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NCT04083248 · ClinicalTrials.gov registry record · NA
Building Self-regulation Capacity in AA T2DM Women: Feasibility of EMI
A NA study, sponsored by University of Illinois at Chicago.
- Terminated
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT04083248: Clinical Trial NA study, sponsored by University of Illinois at Chicago.
NCT04083248 is a NA study that was terminated before completion, run by University of Illinois at Chicago. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04083248, a NA study, was terminated before completion, sponsored by University of Illinois at Chicago.
- TERMINATED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study Summary
In African-Americans, the incidence of type 2 diabetes (T2DM) is \~14%. Adherence to crucial diabetes self-management (DSM) behaviors, such as engaging in physical activity (PA) is dangerously low among AA women living in disadvantaged neighborhoods. These women manage numerous chronic challenges (daily discrimination, poverty, and violence), which drain the internal energy needed for DSM. The ability to self-regulate (modify one's behaviors based on the requirements of a situation) has been associated with adherence to health behaviors, including diet and PA. This 6-week ecological momentary intervention (EMI) feasibility study has been developed to reduce energy needs of DSM through use of self-regulation strategies delivered in real-time, in the real-world setting. Twenty-six AA women will receive personalized diabetes education over two days. They will be given a personalized activity prescription and a Fitbit wrist activity monitor. During the following two weeks, they will get a personal continuous glucose monitor (CGM) and individualized "cue cards" for simple behaviors they can try when glucose levels are too high. The intervention is grounded in self-regulation theory, and targets core self-regulation components, including self-monitoring/assessment, mental contrasting of target values with actual values, and goal-setting/review. The aim for this application is to Determine the feasibility and acceptability of an ecological momentary intervention, consisting of continuous glucose monitoring, activity tracking, and personalized cue cards with behavioral choices (eating/activity) driven by the results of glucose levels. Impact: Real-time feedback on the effects of activity and eating behaviors will enable patients to make choices and see results immediately. Our intervention will offer low-income African-American women opportunities to enact behaviors in their momentary environment, and will encourage autonomous motivation for PA uptake, and improving blood g
Primary Outcome
Total number of hours of usable CGM data while worn.
Interventions
- BEHAVIORAL Feasibility group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2019-09-20 |
| Est. Completion | 2020-07-31 |
| Phase | NA |
Why NCT04083248 stopped before completion
NCT04083248 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Feasibility group is the first listed.
NCT04083248 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04083248 about?
NCT04083248 is a clinical study titled "Building Self-regulation Capacity in AA T2DM Women: Feasibility of EMI". In African-Americans, the incidence of type 2 diabetes (T2DM) is \~14%. Adherence to crucial diabetes self-management (DSM) behaviors, such as engaging in physical activity (PA) is dangerously low among AA women living in disadvantaged neighborhoods. These women manage numerous chronic challenges (d...
What is the current status of trial NCT04083248?
This trial is currently terminated. It is a NA study. The enrollment target is 11 participants. The study started on 2019-09-20. Estimated completion is 2020-07-31.
What interventions are being tested in trial NCT04083248?
The interventions under investigation include: Feasibility group (BEHAVIORAL).
Who is sponsoring clinical trial NCT04083248?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04083248's enrollment target sits among peer trials
11 1927th of 2000 higher than 74 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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