Behavioral Interventions for Weight Loss

Overseen By Sharon O'Toole, M.A.T.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: The Miriam Hospital

Must not be taking: Weight loss medication

Disqualifiers: Heart condition, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people maintain weight loss using smartphone technology and behavioral strategies. Participants will receive a 6-month behavioral obesity treatment to lose weight. Those who lose at least 3% of their starting weight will undergo a year of monitoring through daily smartphone surveys to identify and address risks for weight gain. Known as Control Systems Engineering for Weight Loss Maintenance, this approach suits English speakers who can walk two city blocks without stopping, have a BMI between 25 and 50, and own a smartphone. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to innovative weight loss maintenance strategies.

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 medication.

What prior data suggests that this behavioral intervention is safe for weight loss?

Research shows that using technology to aid weight loss is generally safe and well-received. Studies have found that computer-based tools, such as apps or programs, can assist with losing weight and maintaining it without major safety issues. These tools often track habits and provide feedback.

Participants who used technology alongside regular weight loss programs experienced better short-term results. No serious side effects were reported in these studies, suggesting that this approach is safe for most people. However, discussing any concerns with a healthcare provider before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for weight loss, which often focus on dietary changes, exercise, or medication, the investigational approach in this trial uses control systems engineering for weight loss maintenance. This method involves a unique "system identification" experiment, where participants who lose at least 3% of their initial body weight engage in daily monitoring to better understand their physiological responses over a year. Researchers are excited about this because it could provide personalized strategies to maintain weight loss, potentially offering a more sustainable solution compared to traditional methods.

What evidence suggests that this behavioral intervention is effective for weight loss?

Studies have shown that technology in weight loss programs can help people maintain weight loss. For example, over 36% of participants using a mobile technology system lost at least 5% of their starting weight, while none in a regular care group did. Research also shows that online programs can help prevent weight gain after losing weight. In this trial, participants will engage in a system identification experiment, which uses behavior data to help maintain weight loss. This method predicts when someone might regain weight and addresses those risks, offering a promising tool for long-term success. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who are obese and have successfully lost at least 3% of their initial body weight. Participants should be willing to use a smartphone daily for surveys and passive sensing over a period of 12 months.

Inclusion Criteria

Owns a smartphone

Body mass index (BMI) between 25 and 50 kg/m-squared

I can walk 2 city blocks without needing to stop.

Exclusion Criteria

Has been pregnant within the 6 months prior to enrolling

Plans to become pregnant within 18 months of enrolling

I have had heart issues, chest pain, or fainting in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

A 6-month behavioral obesity treatment is administered to produce weight loss

24 weeks

System Identification Experiment

Participants who lose at least 3% of initial body weight are followed for 12 months with daily smartphone surveys and passive sensing to monitor behaviors

52 weeks

Daily smartphone surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Control Systems Engineering for Weight Loss Maintenance

Trial Overview The study tests interventions aimed at maintaining weight loss by focusing on physical activity, sleep, stress, emotion regulation, motivation, self-efficacy, and eating habits. It uses control systems engineering to predict when someone might regain weight.

How Is the Trial Designed?

Group I: System Identification Experimental Treatment 4 Interventions

All participants who lose at least 3% of their initial body weight will be asked to participate in a system identification experiment every day for 52 weeks.

Who Is Running the Clinical Trial?

The Miriam Hospital

Lead Sponsor

Trials

252

Recruited

39,200+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a study of 501 overweight and obese adults, regular attendance in lifestyle intervention sessions led to better self-monitoring of diet and exercise, which contributed to weight loss.

Specifically, participants who attended more sessions reduced their fat intake and increased self-monitoring, both of which were linked to significant weight loss over a 6-month period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining behavioral processes through which lifestyle interventions promote weight loss: results from PREMIER. Fitzpatrick, SL., Bandeen-Roche, K., Stevens, VJ., et al.[2022]

The BestFIT study is designed to evaluate the effectiveness of two adaptive interventions for individuals struggling with weight loss: using portion-controlled meals to reduce self-regulation demands and switching to acceptance-based treatment to enhance self-regulation skills.

