Behavioral Intervention + Technology for Weight Loss
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Chicago
Must not be taking: Sleep aids, Weight loss drugs
Disqualifiers: Diabetes, Heart disease, Cancer, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Obesity and cardiometabolic risks are significant public health issues, with about two-thirds of U.S. adults overweight or obese. Weight loss can prevent these health problems, but current lifestyle interventions have limited success. New, effective strategies are needed to address this rising issue at the population level. The goal of this clinical trial is to investigate how a behavioral intervention combined with technology impacts weight loss in young adults. The main questions it aims to answer are:
• How does the combination of behavioral intervention and technology influence weight loss in young adults?
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 data supports the effectiveness of the treatment Behavioral Intervention + Technology for Weight Loss?
Research shows that digital behavior change interventions, which include logging meals and reading articles, are linked to successful weight loss. Additionally, lifestyle changes like diet and exercise can lead to significant health improvements, such as reducing the risk of type II diabetes by 58% with a 7% weight loss.
12345Is the Behavioral Intervention + Technology for Weight Loss safe for humans?
The research articles reviewed do not provide specific safety data for the Behavioral Intervention + Technology for Weight Loss, but digital behavior change interventions are generally considered safe as they focus on self-monitoring and lifestyle changes like diet and exercise.
23678How is the Behavioral Intervention + Technology for Weight Loss treatment different from other weight loss treatments?
This treatment is unique because it combines traditional behavioral weight loss methods with digital technology, such as energy monitoring devices and online platforms, to enhance weight loss and improve retention rates. The integration of technology allows for personalized feedback and support, making it more effective than standard in-person interventions alone.
39101112Eligibility Criteria
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.
I am between 18 and 40 years old.
My weight has been stable, with no change over 25 lbs in the last 3 months.
+1 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Lifestyle Intervention IIExperimental Treatment2 Interventions
Diet and exercise coaching
Group II: Lifestyle InterventionExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of ChicagoChicago, IL
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Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor
Northwestern UniversityCollaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
What Intervention Elements Drive Weight Loss in Blended-Care Behavior Change Interventions? A Real-World Data Analysis with 25,706 Patients. [2022]Blended-care behavior change interventions (BBCI) are a combination of digital care and coaching by health care professionals (HCP), which are proven effective for weight loss. However, it remains unclear what specific elements of BBCI drive weight loss.
The Relationship Between Weight Loss Outcomes and Engagement in a Mobile Behavioral Change Intervention: Retrospective Analysis. [2022]There is large variance in weight loss outcomes of digital behavior change interventions (DBCIs). It has been suggested that different patterns of engagement in the program could be responsible for this variance in outcomes. Previous studies have found that the amount of engagement on DBCIs, such as the number of meals logged or articles read, is positively associated with weight loss.
Combining Persuasive System Design Principles and Behavior Change Techniques in Digital Interventions Supporting Long-term Weight Loss Maintenance: Design and Development of eCHANGE. [2022]Long-term weight maintenance after weight loss is challenging, and innovative solutions are required. Digital technologies can support behavior change and, therefore, have the potential to be an effective tool for weight loss maintenance. However, to create meaningful and effective digital behavior change interventions that support end user values and needs, a combination of persuasive system design (PSD) principles and behavior change techniques (BCTs) might be needed.
Lifestyle modification in the treatment of obesity: an educational challenge and opportunity. [2007]As many as two-thirds of adults in developed nations are overweight (body mass index (BMI)=25.0-29.9 kg/m2) or obese (BMI>or=30 kg/m2), and many of these individuals suffer from weight-related comorbidities such as hypertension, hyperlipidemia, and type II diabetes. On a more positive note, recent studies have demonstrated that losses as small as 5-10% of initial weight can improve these health complications. For example, the Diabetes Prevention Program demonstrated that a 7% reduction in initial weight, coupled with 150 min/week of physical activity, reduced the risk of developing type II diabetes by 58% compared with placebo. Behavioral treatment consistently induces weight losses in this range. This paper describes the behavioral treatment of obesity, including its short- and long-term results as well as approaches for improving the maintenance of lost weight. The terms "behavioral treatment," "lifestyle modification," and "behavioral weight control" are often used interchangeably, as they are in this paper. Lifestyle modification includes three principal components: diet, physical activity, and behavior therapy. The latter term, as applied to weight control, refers to a set of principles and techniques to help patients adopt new diet and exercise habits that can be sustained long term to promote health.
Binge eating predicts adherence to digital self-monitoring during behavioral weight loss. [2021]Consistent self-monitoring of dietary intake, weight, and physical activity predicts better outcomes during behavioral weight loss, but the factors that influence self-monitoring adherence are not well understood. This study attempted to fill gaps in the existing literature by examining whether pre-treatment eating behaviors predict adherence to digital self-monitoring during a behavioral weight loss program.
