Trial Outcomes & Findings for Choosing Healthy Options in College Environments and Settings (NCT NCT01134783)
NCT ID: NCT01134783
Last Updated: 2016-06-17
Results Overview
The primary aim of this study is to examine the effectiveness of a 24-month weight gain prevention intervention to positively affect body mass index (BMI) in 2-year college students. Our hypothesis is that students randomized to an intervention condition will experience a smaller increase in mean BMI post treatment as compared to students randomized to the control condition.
COMPLETED
NA
441 participants
Baseline to 24 Months
2016-06-17
Participant Flow
Participant milestones
| Measure |
Intervention Group
224 participants were randomized to the intervention condition
|
Control Group
217 participants were randomized to the control condition
|
|---|---|---|
|
Overall Study
STARTED
|
224
|
217
|
|
Overall Study
COMPLETED
|
188
|
180
|
|
Overall Study
NOT COMPLETED
|
36
|
37
|
Reasons for withdrawal
| Measure |
Intervention Group
224 participants were randomized to the intervention condition
|
Control Group
217 participants were randomized to the control condition
|
|---|---|---|
|
Overall Study
Pregnancy
|
16
|
8
|
|
Overall Study
Withdrawal by Subject
|
15
|
9
|
|
Overall Study
Lost to Follow-up
|
5
|
20
|
Baseline Characteristics
Choosing Healthy Options in College Environments and Settings
Baseline characteristics by cohort
| Measure |
Control Group
n=217 Participants
This control group arm consists of students who served as the comparison group.
|
Intervention Group
n=224 Participants
This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students
|
Total
n=441 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
217 Participants
n=99 Participants
|
224 Participants
n=107 Participants
|
441 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
148 Participants
n=99 Participants
|
150 Participants
n=107 Participants
|
298 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
143 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
201 Participants
n=99 Participants
|
207 Participants
n=107 Participants
|
408 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
40 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
149 Participants
n=99 Participants
|
171 Participants
n=107 Participants
|
320 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
217 participants
n=99 Participants
|
224 participants
n=107 Participants
|
441 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 24 MonthsPopulation: The original study design was 4 arms (1 control \& 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.
The primary aim of this study is to examine the effectiveness of a 24-month weight gain prevention intervention to positively affect body mass index (BMI) in 2-year college students. Our hypothesis is that students randomized to an intervention condition will experience a smaller increase in mean BMI post treatment as compared to students randomized to the control condition.
Outcome measures
| Measure |
Control Group
n=179 Participants
This control group arm consists of students who served as the comparison group.
|
Intervention Group
n=187 Participants
This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students
|
|---|---|---|
|
Change in Body Mass Index (BMI)
|
26.2 kg/m2
Standard Error 0.283
|
26.0 kg/m2
Standard Error 0.280
|
SECONDARY outcome
Timeframe: Baseline to 24 MonthsPopulation: The original study design was 4 arms (1 control \& 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.
The prevalence of overweight/obese between intervention and control students
Outcome measures
| Measure |
Control Group
n=187 Participants
This control group arm consists of students who served as the comparison group.
|
Intervention Group
n=179 Participants
This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students
|
|---|---|---|
|
Prevalence of Overweight/Obese
|
46.6 percentage of participants
|
57.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to 4 MonthsPopulation: The original study design was 4 arms (1 control \& 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.
Comparison of the effects of the intervention and control groups with regard to change in BMI from baseline to 4 months
Outcome measures
| Measure |
Control Group
n=205 Participants
This control group arm consists of students who served as the comparison group.
|
Intervention Group
n=201 Participants
This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students
|
|---|---|---|
|
Change in BMI From Baseline to 4 Months
|
25.5 kg/m2
Standard Error 0.273
|
25.6 kg/m2
Standard Error 0.274
|
SECONDARY outcome
Timeframe: Baseline to 4 MonthsPopulation: The original study design was 4 arms (1 control \& 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.
Comparison of the effects of the intervention and control groups with regard to change in weight from baseline to 4 months
Outcome measures
| Measure |
Control Group
n=205 Participants
This control group arm consists of students who served as the comparison group.
|
Intervention Group
n=201 Participants
This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students
|
|---|---|---|
|
Change in Weight From Baseline to 4 Months
|
72.3 Kg
Standard Error 0.834
|
72.7 Kg
Standard Error 0.840
|
SECONDARY outcome
Timeframe: Baseline to 12 MonthsPopulation: The original study design was 4 arms (1 control \& 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.
