Online Behavioral Weight Loss for Obesity

Overseen By Traci Mancini, BA, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: The Miriam Hospital

Must not be taking: Weight-loss medications

Disqualifiers: Pregnancy, Serious mental/physical health, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

88 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to optimize an online weight loss program specifically for sexual minority women dealing with obesity. It tests various components, such as coping strategies for stress, social support, and body image improvement, to determine which combinations most effectively aid weight loss. Participants will engage in the behavioral weight loss intervention (Online; Rx Weight Loss) and may receive additional support tailored to their unique challenges. Ideal candidates are women who identify as a sexual minority (e.g., lesbian, bisexual), have a BMI between 25 and 50, and have not experienced significant weight loss in the past six months. The goal is to refine these components for a more effective weight loss program for this group. As an unphased trial, this study offers a unique opportunity to contribute to research that could lead to a more personalized and effective weight loss program for sexual minority women.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be taking weight-loss medication to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that online weight loss programs are generally safe and effective. In one study, more than half of the participants in such a program lost significant weight. Another review found these online programs to be as effective as in-person coaching and superior to doing nothing or following usual care. The widespread use of these programs suggests they are user-friendly.

For managing stress, studies indicate that stress can lead to weight gain. While reducing stress might aid weight loss, there is less direct evidence on the safety and effectiveness of stress management programs. However, they are generally considered safe as they focus on coping strategies.

Regarding body image, digital programs aimed at improving body perception have been effective in adults. These programs reduce negative body feelings, potentially enhancing mental health and aiding weight loss. They are typically safe and well-received.

Social support programs in weight management are also deemed safe. Research shows that support from friends, family, or a community can help individuals adhere to their health goals. These programs are often included in weight loss plans for their encouragement and accountability benefits.

Overall, the components of this trial appear safe based on past research. They have been used in various settings with positive results and minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these online behavioral weight loss interventions for obesity because they offer personalized support that addresses the unique challenges faced by individuals. Unlike traditional weight loss methods that might focus solely on diet and exercise, these interventions incorporate strategies for coping with stress, stigma, and negative body image. Moreover, the integration of real-time social support allows participants to engage with others, fostering a supportive community. This comprehensive approach not only targets weight loss but also aims to improve overall mental well-being, setting it apart from more conventional treatments.

What evidence suggests that this trial's treatments could be effective for obesity?

Studies have shown that online weight loss programs, like the one offered in this trial, can help individuals lose about 8% of their body weight in a year. This significant change can lead to better health. In this trial, some participants will receive interventions to cope with stress related to being part of a marginalized group. Research has shown that managing stress can aid in weight management, as stress often leads to weight gain. Other participants will focus on improving body image, which can boost self-esteem and reduce unhealthy eating, aiding weight loss. Additionally, some trial arms include a social support intervention, where participants connect online to give and receive support, making it easier to stick to weight loss goals. These strategies are being tested in various combinations to enhance weight loss treatments for sexual minority women. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for sexual minority women aged 18-70 with a BMI of 25-50 who want to lose weight. Participants must be assigned female at birth, identify as female and have a minority sexual orientation (e.g., lesbian, bisexual). They need regular internet access, haven't lost significant weight recently (>5% in past 6 months), speak English fluently, and can do moderate exercise.

Inclusion Criteria

Self-identify a minority sexual orientation (e.g.,lesbian, bisexual)

BMI=25-50kg/m2

Fluent in English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12 weeks of Rx Weight Loss and are randomized to receive 0-3 tailored components in a full factorial design

12 weeks

Online program participation

Follow-up

Participants are monitored for weight loss outcomes and adherence to the program

6 months

Assessments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral weight loss intervention (Online; Rx Weight Loss)
• Minority stress intervention
• Negative body image intervention
• Social support intervention

Trial Overview The study tests an online behavioral weight loss program tailored for sexual minority women. It includes interventions addressing minority stress, social support deficits, and negative body image. Women will try different combinations of these components over 12 weeks to see which ones help the most with weight loss.

How Is the Trial Designed?

Group I: Weight Loss Program Only Experimental Treatment 1 Intervention

Participants complete an online behavioral weight loss program.

Group II: Weight Loss Program + Social Support Program Experimental Treatment 2 Interventions

Participants complete (1) an online behavioral weight loss program and (2) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts.

Group III: Weight Loss Program + Coping with Stress Program + Social Support Program Experimental Treatment 3 Interventions

Participants complete a (1) online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss, and (3) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts.

Group IV: Weight Loss Program + Coping with Stress Program + Body Image Program + Social Support Program Experimental Treatment 4 Interventions

Participants complete (1) an online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss, (3) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts, and (4) an adjunctive intervention for improving negative body image and reducing its impact on weight loss.

Group V: Weight Loss Program + Coping with Stress Program + Body Image Program Experimental Treatment 3 Interventions

Participants complete (1) an online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss, and (3) an adjunctive intervention for improving negative body image and reducing its impact on weight loss.

Group VI: Weight Loss Program + Coping with Stress Program Experimental Treatment 2 Interventions

Participants complete (1) an online behavioral weight loss program and (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss.

