6-7 points, Poor <6 points

    Measured: Assessments were conducted at the start of the study "Baseline" (November to December 2024) and "6 months" after the intervention (May to June 2025)

Secondary outcomes (2)
  1. multipharmacy

    Patients will be divided into two groups based on the START/STOP criteria:

    Positive > 6 medications Negative < 5 medications A list of the medications taken by the patients will be compiled.

    Measured: Evaluations were conducted at the start of the study "Baseline" (November to December 2024).

  2. Glucose

    Glucose: This information will be obtained from laboratory results in the medical record.

    According to the ADA:

    80-130 mg/dl: controlled >130 mg/dl: uncontrolled

    Measured: Assessments were conducted at the start of the study "Baseline" (November to December 2024) and "6 months" after the intervention (May to June 2025).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2026
  2. Study start30 Nov 2024
  3. Primary completion30 Dec 2025
  4. Study completion30 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
A prospective, longitudinal, a quasi-experimental study, included patients aged 35 to 70 years, with a diagnosis of T2D, were included. Exclusion criteria were oncological disease, psychiatric disorders, and communication limitations. Two groups, each with 52 patients, were included; all patients received training on general concepts related to type 2 diabetes, medical treatment, and healthy lifestyles. They were then divided into two groups: Group I received WhatsApp messages, and Group II underwent the SMART technique to improve treatment adherence.
Masking
None (open label)
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07837856
Sponsor's protocol ID
R-2024-1602-063
Status last verified
Sep 2026
First submitted
10 Sep 2026
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data was collected by Dr. Raúl Jaimes Salgado, who assigned a code to each patient. The data will be recorded on a data collection form and entered into an Excel spreadsheet with the assistance of Drs. María Magdalena Valencia Gutiérrez and María del Pilar Rodríguez. María Magdalena Valencia will then analyze the data.

Publications

  • Buntyn RW, Burtson KM, Grey K, Cox R, Nehzati A, Silverman ML, Mrozek RA, Wilson KR. Diabetes Self-Management Goals in an Internal Medicine Clinic: A Quality Improvement Initiative. Mil Med. 2026 May 1;191(5-6):e1327-e1332. doi: 10.1093/milmed/usaf407.

    PubMed 40829048
  • de Hoogh IM, Winters BL, Nieman KM, Bijlsma S, Krone T, van den Broek TJ, Anderson BD, Caspers MPM, Anthony JC, Wopereis S. A Novel Personalized Systems Nutrition Program Improves Dietary Patterns, Lifestyle Behaviors and Health-Related Outcomes: Results from the Habit Study. Nutrients. 2021 May 22;13(6):1763. doi: 10.3390/nu13061763.

    PubMed 34067248
  • Saluja M, Pillai D. Exercise Prescription in Diabetes- S.M.A.R.T.: A Prospective Study. J Assoc Physicians India. 2021 Feb;69(2):22-24.

    PubMed 33527806
  • Cook HE, Garris LA, Gulum AH, Steber CJ. Impact of SMART Goals on Diabetes Management in a Pharmacist-Led Telehealth Clinic. J Pharm Pract. 2024 Feb;37(1):54-59. doi: 10.1177/08971900221125021. Epub 2022 Sep 2.

    PubMed 36052449
  • Kalyani RR, Neumiller JJ, Maruthur NM, Wexler DJ. Diagnosis and Treatment of Type 2 Diabetes in Adults: A Review. JAMA. 2025 Sep 16;334(11):984-1002. doi: 10.1001/jama.2025.5956.

    PubMed 40549398
  • Alshalani A, AlAhmari N, Amin HA, Aljedai A, AlSudais H. Biochemical Profile Variations Among Type 2 Diabetic Patients Stratified by Hemoglobin A1c Levels in a Saudi Cohort: A Retrospective Study. J Clin Med. 2025 Jul 28;14(15):5324. doi: 10.3390/jcm14155324.