This research aims to determine the optimal timing for these interventions, potentially leading to a more personalized approach to weight loss that could improve outcomes for those who do not respond well to standard programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The BestFIT trial: A SMART approach to developing individualized weight loss treatments. Sherwood, NE., Butryn, ML., Forman, EM., et al.[2022]

Combining diet therapy, exercise, and behavioral therapy is essential for effective weight reduction and long-term maintenance in obese patients, as these methods help correct energy balance.

Specific behavioral strategies like self-monitoring and stress management are crucial for sustaining weight loss, with daily weight charting being particularly effective for reinforcing these changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Behavioral therapy for obesity]. Yoshimatsu, H.[2011]

Obesity rates in adults and children have nearly doubled in the past 30 years, leading to serious health issues like cardiovascular disease and Type 2 diabetes, which are increasingly affecting younger populations.

The article discusses traditional behavioral weight loss strategies and suggests that incorporating insights from behavioral economics and cognitive processing could enhance the effectiveness of these interventions for weight loss and maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral interventions for obesity in children and adults: Evidence base, novel approaches, and translation into practice. Wilfley, DE., Hayes, JF., Balantekin, KN., et al.[2023]

Patients with obesity often have unrealistic expectations about weight loss, so it's important to help them accept moderate weight losses as successful outcomes.

Long-term behavioral change requires ongoing support and training for over a year, emphasizing flexible eating habits rather than strict control, and involving multiple behavioral dimensions to enhance success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The therapeutic challenge: behavioral changes for long-term weight maintenance. Westenhoefer, J.[2014]

Obesity results from a complex imbalance between energy intake and expenditure, regulated by three interconnected control systems: homeostatic, hedonic, and cognitive.

To better understand and address obesity, future research should focus on integrating these systems into dynamic models, as current approaches are often fragmented and lack comprehensive interaction analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic interplay among homeostatic, hedonic, and cognitive feedback circuits regulating body weight. Hall, KD., Hammond, RA., Rahmandad, H.[2022]

A new personalized and dynamic approach to obesity management was developed through a five-year integrative coaching program, involving collaboration among various health professionals and experts in systems thinking.

The program utilized a systems health model to identify key factors influencing obesity and incorporated participant subtyping based on traditional Chinese medicine, allowing for tailored interventions that adapt to individual needs and goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Personalized Integrative Obesity-Coaching Program: A Systems Health Perspective. Brink, SM., Wortelboer, HM., Emmelot, CH., et al.[2022]

Participants who identified negative emotional situations as the most challenging were significantly more likely to experience dietary lapses, with 87% of them lapsing during such situations.

Those who generated more coping strategies for high-risk scenarios at the start of the program tended to lose more weight, indicating that preparation and response strategies can enhance the effectiveness of behavioral weight control programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responses to hypothetical high risk situations: do they predict weight loss in a behavioral treatment program or the context of dietary lapses? Drapkin, RG., Wing, RR., Shiffman, S.[2019]

The Healthy Mom Zone (HMZ) intervention uses a Hybrid Model Predictive Control (HMPC) system to create personalized weight management strategies for pregnant women with overweight or obesity, aiming to address excessive gestational weight gain.

Simulations show that the HMPC framework can optimize complex interventions more effectively than traditional methods, allowing for tailored dosages and strategies based on individual needs, which could lead to better health outcomes for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing Behavioral Interventions to Regulate Gestational Weight Gain With Sequential Decision Policies Using Hybrid Model Predictive Control. Guo, P., Rivera, DE., Dong, Y., et al.[2023]

A study involving 10 adults over 16 weeks showed that personalized text message interventions can effectively influence physical activity and sedentary behavior, with responses varying based on the type of message and individual differences.

