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Choosing Healthy Options in College Environments and Settings (CHOICES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01134783
Recruitment Status : Completed
First Posted : June 2, 2010
Results First Posted : June 17, 2016
Last Update Posted : June 17, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Minnesota

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Obesity
Intervention Behavioral: CHOICES Intervention
Enrollment 441
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description 224 participants were randomized to the intervention condition 217 participants were randomized to the control condition
Period Title: Overall Study
Started 224 217
Completed 188 180
Not Completed 36 37
Reason Not Completed
Pregnancy             16             8
Withdrawal by Subject             15             9
Lost to Follow-up             5             20
Arm/Group Title Control Group Intervention Group Total
Hide Arm/Group Description This control group arm consists of students who served as the comparison group. This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students Total of all reporting groups
Overall Number of Baseline Participants 217 224 441
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 217 participants 224 participants 441 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
217
 100.0%
224
 100.0%
441
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 217 participants 224 participants 441 participants
Female
148
  68.2%
150
  67.0%
298
  67.6%
Male
69
  31.8%
74
  33.0%
143
  32.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 217 participants 224 participants 441 participants
Hispanic or Latino
16
   7.4%
17
   7.6%
33
   7.5%
Not Hispanic or Latino
201
  92.6%
207
  92.4%
408
  92.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 217 participants 224 participants 441 participants
American Indian or Alaska Native
1
   0.5%
1
   0.4%
2
   0.5%
Asian
14
   6.5%
13
   5.8%
27
   6.1%
Native Hawaiian or Other Pacific Islander
1
   0.5%
0
   0.0%
1
   0.2%
Black or African American
40
  18.4%
28
  12.5%
68
  15.4%
White
149
  68.7%
171
  76.3%
320
  72.6%
More than one race
12
   5.5%
11
   4.9%
23
   5.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 217 participants 224 participants 441 participants
217 224 441
1.Primary Outcome
Title Change in Body Mass Index (BMI)
Hide Description 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.
Time Frame Baseline to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Control Group Intervention Group
Hide Arm/Group Description:
This control group arm consists of students who served as the comparison group.
This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students
Overall Number of Participants Analyzed 179 187
Mean (Standard Error)
Unit of Measure: kg/m2
26.2  (0.283) 26.0  (0.280)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Intervention Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.707
Comments The analysis used hierarchical linear models having repeated measures of the outcome regressed on experimental condition, adjusted for baseline age, sex, race, and household education level as well as wave and college.
Method Regression, Logistic
Comments [Not Specified]
2.Secondary Outcome
Title Prevalence of Overweight/Obese
Hide Description The prevalence of overweight/obese between intervention and control students
Time Frame Baseline to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:
This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students
This control group arm consists of students who served as the comparison group.
Overall Number of Participants Analyzed 187 179
Measure Type: Number
Unit of Measure: percentage of participants
46.6 57.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments The analysis used hierarchical linear models having repeated measures of the outcome regressed on experimental condition, adjusted for baseline age, sex, race, and household education level as well as wave and college.
Method Regression, Logistic
Comments [Not Specified]
3.Secondary Outcome
Title Change in BMI From Baseline to 4 Months
Hide Description Comparison of the effects of the intervention and control groups with regard to change in BMI from baseline to 4 months
Time Frame Baseline to 4 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:

The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website

CHOICES Intervention: Academic course on healthy weight behaviors followed by participation in a social networking and social support website.
Control group (serving as a comparison group)
Overall Number of Participants Analyzed 205 201
Mean (Standard Error)
Unit of Measure: kg/m2
25.5  (0.273) 25.6  (0.274)
4.Secondary Outcome
Title Change in Weight From Baseline to 4 Months
Hide Description Comparison of the effects of the intervention and control groups with regard to change in weight from baseline to 4 months
Time Frame Baseline to 4 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:

