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

Trial Summary

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.

What data supports the effectiveness of this treatment for obesity?

Research shows that online behavioral weight loss programs can lead to significant weight loss and high satisfaction among users. These programs often include interactive features and support from counselors, which help keep people engaged and improve outcomes. ^{1 2 3 4 5}

Is online behavioral weight loss treatment safe for humans?

The available research on online behavioral weight loss programs suggests they are generally safe for humans, with no specific safety concerns reported in the studies reviewed. ^{1 4 5 6 7}

How does the online behavioral weight loss treatment differ from other obesity treatments?

The online behavioral weight loss treatment, Rx Weight Loss, is unique because it is delivered entirely over the internet, allowing for greater accessibility and reach. It includes interactive features and counselor contact to enhance engagement and weight loss outcomes, which are not typically part of traditional in-person programs. ^{1 4 5 8 9}

What is the purpose of this trial?

Obesity disproportionately impacts sexual minority women. Behavioral weight loss programs are the gold standard treatment for mild to moderate obesity. The investigators have developed an online behavioral weight loss program that is effective, low-cost, and highly scalable. However, existing research suggests that tailoring treatment to address 3 well-established weight loss barriers in sexual minority women will be critical for maximizing the relevance and efficacy of behavioral weight loss for this group. In the Preparation Phase of this K23, the investigators developed 3 novel treatment components targeting sexual minority women's weight loss barriers (i.e., minority stress, low social support, and negative body image), the investigators piloted the program among sexual minority women of higher weight, and the investigators conducted individual qualitative interviews to elicit feedback on the intervention's acceptability, cultural relevance, usability, and feasibility, and this feedback was used to refine the program. In the Optimization Phase of this K23 (the current phase), 88 women will receive 12 weeks of Rx Weight Loss and will be randomized to receive 0-3 tailored components in a full factorial design with 23 (8) distinct combinations of components. Novel components that increase mean weight loss (by ≥2%) or the proportion of women achieving clinically meaningful weight loss (by ≥10%) at 6 months will be retained in a finalized obesity treatment package that the investigators will evaluate in a future randomized controlled trial (RCT) (Evaluation Phase). The aims of this study are to: Aim 2A (Optimization): Use a factorial experiment to determine how 3 novel components impact mean weight loss and the proportion of women achieving a 5+% weight loss at 6 months. Aim 2B (Mediation): Clarify how tailored components impact weight loss by testing hypothesized mechanisms of action (i.e., coping with stress, perceived social support, weight and shape concerns). This project will tailor and optimize an evidence-based online behavioral obesity treatment to enhance weight loss outcomes in sexual minority women.

Eligibility Criteria

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

I want to lose weight.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Recent advances in internet-delivered, evidence-based weight control programs for adults. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

A Facebook-Delivered Weight Loss Intervention Using Open Enrollment: Randomized Pilot Feasibility Trial. [2022]

3. England 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Rationale and design for a pragmatic effectiveness-implementation trial of online behavioral obesity treatment in primary care. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

An automated internet behavioral weight-loss program by physician referral: a randomized controlled trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Cardiovascular and psychiatric risk profile and patterns of use in patients starting anti-obesity drugs. [2009]

7. United States pubmed.ncbi.nlm.nih.gov

Outcomes and utilization of a low intensity workplace weight loss program. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of a web-based real-life weight management program: Study design, methods, and participants' baseline characteristics. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Motivational interviewing in eHealth and telehealth interventions for weight loss: A systematic review. [2020]