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NCT07001774
Vitalis Cardio Pilot
NA trial testing Vitalis Cardio in Cardiovascular Disease Risk Factor in 120 participants. Completed in 11 August 2025.
11 August 2025
Quick facts
| Lead sponsor | Lucas Carr |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 120 |
| Start date | 19 September 2023 |
| Primary completion | 11 August 2025 |
| Estimated completion | 11 August 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Vitalis Cardio
Conditions studied
- Cardiovascular Disease Risk Factor — all drugs for Cardiovascular Disease Risk Factor →
Sponsor
Lucas Carr
Who can join
Adults 18 to 80, any sex, with Cardiovascular Disease Risk Factor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this study was to evaluate the efficacy and feasibility of a 12-week behavioral counseling intervention that has been integrated into the primary care setting on psychosocial, behavioral, and health outcomes in a large sample of adults with at least one CVD risk factor. Aim 1: Evaluate the efficacy of a 12-week behavioral counseling intervention on psychosocial outcomes of adults with at least one CVD risk factor. H1: We hypothesize participants will improve their behavioral regulation skills and habit formation skills over 12 weeks. Aim 2: Evaluate the efficacy of a 12-week behavioral counseling intervention on behavioral outcomes (physical activity, diet, and sleep) of adults with at least one CVD risk factor. H2: We hypothesize participants will improve PA (daily steps), diet (total daily kilocalories), and sleep (sleep time, sleep efficiency) over the 12-week intervention. Aim 3: Evaluate the efficacy of a 12-week behavioral counseling intervention on health outcomes (blood pressure, weight, waist circumference, body composition, quality of life) of adults with at least one CVD risk factor. H3: We hypothesize participants will improve blood pressure, weight, waist circumference, body composition, quality of life over the 12-week intervention.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07001774
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cardiovascular Disease Risk Factor
Currently open trials in the same condition.
- NCT07187947 — Cardiovascular Health of Transgender Individuals During the Gender-affirming Pathway · recruiting
- NCT07048717 — The Mauritius and Rodrigues Non-Communicable Disease (NCD) Study · active not recruiting
Other Lucas Carr trials
Trials by the same sponsor.
- NCT04601948 — AYActive Study! A Physical Health Activity Intervention · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07001774 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Lucas Carr
- Last refreshed: 12 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07001774.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing