PrediabetesFUERTENCT07878806
Piloting FUERTE: Federally qUalified Health Centers Engaging Hispanic Men at Risk of diabeTEs
A study testing FUERTE Arm in people with Prediabetes, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The goal of this study is to learn whether FUERTE (Federally qUalified Health Centers Engaging Hispanic Men at Risk of diabeTEs) can facilitate referrals of Hispanic men with prediabetes to the Diabetes Prevention Program (DPP) and support their continued engagement in the program. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Prediabetes
- What is being tested?
- FUERTE Arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported Hispanic ethnicity and men
- At least 18 years old
- Have a body mass index (BMI) =>25 kg/m2
- Have a documented HbA1c of 5.7%-6.4% within one year
Who cannot join
- Life expectancy <12 months
- not planning to stay in the geographic area for at least 6 months
- diabetes based on an ICD-10 code in the previous 3 years
- does not speak English or Spanish
- present with a condition or abnormality (e.g., significant neurocognitive dysfunction) that in the opinion of the Investigator would compromise the ability of the patient to provide informed consent for the study activities, or the quality of the data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Weill Cornell Medicine
New York, New York, 10065
Christopher J Gonzalez, MD MS, 646-962-5914, cjg7003@med.cornell.edu
Christopher J Gonzalez, MD MS
About this study
Official title: Aim 3 Piloting FUERTE: Federally qUalified Health Centers Engaging Hispanic Men at Risk of diabeTEs
The goal of this study is to learn whether FUERTE (Federally qUalified Health Centers Engaging Hispanic Men at Risk of diabeTEs) can facilitate referrals of Hispanic men with prediabetes to the Diabetes Prevention Program (DPP) and support their continued engagement in the program.
The main questions it aims to answer are:
Read more
Does implementation of the FUERTE strategy increase the number of DPP-eligible Hispanic men who are referred to and enrolled in the DPP? Does implementation of the FUERTE strategy improve engagement in the DPP and result in greater improvements in weight and hemoglobin A1C among Hispanic men participating in the program?
FUERTE consists of three components:
- Information sessions for healthcare providers to increase awareness of the DPP.
- Text messages sent to DPP-eligible Hispanic men reminding them of appointments and encouraging discussions about prediabetes with healthcare providers.
- Interactive WhatsApp group messages for Hispanic men referred to the DPP, providing tailored content and discussion prompts related to each core DPP session.
Participants will:
- Complete a survey before enrolling in the DPP.
- Complete a survey after completing the DPP.
- Those participating post-implementation of FUERTE will (1) receive text-messages, reminding them of their appointments and encouraging discussions about prediabetes with providers, and (2) receive interactive group-messages, delivered through WhatsApp, to supplement the standard of care DPP with tailored topics and prompts.
Read the detailed description
The goal of this single-site pilot implementation trial is to learn if FUERTE (Federally qUalified Health Centers Engaging Hispanic Men at Risk of diabeTEs), a multi-component implementation strategy for Federally Qualified Health Centers, can feasibly facilitate referrals of Hispanic men with prediabetes to the Diabetes Prevention Program (DPP) and support their continued engagement in the program. FUERTE consists of 3 components: Component 1, information sessions to providers, to increase awareness of the DPP; Component 2, text-messages, delivered through existing appointment notification systems, sent to DPP-eligible Hispanic men, to remind them of their appointments and encourage discussions about prediabetes with providers; and Component 3, interactive group-messages, delivered through WhatsApp, to Hispanic men referred to the DPP, to supplement standard of care (i.e. standard DPP) with tailored topics and prompts relating to each core session of the DPP.
The main questions it aims to answer is whether:
Primary Hypothesis: FUERTE increases the proportion of DPP-eligible Hispanic men seen by a provider who are (1) referred to a Nutritionist for management of prediabetes, and (2) enrolled in a DPP.
Secondary Hypothesis: FUERTE increases (1) the proportion of providers referring DPP-eligible men for prediabetes management, and (2) the mean number of weeks Hispanic men attend the core component of the DPP.
Researchers will compare the results of participants seen by providers post-implementation of FUERTE with those seen pre-implementation of FUERTE.
Participants will:
Complete a survey before enrolling in the DPP, and after completing the program.
Those participating post-implementation of FUERTE will (1) receive text-messages, delivered through existing appointment notification systems, reminding them of their appointments and encouraging discussions about prediabetes with providers, and (2) receive interactive group-messages, delivered through WhatsApp, to supplement standard of care (i.e. standard DPP) with tailored topics and prompts relating to each core session of the DPP.
- Conditions
- Prediabetes
- Being tested
- FUERTE Arm, Standard care, No Intervention
- Keywords
- Diabetes Prevention Program, implementation, Federally Qualified Health Center
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FUERTE ArmBehavioural
Participants will complete a survey before enrolling in the Diabetes Prevention Program (DPP), and after completing the program. Participants will receive interactive group-messages, delivered through WhatsApp, to supplement standard of care (i.e. standard DPP) with tailored topics and prompts relating to each core session of the DPP.
Standard careBehavioural
Participants will complete a survey before enrolling in the Diabetes Prevention Program (DPP), and after completing the program.
No InterventionOther
Referring Providers are assessed Pre and Post Implementation for the proportion of Providers seeing Diabetes Prevention Program (DPP) eligible men who then referred eligible men for Prediabetes Management.
| Study group | Role | What they receive |
|---|---|---|
| FUERTE Arm | Experimental | Outside of this study, as part of their standard care, all participants will receive the Diabetes Prevention Program (DPP) and visits with the nutritionist at their site.
Participants in this arm of the study will complete a survey before enrolling in the DPP, and after completing the program. Participants will receive interactive group-messages, delivered through WhatsApp, to supplement standard of care (i.e. standard DPP) with tailored topics and prompts relating to each core session of the DPP. Receives: Behavioral: FUERTE Arm; Behavioral: Standard care |
| Standard Care | Active comparator | Outside of this study, as part of their standard care, all participants will receive the Diabetes Prevention Program (DPP) and visits with the nutritionist at their site.
Participants in this arm of the study will complete a survey before enrolling in the DPP, and after completing the program. Receives: Behavioral: Standard care |
| Referring Providers | Other | Not described Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of Diabetes Prevention Program-eligible Hispanic men seen by a provider and referred to a Nutritionist for management of prediabetes
Measured: 1 year
DPP Enrollment: The proportion of eligible Hispanic men enrolled in the Diabetes Prevention Program
Measured: 1 year
Secondary outcomes (5)
Mean number of weeks attending the Core Component of the Diabetes Prevention Program, out of 16 possible
Measured: 6 months
Mean change in weight (kg) from baseline at 6 months
Measured: Baseline, 6 months
Mean change in A1C (%) from baseline at 6 months
Measured: Baseline, 6 months
Referring Providers: The proportion of Providers referring eligible Hispanic men to the Diabetes Prevention Program
Measured: 1 year
Referring Providers: The number of referrals placed by a Provider
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher J Gonzalez, MD MS, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878806
- Sponsor's protocol ID
- 26-06030420
- Other IDs
- K23DK139410-01A1
- Acronym
- FUERTE
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
Zhu Y, Sidell MA, Arterburn D, Daley MF, Desai J, Fitzpatrick SL, Horberg MA, Koebnick C, McCormick E, Oshiro C, Young DR, Ferrara A. Racial/Ethnic Disparities in the Prevalence of Diabetes and Prediabetes by BMI: Patient Outcomes Research To Advance Learning (PORTAL) Multisite Cohort of Adults in the U.S. Diabetes Care. 2019 Dec;42(12):2211-2219. doi: 10.2337/dc19-0532. Epub 2019 Sep 19.
PubMed 31537541Diabetes Prevention Program Research Group. Long-term effects of lifestyle intervention or metformin on diabetes development and microvascular complications over 15-year follow-up: the Diabetes Prevention Program Outcomes Study. Lancet Diabetes Endocrinol. 2015 Nov;3(11):866-75. doi: 10.1016/S2213-8587(15)00291-0. Epub 2015 Sep 13.
