Improving Cardiovascular Risk Factors in Black Young Adults
Phase: NA
Conditions: Obesity
Sponsor: Ohio State University

Oﬃcial Title: Improving Cardiovascular Risk Factors in Black Young Adults 
 
NCT Number: NCT04412954 
 
Document Date: 12/1/24 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
The purpose of this randomized controlled trial (RCT) is to demonstrate the efficacy of the investigator 
developed intervention targeting weight loss through healthy eating and increased physical activity in 
Black and Hispanic community college students.  
  
2.2 Primary and Secondary Aims  
  
The primary aim (Aim 1) of the Aspire to Better Health study is to test the efficacy of a 
smartphone app plus health coaching intervention targeting weight loss vs. an attention control 
condition utilizing a device which tracks sleep.  
  
The secondary aim (Aim 2) is to examine mediating variables of the intervention delivery on percent 
weight loss at 6 and 12 months. The mediators include adherence to self-monitoring, levels of 
discrimination, and dietary and physical activity (PA) self-efficacy. Finally, the third aim (Aim 3) will 
explore potential moderators of percent weight loss at 6 and 12 months, including depressive symptoms, 
ideal body image, and motivation for behavior change.  
  
2.3 Design   
  
Participants will be randomized with equal allocation to a 12-month intervention that includes using a 
smartphone app and text messages from a health coach or to an attention-control condition. In total, 256 
individuals will be enrolled and randomized with a target of 80% Non-Hispanic Black, 20% Hispanic 
Black with 50% male representation in each ethnic group. Participants will be enrolled from a community 
college in Columbus, OH. The intervention will be delivered via a smartphone and the health coach will 
send the text messages. This study employs an attention-control condition to keep control participants 
engaged in the study and have them return for data collection visits. Considering the limited number of 
studies describing recruitment and retention methods for this population, an attention-control condition 
rather than a standard control condition is warranted. The study was approved by the Institutional Review 
Board (IRB) at The Ohio State University (OSU).   
  
2.4 Eligibility  
  
Interested participants are instructed to complete an eligibility screening tool they receive via email, or 
complete a screening call with a trained research assistant to determine study eligibility. The project 
coordinator or assistant also screens for symptoms of disordered eating in all interested participants, using 
four behavioral questions from the Eating Attitude Test (EAT-26).16 If an interested participant answers 
“yes” to one of four questions, they are not eligible to enroll in the study.   
  
2.5 Inclusion and Exclusion Criteria  
  
  
Table 1: Inclusion and Exclusion Criteria for the 
ASPIRE Study  
Inclusion  
Exclusion  
• 
Age 17-
25  
• 
Enrolled 
in at least 1 
CC class  
• 
Currently 
pregnant or 
planning to 
become 
pregnant 

• 
Identify 
as Black or 
Hispanic 
Black  
• 
BMI 25 
or greater  
• 
Own a 
smartphone 
(iOS or 
Android) or 
compatible 
device  
• 
Ability 
to return for 
12-month 
visit  
• 
Speak 
and read 
English  
within 12 
months  
• 
Current 
participation 
in another 
weight loss 
program or 
taking weight 
loss 
medications 
or 
medications 
known to 
increase 
weight  
• 
Lost 
³10% of body 
weight in past 
6 months  
• 
Screens 
positive for 
symptoms of 
disordered 
eating  
• 
Diagnosed 
with type 1 
diabetes  
  
  
  
  
2.6 Sample Size and Randomization   
  
A sample size of 256 participants (n=128 per each trial arm) will have sufficient power (80%) to detect 
an  
average between-group difference with a moderate effect size of Cohen’s d = 0.4. The mixed effect 
modeling for repeated outcome measures at 6 and 12 months was used for the power calculation using 
two-sided significance level of 0.05 assuming 1) first-order autoregressive covariance structure, 2) the 
within-structure correlation of 0.8, and 3) 20% attrition rate at 12-month follow-up. After completing the 
informed consent and baseline data collection, participants will be randomly assigned 1:1 to the 
intervention or the attention-control group. Stratified randomization by sex (female vs. male) and 
ethnicity (Non-Hispanic Black vs. Hispanic Black) will be used. For each sex-ethnicity stratum, 
randomization will occur in permuted blocks of varying block sizes. The advantage of permuted block 
randomization is that it will ensure balance in the number of participants in the two trial arms during the 
entire study period.  
  
