N/A
N=256
Improving Cardiovascular Risk Factors in Black Young Adults
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04412954 ↗Enrolled (actual)
256
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Change in Body Weight — -2.5; -0.8 Pounds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Smartphone + Text Messaging with Health Coach (Behavioral)
- Age
- Pediatric, Adult · 17+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Weight |
-2.5; -0.8 | — |
| PRIMARY Physical Activity-Active Minutes/Day |
9.7; 12.9 | — |
| PRIMARY Physical Activity-Steps/Day |
2537; 2659 | — |
| PRIMARY Food Frequency Questionnaire (FFQ) |
3503; 4105 | — |
| PRIMARY Healthy Eating Index (HEI) |
47; 48 | — |
| SECONDARY Rate of Participants Who Are Adherent to Self-Monitoring |
40 | — |
| SECONDARY Dietary Self-Efficacy Scale (Diet-SE) |
27.8; 25.4 | — |
| SECONDARY Self-Efficacy for Exercise Scale |
48.9; 50.1 | — |
| SECONDARY Experiences of Discrimination Scale (EoD) |
8.8; 9.3 | — |
| SECONDARY Patient Health Questionnaire (PHQ) for Adults, PHQ-9 |
5.8; 5.5 | — |
| SECONDARY Ideal Body Image |
3.9; 3.5; 4.1; 3.9 | — |
| SECONDARY Treatment Self-Regulation Questionnaire (TSRQ) for Diet and Exercise |
59.7; 61.2 | — |
| SECONDARY NIH Patient Reported Outcome Measurement Information System (PROMIS) Measure for Emotional Support |
63; 64.2 | — |
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.
Eligibility Criteria
Inclusion
- age 17-25 years
- Current CSCC student
- Identify as Black
- BMI ≥ 25
- Speaks and reads English
- Interested in losing weight through diet and physical activity changes
- Owns a smartphone or iPhone Operating System (iOS) or Android compatible device
- Ability to return for 12-month visit
Exclusion
- currently pregnant or planning to become pregnant in next 12 months
- Currently participating in another structured weight loss program or taking weight loss medications or medication known to increase weight
- Lost 10% or more of body weight in past 6 months
- Screens positive for disordered eating symptoms
- diagnosed with type I diabetes
Data sourced from ClinicalTrials.gov (NCT04412954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.