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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 is a NA study that was terminated before completion, run by University of Illinois at Chicago. The registered enrollment target is 11 participants.
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
Interventions
- BEHAVIORAL Feasibility group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2019-09-20 |
| Est. Completion | 2020-07-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04083248
The ClinicalTrials.gov registry entry for NCT04083248 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Feasibility group is the first listed.
NCT04083248 reports 0 study locations.
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.
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