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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why people with obesity sometimes struggle to stick with diet and exercise plans. Researchers will use smartphone surveys and fitness trackers to monitor what causes these slip-ups in real time. The ultimate goal is to develop a personalized support system that helps individuals stay on track with their weight loss goals through a behavioral weight loss program. Individuals with a BMI between 27 and 50, who own a smartphone, and live in the United States might be a good fit. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to more effective weight loss 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 if you've recently changed a weight-influencing medication in the last 3 months, you may not be eligible to participate.

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

Research shows that weight loss programs focusing on lifestyle changes, such as healthy eating and exercise, are generally safe. These programs do not involve medication or surgery. Studies have found that they help people lose weight and improve health, including heart health, without causing major side effects. Some participants might feel tired or notice mood changes, but these issues are usually minor and temporary. Overall, many have used these programs safely and found them well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard obesity treatments that often involve medication or surgery, the behavioral weight loss program focuses on lifestyle and habit changes to promote weight loss. Researchers are excited about this approach because it empowers individuals to make sustainable changes through personalized strategies, which can lead to long-term success without the need for invasive procedures. This method emphasizes understanding and modifying behaviors related to eating and physical activity, potentially leading to better overall health and well-being.

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

Research has shown that programs focused on changing behavior can help people lose weight. One study found that participants in a detailed program lost about 8–10 kg, approximately 8–10% of their starting weight. About 80% of these participants maintained some weight loss over time. Another study found that these programs improve eating habits, such as reducing overeating and cravings. The U.S. Preventive Services Task Force reported that these programs offer moderate benefits for maintaining weight loss. Overall, these methods improve eating habits and support long-term weight management. ^{6 7 8 9 10}

Who Is on the Research Team?

Rebecca J Crochiere, PhD

Principal Investigator

Williams College

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11884964/

The impact of behavioral weight management interventions on ... We found evidence to suggest that interventions improved uncontrolled eating, external eating, susceptibility to hunger, restraint and intuitive eating at ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.123.009965

Long-Term Outcomes Following Behavioral Weight ... First, the results describe an aggregate effect of BWMP, which is challenging to interpret given the wide range of interventions offered—from ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3233993/

Behavioral Treatment of Obesity - PMC Participants treated with a comprehensive behavioral approach lose approximately 8–10 kg, equal to 8–10% of initial weight. Approximately 80% of patients who ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2212267214010557

Diet or Exercise Interventions vs Combined Behavioral ... Pooled results showed no significant difference in weight loss from baseline or at 3 to 6 months between the BWMPs and diet-only arms (–0.62 kg; 95% CI –1.67 to ...

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2702878

Behavioral Weight Loss Interventions to Prevent Obesity ... The USPSTF found adequate evidence that behavior-based weight loss maintenance interventions are of moderate benefit. The USPSTF found adequate ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5503454/

Behavioral Lifestyle Interventions for Moderate and Severe ... The cognitive-behavioral program achieved a significantly greater percent weight loss than the education program at six months (5.6% vs. 2.8%, P =0.016). Modest ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10487370/

Long-Term Outcomes Following Behavioral Weight ... Overall, the study found evidence that BWMP improved cardiometabolic risk factors except for glycemic control out to 5 years, though weight regain reduced these ...

8. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00599-6/fulltext

Safety and effects of anti-obesity medications on weight ... Primary outcomes included changes in body weight, cardiometabolic indicators, psychological outcomes, and adverse events. Summary data was ...

9. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2702877

Behavioral and Pharmacotherapy Weight Loss ... Health outcomes were infrequently reported in the behavior-based weight loss and maintenance trials (20 trials [n = 9910]). In 4 weight loss ...

10. mhealth.jmir.org mhealth.jmir.org/2019/10/e12612/

Assessment of the Efficacy, Safety, and Effectiveness of ... Our results show that researchers use the following primary end points to measure a study's success: (1) reduction in weight and/or BMI; (2) ...