    PubMed 40806947
  • Bi Y, Li M, Liu Y, Li T, Lu J, Duan P, Xu F, Dong Q, Wang A, Wang T, Zheng R, Chen Y, Xu M, Wang X, Zhang X, Niu Y, Kang Z, Lu C, Wang J, Qiu X, Wang A, Wu S, Niu J, Wang J, Zhao Z, Pan H, Yang X, Niu X, Pang S, Zhang X, Dai Y, Wan Q, Chen S, Zheng Q, Dai S, Deng J, Liu L, Wang G, Zhu H, Tang W, Liu H, Guo Z, Ning G, He J, Xu Y, Wang W; BPROAD Research Group. Intensive Blood-Pressure Control in Patients with Type 2 Diabetes. N Engl J Med. 2025 Mar 27;392(12):1155-1167. doi: 10.1056/NEJMoa2412006. Epub 2024 Nov 16.

    PubMed 39555827
  • Na-Ek N, Srithong J, Aonkhum A, Boonsom S, Charoen P, Demakakos P. Educational level as a cause of type 2 diabetes mellitus: Caution from triangulation of observational and genetic evidence. Acta Diabetol. 2022 Jan;59(1):127-135. doi: 10.1007/s00592-021-01795-7. Epub 2021 Sep 12.

    PubMed 34514530
  • Rognstad S, Brekke M, Fetveit A, Spigset O, Wyller TB, Straand J. The Norwegian General Practice (NORGEP) criteria for assessing potentially inappropriate prescriptions to elderly patients. A modified Delphi study. Scand J Prim Health Care. 2009;27(3):153-9. doi: 10.1080/02813430902992215.

    PubMed 19462339
  • Remelli F, Ceresini MG, Trevisan C, Noale M, Volpato S. Prevalence and impact of polypharmacy in older patients with type 2 diabetes. Aging Clin Exp Res. 2022 Sep;34(9):1969-1983. doi: 10.1007/s40520-022-02165-1. Epub 2022 Jun 20.

    PubMed 35723858
  • Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. doi: 10.1207/S15324796ABM2601_01.

    PubMed 12867348
  • Hayakawa M, Uchimura Y, Omae K, Waki K, Fujita H, Ohe K. A smartphone-based medication self-management system with realtime medication monitoring. Appl Clin Inform. 2013 Jan 30;4(1):37-52. doi: 10.4338/ACI-2012-10-RA-0045. Print 2013.

    PubMed 23650486
  • Vermeire E, Hearnshaw H, Van Royen P, Denekens J. Patient adherence to treatment: three decades of research. A comprehensive review. J Clin Pharm Ther. 2001 Oct;26(5):331-42. doi: 10.1046/j.1365-2710.2001.00363.x.

    PubMed 11679023
  • Burnier M, Egan BM. Adherence in Hypertension. Circ Res. 2019 Mar 29;124(7):1124-1140. doi: 10.1161/CIRCRESAHA.118.313220.

    PubMed 30920917
  • Sun H, Saeedi P, Karuranga S, Pinkepank M, Ogurtsova K, Duncan BB, Stein C, Basit A, Chan JCN, Mbanya JC, Pavkov ME, Ramachandaran A, Wild SH, James S, Herman WH, Zhang P, Bommer C, Kuo S, Boyko EJ, Magliano DJ. IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2022 Jan;183:109119. doi: 10.1016/j.diabres.2021.109119. Epub 2021 Dec 6.

    PubMed 34879977

Questions about this trial

What is this clinical trial studying?

A study testing Group I (WhatsApp) motivational and educational messages delivered periodically and Group II: To implement the SMART method in people with Diabetes Mellitus, Type 2/Prevention & Control and Diabete Type 2, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Therapeutic adherence (time frame: Assessments were conducted at the start of the study "Baseline" (November to December 2024) and "6 months" after the intervention (May to June 2025)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07837856, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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