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NCT03651622 · ClinicalTrials.gov registry record · NA
ACT1ON Phase 2 (SMART Pilot) and Phase 3 (Efficacy Trial Development)
A NA study of Diabetes Mellitus, Type 1 and Overweight and Obesity, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 68
- Enrollment target
- 2
- Study locations
NCT03651622 is a NA study of Diabetes Mellitus, Type 1 and Overweight and Obesity that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 68 participants, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT03651622, a NA study of Diabetes Mellitus, Type 1 and Overweight and Obesity, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 68 participants
- Enrollment target
- 2
- Study locations
Study Summary
An initial pilot and feasibility study will be conducted using a Sequential, Multiple Assignment, Randomized Trial (SMART) design to identify acceptable and effective dietary strategies to optimize both glycemic control and weight management in young adults with Type 1 diabetes (T1D). This pilot trial will include a ten-and-a-half month behavioral intervention, with co-primary outcomes of glycemic control (HbA1C and hypoglycemia) and weight loss. The pilot trial will assess acceptability and adherence to three distinct, evidence-based dietary approaches designed to address weight management and glycemic control. Behavioral counseling strategies, use of carbohydrate counting for insulin dosing, and encouragement of physical activity will be the same across the three dietary approaches. COVID-19 PROVISIONS: Due to restrictions in place on in-person visits due to COVID-19 precautions, some subjects may remain in the study longer than 10.5 months. As of June 2020, the study transitioned to a completely virtual format. Those who were due for a measurement visit during the time that research activities were halted, prior to the approval of the virtual procedures, remained on the diet they were currently assigned to, supported by bi-weekly Registered Dietitian (RD) counseling, until they were able to be scheduled for a virtual visit.
Conditions Studied
Interventions
- BEHAVIORAL Hypocaloric, low carbohydrate diet
- BEHAVIORAL Hypocaloric, moderate low fat diet
- BEHAVIORAL Mediterranean diet, no caloric restriction
Study Locations (2)
California
- Stanford University - Palo Alto
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2018-11-12 |
| Est. Completion | 2021-03-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03651622
The ClinicalTrials.gov registry entry for NCT03651622 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (95% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 3 interventions - of which Hypocaloric, low carbohydrate diet is the first listed.
NCT03651622 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, North Carolina.
Frequently Asked Questions
What is clinical trial NCT03651622 about?
NCT03651622 is a clinical study titled "ACT1ON Phase 2 (SMART Pilot) and Phase 3 (Efficacy Trial Development)". An initial pilot and feasibility study will be conducted using a Sequential, Multiple Assignment, Randomized Trial (SMART) design to identify acceptable and effective dietary strategies to optimize both glycemic control and weight management in young adults with Type 1 diabetes (T1D). This pilot tri...
What is the current status of trial NCT03651622?
This trial is currently completed. It is a NA study. The enrollment target is 68 participants. The study started on 2018-11-12. Estimated completion is 2021-03-31.
What conditions does trial NCT03651622 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1, Overweight and Obesity.
What interventions are being tested in trial NCT03651622?
The interventions under investigation include: Hypocaloric, low carbohydrate diet (BEHAVIORAL), Hypocaloric, moderate low fat diet (BEHAVIORAL), Mediterranean diet, no caloric restriction (BEHAVIORAL).
Who is sponsoring clinical trial NCT03651622?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03651622 being conducted?
This trial has 2 study locations across California, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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