Strategies for Weight Loss

Overseen By Jennifer Webster, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Miriam Hospital

Must not be taking: Weight loss medications

Disqualifiers: Pregnancy, Recent weight loss, Bariatric surgery, others

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

Compensation: Varies

Number of Visits: 26

210 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding online yoga classes can enhance weight loss compared to health and wellness classes, all within an Internet-based weight loss program. Participants will be divided into two groups: one will receive yoga classes, and the other will receive health and wellness classes, both for nine months. The study examines weight loss, eating habits, physical activity, and mental well-being over 18 months. It is suitable for individuals with a BMI between 25-40 who have a smartphone and daily Internet access, but have not recently participated in weight loss programs or yoga-related activities. As an unphased trial, this study provides a unique opportunity to explore innovative weight loss strategies in a supportive environment.

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 participate if you are currently taking weight loss medications.

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

Research has shown that internet-based weight loss programs are generally safe. Studies have found that these programs can help people lose a moderate amount of weight over time without major safety issues. No significant problems have been directly linked to these online programs.

For Iyengar yoga, part of one treatment option, research suggests it is well-tolerated. One study noted minor issues like muscle strain in a few participants, but these were not serious. Overall, less than 3% of participants experienced any problems, and most were not serious.

The health and wellness classes in the other treatment option focus on education and lifestyle changes. These classes are generally safe and do not pose significant risks.

Overall, previous research and experiences consider the treatments in this trial safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these strategies for weight loss because they combine innovative and accessible approaches to lifestyle change. The first treatment pairs a 12-month internet-based weight loss program with Iyengar yoga, which is known for its focus on alignment and precision, potentially offering both physical and mental benefits. The second treatment combines the same internet-based weight loss program with health and wellness classes, delivering a broad education on lifestyle through engaging lectures and discussions. These approaches may offer more holistic support compared to traditional weight loss methods, such as diet alone or in-person exercise classes, which can be less flexible and harder to access consistently.

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

Research has shown that internet-based weight loss programs, one of the treatments in this trial, work well. A study examining various programs found that online group sessions can significantly aid weight loss. Other reviews suggest these digital programs are as effective as in-person meetings.

In this trial, one group of participants will receive an Internet-based weight loss program combined with Iyengar yoga. Iyengar yoga might also aid in weight loss. Some studies found that people who practiced yoga lost more weight than those who didn't. Yoga can also help manage stress, which might make it easier to maintain weight loss.

Another group in this trial will receive the Internet-based weight loss program combined with health and wellness classes. Health and wellness classes have shown mixed results. Some programs lead to moderate weight loss, often by focusing on diet and exercise. However, the success of these programs can vary depending on the specific methods used. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

The PATH Trial is for adults with a BMI of 25-40 who have regular internet access and own a smartphone. It's not suitable for those currently pregnant, planning pregnancy soon, or recently gave birth; anyone in recent weight loss programs or practicing yoga/meditation; individuals with certain medical conditions; recent significant weight losers; users of weight loss meds; post-bariatric surgery patients; or those unable to walk short distances.

Inclusion Criteria

BMI: 25-40 kg/m2

Must own smartphone and have daily, home Internet access

Exclusion Criteria

I can't walk 2 blocks without stopping.

I have had weight loss surgery in the past.

I am currently on medication to lose weight.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Weight Loss Program

Participants receive a 3-month Internet-based weight loss program with weekly multimedia lessons and self-monitoring

12 weeks

Weekly online lessons

Weight Loss Maintenance

Participants continue with a 9-month weight loss maintenance program with monthly video lessons and self-monitoring

9 months

Monthly online lessons

Yoga or Health and Wellness Classes

Participants are randomized to receive either Iyengar yoga or health and wellness classes for 9 months

9 months

Twice weekly for 14 weeks, then weekly

Follow-up

Participants are monitored for weight change and other outcomes after the completion of the program

6 months

Assessments at 12 and 18 months

What Are the Treatments Tested in This Trial?

