OverweightL2WNCT02021383
Lose 2 Win A Novel Method to Motivate Weight Loss Maintenance Among College Students
A study testing Bi-weekly in person meetings with a Registered Dietician and Financial incentives for weight loss maintenance in people with Overweight and Obese, run by University of Minnesota at 1 site in United States.
Trial summary
Investigators are conducting a randomized controlled trial with overweight and obese college students on the University of Minnesota campus. The primary outcome will be weight loss measured 12 months after study enrollment (corresponds to 10 months after the end of treatment). Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obese
- What is being tested?
- Bi-weekly in person meetings with a Registered Dietician and Financial incentives for weight loss maintenance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2012to 28 Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-24 years of age
- University of Minnesota Freshman, Sophomore, or Junior
- Plan on enrolling at the U of Minnesota through Spring 2013
- BMI greater than or equal to 26 and less than or equal to 35.5
- Have working internet and phone access
- Ability to read/write English
- Ability to safely engage in exercise
Who cannot join
- Currently pregnant or breastfeeding
- Prior or planned weight loss surgery
- Having a special diet or being a member of an "organized weight loss program"
- Diagnosis of Diabetes
- Have had Binge Eating Disorder
- Have lost greater than or equal to 10 pounds in the last 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
Official title: "Lose 2 Win" Contests: A Novel Method to Motivate Weight Loss Maintenance Among College Students
Investigators are conducting a randomized controlled trial with overweight and obese college students on the University of Minnesota campus. The primary outcome will be weight loss measured 12 months after study enrollment (corresponds to 10 months after the end of treatment).
Read the detailed description
Approximately 30% of college students are overweight or obese. Intervening on excess weight early may eliminate obesity-related morbidity. Evidence supports use of monetary incentives to encourage weight-loss; questions remain about the efficacy of contingency management on weight loss maintenance.
"Lose 2 Win" contests in which participants who achieve weight-loss goals are eligible for cash prizes, appear well-suited for implementation on campuses. Our objective in this two-phase trial is to evaluate the feasibility, acceptability and efficacy of Lose 2 Win for weight-loss maintenance among college students.
- Conditions
- Overweight, Obese
- Being tested
- Bi-weekly in person meetings with a Registered Dietician, Financial incentives for weight loss maintenance
- Keywords
- Weight loss, Weight maintenance, Contingency Management, College students, Financial incentives
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bi-weekly in person meetings with a Registered DieticianBehavioural
Participants in the Contest Plus group had the opportunity to receive 5 in person meetings with a Registered Dietician. These meetings took place bi-weekly and gave the participants a chance to discuss food consumption, physical activity, meal planning and assessed the participant's weight at each visit.
Participants in the Contest only and Control group were not eligible to receive these meetings.
Financial incentives for weight loss maintenanceBehavioural
Participants in the Contest Plus and Contest Only groups were eligible for a lottery based financial incentive for maintaining their weight lost during phase 1 (Baseline to week 10) of the trial. There were three, month-long follow up assessments (weeks 16, 20 and 24) that participants were eligible for. The lottery prize was contingent upon the length of time they maintained their weight loss.
| Study group | Role | What they receive |
|---|---|---|
| Contest Plus | Experimental | The Contest Plus group were eligible to receive the financial incentives for weight loss maintenance at three monthly follow ups; weeks 16, 20 and 24. Eligible participants completed online surveys and in person weigh ins verifying weight maintenance. In addition to the financial incentives, participants in this group had bi-weekly in person meetings with a Registered Dietician during phase 2 (week 16-24) of the trial. They also received an in home scale to monitor weight daily. Receives: Behavioral: Bi-weekly in person meetings with a Registered Dietician; Behavioral: Financial incentives for weight loss maintenance |
| Control | No intervention | The Control condition did not receive any intervention and were not eligible to win the lottery based incentive. Participants completed follow surveys (weeks 16, 20 and 24) and received remuneration for completing surveys and in person weigh in. |
| Contest Only | Experimental | The Contest only group were eligible to receive the financial incentives for weight loss maintenance for maintaining weight lost at three monthly follow ups; weeks 16, 20 and 24. Eligible participants completed online surveys and in person weigh ins verifying weight maintenance. Receives: Behavioral: Financial incentives for weight loss maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of the weight lost from Baseline to Week 10 (Phase 1) measured ten months (week 52) after end of treatment (week 10).
