Behavioral Weight Loss Program for Obesity

Overseen By Rebecca J Crochiere, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Williams College

Disqualifiers: Pregnancy, Eating disorders, Recent medication change, others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

100 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 if you've recently changed a weight-influencing medication in the last 3 months, you may not be eligible to participate.

What data supports the effectiveness of the treatment Behavioral weight loss program for obesity?

Research shows that behavioral weight loss programs help people lose weight and keep it off, which can improve health and reduce the risk of diseases like diabetes and heart disease. These programs often include diet changes, exercise, and behavior modification, and are recommended as a first-line treatment for obesity. ^{1 2 3 4 5}

Is the Behavioral Weight Loss Program safe for humans?

Behavioral weight loss programs are generally considered safe for humans, as they focus on lifestyle changes like diet and exercise. A study on a community-based program showed participants had sustained weight loss and improvements in health measures without significant adverse effects. ^{6 7 8 9 10}

How does the Behavioral Weight Loss Program treatment for obesity differ from other treatments?

The Behavioral Weight Loss Program is unique because it focuses on changing not just eating habits but also exercise, attitudes, and social relationships, making it a comprehensive approach. It emphasizes self-monitoring and environmental changes to help maintain weight loss, which is often a challenge with other treatments. ^{5 11 12 13 14}

What is the purpose of this trial?

This trial aims to help overweight or obese adults stick to their diet and exercise plans by using smartphone surveys and wearable devices to provide real-time support. The goal is to reduce moments when people are likely to break their routines, improving their chances of successful weight loss.

Research Team

Rebecca J Crochiere, PhD

Principal Investigator

Williams College

Eligibility Criteria

This trial is for adults aged 18-65 in the U.S. with a BMI of 27-50, who own a smartphone with data and can understand English. It's not for those in other weight loss programs, pregnant or planning to be, recently changed weight-related meds, have certain medical/psychiatric risks or eating disorders.

Inclusion Criteria

You possess linguistic aptitude in English, including the ability to comprehend and communicate verbally as well as legibly.

My BMI is between 27 and 50.

You reside in the United States.

Exclusion Criteria

I've changed my medication that affects my weight in the last 3 months.

You have a medical or mental health condition that could be risky for you during the program, affect your weight, eating habits, or ability to follow the program.

You have difficulties controlling how much food you eat or struggle with eating disorders.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a behavioral weight loss intervention using ecological momentary assessments and sensor technology to monitor dietary and physical activity lapses

12 weeks

EMA surveys delivered in 2-week bursts at the beginning, middle, and end of treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Behavioral weight loss program

Trial Overview The study tests how technology like smartphones and Fitbit can track real-time risk factors that lead to lapses during weight loss efforts. The goal is to develop personalized interventions that provide immediate support to prevent these lapses.

Participant Groups

Group I: Behavioral Weight Loss Intervention Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Williams College

Lead Sponsor

Trials

2

Recruited

470+

Temple University

Collaborator

Trials

321

Recruited

89,100+

Findings from Research

Participants who followed a 12-month clustered campaign treatment schedule regained significantly less weight (0.35 kg) compared to those in a self-directed program (2.40 kg), indicating that structured support can help maintain weight loss after an initial treatment.

The clustered campaign approach allowed participants to maintain 87% of their weight loss, while those in the self-directed group maintained only 64%, highlighting the effectiveness of group-based support in preventing weight regain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of an alternative schedule of extended care contacts to a self-directed control: a randomized trial of weight loss maintenance. Dutton, GR., Gowey, MA., Tan, F., et al.[2021]

Obesity is a significant public health issue that increases the risk of serious health conditions like type 2 diabetes, hypertension, and heart disease, highlighting the importance of effective weight management.

A successful weight loss program should be personalized and may include dietary changes, physical activity, behavior modification, and, for some patients, medications or surgery to ensure safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe and effective management of the obese patient. Collazo-Clavell, ML.[2022]

A behavioral approach to treating obesity, guided by the nursing process, has been shown to effectively help clients lose weight and maintain their weight loss in outpatient settings.

Key components of this approach include assessing motivation and behaviors, creating realistic treatment plans, and using intervention techniques like stimulus control and problem solving, all of which are crucial for successful weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral intervention for the obese client. White, JH.[2019]

In a study of 236 participants from the POWER Hopkins Trial, individual telephone sessions, online weight tracking, and coach reviews were rated as the most helpful components of a behavioral weight loss program, indicating their effectiveness in supporting weight loss efforts.

Demographic factors influenced perceptions of helpfulness, with older adults, Black participants, and those with lower education levels finding the intervention components more beneficial, suggesting the need for tailored approaches in weight loss programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived helpfulness of the individual components of a behavioural weight loss program: results from the Hopkins POWER Trial. Dalcin, AT., Jerome, GJ., Fitzpatrick, SL., et al.[2021]

In a study of 95,251 adults undergoing bariatric surgery, Roux-en-Y gastric bypass (RYGB) had the highest rate of 30-day adverse events (3.8%) compared to adjustable gastric banding (AGB) and sleeve gastrectomy (SG), which had rates of 3.1% and 2.8%, respectively.