Group VII: Weight Loss Program + Body Image Program + Social Support Program Experimental Treatment 3 Interventions

Participants complete (1) an online behavioral weight loss program, (2) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts, and (3) an adjunctive intervention for improving negative body image and reducing its impact on weight loss.

Group VIII: Weight Loss Program + Body Image Program Experimental Treatment 2 Interventions

Participants complete (1) an online behavioral weight loss program and (2) an adjunctive intervention for improving negative body image and reducing its impact on weight loss.

Who Is Running the Clinical Trial?

The Miriam Hospital

Lead Sponsor

Trials

252

Recruited

39,200+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

Motivational interviewing delivered through digital health interventions, particularly telephone-based counseling, shows promise for weight loss in adults with obesity, demonstrating greater weight loss compared to no-treatment controls in 6 out of 11 studies reviewed.

However, the effectiveness of motivational interviewing compared to other active treatments was less consistent, with only 1 out of 7 studies showing superior results, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing in eHealth and telehealth interventions for weight loss: A systematic review. Patel, ML., Wakayama, LN., Bass, MB., et al.[2020]

The study found that an open enrollment model for a Facebook-delivered weight loss intervention was as feasible and acceptable as a closed enrollment model, with high retention rates of 88% and 98% respectively.

Participants in the open enrollment group showed a greater volume of engagement, which was linked to better weight loss outcomes, with 30% achieving a ≥5% weight loss compared to 18% in the closed group, suggesting that larger, more engaged groups may enhance weight loss success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Facebook-Delivered Weight Loss Intervention Using Open Enrollment: Randomized Pilot Feasibility Trial. Pagoto, SL., Schroeder, MW., Xu, R., et al.[2022]

The Healthy Weight Coaching (HWC) program is a comprehensive 12-month internet-based intervention for obesity management that combines Acceptance and Commitment Therapy with personalized coaching, targeting diet, physical activity, psychological factors, and sleep.

With 1189 participants enrolled, the program emphasizes ongoing support through weekly weight logs and 26 scheduled online discussions with coaches, aiming to provide effective long-term weight management solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a web-based real-life weight management program: Study design, methods, and participants' baseline characteristics. Suojanen, LU., Ahola, AJ., Kupila, S., et al.[2022]

Online behavioral weight control programs have been effective in producing significant weight loss in adults, with newer programs showing even larger losses and higher consumer satisfaction.

Key features that may enhance engagement and outcomes in online obesity interventions include interactive website elements and real-time counselor support, though more research is needed to identify the most effective components and assess cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in internet-delivered, evidence-based weight control programs for adults. Krukowski, RA., West, DS., Harvey-Berino, J.[2021]

The Rx Weight Loss (RxWL) program will be tested in about 60 primary care clinics to evaluate its effectiveness and feasibility as a behavioral intervention for obesity treatment, focusing on program uptake and completion rates.

The study will compare two methods for maintaining weight loss—Monthly Lessons and Refresher Courses—against an educational control, aiming to identify the best strategies for long-term weight management in a primary care setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design for a pragmatic effectiveness-implementation trial of online behavioral obesity treatment in primary care. Espel-Huynh, HM., Wing, RR., Goldstein, CM., et al.[2020]

Patients starting anti-obesity drugs had a higher prevalence of cardiovascular and psychiatric co-morbidities compared to those not prescribed these drugs, indicating a baseline risk that could lead to increased adverse effects during treatment.

A significant number of patients (77.7%) discontinued anti-obesity drugs within 90 days, which may limit the potential cardiovascular benefits associated with weight loss from these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular and psychiatric risk profile and patterns of use in patients starting anti-obesity drugs. Willemen, MJ., Mantel-Teeuwisse, AK., Straus, SM., et al.[2009]

In a low-intensity, employer-sponsored weight loss program involving 3 counseling calls and a comprehensive website, one third of participants lost at least 5% of their body weight after six months, indicating the program's efficacy.

Utilization of both counseling and the website, particularly the weight tracking tool, was linked to successful weight loss, along with positive health behavior changes like increased fruit and vegetable intake and physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes and utilization of a low intensity workplace weight loss program. Carpenter, KM., Lovejoy, JC., Lange, JM., et al.[2021]

A core outcome set for behavioral weight management programs (BWMPs) is being developed to standardize how outcomes are reported, allowing for better comparison of different interventions for adults with overweight and obesity.

The study will utilize a Delphi process involving 40 experts to reach consensus on which outcomes to measure and the definitions or instruments to use, ensuring that the findings are relevant and applicable in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a core outcome set for behavioural weight management programmes for adults with overweight and obesity: protocol for obtaining expert consensus using Delphi methodology. Mackenzie, RM., Ells, LJ., Simpson, SA., et al.[2023]

A study involving 154 overweight or obese patients showed that those referred to an automated Internet-based behavioral weight-loss intervention lost significantly more weight than those in an education-only control group, with average losses of 5.5 kg at 3 months and 5.4 kg at 6 months.

Over half of the participants in the Internet-based intervention achieved a clinically significant weight loss of 5% or more of their initial body weight, indicating the intervention's effectiveness in promoting weight control behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An automated internet behavioral weight-loss program by physician referral: a randomized controlled trial. Thomas, JG., Leahey, TM., Wing, RR.[2022]

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