Trial Outcomes & Findings for Improving Cardiovascular Risk Factors in Black Young Adults (NCT NCT04412954)
NCT ID: NCT04412954
Last Updated: 2025-04-16
Results Overview
Body weight will be measured in light clothing without shoes using the Tanita Body Scale (BS)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
256 participants
Primary outcome timeframe
Baseline to 12 months
Results posted on
2025-04-16
Participant Flow
Participant milestones
| Measure |
Intervention
Health coach with Smartphone application for diet and physical activity
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.
|
Control
No intervention, using a Smartphone application for sleep monitoring
|
|---|---|---|
|
Overall Study
STARTED
|
128
|
128
|
|
Overall Study
COMPLETED
|
98
|
108
|
|
Overall Study
NOT COMPLETED
|
30
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Cardiovascular Risk Factors in Black Young Adults
Baseline characteristics by cohort
| Measure |
Intervention
n=128 Participants
Health coach with Smartphone application for diet and physical activity
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.
|
Control
n=128 Participants
No intervention, using a Smartphone application for sleep monitoring
|
Total
n=256 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
126 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
252 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
106 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
90 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
128 participants
n=5 Participants
|
128 participants
n=7 Participants
|
256 participants
n=5 Participants
|
|
Weight
|
208.9 Pounds
STANDARD_DEVIATION 49.2 • n=5 Participants
|
210.6 Pounds
STANDARD_DEVIATION 43.9 • n=7 Participants
|
209.4 Pounds
STANDARD_DEVIATION 45.6 • n=5 Participants
|
|
Body Mass Index
|
32.8 weight (lb) ÷ height2 (inches) * 703
STANDARD_DEVIATION 7.1 • n=5 Participants
|
33.3 weight (lb) ÷ height2 (inches) * 703
STANDARD_DEVIATION 6.0 • n=7 Participants
|
33.2 weight (lb) ÷ height2 (inches) * 703
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Active Minutes Exercise
|
30.5 Minutes
STANDARD_DEVIATION 40.4 • n=5 Participants
|
27.2 Minutes
STANDARD_DEVIATION 37.8 • n=7 Participants
|
28.9 Minutes
STANDARD_DEVIATION 39.1 • n=5 Participants
|
|
Steps Exercise
|
5553 Steps per day
STANDARD_DEVIATION 4274 • n=5 Participants
|
5452 Steps per day
STANDARD_DEVIATION 4289 • n=7 Participants
|
5503 Steps per day
STANDARD_DEVIATION 4281 • n=5 Participants
|
|
Patient Health Questionnaire 9
|
6.5 Score on a scale
STANDARD_DEVIATION 4.8 • n=5 Participants
|
6.6 Score on a scale
STANDARD_DEVIATION 4.8 • n=7 Participants
|
6.6 Score on a scale
STANDARD_DEVIATION 4.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsBody weight will be measured in light clothing without shoes using the Tanita Body Scale (BS)
Outcome measures
| Measure |
Control
n=108 Participants
Control condition received an application for sleep
|
Intervention
n=108 Participants
Intervention group received health coaching and a smartphone application for weight loss.
|
Intervention Male
Health coach with Smartphone application for diet and physical activity
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.
|
Control Male
No intervention, using a Smartphone application for sleep monitoring
|
|---|---|---|---|---|
|
Change in Body Weight
|
-2.5 Pounds
Standard Deviation 15.3
|
-0.8 Pounds
Standard Deviation 17.2
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: minutes/day
Will be measured objectively using the FitBit Charge for 7 days at each time period of data collection. Average active minutes per day will be used as measurement. This data represents active minutes per day at 12 months
Outcome measures
| Measure |
Control
n=98 Participants
Control condition received an application for sleep
|
Intervention
n=103 Participants
Intervention group received health coaching and a smartphone application for weight loss.
|
Intervention Male
Health coach with Smartphone application for diet and physical activity
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.
|
Control Male
No intervention, using a Smartphone application for sleep monitoring
|
|---|---|---|---|---|
|
Physical Activity-Active Minutes/Day
|
9.7 Minutes/day
Standard Deviation 21
|
12.9 Minutes/day
Standard Deviation 24.2
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: steps/day
Will be measured objectively using the FitBit Charge for 7 days at each time period of data collection. Average steps taken per day will be used as measurement.
