NCT03720327: GET FIT

The Effects of a Mobile Health Intervention and Health Coach Text Messaging on Cardiovascular Risk of Older Adults

Completed NA Last updated 18 November 2022

What this trial tests

NA trial testing Get FIT in Cardiovascular Diseases in 54 participants. Completed in 12 March 2022.

Timeline

10 January 2019

Primary endpoint
12 March 2022

12 March 2022

Quick facts

Lead sponsor	University of California, Irvine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	supportive care
Enrollment	54
Start date	10 January 2019
Primary completion	12 March 2022
Estimated completion	12 March 2022
Sites	5 locations across United States

Drugs / interventions tested

• Get FIT
• Get FIT+

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Cardiovascular Risk Factor — all drugs for Cardiovascular Risk Factor →

Sponsor

University of California, Irvine

Who can join

60 and older, any sex, with Cardiovascular Diseases or Cardiovascular Risk Factor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study, "Fitness Intensive Therapy (Get FIT) to Promote Healthy Living in Older Adults", will test a mobile-health based intervention which includes use of a Fitbit activity tracker for 3 months, a smartphone application that tracks daily food intake, and one 45 minute counseling session to create personal goals and provide patient education by a health coach; versus Get FIT+ (the same items) plus personalized text messages focusing on participant's activity and nutrition progress as monitored in the app, from the health coach for 3 months. The investigators will measure the impact on participant's diet, physical activity, clinical outcomes, psychosocial well-being, and engagement.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Investigation of wearable health tracker version updates.
   Woolley SI, Collins T, Mitchell J, Fredericks D. · · 2019 · cited 6× · PMID 31597642 · DOI 10.1136/bmjhci-2019-100083
2. Task effectiveness, usability, and acceptability of mHealth technologies among older adults at risk for cardiovascular disease: a feasibility study.
   Reyes AT, Candelaria D, Serafica R, Hildebrand JA, et al · · 2025 · cited 2× · PMID 40896236 · DOI 10.1007/s12553-025-00969-5
3. Digital Health Technologies to Promote Healthy Eating and Physical Activity and Reduce Risk Factors for Cardiovascular Disease in Older Adults: A Pilot Study.
   Cacciata M, Candelaria D, Reyes AT, Serafica R, et al · · 2025 · cited 2× · PMID 40059110 · DOI 10.1097/jcn.0000000000001184
4. Patient activation improves with a multi-component personalized mHealth intervention in older patients at risk of cardiovascular disease: a pilot randomized controlled trial.
   Candelaria D, Cacciata M, Serafica R, Reyes AT, et al · · 2025 · cited 1× · PMID 39756174 · DOI 10.1093/eurjcn/zvae159
5. Enhancing Psychological Health and Weight-Related Behaviors in Older Adults Through Digital Interventions: Findings from the <i>Get FIT</i> Randomized Pilot Trial.
   Candelaria D, Reyes AT, Serafica R, Cacciata M, et al · · 2026 · PMID 42013110 · DOI 10.1080/07317115.2026.2663008