PubMed 26377054Ely EK, Gruss SM, Luman ET, Gregg EW, Ali MK, Nhim K, Rolka DB, Albright AL. A National Effort to Prevent Type 2 Diabetes: Participant-Level Evaluation of CDC's National Diabetes Prevention Program. Diabetes Care. 2017 Oct;40(10):1331-1341. doi: 10.2337/dc16-2099. Epub 2017 May 12.
PubMed 28500215Jackson MC, Dai S, Skeete RA, Owens-Gary M, Cannon MJ, Smith BD, Jabrah R, Masalovich SE, Soler RE. An Examination of Gender Differences in the National Diabetes Prevention Program's Lifestyle Change Program. Diabetes Educ. 2020 Dec;46(6):580-586. doi: 10.1177/0145721720964585. Epub 2020 Oct 16.
PubMed 33063641Cannon MJ, Masalovich S, Ng BP, Soler RE, Jabrah R, Ely EK, Smith BD. Retention Among Participants in the National Diabetes Prevention Program Lifestyle Change Program, 2012-2017. Diabetes Care. 2020 Sep;43(9):2042-2049. doi: 10.2337/dc19-2366. Epub 2020 Jul 2.
PubMed 32616617Venkataramani M, Pollack CE, Yeh HC, Maruthur NM. Prevalence and Correlates of Diabetes Prevention Program Referral and Participation. Am J Prev Med. 2019 Mar;56(3):452-457. doi: 10.1016/j.amepre.2018.10.005. Epub 2019 Jan 17.
PubMed 30661888Ali MK, McKeever Bullard K, Imperatore G, Benoit SR, Rolka DB, Albright AL, Gregg EW. Reach and Use of Diabetes Prevention Services in the United States, 2016-2017. JAMA Netw Open. 2019 May 3;2(5):e193160. doi: 10.1001/jamanetworkopen.2019.3160.
PubMed 31074808Toro-Ramos T, Michaelides A, Anton M, Karim Z, Kang-Oh L, Argyrou C, Loukaidou E, Charitou MM, Sze W, Miller JD. Mobile Delivery of the Diabetes Prevention Program in People With Prediabetes: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jul 8;8(7):e17842. doi: 10.2196/17842.
PubMed 32459631Katula JA, Dressler EV, Kittel CA, Harvin LN, Almeida FA, Wilson KE, Michaud TL, Porter GC, Brito FA, Goessl CL, Jasik CB, Sweet CMC, Schwab R, Estabrooks PA. Effects of a Digital Diabetes Prevention Program: An RCT. Am J Prev Med. 2022 Apr;62(4):567-577. doi: 10.1016/j.amepre.2021.10.023. Epub 2022 Feb 10.
PubMed 35151522Joiner KL, Nam S, Whittemore R. Lifestyle interventions based on the diabetes prevention program delivered via eHealth: A systematic review and meta-analysis. Prev Med. 2017 Jul;100:194-207. doi: 10.1016/j.ypmed.2017.04.033. Epub 2017 Apr 27.
PubMed 28456513Grock S, Ku JH, Kim J, Moin T. A Review of Technology-Assisted Interventions for Diabetes Prevention. Curr Diab Rep. 2017 Sep 23;17(11):107. doi: 10.1007/s11892-017-0948-2.
PubMed 28942537Bian RR, Piatt GA, Sen A, Plegue MA, De Michele ML, Hafez D, Czuhajewski CM, Buis LR, Kaufman N, Richardson CR. The Effect of Technology-Mediated Diabetes Prevention Interventions on Weight: A Meta-Analysis. J Med Internet Res. 2017 Mar 27;19(3):e76. doi: 10.2196/jmir.4709.
PubMed 28347972Fischer HH, Fischer IP, Pereira RI, Furniss AL, Rozwadowski JM, Moore SL, Durfee MJ, Raghunath SG, Tsai AG, Havranek EP. Text Message Support for Weight Loss in Patients With Prediabetes: A Randomized Clinical Trial. Diabetes Care. 2016 Aug;39(8):1364-70. doi: 10.2337/dc15-2137. Epub 2016 Feb 9.
