An interventional study of FUERTE Arm and Standard care in Prediabetes, sponsored by Weill Medical College of Cornell University. Not yet recruiting at 1 site in United States. Open to male participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Health services research
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:
Participants will:
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.
1,021 studies on the registry are indexed under Prediabetic State; 242 are open to participants now.
This study's planned enrollment of 50 is below the median of 66 across 861 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Weill Medical College of Cornell University is the lead sponsor of 890 studies on the registry; 164 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: FUERTE Arm · Behavioral: Standard care
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.
Behavioral: Standard care
Other: No Intervention
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.
Participants will complete a survey before enrolling in the Diabetes Prevention Program (DPP), and after completing the program.
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.
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
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
Plan to share: Yes — All of the individual participant data collected during the trial, after deidentification.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Immediately following publication. No end date.
Access criteria: Anyone who wishes to access the data.
Start is estimated for Oct 2026; primary completion for Dec 2028, 26 months later.
Of 415 non-industry interventional studies with no phase under Prediabetic State, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's planned 26 months is close to that.
Counting every sponsor, half of 466 studies reached it within 24 months; a quarter within 11 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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