ObesityCHOICESNCT01134783
Choosing Healthy Options in College Environments and Settings
A study testing CHOICES Intervention in people with Obesity, run by University of Minnesota at 3 sites in United States.
Trial summary
Examine the effectiveness of a weight gain prevention intervention to positively affect body mass index in 2-year college students Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- CHOICES Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 441 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2011to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-35 years
- Intending to be available for a 24 month intervention
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Anoka Ramsey Community College
Coon Rapids, Minnesota, 55433
Inver Hills Community College
Inver Grove Heights, Minnesota, 55076
Saint Paul College
Saint Paul, Minnesota, 55102
About this study
Official title: Evaluating Innovative Weight Reduction Strategies for College Students
Examine the effectiveness of a weight gain prevention intervention to positively affect body mass index in 2-year college students
Read the 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.
- Conditions
- Obesity
- Being tested
- CHOICES Intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHOICES InterventionBehavioural
Academic course on healthy weight behaviors followed by participation in a social networking and social support website.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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 Receives: Behavioral: CHOICES Intervention |
| Control Group | No intervention | Control group (serving as a comparison group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 24 Months
Secondary outcomes (5)
Prevalence of Overweight/Obese
The prevalence of overweight/obese between intervention and control students
Measured: Baseline to 24 Months
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
Measured: Baseline to 4 Months
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
Measured: Baseline to 4 Months
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
Measured: Baseline to 12 Months
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
Measured: Baseline to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startMar 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Melissa N. Laska, PhD, RD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134783
- Sponsor's protocol ID
- 0908S71521
- Other IDs
- 1U01HL096767
- Acronym
- CHOICES
- Status last verified
- May 2016
- First submitted
- 28 May 2010
- Last updated
- 17 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lytle LA, Laska MN, Linde JA, Moe SG, Nanney MS, Hannan PJ, Erickson DJ. Weight-Gain Reduction Among 2-Year College Students: The CHOICES RCT. Am J Prev Med. 2017 Feb;52(2):183-191. doi: 10.1016/j.amepre.2016.10.012. Epub 2016 Dec 6.
PubMed 27939237Laska MN, Lytle LA, Nanney MS, Moe SG, Linde JA, Hannan PJ. Results of a 2-year randomized, controlled obesity prevention trial: Effects on diet, activity and sleep behaviors in an at-risk young adult population. Prev Med. 2016 Aug;89:230-236. doi: 10.1016/j.ypmed.2016.06.001. Epub 2016 Jun 7.
PubMed 27283096
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Innovative Weight Reduction Strategies for College Students
- ClinicalTrials.gov ID
- NCT01134783
- Acronym / sponsor ID
- CHOICES / 0908S71521
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 441 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 2 Jun 2010 (estimated)
- Results
- Posted 17 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: CHOICES InterventionThe CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website |
| Control Group | No intervention | –Control group (serving as a comparison group) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-35 years
- Intending to be available for a 24 month intervention
Key exclusion criteria (13 listed)
- 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"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHOICES InterventionAcademic course on healthy weight behaviors followed by participation in a social networking and social support website. | Behavioural | Intervention Group |
Primary outcome
Change in Body Mass Index (BMI)
Time frame: 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.
5 secondary outcomes
Prevalence of Overweight/Obese
Time frame: Baseline to 24 Months
Change in BMI From Baseline to 4 Months
Time frame: Baseline to 4 Months
Change in Weight From Baseline to 4 Months
Time frame: Baseline to 4 Months
Change in BMI From Baseline to 12 Months
Time frame: Baseline to 12 Months
Change in Weight From Baseline to 12 Months
Time frame: Baseline to 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27939237Lytle LA, Laska MN, Linde JA, Moe SG, Nanney MS, Hannan PJ, Erickson DJ. Weight-Gain Reduction Among 2-Year College Students: The CHOICES RCT. Am J Prev Med. 2017 Feb;52(2):183-191. doi: 10.1016/j.amepre.2016.10.012. Epub 2016 Dec 6.
- Derived from this study: PubMed 27283096Laska MN, Lytle LA, Nanney MS, Moe SG, Linde JA, Hannan PJ. Results of a 2-year randomized, controlled obesity prevention trial: Effects on diet, activity and sleep behaviors in an at-risk young adult population. Prev Med. 2016 Aug;89:230-236. doi: 10.1016/j.ypmed.2016.06.001. Epub 2016 Jun 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa N. Laska, PhD, RD principal investigator
University of Minnesota
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHOICES Intervention in people with Obesity, run by University of Minnesota at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index (BMI) (time frame: Baseline to 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01134783, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2016.