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Improving Cardiovascular Risk Factors in Black Young Adults

NCT04412954 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2025-04-16

Study results available
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Summary

The objectives of the study are to conduct a randomized controlled trial to test the efficacy of the Smartphone intervention on % weight loss and maintaining % weight loss at 6 and 12 months in a sample (N=256) of Black community college students who are overweight or obese, ages 18-25 years. Investigators will also examine mediating variables of the intervention on weight at 6 and 12 months, including adherence to self-monitoring, discrimination, and dietary and physical activity self-efficacy. In addition, investigators will explore potential moderators of weight loss at 6 months and 12 months, including depressive symptoms, ideal body image, and motivation.

Conditions

Interventions

BEHAVIORAL

Smartphone + Text Messaging with Health Coach

The program includes (1) use of a free commercially available smartphone application program for 12 months, (2) a wearable Fitbit Charge device that will be provided by the study to monitor active minutes, and (3) one 45-minute behavioral counseling session focused on healthy eating and exercise and (4) personalized text messaging for 6 months by a health coach. The health coach will not send feedback during months 6-12. The intervention will be fully self-directed in these months, as there will be no contact between the 6 months visit and 12-month visit.

Sponsors & Collaborators

  • Ohio State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-05
Primary Completion
2024-01-01
Completion
2024-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04412954 on ClinicalTrials.gov