Use of a computerized tracking system to monitor and provide feedback on dietary goals for calorie-restricted diets: the POUNDS LOST study. [2021]The use of self-monitoring as a tool to facilitate behavioral modification is common in many lifestyle-based weight loss interventions. Electronic tracking programs, including computer-based systems and smart phone applications, have been developed to allow individuals to self-monitor their behavior digitally. These programs offer an advantage over traditional self-report modalities in that they can provide users with direct feedback about dietary and/or physical activity adherence levels and thereby assist them in real-time decision making. This article describes the use of an Internet-based computerized tracking system (CTS) that was developed specifically for the POUNDS LOST study, a 2-year randomized controlled trial designed to test the efficacy of four macronutrient diets for weight and fat reduction in healthy, overweight men and women (body mass index range = 25.0-39.9 kg/m(2)). The CTS served many functions in this study, including data collection, dietary and exercise assessment and feedback, messaging system, and report generation. Across all groups, participants with high usage of the CTS during the initial 8 weeks lost greater amounts of weight than participants with low usage (8.7% versus 5.5% of initial body weight, respectively; p
Sharing digital self-monitoring data with others to enhance long-term weight loss: A randomized controlled trial. [2023]Participants in behavioral weight loss (BWL) programs increasingly use digital tools to self-monitor weight, physical activity, and dietary intake. Data collected with these tools can be systematically shared with other parties in ways that might support behavior change.
Theory-based digital intervention to promote weight loss and weight loss maintenance (Choosing Health): protocol for a randomised controlled trial. [2021]Label="INTRODUCTION">Digital behavioural weight loss interventions have the potential to improve public health; however, these interventions are often not adequately tailored to the needs of the participants. This is the protocol for a trial that aims to determine the effectiveness and cost-effectiveness of the Choosing Health programme as a means to promote weight loss and weight loss maintenance among overweight/obese adults.
The comparison of a technology-based system and an in-person behavioral weight loss intervention. [2021]The purpose of this study was to compare a technology-based system, an in-person behavioral weight loss intervention, and a combination of both over a 6-month period in overweight adults. Fifty-one subjects (age: 44.2 ± 8.7 years, BMI: 33.7 ± 3.6 kg/m(2)) participated in a 6-month behavioral weight loss program and were randomized to one of three groups: standard behavioral weight loss (SBWL), SBWL plus technology-based system (SBWL+TECH), or technology-based system only (TECH). All groups reduced caloric intake and progressively increased moderate intensity physical activity. SBWL and SBWL+TECH attended weekly meetings. SBWL+TECH also received a TECH that included an energy monitoring armband and website to monitor energy intake and expenditure. TECH used the technology system and received monthly telephone calls. Body weight and physical activity were assessed at 0 and 6 months. Retention at 6 months was significantly different (P = 0.005) between groups (SBWL: 53%, SBWL+TECH: 100%, and TECH: 77%). Intent-to-treat (ITT) analysis revealed significant weight losses at 6 months in SBWL+TECH (-8.8 ± 5.0 kg, -8.7 ± 4.7%), SBWL (-3.7 ± 5.7 kg, -4.1 ± 6.3%), and TECH (-5.8 ± 6.6 kg, -6.3 ± 7.1%) (P
An Evaluation of a Personalized Multicomponent Commercial Digital Weight Management Program: Single-Arm Behavioral Trial. [2023]Digital behavioral weight loss programs are scalable and effective, and they provide an opportunity to personalize intervention components. However, more research is needed to test the acceptability and efficacy of personalized digital behavioral weight loss interventions.
Technology-based interventions in the treatment of overweight and obesity: A systematic review. [2022]The prevalence of obesity increases worldwide. The use of technology-based interventions can be beneficial in weight loss interventions. This review aims to provide insight in the effectiveness of technology-based interventions on weight loss and quality of life for patients suffering overweight or obesity compared to standard care. Pubmed, PsycInfo, Web of Science, ScienceDirect, CINAHL and Embase were searched from the earliest date (of each database) up to February 2015. Interventions needed to be aimed at reducing or maintaining weight loss in persons with a body mass index (BMI) ≥ 25 kg/m(2) and have a technology aspect. Cochrane Collaboration's tool for assessing risk of bias was used for rating the methodological quality. Twenty-seven trials met inclusion criteria. Thirteen studies showed significant effects on weight loss compared to controls. Most interventions used a web-based approach (42%). Interventions were screened for five technical key components: self-monitoring, counsellor feedback and communication, group support, use of a structured program and use of an individually tailored program. All interventions that used a combination of all five or four components showed significant decreases in weight compared to controls. No significant results for quality of life were found. Outcomes on program adherence were reported in six studies. No significant results were found between weight loss and program adherence. Evidence is lacking about the optimal use of technology in weight loss interventions. However, when the optimal combination of technological components is found, technology-based interventions may be a valid tool for weight loss. Furthermore, more outcomes on quality of life and information about the effect of technology-based intervention after bariatric surgery are needed.
Evaluation of intervention components to maximize outcomes of behavioral obesity treatment delivered online: A factorial experiment following the multiphase optimization strategy framework. [2022]Behavioral lifestyle intervention (BLI) is recommended as a first-line treatment for obesity. While BLI has been adapted for online delivery to improve potential for dissemination while reducing costs and barriers to access, weight losses are typically inferior to gold standard treatment delivered in-person. It is therefore important to refine and optimize online BLI in order to improve the proportion of individuals who achieve a minimum clinically significant weight loss and mean weight loss.