2.7 Consent  
  
Informed consent will be obtained in a private session by a trained study team member (research 
coordinator/assistant). Potential participants will be assured that: 1) their participation is voluntary; 2) 
they are free to withdraw from the study at any time; and 3) if they decline to participate or withdraw 

from the study, it will not affect their future care or participation in other activities. For participants under 
the age of 18, a parent or legal guardian must accompany them to their enrollment appointment. Once the 
participant is 18 years of age, they will repeat the consent process again at their next in-person visit and 
sign the relevant form.   
  
2.8 Community Advisory Board  
  
The study convenes a community advisory board (CAB) comprised of faculty, alumni, staff, and current 
students at CSCC. The CAB is comprised of a diverse group of individuals, most of whom identify as a 
racial or ethnic minority. The board is also made up of individuals who specialize in student needs, such 
as mental health counseling and student services. The CAB meets regularly to discuss recruitment 
standards and methods, intervention methods, current manuscripts and abstracts, as well as ethical 
standards, and dissemination of findings. The CAB contributes in a meaningful way to the ongoing study 
by partnering with the research team to contribute new ideas and to create process-related changes 
necessary for the deployment of a successful project.   
  
  
3. Program Implementation  
  
3.1 Components of Intervention  
  
Intervention components include the following: 1) access to a smartphone app called Lose It! 2) Health 
Coach counseling session, 3) Health coach text messages, 4) Fitbit Inspire 2 accelerometer.  
  
3.2 Smartphone Application (Lose It!)  
  
The Lose It! app is a free program, commercially available on both Android and iOS devices. The 
application is capable of monitoring energy intake, body measurements, and weight loss goals 
personalized to the participant. The Lose it!! application has previously been examined for behavioral 
theory content in five distinct categories: knowledge, cognitive strategies, behavior strategies, emotion-
focused strategies, and therapeutic interventions. Further, it was ranked number one overall for behavioral 
theory score and persuasive technology score, and has been successfully employed in a similar study with 
a racially diverse group of young adults17. Participants can self-monitor their energy intake by scanning 
barcodes on food labels or using the large, international database of foods/drinks available on the app.18 
Participants will be given a manual for use of the app.   
  
The smartphone app is associated with a program called Ascend, which provides health 
coaches access to real-time data from each of their participants, including food intake, calories 
consumed, macronutrient and micronutrient intake, and physical activity performed. The health coaches 
use these data to send text messages to participants. All user data are stored on a system with a user 
identifier and placed in a separate data store. The data stores are hosted in a secure data system with 
industry standard approaches to access control. Data transfer between participant devices (phone and 
computer) takes place over an authenticated HTTPS channel. Only the health coach and research staff 
have access to all participant data.  
  
  
3.3 Health Coach  
  
Health and wellness coaches have been recruited from the Health and Wellness Innovation in Healthcare 
Program at OSU and are responsible for delivering intervention components. They are selected as health 
coaches by the Director of Health Coaches (Investigator B.B.) and then interviewed to ensure fit for the 

study. In addition to having a healthcare background (ie. registered nurse, patient care nursing assistant, 
etc.) coaches received training from the principal investigator (PI) and Director of Health Coaches and are 
continuously monitored throughout the study with in-person meetings with the study PI.  
  
The director of health coaches attends approximately 20% of all baseline coaching sessions to ensure 
intervention fidelity. The project coordinator and the study PI monitor text messages sent from the health 
coaches to participants to ensure duplicate messages are not sent and that health coaches are following 
text message guidelines.  
  
  
3.4 Counseling Session with Health Coach   
  
Participants in the intervention group are seen for a one-time, 45-minute counseling session at baseline. 
Due to COVID-19, these meetings will take place via Zoom and all are conducted in English. The 
counseling will focus on (1) adhering to good nutrition practices, (2) PA guidelines, (3) motivators and 
outcome expectations for weight loss, (4) goal-setting for diet and PA. Each participant works with their 
health coach to identify appropriate and individualized goals for energy consumption and physical 
activity.  
  
3.5 Content of Text Messages from Health Coach  
  
The health and wellness coaches are responsible for electronically monitoring the daily progress of the 
participant and interact with the participant through push-only text messaging (no response from 
participant). Health coaches will send one text message per day to each participant. Text messages will 
not be repeated from the health coach. A database of text messages was created and tested in our previous 
study and will be used as message stems for the current study. The database contains over 3,000 basic text 
messages (stems), derived from Social Cognitive Theory, organized by content and mechanism to 
increase self-efficacy (Table 2). The health and wellness coach will select an area of focus (sodium 
content, calories, etc.) based on the participant’s daily electronic log and select a text message stem and 
then will personalize that stem based on their client’s specific goals or progress for that day. Health 
coaches also have the ability to create new messages based on the participant’s current progress and 
needs. In addition, due to the ongoing Covid-19 pandemic, health coaches send text messages related to 
mental wellness and stress management.   
  