Outcome measures
| Measure |
Control
n=95 Participants
Control condition received an application for sleep
|
Intervention
n=99 Participants
Intervention group received health coaching and a smartphone application for weight loss.
|
Intervention Male
Health coach with Smartphone application for diet and physical activity
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.
|
Control Male
No intervention, using a Smartphone application for sleep monitoring
|
|---|---|---|---|---|
|
Physical Activity-Steps/Day
|
2537 Steps/day
Standard Deviation 4333
|
2659 Steps/day
Standard Deviation 3853
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: mg of sodium/day
The full-length block FFQ will be used to assess diet for 7 days at each period of data collection. This is not a scale, this is a measure of foods consumed over a period of 7 days. We measured and target sodium as the nutrient of choice to analyze
Outcome measures
| Measure |
Control
n=110 Participants
Control condition received an application for sleep
|
Intervention
n=105 Participants
Intervention group received health coaching and a smartphone application for weight loss.
|
Intervention Male
Health coach with Smartphone application for diet and physical activity
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.
|
Control Male
No intervention, using a Smartphone application for sleep monitoring
|
|---|---|---|---|---|
|
Food Frequency Questionnaire (FFQ)
|
3503 Mg of sodium per day
Standard Deviation 1205
|
4105 Mg of sodium per day
Standard Deviation 1100
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 monthsA healthy eating index score will be calculated at each time period from the FFQ. The scale ranges from 0-100 with 100 being the best possible score indicating healthy diet aligning with key dietary recommendations.
Outcome measures
| Measure |
Control
n=110 Participants
Control condition received an application for sleep
|
Intervention
n=105 Participants
Intervention group received health coaching and a smartphone application for weight loss.
|
Intervention Male
Health coach with Smartphone application for diet and physical activity
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.
|
Control Male
No intervention, using a Smartphone application for sleep monitoring
|
|---|---|---|---|---|
|
Healthy Eating Index (HEI)
|
47 Score on a scale
Standard Deviation 6.8
|
48 Score on a scale
Standard Deviation 7.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Intervention group who used app on or more than 80% of days to enter food
Intervention condition only. Adherence will be defined as those participants who enter at least 50% of their caloric goal on at least 80% of days (or 24 days per months).
Outcome measures
| Measure |
Control
n=124 Participants
Control condition received an application for sleep
|
Intervention
Intervention group received health coaching and a smartphone application for weight loss.
|
Intervention Male
Health coach with Smartphone application for diet and physical activity
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.
|
Control Male
No intervention, using a Smartphone application for sleep monitoring
|
|---|---|---|---|---|
|
Rate of Participants Who Are Adherent to Self-Monitoring
|
40 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 12 month total score
14 questions that examine the participant's belief in their ability to cut down on high caloric foods. Scale ranges from 0-4 with 0 being "not at all confident" and 4 being "very confident" Higher overall score indicates higher levels of self confidence. Total score ranges from 0-56. Total score is reported.
Outcome measures
| Measure |
Control
n=97 Participants
Control condition received an application for sleep
|
Intervention
n=98 Participants
Intervention group received health coaching and a smartphone application for weight loss.
|
Intervention Male
Health coach with Smartphone application for diet and physical activity
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.
|
Control Male
No intervention, using a Smartphone application for sleep monitoring
|
|---|---|---|---|---|
|
Dietary Self-Efficacy Scale (Diet-SE)
|
27.8 score on a scale
Standard Deviation 9.7
|
25.4 score on a scale
Standard Deviation 10.1
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Total score at 12 months
9 questions that examine the participant's belief in their ability to complete physical activity in given circumstances. Scale ranges from 0-10 with 0 being not at all confident and 10 being the most confident. Overall scores range from 0-90 with 90 indicating high confidence levels for exercise.
