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NCT04132739 · ClinicalTrials.gov registry record · NA
Piloting Diet and Exercise Interventions in Older Hispanics With Diabetes
A NA study, sponsored by Florida International University.
- Terminated
- Registry status
- NA
- Development phase
- 39
- Enrollment target
NCT04132739: Clinical Trial NA study, sponsored by Florida International University.
NCT04132739 is a NA study that was terminated before completion, run by Florida International University. The registered enrollment target is 39 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04132739, a NA study, was terminated before completion, sponsored by Florida International University.
- TERMINATED
- Registry status
- NA
- Development phase
- 39 participants
- Enrollment target
Study Summary
Type 2 diabetes affects 9.3% of the U.S. population and health disparities are evident. Compared to non-Hispanic Whites, twice as many Hispanics have type 2 diabetes. The estimated cost of diabetes was $327 billion in 2017. Older adults with type 2 diabetes often have increased risk of falls. Type 2 diabetes standard of care includes one annual self-management session, which rarely include assessments of mobility impairments and falls, and diabetes education programs are less likely to be offered and more likely to be discontinued in economically disadvantaged communities. Consequently, diabetes-related hospitalizations have doubled in the past 20 years. The objective of this study is to pilot test nutrition and exercise interventions to improve diabetes management (e.g. glycemic control and diet quality) and physical function, reduce falls and related healthcare use by disadvantaged older Hispanics with type 2 diabetes. The interventions will be tested separately and in combination to assess their individual and combined effects. We will recruit 60 older Hispanics with type 2 diabetes from 4 senior centers. The exercise intervention was adapted from the evidence-based Otago Exercise Program for falls prevention in older adults. The nutrition intervention aims to improve glycemic control and diet quality. We will cluster-randomize the participants into the following arms (n=15/arm) based on the congregate meal sites they attend: 1) Control (no intervention); 2) Exercise only; 3) Nutrition only, and 4) Exercise+Nutrition. The project will last 15 months; the duration of the interventions will be 6 months, and assessments will be completed at baseline, 3, 6, 9, and 12 months. The impact of the interventions will be assessed based on hemoglobin A1C levels (glycemic control), diet quality (Healthy Eating Index), blood pressure, physical function (balance, gait, strength, body composition, and fear of falls), and self-reported falls and healthcare use.
Primary Outcome
Changes in hemoglobin A1C.
Interventions
- BEHAVIORAL Exercise
- BEHAVIORAL Diet
- BEHAVIORAL Diet and exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2019-03-01 |
| Est. Completion | 2020-03-30 |
| Phase | NA |
Why NCT04132739 stopped before completion
NCT04132739 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Exercise is the first listed.
NCT04132739 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04132739 about?
NCT04132739 is a clinical study titled "Piloting Diet and Exercise Interventions in Older Hispanics With Diabetes". Type 2 diabetes affects 9.3% of the U.S. population and health disparities are evident. Compared to non-Hispanic Whites, twice as many Hispanics have type 2 diabetes. The estimated cost of diabetes was $327 billion in 2017. Older adults with type 2 diabetes often have increased risk of falls. Type 2...
What is the current status of trial NCT04132739?
This trial is currently terminated. It is a NA study. The enrollment target is 39 participants. The study started on 2019-03-01. Estimated completion is 2020-03-30.
What interventions are being tested in trial NCT04132739?
The interventions under investigation include: Exercise (BEHAVIORAL), Diet (BEHAVIORAL), Diet and exercise (BEHAVIORAL).
Who is sponsoring clinical trial NCT04132739?
This trial is sponsored by Florida International University, which has 89 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04132739's enrollment target sits among peer trials
39 1536th of 2000 higher than 463 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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