RYGB also showed higher hospitalization rates and mortality compared to AGB and SG, indicating that while RYGB may be effective, it carries more immediate and long-term risks than the other procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions and Operations after Bariatric Surgery in a Health Plan Research Network Cohort from the PCORnet, the National Patient-Centered Clinical Research Network. Ma, Q., Shambhu, S., Arterburn, DE., et al.[2021]

Several commercial weight loss programs, including the National Diabetes Prevention Program, WW, Jenny Craig, Medifast, and OPTIFAST, have shown effective and safe 12-month weight loss results, aligning with evidence-based recommendations.

Clinicians are encouraged to refer patients to these programs based on peer-reviewed evidence, while also considering patient preferences and costs, as some other programs still require more evidence for safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commercial Weight Loss Programs in the Management of Obesity: an Update. Laudenslager, M., Chaudhry, ZW., Rajagopal, S., et al.[2022]

A community-based weight-loss treatment program involving 90 participants led to significant weight loss and sustained health improvements, including reductions in waist circumference and cholesterol levels, over an 18-month period.

Participants maintained their weight loss without significant regain at follow-ups, demonstrating the effectiveness of the program in promoting long-term behavioral and psychological benefits for overweight and obese adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based behavioral weight-loss treatment: long-term maintenance of weight loss, physiological, and psychological outcomes. Latner, JD., Ciao, AC., Wendicke, AU., et al.[2013]

A total of 25 anti-obesity medications were withdrawn between 1964 and 2009, primarily due to adverse reactions related to their effects on monoamine neurotransmitters, with 80% of withdrawals supported by case reports.

The most common reasons for withdrawal included psychiatric disturbances, cardiotoxicity, and drug dependence, raising concerns about the safety of using medications that target neurotransmitters for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-marketing withdrawal of anti-obesity medicinal products because of adverse drug reactions: a systematic review. Onakpoya, IJ., Heneghan, CJ., Aronson, JK.[2022]

Comprehensive behavioral weight loss programs have evolved to include systematic work on various factors such as eating behavior, exercise, attitudes, and social relationships, leading to significant weight losses of 25 to 30 pounds.

The most notable strength of these behavioral programs is their effectiveness in maintaining weight loss over time, which is crucial for long-term success in obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral management of obesity. Brownell, KD., Kramer, FM.[2019]

A comprehensive weight-loss program that included changes to the home environment led to better weight loss results at 6 months compared to a standard behavioral weight-loss program, particularly benefiting women.

However, by 18 months, both groups showed similar weight regain, indicating that while initial environmental changes can enhance weight loss, they may not lead to long-term maintenance of weight loss, highlighting the need for further research on sustained strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a comprehensive home environment-focused weight-loss program for adults. Gorin, AA., Raynor, HA., Fava, J., et al.[2022]

Behavioral therapy is a key part of obesity treatment, focusing on self-monitoring and various techniques like stimulus control and cognitive restructuring, but most patients tend to regain weight over time, highlighting the need for long-term strategies.

To improve long-term success, behavioral therapy can be supplemented with other treatments like very-low-calorie diets or medications, and it's important to tailor approaches to individual needs, especially for subgroups like those with binge eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of behavioral therapy in the management of obesity. Yanovski, SZ., Devlin, MJ.[2021]

References

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Obesity-related health status changes and weight-loss treatment utilization. [2014]

2. England pubmed.ncbi.nlm.nih.gov

Comparison of an alternative schedule of extended care contacts to a self-directed control: a randomized trial of weight loss maintenance. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Safe and effective management of the obese patient. [2022]

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

Behavioral intervention for the obese client. [2019]

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

Perceived helpfulness of the individual components of a behavioural weight loss program: results from the Hopkins POWER Trial. [2021]

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

Interventions and Operations after Bariatric Surgery in a Health Plan Research Network Cohort from the PCORnet, the National Patient-Centered Clinical Research Network. [2021]

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

Long-Term Effect of Weight Regain Following Behavioral Weight Management Programs on Cardiometabolic Disease Incidence and Risk: Systematic Review and Meta-Analysis. [2023]

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

Commercial Weight Loss Programs in the Management of Obesity: an Update. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Community-based behavioral weight-loss treatment: long-term maintenance of weight loss, physiological, and psychological outcomes. [2013]

10. England pubmed.ncbi.nlm.nih.gov

Post-marketing withdrawal of anti-obesity medicinal products because of adverse drug reactions: a systematic review. [2022]

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Randomized controlled trial of a comprehensive home environment-focused weight-loss program for adults. [2022]

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

Role of behavioral therapy in the management of obesity. [2021]