Behavioral Intervention + Technology for Weight Loss

Overseen By Olivia Hughes

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Must not be taking: Sleep aids, Weight loss drugs

Disqualifiers: Diabetes, Heart disease, Cancer, others

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

Compensation: Varies

Number of Visits: 5

Duration: 6 months

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how combining behavioral changes with technology can help young adults effectively lose weight. It focuses on individuals who are overweight or obese and seek new methods for sustainable weight loss. Participants will receive diet and exercise coaching as part of the Lifestyle and Lifestyle II interventions to evaluate how these interventions work together to improve health. Ideal candidates are individuals aged 18 to 40 who have a stable weight, own a smartphone, and are open to trying a new approach to weight management. As an unphased trial, this study provides a unique opportunity to explore innovative weight management strategies.

Will I have to stop taking my current medications?

The trial excludes participants taking any prescription or over-the-counter drugs or supplements that can affect sleep or weight. You may need to stop taking such medications to participate.

What prior data suggests that this behavioral intervention combined with technology is safe for weight loss in young adults?

Research has shown that lifestyle changes for weight loss, such as diet and exercise coaching, are generally safe. Studies have found that these changes can lead to significant weight loss without serious side effects. For instance, participants in structured programs often lose about 5% of their body weight, which is a healthy and achievable goal.

One study found that using digital tools, like apps, to support these lifestyle changes can improve weight loss results. These digital methods are also safe, with no major safety concerns reported.

Overall, research indicates that both traditional and technology-enhanced lifestyle changes are safe. They help people lose weight and improve their health without significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they combine behavioral interventions with technology to enhance weight loss. While traditional weight loss methods often rely solely on diet and exercise, these interventions integrate coaching with tech tools that can provide personalized feedback and support. This innovative approach aims to increase engagement and adherence to lifestyle changes, potentially leading to more sustainable weight loss outcomes.

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

Research has shown that combining technology with behavior changes can aid in weight loss. In this trial, participants will join one of two treatment arms: the Lifestyle Intervention or the Lifestyle Intervention II. One review found that online tools are more effective than no intervention and work as well as in-person meetings. Another study demonstrated that digital programs focusing on exercise, healthy eating, sleep, and stress can promote weight loss and improve health. Traditional methods, such as altering diet and exercise habits, also help many people lose weight. These findings suggest that integrating technology with behavior changes could effectively assist young adults in losing weight. ^{1 2 3 6 7}

Who Is on the Research Team?

Esra Tasali, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for overweight or obese young adults aged 18 to 40 with a BMI of 25.5-34.9, who have had stable weight in the last three months and own a smartphone they're willing to use for the study.

Inclusion Criteria

My BMI is between 25.5 and 34.9.

My weight has been stable, with no change over 25 lbs in the last 3 months.

I own a smartphone and agree to install the study app.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a behavioral intervention combined with technology for weight loss, including diet and exercise coaching, regular weight recording, food intake tracking, and physical activity monitoring

6 months

Up to 5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lifestyle
• Lifestyle II

Trial Overview The trial is testing two lifestyle interventions aimed at weight loss in young adults. It explores how behavioral changes combined with technology can help manage obesity and prevent related health risks.

How Is the Trial Designed?

Group I: Lifestyle Intervention II Experimental Treatment 2 Interventions

Diet and exercise coaching

Group II: Lifestyle Intervention Experimental Treatment 1 Intervention

Diet and exercise coaching

Lifestyle is already approved in United States, European Union for the following indications:

Approved in United States as Behavioral Weight Loss Intervention for:

• Obesity
• Overweight
• Cardiometabolic Risks

Approved in European Union as Lifestyle Intervention for:

• Weight Loss
• Obesity Prevention
• Cardiovascular Disease Prevention

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

The study developed a digital behavior change intervention called eCHANGE, which integrates persuasive system design (PSD) principles and behavior change techniques (BCTs) to support long-term weight maintenance, based on input from 45 stakeholders including end users and health care providers.

