Daily Self-Weighing for Obesity Management

(SWOP Trial)

Overseen By Gareth R Dutton, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Weight loss medications

Disqualifiers: Pregnancy, Bariatric surgery, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

396 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Many adults with obesity continue to gain weight even though they do not want to. This project will test the effects of a primary care intervention in which people with obesity receive an electronic scale and recommendations to weigh themselves daily. This will help us understand whether daily self-weighing might be a way to prevent continued weight gain.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on prescription weight loss medications, you must not have taken them in the past 6 months to be eligible.

Is daily self-weighing for obesity management safe for humans?

The safety of daily self-weighing itself is not directly addressed in the research, but varenicline, a medication sometimes used in related contexts, has been associated with some risks, including nausea, cardiovascular events, and neuropsychiatric symptoms like depression and suicidal thoughts. It's important to consult with a healthcare provider to understand the safety of any treatment. ^{1 2 3 4 5}

How does daily self-weighing differ from other treatments for obesity management?

Daily self-weighing is unique because it involves regularly checking your weight using a digital scale to help manage obesity, rather than relying on medication or other interventions. This approach focuses on self-monitoring and behavior change, making it a potentially scalable and cost-effective way to prevent age-related weight gain. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Daily Self-Weighing, Standard Care, Varenicline, Chantix, Apovarenicline, Champix, Nocrav for obesity management?

Research shows that varenicline is effective for smoking cessation, and when combined with lorcaserin, it may help prevent weight gain after quitting smoking. While not directly related to obesity management, this suggests potential benefits in weight control. ^{11 12 13 14 15}

Are You a Good Fit for This Trial?

This trial is for adults aged 19-65 with obesity (BMI of 30-50) who are patients at participating clinics, live in one place most of the week, and have a smartphone with internet. It's not for those planning to move soon, who've lost significant weight recently or taken weight loss drugs, had bariatric surgery within two years, are pregnant or might become so during the study.

Inclusion Criteria

I am between 19 and 65 years old.

Receives care at one of the participating primary care clinics

You have a body mass index (BMI) between 30 and 50, which means you may be overweight or obese.

Exclusion Criteria

Current participation in another weight loss study

Potential participants living farther than 50 miles driving distance from UAB will be excluded from the study. It is expected that those living farther away will be more difficult to retain as study participants.

Unwilling or unable to do any of the following: give informed consent, accept random assignment, attend five measurement assessments

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an electronic scale and recommendations to weigh themselves daily

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Daily Self-Weighing
• Standard Care

Trial Overview The trial tests if daily self-weighing using an electronic scale can help manage obesity in primary care settings. Participants will either receive standard care or be asked to weigh themselves every day to see if this prevents further weight gain.

How Is the Trial Designed?

Group I: Daily Self-Weighing Experimental Treatment 1 Intervention

Participants randomly assigned to this arm will receive standardized weight management educational materials plus a commercially available wireless scale. Participants will be instructed to weigh daily and view their weight on the scale's digital display.

Group II: Standard Care Active Control 1 Intervention

Participants randomly assigned to this arm will receive standardized weight management educational materials plus a monetary gift of $60 that can be used to purchase health-promoting supplies to support weight management.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Indiana University

Collaborator

Trials

1,063

Recruited

1,182,000+

Cornell University

Collaborator

Trials

179

Recruited

14,090,000+

Published Research Related to This Trial

Pharmacotherapy for obesity can be considered for individuals with a BMI of 30 or greater, or 27 or greater with weight-related health issues, highlighting the importance of medication in weight management when lifestyle changes alone are insufficient.

The effectiveness of antiobesity medications, such as phentermine and liraglutide, relies on customizing treatment to individual patient behaviors and health conditions, along with careful monitoring of their safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity Pharmacotherapy. Saunders, KH., Umashanker, D., Igel, LI., et al.[2022]

Naltrexone/bupropion ER, marketed as Contrave, is a newly approved medication specifically designed for chronic weight management in obese adults.

This combination therapy targets both appetite suppression and energy expenditure, offering a new option for individuals struggling with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naltrexone/Bupropion ER (Contrave): Newly Approved Treatment Option for Chronic Weight Management in Obese Adults. Sherman, MM., Ungureanu, S., Rey, JA.[2020]

Phentermine-topiramate extended release (ER) has been shown to help obese individuals lose an average of 10% of their initial weight, which is about 8% more than a placebo, and it also reduces the risk of developing type 2 diabetes and improves cardiovascular disease risk factors.

While effective for weight loss, phentermine-topiramate ER can increase heart rate and poses risks for women of child-bearing age due to potential harm to infants, highlighting the need for careful monitoring and consideration in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination phentermine and topiramate extended release in the management of obesity. Alfaris, N., Minnick, AM., Hopkins, CM., et al.[2018]

In a study of 338 smokers using varenicline for smoking cessation, 45.9% reported at least one adverse event, with a notably higher incidence in women (51.5%) compared to men (40.5%).