PubMed 26861922Formagini T, Gonzalez CJ, Dias J, Arredondo EM, Hekler E, O'Brien MJ. Advancing Type 2 Diabetes Prevention through Text-Messaging Interventions: A Narrative Review. Curr Diab Rep. 2024 Dec 4;25(1):9. doi: 10.1007/s11892-024-01568-w.
PubMed 39630283O'Brien MJ, Vargas MC, Lopez A, Feliciano Y, Gregory DL, Carcamo P, Mohr L, Mohanty N, Padilla R, Ackermann RT, Persell SD, Feinglass J. Development of a novel clinical decision support tool for diabetes prevention and feasibility of its implementation in primary care. Prev Med Rep. 2022 Sep 7;29:101979. doi: 10.1016/j.pmedr.2022.101979. eCollection 2022 Oct.
PubMed 36161117
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aim 3 Piloting FUERTE: Federally qUalified Health Centers Engaging Hispanic Men at Risk of diabeTEs
- ClinicalTrials.gov ID
- NCT07878806
- Acronym / sponsor ID
- FUERTE / 26-06030420
- Conditions
- Prediabetes
- Keywords
- Diabetes Prevention Program, implementation, Federally Qualified Health Center
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to learn whether FUERTE (Federally qUalified Health Centers Engaging Hispanic Men at Risk of diabeTEs) can facilitate referrals of Hispanic men with prediabetes to the Diabetes Prevention Program (DPP) and support their continued engagement in the program.
The main questions it aims to answer are:
Does implementation of the FUERTE strategy increase the number of DPP-eligible Hispanic men who are referred to and enrolled in the DPP? Does implementation of the FUERTE strategy improve engagement in the DPP and result in greater improvements in weight and hemoglobin A1C among Hispanic men participating in the program?
FUERTE consists of three components:
- Information sessions for healthcare providers to increase awareness of the DPP.
- Text messages sent to DPP-eligible Hispanic men reminding them of appointments and encouraging discussions about prediabetes with healthcare providers.
- Interactive WhatsApp group messages for Hispanic men referred to the DPP, providing tailored content and discussion prompts related to each core DPP session.
Participants will:
- Complete a survey before enrolling in the DPP.
- Complete a survey after completing the DPP.
- Those participating post-implementation of FUERTE will (1) receive text-messages, reminding them of their appointments and encouraging discussions about prediabetes with providers, and (2) receive interactive group-messages, delivered through WhatsApp, to supplement the standard of care DPP with tailored topics and prompts.
Detailed description
The goal of this single-site pilot implementation trial is to learn if FUERTE (Federally qUalified Health Centers Engaging Hispanic Men at Risk of diabeTEs), a multi-component implementation strategy for Federally Qualified Health Centers, can feasibly facilitate referrals of Hispanic men with prediabetes to the Diabetes Prevention Program (DPP) and support their continued engagement in the program. FUERTE consists of 3 components: Component 1, information sessions to providers, to increase awareness of the DPP; Component 2, text-messages, delivered through existing appointment notification systems, sent to DPP-eligible Hispanic men, to remind them of their appointments and encourage discussions about prediabetes with providers; and Component 3, interactive group-messages, delivered through WhatsApp, to Hispanic men referred to the DPP, to supplement standard of care (i.e. standard DPP) with tailored topics and prompts relating to each core session of the DPP.
The main questions it aims to answer is whether:
Primary Hypothesis: FUERTE increases the proportion of DPP-eligible Hispanic men seen by a provider who are (1) referred to a Nutritionist for management of prediabetes, and (2) enrolled in a DPP.
Secondary Hypothesis: FUERTE increases (1) the proportion of providers referring DPP-eligible men for prediabetes management, and (2) the mean number of weeks Hispanic men attend the core component of the DPP.
Researchers will compare the results of participants seen by providers post-implementation of FUERTE with those seen pre-implementation of FUERTE.
Participants will:
Complete a survey before enrolling in the DPP, and after completing the program.