  
Table 2: Example Text Message Stems  
Self-Efficacy 
Enhancing 
Mechanism  
Content Area  Example 
Stem  
Social Modeling  
Physical 
Activity 
Motivation  
Find a 
friend that 
needs or 
wants to 
exercise 
and ask 
them to 
take a 
walk or 
jog with 
you today  

  
Verbal Persuasion  Breakfast 
Consumption  
Did you 
know that 
people 
who skip 
breakfast 
tend to 
snack 
more 
during the  
day?  
  
Self-
Regulation/Mastery  
Cultural 
Foods  
Not 
finding 
your 
homemade 
family 
meals on 
the app? 
Create 
your own 
recipe in 
Lose it! 
To help 
you keep 
track!  
  
Improving 
Physical/Emotional 
State  
Body Image 
Ideals  
Find 
YOUR 
ideal and 
work 
towards 
it!  
  
  
  
3.6 Fitbit  
  
A Fitbit Inspire 2 device will be given to each participant in the intervention group and they will be asked 
to wear it daily for the duration of the study (12 months). The Fitbit Inspire 2 syncs automatically with the 
Lose it! App and will update the participant’s PA log in real-time. It will also update the participant’s 
daily energy intake needs based on energy expenditure. Health coaches use this adjustment and the real-
time PA data for personalization of text messages. Lost or malfunctioning Fitbits are replaced by the 
study team at no cost to the participant.  
  
3.7 Fitabase  
  
This study utilizes the Fitabase program. Fitabase LLC offers a robust data management platform 
designed to remotely collect wearable device data. Using Fitabase with wearable devices enables access to 
daily and intraday data for a variety of tracked types of data including steps, intensity, calories, heart rate 

and sleep. This study employs Fitabase to aggregate the active minutes data. Fitbit determines active 
minutes using a metabolic equivalents measurement ratio (rate of energy expended during an activity: rate 
of energy expended during rest) that factors in a participant’s body mass and heart rate. Fitabase then 
charts and aggregates this data into categories of light, moderate, and intense minutes. These data are 
collected for a period of seven days in accordance with their baseline visit, and their 6- and 12-month 
visits.   
  
Fitabase is a fully hosted, cloud-based software solution that implements robust industry standards to 
maintain secure databases and keep data private. Fitabase stores information provided to it by the Fitbit 
Application Programming Interface (API). Data is stored and indexed in the Fitabase SQL Server 
database in day total, hour, and minute-by-minute intervals. The account for this study is password 
protected and only the research staff have access to the credentials.    
  
3.8 Attention Control Condition  
  
Participants in the attention-control condition will also receive a Fitbit Inspire 2 device to track their sleep 
daily for 12 months. The Fitbit app offers sleep quality tracking and enables users to track pertinent sleep 
statistics. Participants will passively track their sleep daily and can also actively enter items about their 
day to help understand their sleep habits.   
  
Participants will be asked to wear the Fitbit Inspire 2 on their non-dominant wrist for 7 days continuously 
for baseline, 6-month, and 12-month data collection. Their data will be automatically downloaded for use 
by the research team through the Fitabase platform.. At the final 12-month visit, the attention-control 
group will download and receive a training session on the Lose it! App, as well as keep their Fitbit.  
  
3.9 Systems of Support  
  
Project staff are provided cell phones to enable accessible and timely communication with participants in 
regarding technological issues, scheduling, and other emergency circumstances. Acknowledging the 
various social determinants of health that CC students of color experience, project staff have designed an 
ecosystem of support in collaboration with the community college to enable access to mental and physical 
health, financial, educational, and housing services if requested by the student. If students screen 
positively for suicidal ideation on the administered PHQ-9, they are immediately connected to services 
and study staff follow up with participants until they participate in their first appointment. Additionally, 
project staff are trained in Mental Health First Aid to equip them with the tools and skills to manage a 
mental health crisis in a young adult, e.g. recognizing signs and symptoms, how to listen non-
judgmentally and give reassurance, and how to refer someone to appropriate services.    
  
