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ACT1ON Phase 2 (SMART Pilot) and Phase 3 (Efficacy Trial Development)
NCT03651622 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 725 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Overweight and Obesity appearing as the primary indexed condition, and to 3 interventions — of which Hypocaloric, low carbohydrate diet is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03651622 reports 2 study locations spanning 2 distinct geographic areas — top geographies include California, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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: Overweight and Obesity, Diabetes Mellitus, Type 1. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03651622?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 725 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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