Weight Loss Program for Obesity

Overseen By Jacqueline F Hayes, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The Miriam Hospital

Must not be taking: Obesity medications

Disqualifiers: Anorexia, Bulimia, Alcohol use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new weight loss program, BWLI-College, designed for college students struggling with being overweight. It focuses on small, sustainable changes in diet, exercise, and behavior to determine if they lead to meaningful weight loss and are well-received by students. Participants will either engage in the new program with both in-person and online sessions or attend a single group session with general weight loss tips. Ideal candidates are English-speaking college students with a BMI of 25 or greater who are not currently in another weight loss program or using obesity medications. As an unphased trial, this study provides a unique opportunity for students to explore innovative weight loss strategies tailored to their lifestyle.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using obesity medications.

What prior data suggests that this behavioral weight loss intervention is safe for emerging adult college students?

Research has shown that programs like the BWLI-College, which assist with weight loss, are generally easy for participants to manage. These programs focus on changing eating habits, increasing exercise, and making small lifestyle adjustments. Studies have found that such programs can help college students manage their weight without major safety concerns.

Although specific data on side effects for the BWLI-College program is unavailable, similar programs have not reported serious problems. The emphasis on small, manageable changes rather than large ones helps keep risks low. This approach makes the program safe for most people, especially with professional guidance. Prospective trial participants may find this information reassuring regarding the program's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about BWLI-College because it offers a fresh approach to weight loss by catering to young adults' preferences, which is often overlooked in traditional treatments. Unlike many current options that might involve medication or rigid diet plans, BWLI-College combines diet, exercise, and behavioral changes in a flexible format. This hybrid delivery method, featuring both in-person and live online sessions, is designed to fit seamlessly into the busy lives of college students, making it more accessible and potentially more effective for this age group.

What evidence suggests that BWLI-College might be an effective treatment for obesity?

Studies have shown that programs tailored to help young adults lose weight effectively address their specific challenges. These programs focus on improving diet, increasing physical activity, and making lifestyle changes suited to young adults' needs. Research indicates that traditional weight loss programs often fail to work as well for young adults, resulting in less weight loss and lower retention compared to older adults. The BWLI-College program, offered to participants in this trial, is specifically designed for college students, potentially increasing its success for this group. Early results from similar programs have shown promising outcomes in achieving significant weight loss. ^{1 2 6 7 8}

Who Is on the Research Team?

Jacqueline F Hayes, PhD

Principal Investigator

Brown University

Are You a Good Fit for This Trial?

This trial is for college students who are currently overweight or obese. It's designed to see if a new 'small change' approach to weight loss can work for them and be something they're willing to stick with.

Inclusion Criteria

Enrolled at college/university where study will take place

English-speaking

BMI of 25 or greater

Exclusion Criteria

Psychiatric hospitalization in the past 12 months

I have had weight loss surgery in the past.

I have lost more than 5% of my body weight recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 10-week behavioral weight loss intervention using a 'small change' approach, delivered in a hybrid format with in-person and remotely-delivered synchronous sessions.

10 weeks

Hybrid format with in-person and remote sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BWLI-College

Trial Overview The study is testing a behavioral weight loss program called BWLI-College against a control group that does not receive the intervention. The focus is on whether making small lifestyle changes can lead to significant weight loss in students.

How Is the Trial Designed?

Group I: BWLI-College Experimental Treatment 1 Intervention

BWLI-College is a multicomponent behavioral weight loss intervention to reduce weight through diet, physical activity, and behavioral modifications designed to be responsive to emerging adult preferences. It will be delivered in a hybrid format with in-person and remotely-delivered synchronous sessions. As presently designed, the intervention will last 10 weeks.

Group II: Control Active Control 1 Intervention

The Control intervention consists of 1 in-person psychoeducational group session on general weight loss information and myths. Public web-resources about healthy eating and physical activity will be provided. Newsletters with similar content will be sent to promote retention.

Who Is Running the Clinical Trial?

The Miriam Hospital

Lead Sponsor

Trials

252

Recruited

39,200+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11562231/

Behavioral weight loss interventions in college health centers Offering BWLIs in college health centers may help to address obesity in emerging adulthood by reducing student barriers associated with participation.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06994923

Study Details | NCT06994923 | Weight Management ... Study Plan​​ BWLI-College is a multicomponent behavioral weight loss intervention to reduce weight through diet, physical activity, and behavioral modifications ...

3. paperdigest.org paperdigest.org/grant/?grant_id=nih_10746762

Grant: "Developing A Behavioral Weight Loss Intervention ... Finally, I will test BWLI-College against a one-session psychoeducational control group in a small randomized-controlled pilot trial (N=60; Aim 3). This ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2996044/

Are standard behavioral weight loss programs effective for ... Standard programs do not meet the weight control needs of young adults, with less weight loss and lower retention compared to adults.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2211335520300218

A randomized controlled trial to improve weight-loss ... At baseline, mean (SD) weight was 83.2 (15.5 kg) among intervention and 80.7 (14.5 kg) among control participants. After 50 weeks, intervention participants had ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02342912

Social Media Obesity Treatment for College Students This is a randomized trial designed to translate and deliver programs via social media for a healthy body weight to university students.

7. researchgate.net researchgate.net/publication/385813971_Behavioral_weight_loss_interventions_in_college_health_centers_A_qualitative_analysis_of_barriers_and_facilitators_to_implementation

Behavioral weight loss interventions in college health centers Conclusions: Students with obesity have poorer health and health behaviors relative to students of healthy weight; students with overweight were in between.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7963295/

Implementation intentions for weight loss in college ... The purpose of this study was to examine the efficacy of an implementation intention weight loss intervention in college students.