The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website

CHOICES Intervention: Academic course on healthy weight behaviors followed by participation in a social networking and social support website.
Control group (serving as a comparison group)
Overall Number of Participants Analyzed 205 201
Mean (Standard Error)
Unit of Measure: Kg
72.3  (0.834) 72.7  (0.840)
5.Secondary Outcome
Title Change in BMI From Baseline to 12 Months
Hide Description Comparison of the effects of the intervention and control groups with regard to change in BMI from baseline to 12 months
Time Frame Baseline to 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:

The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website

CHOICES Intervention: Academic course on healthy weight behaviors followed by participation in a social networking and social support website.
Control group (serving as a comparison group)
Overall Number of Participants Analyzed 197 190
Mean (Standard Error)
Unit of Measure: kg/m2
25.5  (0.274) 25.7  (0.276)
6.Secondary Outcome
Title Change in Weight From Baseline to 12 Months
Hide Description Comparison of the effects of the intervention and control groups with regard to change in weight from baseline to 12 months
Time Frame Baseline to 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:

The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website

CHOICES Intervention: Academic course on healthy weight behaviors followed by participation in a social networking and social support website.
Control group (serving as a comparison group)
Overall Number of Participants Analyzed 197 190
Mean (Standard Error)
Unit of Measure: Kg
72.4  (0.839) 73.1  (0.844)
Time Frame Baseline to 24 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description This intervention group is a combination of the face-to-face class students, hybrid class students and online class students. This control group consists of students who served as the comparison group.
All-Cause Mortality
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Intervention Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/224 (4.91%)      11/217 (5.07%)    
Cardiac disorders     
CVD Events and Procedures †  1/224 (0.45%)  1 0/217 (0.00%)  0
General disorders     
Fainting †  1/224 (0.45%)  1 0/217 (0.00%)  0
Motor Vehicle Accident †  1/224 (0.45%)  1 0/217 (0.00%)  0
Other †  2/224 (0.89%)  2 4/217 (1.84%)  4
Musculoskeletal and connective tissue disorders     
Musculoskeletal †  3/224 (1.34%)  4 3/217 (1.38%)  3
Psychiatric disorders     
Psychiatric †  2/224 (0.89%)  2 4/217 (1.84%)  4
Respiratory, thoracic and mediastinal disorders     
Asthma †  1/224 (0.45%)  1 0/217 (0.00%)  0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   82/224 (36.61%)      80/217 (36.87%)    
Cardiac disorders     
CVD Events and Procedures †  0/224 (0.00%)  0 1/217 (0.46%)  1
Gastrointestinal disorders     
Gall Bladder †  1/224 (0.45%)  1 0/217 (0.00%)  0
General disorders     
Fainting †  3/224 (1.34%)  3 9/217 (4.15%)  10
Motor Vehicle Accident †  10/224 (4.46%)  10 14/217 (6.45%)  15
Other †  30/224 (13.39%)  30 15/217 (6.91%)  16
Musculoskeletal and connective tissue disorders     
Musculoskeletal †  25/224 (11.16%)  25 21/217 (9.68%)  22
Pregnancy, puerperium and perinatal conditions     
Obstetric †  0/224 (0.00%)  0 2/217 (0.92%)  2
Psychiatric disorders     
Psychiatric †  10/224 (4.46%)  11 16/217 (7.37%)  19
Respiratory, thoracic and mediastinal disorders     
Asthma †  3/224 (1.34%)  3 2/217 (0.92%)  2
†
Indicates events were collected by systematic assessment
Because of sample size constraints we combined overweight and obese participants into one category. Additional insights might be gleaned from examining intervention impact and transitions between three categories of weight status.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Leslie A. Lytle
Organization: University of North Carolina, Chapel Hill
Phone: 919-843-8171
EMail: llytle@email.unc.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT01134783    
Other Study ID Numbers: 0908S71521
1U01HL096767 ( U.S. NIH Grant/Contract )
First Submitted: May 28, 2010
First Posted: June 2, 2010
Results First Submitted: August 24, 2015
Results First Posted: June 17, 2016
Last Update Posted: June 17, 2016