Seventeen key design features were identified and grouped into four main components of the intervention, emphasizing personalization, self-monitoring, and social support, which are crucial for engaging users and promoting sustainable behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining Persuasive System Design Principles and Behavior Change Techniques in Digital Interventions Supporting Long-term Weight Loss Maintenance: Design and Development of eCHANGE. Asbjørnsen, RA., Hjelmesæth, J., Smedsrød, ML., et al.[2022]

In a 6-month trial involving 153 adults with overweight and obesity, a personalized digital weight loss program (WeightWatchers) led to an average weight loss of 5.05% from baseline, with 51% of participants achieving at least a 5% weight loss, indicating its efficacy.

Participants reported high satisfaction and engagement with the program, with significant improvements in various health-related behaviors, including increased fruit and vegetable intake, physical activity, and better sleep quality, suggesting the program's positive impact on overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Evaluation of a Personalized Multicomponent Commercial Digital Weight Management Program: Single-Arm Behavioral Trial. Pagoto, S., Xu, R., Bullard, T., et al.[2023]

In a study of 11,252 participants using the Noom mobile app, higher engagement in activities like logging meals and reading articles was significantly associated with achieving moderate (5-10% weight loss) and high (10% or greater weight loss) outcomes compared to stable weight.

The relationship between engagement and weight loss outcomes was consistent over time, indicating that sustained participation in the program is crucial for long-term weight management success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Relationship Between Weight Loss Outcomes and Engagement in a Mobile Behavioral Change Intervention: Retrospective Analysis. Carey, A., Yang, Q., DeLuca, L., et al.[2022]

This study aims to enhance online behavioral lifestyle interventions (BLI) for obesity by testing five innovative components, including virtual reality training and tailored physical activity promotion, with 384 adults over a 12-month period.

The research will use a systematic approach to identify the most effective combination of these components, potentially leading to improved weight loss outcomes and a better understanding of how these interventions work for different individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of intervention components to maximize outcomes of behavioral obesity treatment delivered online: A factorial experiment following the multiphase optimization strategy framework. Thomas, JG., Goldstein, CM., Bond, DS., et al.[2022]

In a 2-year randomized controlled trial involving overweight participants, those who used an Internet-based computerized tracking system (CTS) more frequently in the first 8 weeks lost significantly more weight (8.7% of initial body weight) compared to those with low usage (5.5%; p < .001).

The study highlights that while the CTS was effective in promoting weight loss through enhanced self-monitoring, its usage declined over time, suggesting a need for strategies to maintain user engagement in long-term health programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a computerized tracking system to monitor and provide feedback on dietary goals for calorie-restricted diets: the POUNDS LOST study. Anton, SD., LeBlanc, E., Allen, HR., et al.[2021]

The Choosing Health program is being tested in a randomized controlled trial with 285 overweight or obese adults to see if a tailored digital intervention can lead to greater weight loss compared to a control group receiving generic advice.

The study will measure weight loss and other health outcomes over 12 months, using personalized assessments to adapt the intervention to individual needs, which may enhance its effectiveness and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Theory-based digital intervention to promote weight loss and weight loss maintenance (Choosing Health): protocol for a randomised controlled trial. Kwasnicka, D., Luszczynska, A., Hagger, MS., et al.[2021]

Weight loss of just 5-10% can significantly improve health issues related to obesity, such as hypertension and type II diabetes, as shown in studies like the Diabetes Prevention Program, which found a 7% weight reduction reduced diabetes risk by 58%.

Behavioral treatments, which include diet changes, increased physical activity, and behavior therapy, are effective in achieving and maintaining this level of weight loss, promoting long-term health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle modification in the treatment of obesity: an educational challenge and opportunity. Jones, LR., Wilson, CI., Wadden, TA.[2007]

In a study of 77 participants over 12 weeks, those with more severe binge eating behaviors at the start were more likely to consistently self-monitor their weight and food intake using digital tools, suggesting a potential motivation linked to their eating habits.

