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

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 participate if you are currently taking weight loss medications.

What data supports the effectiveness of the treatment for weight loss?

Research shows that internet-based weight loss programs can help people lose weight, especially when combined with some in-person support. These programs have led to weight losses of 4-7 kg over 6 months to a year, and a specific web-based program showed significant weight loss and health improvements in participants. ^{1 2 3 4 5}

Is the web-based weight loss program safe for humans?

The research does not provide specific safety data for web-based weight loss programs, but they are generally considered safe as they focus on lifestyle changes like diet and exercise. ^{2 5 6 7 8}

How is the Internet-based weight loss program treatment different from other weight loss treatments?

The Internet-based weight loss program is unique because it allows users to self-guide their weight loss journey through online tools like visual progress charts and self-monitoring of weight, diet, and exercise, making it accessible to a large population without the need for in-person visits. ^{2 7 8 9 10}

What is the purpose of this trial?

The purpose of this study is to examine whether the addition of online yoga classes, compared to health and wellness classes, can improve the amount of weight loss produced from an Internet-based weight loss program. All individuals will receive a 12-month, automated Internet-based weight loss program. Following 3 months of of weight loss treatment, individuals will be randomized to also receive yoga classes or health and wellness classes for 9 months. Assessments will occur at baseline, 3, 6, 12, and 18 months and will include measures of weight, eating behaviors, physical activity, and psychosocial factors.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Minimal in-person support as an adjunct to internet obesity treatment. [2018]

2. Canada 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. [2022]

3. Canada 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

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

5. China 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. [2018]

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

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

7. Canada pubmed.ncbi.nlm.nih.gov

Features predicting weight loss in overweight or obese participants in a web-based intervention: randomized trial. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

One-Year Weight Loss with a Telephone-Based Lifestyle Program. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Determinants of successful weight loss after using a commercial web-based weight reduction program for six months: cohort study. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Design and Methods of a Synchronous Online Motivational Interviewing Intervention for Weight Management. [2020]