N/A
N=441
Choosing Healthy Options in College Environments and Settings
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01134783 ↗Enrolled (actual)
441
Serious AEs
5.0%
Results posted
Jun 2016
Primary outcome: Primary: Change in Body Mass Index (BMI) — 26.2; 26.0 kg/m2 — p=0.707
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CHOICES Intervention (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Mass Index (BMI) |
26.2; 26.0 | 0.707 |
| SECONDARY Prevalence of Overweight/Obese |
46.6; 57.1 | 0.049 sig |
| SECONDARY Change in BMI From Baseline to 4 Months |
25.5; 25.6 | — |
| SECONDARY Change in Weight From Baseline to 4 Months |
72.3; 72.7 | — |
| SECONDARY Change in BMI From Baseline to 12 Months |
25.5; 25.7 | — |
| SECONDARY Change in Weight From Baseline to 12 Months |
72.4; 73.1 | — |
Summary
Examine the effectiveness of a weight gain prevention intervention to positively affect body mass index in 2-year college students
Eligibility Criteria
Inclusion Criteria
- Age 18-35 years
- Intending to be available for a 24 month intervention
Exclusion Criteria
- Unable to provide informed consent
- BMI /=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.
Data sourced from ClinicalTrials.gov (NCT01134783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.