Obesity
Conditions
Brief summary
Examine the effectiveness of a weight gain prevention intervention to positively affect body mass index in 2-year college students
Detailed description
The goal of this research is to develop and test innovative strategies to help prevent unhealthy weight gain in college students attending 2-year community or technical colleges. The intervention we propose for Phase 2, and will refine through our formative experiences in Phase 1, will be based on social ecological and social networks models with students randomized to conditions. Students (n=440) with BMIs between 20.0 and 34.9 will be recruited to participate in an intervention trial that lasts 24 months. After the initial screening and consent procedures, students will complete baseline measures that include: assessment of body composition; blood pressure and a blood draw; a behavioral and psychosocial survey; medical and weight history and two 24-hour online dietary recalls. After the completion of baseline assessments, students will be randomized into treatment or control conditions. Students randomized into the intervention condition will participate in a 1-credit course offered through their 2-year college that focuses on eating, activity, sleep and stress management as ways to help maintain or achieve a healthy weight; three course sections will be offered to accommodate students' scheduling needs and learning preferences. A web-based social network and support component will be introduced as part of this course and will continue as the intervention channel for 20 months following the 1-credit course. This supported intervention phase will use a study-designed website to reinforce, inform and encourage exchange and support between all intervention participants. Students will be asked to track their weight and weight-control behaviors on the website and intervention staff will interact with participants electronically or through phone calls offering encouragement and helping with problem solving. Control students will receive their health assessments and usual care including existing public health information on maintaining a healthy weight and information regarding health services offered on their school's campus. The effectiveness and sustainability of the intervention approaches will be evaluated. The primary aim is to examine the effectiveness of a 24-month weight gain prevention intervention to positively affect 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. The secondary aims of this study are to: 1) Examine the effectiveness of a weight gain prevention intervention to positively affect weight in 2-year college students' and 2) compare the effects of the intervention and control groups with regard to change in BMI and weight from baseline to four months and from baseline to 12 months.
Interventions
BEHAVIORALCHOICES Intervention
Academic course on healthy weight behaviors followed by participation in a social networking and social support website.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-35 years * Intending to be available for a 24 month intervention
Exclusion criteria
* Unable to provide informed consent * BMI \< 18.5 kg/m2, \>/=35 kg/m2 * Household member on study staff * Past or planned (within the next 24 months) weight loss surgery (e.g. gastric bypass, lap band, or liposuction); current participation in a commercial weight loss program (e.g. Weight Watcher's, Jenny Craig); current or planned enrollment in another diet/physical activity/weight loss intervention study * Regular use of systemic steroids, prescription weight loss drugs, and/or diabetes medications (oral or injected). Regular use is defined as taking this medication most days of the week for the previous month * Current treatment for an eating disorder * Cardiovascular event (heart attack, stroke, episode of heart failure, or revascularization procedure) within the last 6 months * Current treatment for malignancy (other than non-melanoma skin cancer) * Investigator discretion * Currently pregnant or gave birth within the last 6 months, currently lactating or breastfeeding within the last 3 months, actively planning pregnancy within the next 24 months. * Systolic BP at screening \>/= 160 mmHg or diastolic BP \>/= 100 mmHg. If BP exceeds this level, participants can return for re-screening after being evaluated and treated for hypertension. * Weight loss of more than 15 lbs over the past three months * Trying to gain weight.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (BMI) | Baseline to 24 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Overweight/Obese | Baseline to 24 Months | The prevalence of overweight/obese between intervention and control students |
| Change in BMI From Baseline to 4 Months | Baseline to 4 Months | Comparison of the effects of the intervention and control groups with regard to change in BMI from baseline to 4 months |
| Change in Weight From Baseline to 4 Months | Baseline to 4 Months | Comparison of the effects of the intervention and control groups with regard to change in weight from baseline to 4 months |
| Change in BMI From Baseline to 12 Months | Baseline to 12 Months | Comparison of the effects of the intervention and control groups with regard to change in BMI from baseline to 12 months |
| Change in Weight From Baseline to 12 Months | Baseline to 12 Months | Comparison of the effects of the intervention and control groups with regard to change in weight from baseline to 12 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group This control group arm consists of students who served as the comparison group. | 217 |
| Intervention Group This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students | 224 |
| Total | 441 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 20 |
| Overall Study | Pregnancy | 16 | 8 |
| Overall Study | Withdrawal by Subject | 15 | 9 |
Baseline characteristics
| Characteristic | Control Group | Intervention Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 217 Participants | 224 Participants | 441 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 17 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 201 Participants | 207 Participants | 408 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 13 Participants | 27 Participants |
| Race (NIH/OMB) Black or African American | 40 Participants | 28 Participants | 68 Participants |
| Race (NIH/OMB) More than one race | 12 Participants | 11 Participants | 23 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 149 Participants | 171 Participants | 320 Participants |
| Region of Enrollment United States | 217 participants | 224 participants | 441 participants |
| Sex: Female, Male Female | 148 Participants | 150 Participants | 298 Participants |
| Sex: Female, Male Male | 69 Participants | 74 Participants | 143 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 82 / 224 | 80 / 217 |
| serious Total, serious adverse events | 11 / 224 | 11 / 217 |
Outcome results
Primary
Change in Body Mass Index (BMI)
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change in Body Mass Index (BMI) | 26.2 kg/m2 | Standard Error 0.283 |
| Intervention Group | Change in Body Mass Index (BMI) | 26.0 kg/m2 | Standard Error 0.28 |
p-value: 0.707Regression, Logistic
Secondary
Change in BMI From Baseline to 12 Months
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change in BMI From Baseline to 12 Months | 25.5 kg/m2 | Standard Error 0.274 |
| Intervention Group | Change in BMI From Baseline to 12 Months | 25.7 kg/m2 | Standard Error 0.276 |
Secondary
Change in BMI From Baseline to 4 Months
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change in BMI From Baseline to 4 Months | 25.5 kg/m2 | Standard Error 0.273 |
| Intervention Group | Change in BMI From Baseline to 4 Months | 25.6 kg/m2 | Standard Error 0.274 |
Secondary
Change in Weight From Baseline to 12 Months
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change in Weight From Baseline to 12 Months | 72.4 Kg | Standard Error 0.839 |
| Intervention Group | Change in Weight From Baseline to 12 Months | 73.1 Kg | Standard Error 0.844 |
Secondary
Change in Weight From Baseline to 4 Months
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change in Weight From Baseline to 4 Months | 72.3 Kg | Standard Error 0.834 |
| Intervention Group | Change in Weight From Baseline to 4 Months | 72.7 Kg | Standard Error 0.84 |
Secondary
Prevalence of Overweight/Obese
The prevalence of overweight/obese between intervention and control students
Time frame: Baseline to 24 Months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Prevalence of Overweight/Obese | 46.6 percentage of participants |
| Intervention Group | Prevalence of Overweight/Obese | 57.1 percentage of participants |
p-value: 0.049Regression, Logistic