Comparison of the effects of the intervention and control groups with regard to change in BMI from baseline to 12 months
Outcome measures
| Measure |
Control Group
n=197 Participants
This control group arm consists of students who served as the comparison group.
|
Intervention Group
n=190 Participants
This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students
|
|---|---|---|
|
Change in BMI From Baseline to 12 Months
|
25.5 kg/m2
Standard Error 0.274
|
25.7 kg/m2
Standard Error 0.276
|
SECONDARY outcome
Timeframe: Baseline to 12 MonthsPopulation: The original study design was 4 arms (1 control \& 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.
Comparison of the effects of the intervention and control groups with regard to change in weight from baseline to 12 months
Outcome measures
| Measure |
Control Group
n=197 Participants
This control group arm consists of students who served as the comparison group.
|
Intervention Group
n=190 Participants
This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students
|
|---|---|---|
|
Change in Weight From Baseline to 12 Months
|
72.4 Kg
Standard Error 0.839
|
73.1 Kg
Standard Error 0.844
|
Adverse Events
Intervention Group
Control Group
Serious adverse events
| Measure |
Intervention Group
n=224 participants at risk
This intervention group is a combination of the face-to-face class students, hybrid class students and online class students.
|
Control Group
n=217 participants at risk
This control group consists of students who served as the comparison group.
|
|---|---|---|
|
Cardiac disorders
CVD Events and Procedures
|
0.45%
1/224 • Number of events 1 • Baseline to 24 Months
|
0.00%
0/217 • Baseline to 24 Months
|
|
General disorders
Fainting
|
0.45%
1/224 • Number of events 1 • Baseline to 24 Months
|
0.00%
0/217 • Baseline to 24 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
1.3%
3/224 • Number of events 4 • Baseline to 24 Months
|
1.4%
3/217 • Number of events 3 • Baseline to 24 Months
|
|
Psychiatric disorders
Psychiatric
|
0.89%
2/224 • Number of events 2 • Baseline to 24 Months
|
1.8%
4/217 • Number of events 4 • Baseline to 24 Months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.45%
1/224 • Number of events 1 • Baseline to 24 Months
|
0.00%
0/217 • Baseline to 24 Months
|
|
General disorders
Motor Vehicle Accident
|
0.45%
1/224 • Number of events 1 • Baseline to 24 Months
|
0.00%
0/217 • Baseline to 24 Months
|
|
General disorders
Other
|
0.89%
2/224 • Number of events 2 • Baseline to 24 Months
|
1.8%
4/217 • Number of events 4 • Baseline to 24 Months
|
Other adverse events
| Measure |
Intervention Group
n=224 participants at risk
This intervention group is a combination of the face-to-face class students, hybrid class students and online class students.
|
Control Group
n=217 participants at risk
This control group consists of students who served as the comparison group.
|
|---|---|---|
|
Cardiac disorders
CVD Events and Procedures
|
0.00%
0/224 • Baseline to 24 Months
|
0.46%
1/217 • Number of events 1 • Baseline to 24 Months
|
|
General disorders
Fainting
|
1.3%
3/224 • Number of events 3 • Baseline to 24 Months
|
4.1%
9/217 • Number of events 10 • Baseline to 24 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
11.2%
25/224 • Number of events 25 • Baseline to 24 Months
|
9.7%
21/217 • Number of events 22 • Baseline to 24 Months
|
|
Gastrointestinal disorders
Gall Bladder
|
0.45%
1/224 • Number of events 1 • Baseline to 24 Months
|
0.00%
0/217 • Baseline to 24 Months
|
|
Psychiatric disorders
Psychiatric
|
4.5%
10/224 • Number of events 11 • Baseline to 24 Months
|
7.4%
16/217 • Number of events 19 • Baseline to 24 Months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.3%
3/224 • Number of events 3 • Baseline to 24 Months
|
0.92%
2/217 • Number of events 2 • Baseline to 24 Months
|
|
Pregnancy, puerperium and perinatal conditions
Obstetric
|
0.00%
0/224 • Baseline to 24 Months
|
0.92%
2/217 • Number of events 2 • Baseline to 24 Months
|
|
General disorders
Motor Vehicle Accident
|
4.5%
10/224 • Number of events 10 • Baseline to 24 Months
|
6.5%
14/217 • Number of events 15 • Baseline to 24 Months
|
|
General disorders
Other
|
13.4%
30/224 • Number of events 30 • Baseline to 24 Months
|
6.9%
15/217 • Number of events 16 • Baseline to 24 Months
|
Additional Information
Dr. Leslie A. Lytle
University of North Carolina, Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place