  
4. Measurements   
  
The study team will collect outcome measure data (Tables 3 and 4) from all participants at in-person or 
Zoom visits at baseline (prior to randomization), 6- and 12-months. The project coordinator and research 
assistant are not blinded to the treatment condition. At the conclusion of the 12-month visit, participants 
complete a quality assessment survey to detail their satisfaction with or suggestions for the program.   
  
  
Table 3: Main Outcome Measures  
Outcome  
Time 
Measured  
Definition  Measurement 
Procedure  
Measurement Tool  

Weight  
Baseline, 
6 and 12 
months  
Body 
weight 
(kilograms)  
Wears light 
clothing, no 
shoes; 2 
measurements 
taken and 
averaged  
  
Tanita BS-549 Ironman 
Scale  
Percent 
Weight Loss  
6 and 12 
months  
Comparison 
of current 
weight to 
baseline 
weight, then 
convert to 
% of 
baseline 
weight  
 
Same as 
above  
Same as above  
Weight Loss 
Maintenance  
12 
months  
Sustained 
weight loss 
of 5- 10% 
of baseline 
body weight 
OR 
maintenance 
of % weight 
lost at 6-
months  
 
Same as 
above  
Same as above  
Height  
Baseline  Length of 
individual 
(meters)  
 
Same as 
above  
Seca 213 portable 
stadiometer  
 
Body Mass 
Index  
Baseline, 
6 and 12 
months  
Weight to 
height ratio  
Height and 
weight of 
participant  
Quetelet index (kg/m2)  
 
Physical 
Activity  
Baseline, 
6 and 12 
months  
Active 
minutes per 
day  
Wear Fitbit 
on non-
dominant 
wrist 
continually 
except for 
shower, bath, 
swimming 
Staff 
calculate 
average 
active 
minutes/day 
over 7 days at 
each time 
Fitbit Inspire 2  
• 
High 
correlation 
with steps 
recorded by 
the 
Actigraph 
and the 
Yamax 
pedometer.  
• 
Reliable 
and valid 
device for 
measuring 
activity 

point Data 
collected 
remotely over 
Fitbit’s open 
application 
programming 
interface  
  
levels 
(minutes) in 
young 
adults.  
 
Diet   
Baseline, 
6 and 12 
months  
Compliance 
with dietary 
guidelines 
for 
Americans  
Participant 
completed 
Food 
Frequency 
Questionnaire 
(FFQ) at each 
time point, 
FFQ analyzed 
offsite, 
returned to 
researchers. 
Researchers 
compute 
Healthy 
Eating Index 
(HEI) score  
  
2014 Full-length Block 
FFQ is converted HEI 
Score  
• 
Reliable 
and valid in 
a population 
>18 years of 
age, with the 
FFQ very 
close to 
standardized 
interviewer 
administered 
24-hour 
food recalls  
 
  
Table 4: Proposed Mediators and Moderators  
Mediator/Moderator 
Name  
Measure Tool 
and Procedure  
Definition  
Reliability/Validity  
Adherence to Self-
Monitoring 
(mediator)  
Health coach 
tracks through 
Ascend app 
using diet 
entry of 50% 
or more of 
caloric intake  
Entering at 
least 50% of 
caloric goal on 
at least 80% of 
days (or 24 
days/month)  
This method has 
been used 
successfully in 
previous studies.19   
  
Dietary Self 
Efficacy (mediator)  
Dieting Self-
Efficacy Scale 
(DIET-SE)  
Examines 
three factors 
of a person’s 
belief in their 
ability to eat in 
a certain way: 
(1) high 
caloric foods, 
(2) social and 
internal 
factors, and 
(3) negative 
emotional 
events.  
Internal consistency 
between 0.82-0.87 
in college students. 
The test-retest 
reliability of the 
scales is 0.83 for a 
2-3 week 
interval.20   
  

Physical Activity 
Self-Efficacy 
(mediator)  
Self-Efficacy 
for Exercise 
scale (14 
questions)  
Making time 
for exercise 
and sticking to 
exercise.  
In a population of 
adults, the internal 
consistency was 
0.90 and a test-
retest correlation 
was 0.67.21  
  