Outcome measures
| Measure |
Control
n=97 Participants
Control condition received an application for sleep
|
Intervention
n=98 Participants
Intervention group received health coaching and a smartphone application for weight loss.
|
Intervention Male
Health coach with Smartphone application for diet and physical activity
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.
|
Control Male
No intervention, using a Smartphone application for sleep monitoring
|
|---|---|---|---|---|
|
Self-Efficacy for Exercise Scale
|
48.9 score on a scale
Standard Deviation 22.2
|
50.1 score on a scale
Standard Deviation 23.2
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Total score at 12 months
Examines perceived experiences of discrimination in given circumstances, such as work, public settings, banks, schools, medical care. 17 questions total. Scale ranges from never to four or more times. Four or more times being selected indicates higher levels of discrimination experiences. Total score reported. Higher score means higher levels of discrimination. Total score can range from 0 - 68
Outcome measures
| Measure |
Control
n=107 Participants
Control condition received an application for sleep
|
Intervention
n=113 Participants
Intervention group received health coaching and a smartphone application for weight loss.
|
Intervention Male
Health coach with Smartphone application for diet and physical activity
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.
|
Control Male
No intervention, using a Smartphone application for sleep monitoring
|
|---|---|---|---|---|
|
Experiences of Discrimination Scale (EoD)
|
8.8 score on a scale
Standard Deviation 9.5
|
9.3 score on a scale
Standard Deviation 9.5
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Total score at 12 months
Measures depressive symptoms using the patient health questionnaire for adults. Questions are scored from 0-3, with lower scores indicating no/lower depressive symptoms. Total score can range from 0-27
Outcome measures
| Measure |
Control
n=97 Participants
Control condition received an application for sleep
|
Intervention
n=98 Participants
Intervention group received health coaching and a smartphone application for weight loss.
|
Intervention Male
Health coach with Smartphone application for diet and physical activity
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.
|
Control Male
No intervention, using a Smartphone application for sleep monitoring
|
|---|---|---|---|---|
|
Patient Health Questionnaire (PHQ) for Adults, PHQ-9
|
5.8 Total score on scale
Standard Deviation 4.9
|
5.5 Total score on scale
Standard Deviation 4.2
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Ideal body image at 12 months
Measures patient perception of their current body image and their ideal body. image using a graphic scale ranging from 0-9, with 9 indicating higher levels of overweight/obesity.
Outcome measures
| Measure |
Control
n=51 Participants
Control condition received an application for sleep
|
Intervention
n=50 Participants
Intervention group received health coaching and a smartphone application for weight loss.
|
Intervention Male
n=43 Participants
Health coach with Smartphone application for diet and physical activity
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.
|
Control Male
n=48 Participants
No intervention, using a Smartphone application for sleep monitoring
|
|---|---|---|---|---|
|
Ideal Body Image
|
3.9 score on a scale
Standard Deviation 1.1
|
3.5 score on a scale
Standard Deviation 0.9
|
4.1 score on a scale
Standard Deviation 1.2
|
3.9 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Score at 12 months
30 questions to measure motivation to lose weight by examining three types of motivation. Scale ranges from 0-7 with 0 being "not at all" and 7 being "very true". A higher score indicates higher levels of motivation for diet and exercise habits. Total score can range from 0 - 210
Outcome measures
| Measure |
Control
n=97 Participants
Control condition received an application for sleep
|
Intervention
n=98 Participants
Intervention group received health coaching and a smartphone application for weight loss.
|
Intervention Male
Health coach with Smartphone application for diet and physical activity
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.
|
Control Male
No intervention, using a Smartphone application for sleep monitoring
|
|---|---|---|---|---|
|
Treatment Self-Regulation Questionnaire (TSRQ) for Diet and Exercise
|
59.7 Score on survey
Standard Deviation 11.3
|
61.2 Score on survey
Standard Deviation 12.7
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Total Score at 12 months
16 questions to measure perceived levels of emotional support. Scale ranges from 1-5 with 1 being "never" and 5 being "always. A higher level score indicates higher level of emotional support. Total scores can range from 16-80
Outcome measures
| Measure |
Control
n=97 Participants
Control condition received an application for sleep
|
Intervention
n=98 Participants
Intervention group received health coaching and a smartphone application for weight loss.
|
Intervention Male
Health coach with Smartphone application for diet and physical activity
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.
|
Control Male
No intervention, using a Smartphone application for sleep monitoring
|
|---|---|---|---|---|
|
NIH Patient Reported Outcome Measurement Information System (PROMIS) Measure for Emotional Support
|
63 Score on survey
Standard Deviation 13.8
|
64.2 Score on survey
Standard Deviation 15.0
|
—
|
—
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place