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NCT04392284 · ClinicalTrials.gov registry record · NA
Developing an Adaptive Lifestyle Intervention Program in Family Medicine Clinics
A NA study of Obesity and Hypertension, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04392284 is a NA study of Obesity and Hypertension that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 40 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04392284, a NA study of Obesity and Hypertension, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to investigate the feasibility of conducting a multicomponent lifestyle intervention research study within the UAB Family Medicine Clinic at Highlands and to obtain preliminary data on the effectiveness of the adaptive treatment strategies being investigated to produce improvements in insulin resistance. This study is a Sequential Multiple Assignment Randomized Trial (SMART) with initial randomization groups of individualized nutrition counseling vs. individualized exercise counseling. Note that these initial nutrition or exercise interventions are NOT intended to produce significant weight loss. Participants that do not sufficiently improve their insulin resistance score after 8 weeks will be re-randomized to 2nd stage interventions of either receiving dietary counseling for weight loss or receiving a prescription for metformin. We will collect data on the effectiveness of the intervention to improve insulin resistance/metabolic health in the family medicine clinic as well as potential predictors or moderators of treatment success.
Conditions Studied
Interventions
- BEHAVIORAL Diet Counseling
- BEHAVIORAL Exercise Counseling
Study Locations (1)
Alabama
- UAB Highlands Family and Community Medicine Clinic - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-04-19 |
| Est. Completion | 2022-06-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04392284
The ClinicalTrials.gov registry entry for NCT04392284 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (95% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Diet Counseling is the first listed.
NCT04392284 reports 1 study location spanning 1 distinct geographic area - top geographies include Alabama.
Frequently Asked Questions
What is clinical trial NCT04392284 about?
NCT04392284 is a clinical study titled "Developing an Adaptive Lifestyle Intervention Program in Family Medicine Clinics". The purpose of this study is to investigate the feasibility of conducting a multicomponent lifestyle intervention research study within the UAB Family Medicine Clinic at Highlands and to obtain preliminary data on the effectiveness of the adaptive treatment strategies being investigated to produce i...
What is the current status of trial NCT04392284?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2021-04-19. Estimated completion is 2022-06-03.
What conditions does trial NCT04392284 study?
This clinical trial studies the following conditions: Obesity, Hypertension, Diabetes, Insulin Resistance, Metabolic Syndrome.
What interventions are being tested in trial NCT04392284?
The interventions under investigation include: Diet Counseling (BEHAVIORAL), Exercise Counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT04392284?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04392284 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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