Those participating post-implementation of FUERTE will (1) receive text-messages, delivered through existing appointment notification systems, reminding them of their appointments and encouraging discussions about prediabetes with providers, and (2) receive interactive group-messages, delivered through WhatsApp, to supplement standard of care (i.e. standard DPP) with tailored topics and prompts relating to each core session of the DPP.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FUERTE Arm | Experimental | Behavioral: FUERTE Arm, Behavioral: Standard careOutside of this study, as part of their standard care, all participants will receive the Diabetes Prevention Program (DPP) and visits with the nutritionist at their site. Participants in this arm of the study will complete a survey before enrolling in the DPP, and after completing the program. Participants will receive interactive group-messages, delivered through WhatsApp, to supplement standard of care (i.e. standard DPP) with tailored topics and prompts relating to each core session of the DPP. |
| Standard Care | Active comparator | Behavioral: Standard careOutside of this study, as part of their standard care, all participants will receive the Diabetes Prevention Program (DPP) and visits with the nutritionist at their site. Participants in this arm of the study will complete a survey before enrolling in the DPP, and after completing the program. |
| Referring Providers | Other | Other: No Intervention |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self-reported Hispanic ethnicity and men
- At least 18 years old
- Have a body mass index (BMI) =>25 kg/m2
- Have a documented HbA1c of 5.7%-6.4% within one year
Key exclusion criteria (5 listed)
- Life expectancy <12 months
- not planning to stay in the geographic area for at least 6 months
- diabetes based on an ICD-10 code in the previous 3 years
- does not speak English or Spanish
- present with a condition or abnormality (e.g., significant neurocognitive dysfunction) that in the opinion of the Investigator would compromise the ability of the patient to provide informed consent for the study activities, or the quality of the data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FUERTE ArmParticipants will complete a survey before enrolling in the Diabetes Prevention Program (DPP), and after completing the program. Participants will receive interactive group-messages, delivered through WhatsApp, to supplement standard of care (i.e. standard DPP) with tailored topics and prompts relating to each core session of the DPP. | Behavioural | FUERTE Arm |
| Standard careParticipants will complete a survey before enrolling in the Diabetes Prevention Program (DPP), and after completing the program. | Behavioural | FUERTE Arm, Standard Care |
| No InterventionReferring Providers are assessed Pre and Post Implementation for the proportion of Providers seeing Diabetes Prevention Program (DPP) eligible men who then referred eligible men for Prediabetes Management. | Other | Referring Providers |
Primary outcome
The proportion of Diabetes Prevention Program-eligible Hispanic men seen by a provider and referred to a Nutritionist for management of prediabetes
Time frame: 1 year
DPP Enrollment: The proportion of eligible Hispanic men enrolled in the Diabetes Prevention Program
Time frame: 1 year
5 secondary outcomes
Mean number of weeks attending the Core Component of the Diabetes Prevention Program, out of 16 possible
Time frame: 6 months
Mean change in weight (kg) from baseline at 6 months
Time frame: Baseline, 6 months
Mean change in A1C (%) from baseline at 6 months
Time frame: Baseline, 6 months
Referring Providers: The proportion of Providers referring eligible Hispanic men to the Diabetes Prevention Program
Time frame: 1 year
Referring Providers: The number of referrals placed by a Provider
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 31537541Zhu Y, Sidell MA, Arterburn D, Daley MF, Desai J, Fitzpatrick SL, Horberg MA, Koebnick C, McCormick E, Oshiro C, Young DR, Ferrara A. Racial/Ethnic Disparities in the Prevalence of Diabetes and Prediabetes by BMI: Patient Outcomes Research To Advance Learning (PORTAL) Multisite Cohort of Adults in the U.S. Diabetes Care. 2019 Dec;42(12):2211-2219. doi: 10.2337/dc19-0532. Epub 2019 Sep 19.
- Background: PubMed 26377054Diabetes Prevention Program Research Group. Long-term effects of lifestyle intervention or metformin on diabetes development and microvascular complications over 15-year follow-up: the Diabetes Prevention Program Outcomes Study. Lancet Diabetes Endocrinol. 2015 Nov;3(11):866-75. doi: 10.1016/S2213-8587(15)00291-0. Epub 2015 Sep 13.
