CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 256 enrolled
Drug / intervention
Smartphone + Text Messaging with Health Coachbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04412954
NCT04412954N/ACompleted

Improving Cardiovascular Risk Factors in Black Young Adults

Ohio State University·interventional·Posted Jun 2, 2020·Updated Apr 16, 2025

In Brief

A clinical study evaluating Smartphone + Text Messaging with Health Coach for Obesity. Completed, enrolled 256 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJun 2, 2020
Enrollment StartDec 5, 2020
Primary CompletionJan 1, 2024
Study CompletionNov 30, 2024
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 6.1 years ago

Interventions

Smartphone + Text Messaging with Health Coachbehavioral

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.