The use of control systems engineering to model these responses suggests a promising approach for creating tailored interventions that optimize physical activity behaviors in real-time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized models of physical activity responses to text message micro-interventions: A proof-of-concept application of control systems engineering methods. Conroy, DE., Hojjatinia, S., Lagoa, CM., et al.[2022]

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]

The study aims to investigate dietary lapses in behavioral obesity treatment (BOT) using a multi-method approach, involving 40 participants over a 24-week period, to better understand how these lapses affect weight loss outcomes.

Preliminary data from pilot participants indicate that combining ecological momentary assessment (EMA) with continuous monitoring of eating behavior through wearable devices can provide valuable insights into dietary lapses, which may help develop more effective interventions for individuals struggling with weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining ecological momentary assessment, wrist-based eating detection, and dietary assessment to characterize dietary lapse: A multi-method study protocol. Goldstein, SP., Hoover, A., Evans, EW., et al.[2022]

Conventional weight loss interventions often lead to relapse over time, suggesting that they may not provide sufficient practice in new skills across various community contexts for sustainable weight loss.

Using computer simulation models, the study estimates a potential 12.9% decrease in child percent overweight over 30 months with a novel socio-environmental treatment approach, indicating promise for future large-scale trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of biosimulation in the design of a novel multilevel weight loss maintenance program for overweight children. Wilfley, DE., Van Buren, DJ., Theim, KR., et al.[2021]

In a study of 36 participants who completed a 10-week behavioral weight control program, most individuals regained a significant amount of weight, averaging 11.94 pounds, and were, on average, heavier than their starting weight after 5 years.

Low adherence to the treatment program after it ended was common, but those who consistently used more program techniques and for longer periods experienced less weight regain, highlighting the importance of ongoing commitment to weight management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do behavioral treatments of obesity last? A five-year follow-up investigation. Stalonas, PM., Perri, MG., Kerzner, AB.[2019]

The article explores the application of control systems engineering techniques to improve physical activity interventions, suggesting that these methods can refine our understanding of how to encourage physical activity.

The authors propose that personalized, adaptive interventions based on individual behavior patterns will be more effective in increasing physical activity levels compared to traditional, one-size-fits-all approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engineering Person-Specific Behavioral Interventions to Promote Physical Activity. Conroy, DE., Lagoa, CM., Hekler, E., et al.[2022]

Citations

1. ctv.veeva.com ctv.veeva.com/study/control-systems-engineering-for-weight-loss-maintenance

Control Systems Engineering for Weight Loss Maintenance A 6-month behavioral obesity treatment will be administered to produce weight loss. Participants losing at least 3% of initial body weight will ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3996838/

Interactive computer‐based interventions for weight loss or ... To assess the effects of interactive computer‐based interventions for weight loss or weight maintenance in overweight or obese people.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3684245/

Integrating Technology into Standard Weight Loss Treatment More than 36% of participants utilizing the mobile technology system and coaching, compared to 0% in the Standard of care condition, lost at least 5% of initial ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2839206

Adaptive vs Monthly Support for Weight-Loss Maintenance Findings Results of this randomized clinical trial with 255 participants demonstrated no difference in weight regain from month 4 to 24 in ...

5. mdpi.com mdpi.com/2076-328X/7/4/76

Efficacy of Web-Based Weight Loss Maintenance Programs In conclusion, a web-based WLM program was effective in preventing weight regain over one year following weight loss. However, the addition of personalized e- ...

6. researchgate.net researchgate.net/publication/318383679_Control_Systems_Engineering_for_Optimizing_Behavioral_mHealth_Interventions

Control Systems Engineering for Optimizing Behavioral ... Control systems engineering is a broad-based field that examines how system variables can be adjusted over time to improve important process outcomes.

7. mdpi.com mdpi.com/2072-6643/14/6/1259

Weight Maintenance after Dietary Weight Loss: Systematic ... This systematic review and meta-analysis aims to explore whether patients undergoing intensive intervention during the maintenance phase have a greater ...