Measured: Baseline, Week 10, Week 24, Week 52
Secondary outcomes (4)
Change in physical activity from baseline on the Physical Activity Questionnaire at week 24
Measured: Baseline, Week 24
Change in physical activity from baseline on the Physical Activity Questionnaire at week 52
Measured: Baseline, Week 52
Change in nutritional quality of diet from baseline on the Block Food Questionnaire at week 24
Measured: Baseline, Week 24
Change in nutritional quality of diet from baseline on the Block Food Questionnaire at week 52
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study start1 Mar 2012
- Primary completion28 Feb 2014
- Study completion28 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janet L Thomas, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021383
- Sponsor's protocol ID
- 1207S16661
- Other IDs
- 20807
- Acronym
- L2W
- Status last verified
- May 2019
- First submitted
- 19 Dec 2013
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Lose 2 Win" Contests: A Novel Method to Motivate Weight Loss Maintenance Among College Students
- ClinicalTrials.gov ID
- NCT02021383
- Acronym / sponsor ID
- L2W / 1207S16661
- Conditions
- Overweight, Obese
- Keywords
- Weight loss, Weight maintenance, Contingency Management, College students, Financial incentives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Mar 2012 (actual)
- Primary completion
- 28 Feb 2014 (actual)
- Study completion
- 28 Feb 2014 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators are conducting a randomized controlled trial with overweight and obese college students on the University of Minnesota campus. The primary outcome will be weight loss measured 12 months after study enrollment (corresponds to 10 months after the end of treatment).
Detailed description
Approximately 30% of college students are overweight or obese. Intervening on excess weight early may eliminate obesity-related morbidity. Evidence supports use of monetary incentives to encourage weight-loss; questions remain about the efficacy of contingency management on weight loss maintenance.
"Lose 2 Win" contests in which participants who achieve weight-loss goals are eligible for cash prizes, appear well-suited for implementation on campuses. Our objective in this two-phase trial is to evaluate the feasibility, acceptability and efficacy of Lose 2 Win for weight-loss maintenance among college students.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Contest Plus | Experimental | Behavioral: Bi-weekly in person meetings with a Registered Dietician, Behavioral: Financial incentives for weight loss maintenanceThe Contest Plus group were eligible to receive the financial incentives for weight loss maintenance at three monthly follow ups; weeks 16, 20 and 24. Eligible participants completed online surveys and in person weigh ins verifying weight maintenance. In addition to the financial incentives, participants in this group had bi-weekly in person meetings with a Registered Dietician during phase 2 (week 16-24) of the trial. They also received an in home scale to monitor weight daily. |
| Control | No intervention | –The Control condition did not receive any intervention and were not eligible to win the lottery based incentive. Participants completed follow surveys (weeks 16, 20 and 24) and received remuneration for completing surveys and in person weigh in. |
| Contest Only | Experimental | Behavioral: Financial incentives for weight loss maintenanceThe Contest only group were eligible to receive the financial incentives for weight loss maintenance for maintaining weight lost at three monthly follow ups; weeks 16, 20 and 24. Eligible participants completed online surveys and in person weigh ins verifying weight maintenance. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-24 years of age
- University of Minnesota Freshman, Sophomore, or Junior
- Plan on enrolling at the U of Minnesota through Spring 2013
- BMI greater than or equal to 26 and less than or equal to 35.5
- Have working internet and phone access
Key exclusion criteria (6 listed)
- Currently pregnant or breastfeeding
- Prior or planned weight loss surgery
- Having a special diet or being a member of an "organized weight loss program"
- Diagnosis of Diabetes
- Have had Binge Eating Disorder
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 |
|---|---|---|
| Bi-weekly in person meetings with a Registered DieticianParticipants in the Contest Plus group had the opportunity to receive 5 in person meetings with a Registered Dietician. These meetings took place bi-weekly and gave the participants a chance to discuss food consumption, physical activity, meal planning and assessed the participant's weight at each visit. Participants in the Contest only and Control group were not eligible to receive these meetings. | Behavioural | Contest Plus |
| Financial incentives for weight loss maintenanceParticipants in the Contest Plus and Contest Only groups were eligible for a lottery based financial incentive for maintaining their weight lost during phase 1 (Baseline to week 10) of the trial. There were three, month-long follow up assessments (weeks 16, 20 and 24) that participants were eligible for. The lottery prize was contingent upon the length of time they maintained their weight loss. | Behavioural | Contest Only, Contest Plus |
Primary outcome
Maintenance of the weight lost from Baseline to Week 10 (Phase 1) measured ten months (week 52) after end of treatment (week 10).
Time frame: Baseline, Week 10, Week 24, Week 52
4 secondary outcomes
Change in physical activity from baseline on the Physical Activity Questionnaire at week 24
Time frame: Baseline, Week 24
Change in physical activity from baseline on the Physical Activity Questionnaire at week 52
Time frame: Baseline, Week 52
Change in nutritional quality of diet from baseline on the Block Food Questionnaire at week 24
Time frame: Baseline, Week 24
Change in nutritional quality of diet from baseline on the Block Food Questionnaire at week 52
Time frame: Baseline, Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
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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.
Janet L Thomas, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bi-weekly in person meetings with a Registered Dietician and Financial incentives for weight loss maintenance in people with Overweight and Obese, run by University of Minnesota at 1 site 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 7 inclusion and 6 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 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maintenance of the weight lost from Baseline to Week 10 (Phase 1) measured ten months (week 52) after end of treatment (week 10). (time frame: Baseline, Week 10, Week 24, Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2019.