- Background: PubMed 28500215Ely EK, Gruss SM, Luman ET, Gregg EW, Ali MK, Nhim K, Rolka DB, Albright AL. A National Effort to Prevent Type 2 Diabetes: Participant-Level Evaluation of CDC's National Diabetes Prevention Program. Diabetes Care. 2017 Oct;40(10):1331-1341. doi: 10.2337/dc16-2099. Epub 2017 May 12.
- Background: PubMed 33063641Jackson MC, Dai S, Skeete RA, Owens-Gary M, Cannon MJ, Smith BD, Jabrah R, Masalovich SE, Soler RE. An Examination of Gender Differences in the National Diabetes Prevention Program's Lifestyle Change Program. Diabetes Educ. 2020 Dec;46(6):580-586. doi: 10.1177/0145721720964585. Epub 2020 Oct 16.
- Background: PubMed 32616617Cannon MJ, Masalovich S, Ng BP, Soler RE, Jabrah R, Ely EK, Smith BD. Retention Among Participants in the National Diabetes Prevention Program Lifestyle Change Program, 2012-2017. Diabetes Care. 2020 Sep;43(9):2042-2049. doi: 10.2337/dc19-2366. Epub 2020 Jul 2.
- Background: PubMed 30661888Venkataramani M, Pollack CE, Yeh HC, Maruthur NM. Prevalence and Correlates of Diabetes Prevention Program Referral and Participation. Am J Prev Med. 2019 Mar;56(3):452-457. doi: 10.1016/j.amepre.2018.10.005. Epub 2019 Jan 17.
- Background: PubMed 31074808Ali MK, McKeever Bullard K, Imperatore G, Benoit SR, Rolka DB, Albright AL, Gregg EW. Reach and Use of Diabetes Prevention Services in the United States, 2016-2017. JAMA Netw Open. 2019 May 3;2(5):e193160. doi: 10.1001/jamanetworkopen.2019.3160.
- Background: PubMed 32459631Toro-Ramos T, Michaelides A, Anton M, Karim Z, Kang-Oh L, Argyrou C, Loukaidou E, Charitou MM, Sze W, Miller JD. Mobile Delivery of the Diabetes Prevention Program in People With Prediabetes: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jul 8;8(7):e17842. doi: 10.2196/17842.
- Background: PubMed 35151522Katula JA, Dressler EV, Kittel CA, Harvin LN, Almeida FA, Wilson KE, Michaud TL, Porter GC, Brito FA, Goessl CL, Jasik CB, Sweet CMC, Schwab R, Estabrooks PA. Effects of a Digital Diabetes Prevention Program: An RCT. Am J Prev Med. 2022 Apr;62(4):567-577. doi: 10.1016/j.amepre.2021.10.023. Epub 2022 Feb 10.
- Background: PubMed 28456513Joiner KL, Nam S, Whittemore R. Lifestyle interventions based on the diabetes prevention program delivered via eHealth: A systematic review and meta-analysis. Prev Med. 2017 Jul;100:194-207. doi: 10.1016/j.ypmed.2017.04.033. Epub 2017 Apr 27.
- Background: PubMed 28942537Grock S, Ku JH, Kim J, Moin T. A Review of Technology-Assisted Interventions for Diabetes Prevention. Curr Diab Rep. 2017 Sep 23;17(11):107. doi: 10.1007/s11892-017-0948-2.
- Background: PubMed 28347972Bian RR, Piatt GA, Sen A, Plegue MA, De Michele ML, Hafez D, Czuhajewski CM, Buis LR, Kaufman N, Richardson CR. The Effect of Technology-Mediated Diabetes Prevention Interventions on Weight: A Meta-Analysis. J Med Internet Res. 2017 Mar 27;19(3):e76. doi: 10.2196/jmir.4709.
- Ruby D. Whatsapp Statistics 2023 - How Many People Use Whatsapp. DemandSage.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher J Gonzalez, MD MS principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FUERTE Arm in people with Prediabetes, run by Weill Medical College of Cornell University at 1 site in United States.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 16 Oct 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher J Gonzalez, MD MS (646-962-5914, cjg7003@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of Diabetes Prevention Program-eligible Hispanic men seen by a provider and referred to a Nutritionist for management of prediabetes (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT07878806, which also lists 24 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 16 Oct 2026.