Interventions

• Health and Wellness
• Internet-based weight loss program
• Yoga

Trial Overview This study tests if adding online yoga classes enhances the effectiveness of an automated Internet-based weight loss program compared to health and wellness classes. Participants will first undergo 3 months of the weight loss program before being randomly assigned to one of the two additional class types for another 9 months.

How Is the Trial Designed?

Group I: Internet-based weight loss program + Iyengar yoga Experimental Treatment 2 Interventions

Participants randomized to this group will receive a 12-month automated weight loss program which is delivered via the Internet and will also receive a 9-month Iyengar yoga intervention (delivered during months 4-12). Yoga classes will be delivered live (via Zoom) and participants will be instructed to attend two classes per week for the first 14 weeks and one class per week thereafter. They will also be asked to do self-guided yoga practice on their own and report their yoga practice on the study website.

Group II: Internet-based weight loss program + health and wellness classes Active Control 2 Interventions

Participants randomized to this group will receive a 12-month automated weight loss program which is delivered via the Internet and will also receive a 9-month health and wellness intervention (delivered during months 4-12). Health and wellness classes will be delivered live (via Zoom) and participants will be instructed to attend two classes per week for the first 14 weeks and one class per week thereafter. Classes will consist of lectures, videos, and discussions and will provide education around a variety of lifestyle topics.

Who Is Running the Clinical Trial?

The Miriam Hospital

Lead Sponsor

Trials

252

Recruited

39,200+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

A telephone-based lifestyle program for weight loss led to a significant average weight loss of 4.25 kg over 12 months among participants, indicating its effectiveness as an alternative to face-to-face obesity treatments.

The program was well-accepted, especially by men, and resulted in additional health benefits such as reduced abdominal girth and lower cholesterol levels, suggesting it can improve overall metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-Year Weight Loss with a Telephone-Based Lifestyle Program. Holzapfel, C., Merl, M., Stecher, L., et al.[2022]

A study of 479 KiloCoach users over 6 months showed that those who lost more weight early on (weeks 3-4) were more likely to achieve greater overall weight loss, with the high success group losing an average of 14.2% of their initial weight.

Close adherence to the program, such as following dietary protocols and regularly entering weight, significantly predicted better weight loss outcomes, highlighting the importance of consistent engagement with the weight loss program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants of successful weight loss after using a commercial web-based weight reduction program for six months: cohort study. Postrach, E., Aspalter, R., Elbelt, U., et al.[2022]

A study involving 123 participants found that adding monthly in-person meetings to an Internet-based weight-loss program did not lead to significantly greater weight loss compared to the Internet-only program over 12 months.

Both groups showed similar weight loss results, suggesting that the interactive and supportive features of the online program may be sufficient for achieving weight loss without the need for additional in-person support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal in-person support as an adjunct to internet obesity treatment. Micco, N., Gold, B., Buzzell, P., et al.[2018]

Internet treatment programs for overweight and obese individuals have been shown to be effective, resulting in weight losses of 4-7 kg over periods of 6 months to 1 year, based on various randomized trials.

These programs utilize methods such as e-mail support, automated messages, and chat rooms to enhance motivation and provide behavioral counseling, suggesting potential applications for similar approaches in treating substance use and misuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A series of studies examining Internet treatment of obesity to inform Internet interventions for substance use and misuse. Tate, DF.[2010]

In a study involving 8112 overweight/obese Australian adults over 12 weeks, web-based weight loss programs with supportive features led to higher engagement compared to information-only sites, but did not result in significantly greater weight loss.

While personalized meal planning and social networking features did not enhance weight loss outcomes, increased usage of the weight tracker tool was linked to better weight loss results among participants using supportive websites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Features predicting weight loss in overweight or obese participants in a web-based intervention: randomized trial. Brindal, E., Freyne, J., Saunders, I., et al.[2022]

A web-based weight loss program requiring only 2 personal interviews over 6 months led to a significant average weight loss of 2.7% among 20 obese participants, indicating its efficacy as a low-resource intervention.