Discrimination 
(mediator)  
Experiences of 
Discrimination 
(EOD) 
measure  
9 item 
questionnaire 
measuring 
exposure to 
racial 
discrimination  
Confirmatory factor 
analysis of 0.74 and 
test/re-test 
coefficient of 0.70 
and validity of 
r=0.79 in a 
population of 
African American 
and Latino adults.22  
Depressive 
Symptoms 
(moderator)  
CDE Patient 
Health 
Questionnaire 
for adults 
(PHQ-9)  
10 questions 
that assess 
depressive 
symptoms. 
Questions are 
scored on a 0-
3 scale. Total 
scores range 
from 0 (no 
depression) to 
27 (severe 
depression).  
Reliable and valid 
in a diverse group 
of adults over 18, 
with a Cronbach 
alpha reported at 
0.89 and 0.86 in 
two studies and a 
test-retest score of 
0.84.23   
  
Ideal Body Image 
(moderator)  
Contour 
Drawing 
Rating Scale  
Contour 
drawing of 
graduated 
sizes, with 9 
images for 
males and 9 
images for 
females.24 
Participants 
will circle the 
figure that 
represents 
their ideal 
body image.  
Test-retest 
reliability was 
confirmed in 
college students 
with a reliability 
rating of 0.78 and 
validity was 
confirmed in 
college students 
with 95% accuracy 
in correct ordering 
of images.24   
  
Motivation 
(moderator)  
Treatment 
Self-
Regulation 
Questionnaire 
(TSRQ)  
15 questions 
to assess diet 
and 15 
questions to 
assess 
exercise. The 
TSRQ 
measures three 
The TSRQ for diet 
and exercise was 
proven reliable in a 
racially/ethnically 
diverse group of 
males and females, 
aged 18+ years, 

types of 
motivation: (1) 
controlled, (2) 
autonomous, 
and (3) 
amotivation.  
with Cronbach 
alphas >0.73.25   
  
Emotional Support 
(moderator)  
NIH PROMIS 
tool for 
emotional 
support (16 
questions)  
Assesses 
perceived 
feelings of 
being cared 
for and valued 
as a person 
and having 
confidant 
relationships  
Questionnaire has 
been validated in 
adult populations.26  
  
  
  
  
6. Statistical Analysis  
  
Aim 1: Descriptive statistics will be used to check the distribution of the data, identify outliers, and 
describe the sample characteristics. Bivariate statistics will be used to comparebaseline characteristics 
between the two trial arms. We will use mixed-effects linear regression modeling for repeated measures 
to 1) estimate the fixed effects of intervention, time, and their interactions, 2) drive contrast estimates for 
between-group differences in % weight loss at 6 months and 12 months, 3) adjust for covariates (e.g., any 
imbalance in baseline characteristics) and within-subject dependency from repeated measures.27 All tests 
will be performed using Intent-to-Treat (ITT) analysis.  
Aim 2: We denote X = Independent variable, Y= Outcome measures, and M = Potential mediator. 
Mediation will be tested through first showing that X (e.g. intervention) is associated with both M (e.g., 
dietary self-efficacy) and Y (e.g., % weight change) using mixed-effects regression models as described 
above. Then, we will sequentially model the effect of X on Y, without and with adjusting for potential 
mediators. At last, we will use mediation path analysis to simultaneously regress (a) Y on M and X, and 
(b) M on X.. Estimates for the mediation effect will be derived using delta method or bootstrapping 
method if lack of normality is evident.28 Adequacy fit of the path model is indicated by a non-significant 
χ2 statistic, Comparative Fit Index (CFI) and Tucker-Levis Index (TLI) ≥ 0.9, and a root mean square 
error approximation (RMSEA) ≤ 0.08.  
Aim 3:Similarly, we specify X = independent variable (e.g., intervention), Y = outcome variables (e.g., % 
weight change), and W = potential moderator (e.g., depressive symptoms). We will then test the 
significance of the moderating effect by including the interaction term of X and W in the mixed-effects 
regression models. A significant interaction between X and W suggest that the effect of X on Y changes 
at different levels of W.   
Missing data: We will carefully examine the pattern of missing data and conduct appropriate multiple 
imputation if data are missing at random. If missing not at random is indicated, pattern mixture modeling 
will be used instead. Sensitivity analysis will be used to evaluate the robustness of study findings under 
different methods.  
  
  
7. Data Management  
  
REDCap data collection projects rely on a study-specific data dictionary defined in an iterative self-
documenting process. REDCap supports electronic signatures by positively identifying the user through a 
unique username and password combination. The provisioning of accounts for system authentication is 

integrated with the OSU Wexner Medical Center (OSUWMC) LDAP authentication service for studies 
containing protected health information (PHI) and is secured behind the OSUWMC firewall.