This research highlights a unique relationship between binge eating severity and adherence to self-monitoring in weight loss programs, indicating that individuals with higher binge eating may possess traits that support their commitment to tracking their progress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Binge eating predicts adherence to digital self-monitoring during behavioral weight loss. Martinelli, MK., D'Adamo, L., Butryn, ML.[2021]

In a 6-month study involving 51 overweight adults, the combination of a standard behavioral weight loss program with a technology-based system led to the greatest weight loss of -8.8 kg, compared to -3.7 kg for the standard program alone and -5.8 kg for the technology-only group.

Retention rates were highest in the combined group (100%), suggesting that incorporating technology may enhance participant engagement and adherence to weight loss interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The comparison of a technology-based system and an in-person behavioral weight loss intervention. Pellegrini, CA., Verba, SD., Otto, AD., et al.[2021]

Blended-care behavior change interventions (BBCI) effectively promote weight loss, with participants losing an average of 6.55 kg over 12 months, based on data from 25,706 patients.

Coaching, self-monitoring, and self-management are key components that positively influence weight loss, while excessive appointments with dietitian coaches may hinder progress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Intervention Elements Drive Weight Loss in Blended-Care Behavior Change Interventions? A Real-World Data Analysis with 25,706 Patients. Schirmann, F., Kanehl, P., Jones, L.[2022]

The study will involve adults aged 18 to 70 with overweight or obesity, using digital tools for self-monitoring in a 24-month behavioral weight loss program aimed at achieving and maintaining a 10% weight loss.

It will explore the effectiveness of different data sharing partnerships (with coaches, group members, and friends/family) on long-term weight loss, potentially revealing how these interactions can enhance weight loss outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sharing digital self-monitoring data with others to enhance long-term weight loss: A randomized controlled trial. Miller, NA., Ehmann, MM., Hagerman, CJ., et al.[2023]

Technology-based interventions for weight loss, particularly those incorporating multiple key components like self-monitoring and counselor feedback, can lead to significant weight loss compared to standard care, as shown in 13 out of 27 reviewed trials.

However, there is currently no evidence that these interventions improve quality of life, and more research is needed to determine the best ways to use technology effectively in weight loss programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-based interventions in the treatment of overweight and obesity: A systematic review. Raaijmakers, LC., Pouwels, S., Berghuis, KA., et al.[2022]

Citations

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Behavioral Lifestyle Interventions for Moderate and Severe ... Among the 25 behavioral interventions in the 12 studies, 18 reported percent of participants achieving clinically significant weight loss up to 12 months (32–97 ...

2. cdc.gov cdc.gov/pcd/issues/2024/23_0347.htm

Weight Loss in Short-Term Interventions for Physical ... Short-term multicomponent interventions involving physical activity and nutrition can achieve weight loss for adults with overweight or obesity.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2212267215002592

Lifestyle Weight-Loss Intervention Outcomes in Overweight ... The majority of lifestyle weight-loss interventions in overweight or obese adults with type 2 diabetes resulted in weight loss <5% and did not result in ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3082279/

Effects of Diet and Physical Activity Interventions on Weight ... In conclusion, intensive lifestyle interventions using a behavior-based approach can result in clinically significant and meaningful weight loss and ...

5. nyaspubs.onlinelibrary.wiley.com nyaspubs.onlinelibrary.wiley.com/doi/full/10.1111/nyas.15278

Behavior‐change lifestyle interventions for the treatment of ... Most behavior-change lifestyle interventions had moderate effects in reducing obesity outcomes (e.g., body weight, BMI, and BMI z-score). The ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016508517301397

Intensive Lifestyle Intervention for Obesity The Guidelines recommend a minimum of 6 months of high-intensity, comprehensive lifestyle intervention, consisting of a reduced-calorie diet, increased physical ...

7. diabetesjournals.org diabetesjournals.org/care/article/48/Supplement_1/S167/157555/8-Obesity-and-Weight-Management-for-the-Prevention

8. Obesity and Weight Management for the Prevention and ... Approximately half of intensive lifestyle intervention participants lost and maintained ≥5% of their initial body weight (44). Tailoring ...