Participants also experienced a notable 12.6% reduction in abdominal visceral fat and improvements in liver enzyme levels, suggesting additional health benefits beyond weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of a web-based weight loss program with auto-extraction of behavioural objectives and recording of daily weight and steps in pre-obese outpatients. Matsumoto, Y., Yoshiuchi, S., Miyauchi, T., et al.[2018]

This study is testing a new online weight loss program that combines group-based behavioral strategies with individual motivational interviewing (MI) sessions delivered by trained psychologists, aiming to improve weight loss outcomes over 18 months.

If successful, this innovative approach could enhance the effectiveness of online weight management programs, making them more comparable to in-person interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Methods of a Synchronous Online Motivational Interviewing Intervention for Weight Management. Krukowski, RA., DiLillo, V., Ingle, K., et al.[2020]

In a study of 301 overweight and obese adults, the enhanced online weight-loss program showed better participant retention (81.0% vs. 68.5% in the basic program) but did not result in significantly greater weight loss or BMI reduction after 24 weeks.

Participants in the enhanced program logged in more frequently, which correlated with weight loss, suggesting that while the additional features did not improve outcomes, they may help keep users engaged in the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of standard versus enhanced features in a Web-based commercial weight-loss program for obese adults, part 2: randomized controlled trial. Collins, CE., Morgan, PJ., Hutchesson, MJ., et al.[2022]

Web-based weight management programs are more effective than minimal or control conditions for both weight loss and weight loss maintenance, based on a meta-systematic review of 20 high-quality studies.

The effectiveness of these Web-based interventions for maintaining weight loss appears to be stronger than for initial weight loss, but more research is needed to clarify their overall efficacy compared to non-Web-based interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Interventions for Weight Loss or Weight Loss Maintenance in Overweight and Obese People: A Systematic Review of Systematic Reviews. Sorgente, A., Pietrabissa, G., Manzoni, GM., et al.[2022]

A review of eight studies on Internet-based weight loss programs showed that most programs were effective for weight loss, suggesting that the Internet could be a viable alternative to traditional face-to-face interventions.

However, the long-term maintenance of weight loss through these programs remains uncertain, and the studies primarily involved white, educated women, which limits the generalizability of the findings to more diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of weight loss programs delivered via the Internet. Weinstein, PK.[2022]

Citations

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Based Approach in Obese Women: A Pilot-Trial of the “Health ... This study explored the effects of Health at Every Size®-based intervention on obese women by qualitatively evaluating participants' perception toward the ...

2. withpower.com withpower.com/trial/phase-2-disease-1-2023-942a6

Whole Health Intervention for PTSD (OS RCT Trial) The Holistic Healing Arts Retreat study suggests that intensive, experiential interventions can help improve symptoms of trauma, depression, and stress, which ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04793113

A Study to Assess the Effects of Freshly Fit Meals on Body ... The primary objective of this trial is to examine the weight-loss efficacy of Freshly Fit meals, as well as body composition, waist/hip circumference ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002822307014836

A Systematic Review and Meta-Analysis of Weight-Loss ... Weight-loss interventions utilizing a reduced-energy diet and exercise are associated with moderate weight loss at 6 months.

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based approach in obese women: a pilot-trial of the " ... This study explored the effects of Health at Every Size ®-based intervention on obese women by qualitatively evaluating participants' ...

6. trialx.com trialx.com/clinical-trials/listings/264498/whole-health-in-va-mental-health-omnis-salutis/?&radius=50

Whole Health in VA Mental Health: Omnis Salutis Veterans will be randomly assigned to receive three sessions of Omnis Salutis or three sessions of an active control, health, and wellness ...

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A Randomized Controlled Trial of Omnis Salutis Omnis Salutis is a three-session intervention in which Veterans learn about Whole Health and complete a brief Personal Health Inventory, practice creating ...

9. research.va.gov research.va.gov/about/funded_research/proj-details-FY2024.cfm?pid=746929

A Randomized Controlled Trial of Omnis Salutis Title: Whole Health in VA Mental Health: A Randomized Controlled Trial of Omnis Salutis ; Principal Investigator: Samantha Hack ; Location: Denver, CO.