The study identified 32 unexpected adverse events, including 19 psychiatric issues, raising concerns about the tolerability of varenicline and suggesting the need for further research on its safety profile and potential dosage adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Tolerability profile of varenicline in current medical practice]. Dupont, P., Gillet, C., Guerin, M., et al.[2016]

Varenicline, a medication used for smoking cessation, has been linked to serious cardiovascular events, including pulmonary thromboembolism (PTE), which may occur even in patients without pre-existing cardiovascular conditions.

A case report highlighted a probable association between varenicline and PTE, indicating that this adverse effect should be considered when prescribing the medication, especially since the patient had a low risk for such events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taking varenicline for smoking cessation: A rare cause of pulmonary thromboembolism with infarction. Lee, SH., Yun, SJ., Ryu, S., et al.[2017]

Varenicline is an effective smoking cessation aid that works as a partial agonist at nicotinic acetylcholine receptors, with a standard dosage of 1 mg twice daily for 12 weeks, showing a linear pharmacokinetic profile across various populations including smokers and nonsmokers.

The drug is primarily excreted unchanged in urine and does not significantly interact with other medications, making it safe for use alongside common drugs; however, nausea is the most common side effect, particularly at higher doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the clinical pharmacokinetics and pharmacodynamics of varenicline for smoking cessation. Faessel, HM., Obach, RS., Rollema, H., et al.[2022]

In a study of 12,159 patients, varenicline was associated with reported neuropsychiatric events, particularly anxiety, but no significant increase in these events was found over time, suggesting that the drug's safety profile remains largely stable.

While 7-17% of neuropsychiatric events were attributed to varenicline by general practitioners, the analysis did not raise significant safety concerns, indicating that further investigation is needed to clarify the relationship between varenicline and anxiety symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England. Buggy, Y., Cornelius, V., Fogg, C., et al.[2021]

In a review of ten randomized controlled trials involving 3091 participants, varenicline did not show a significant increase in overall psychiatric disorders compared to placebo, with an incidence of 10.7% in the varenicline group versus 9.7% in the placebo group.

While varenicline was associated with a higher incidence of sleep disorders, there were no reported cases of suicidal ideation or behavior in the analyzed studies, suggesting that varenicline is generally safe for smokers without current psychiatric conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychiatric adverse events in randomized, double-blind, placebo-controlled clinical trials of varenicline: a pooled analysis. Tonstad, S., Davies, S., Flammer, M., et al.[2022]

Only 35% of primary care patients with overweight or obesity self-weigh weekly, and less than 23% do so daily, indicating a need for increased awareness of self-weighing as a tool for weight management.

Patients who self-weighed daily had a lower average BMI (29 kg/m²) compared to those who did not (31 kg/m²), suggesting that regular self-weighing may help in preventing obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding Primary Care Patients' Self-weighing Habits: Cohort Analysis from the PaTH Clinical Data Research Network. Bramante, CT., McTigue, KM., Lehmann, HP., et al.[2020]

Daily self-weighing was found to be a motivating factor for individuals who successfully lost weight during a 12-month intervention, with participants feeling more in control of their weight management.

The study identified both positive aspects and barriers to daily weighing, suggesting that understanding these factors can help improve adherence to self-weighing as a weight loss strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of Daily Weighing Among Successful Weight Loss Individuals During a 12-Month Weight Loss Study. Zheng, Y., Terry, MA., Danford, CA., et al.[2018]

In a study of 74 adults with overweight and obesity over 12 weeks, it was found that daily self-weighing is an effective strategy for weight loss, with high adherence rates of 87% for weighing and 85% for caloric intake.

The research revealed that increased caloric intake on one day significantly raised the likelihood of not self-weighing the next day, suggesting that weight management programs should offer additional support to participants who overeat to maintain adherence to self-monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overeat today, skip the scale tomorrow: An examination of caloric intake predicting nonadherence to daily self-weighing. Tanenbaum, ML., Ross, KM., Wing, RR.[2018]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Combination Varenicline and Lorcaserin for Tobacco Dependence Treatment and Weight Gain Prevention in Overweight and Obese Smokers: A Pilot Study. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Varenicline and Lorcaserin for Smoking Cessation and Weight Gain Prevention: A Randomized Clinical Trial. [2022]

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

Obesity Pharmacotherapy. [2022]

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

Naltrexone/Bupropion ER (Contrave): Newly Approved Treatment Option for Chronic Weight Management in Obese Adults. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Combination phentermine and topiramate extended release in the management of obesity. [2018]

6. France pubmed.ncbi.nlm.nih.gov

[Tolerability profile of varenicline in current medical practice]. [2016]

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

Taking varenicline for smoking cessation: A rare cause of pulmonary thromboembolism with infarction. [2017]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A review of the clinical pharmacokinetics and pharmacodynamics of varenicline for smoking cessation. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England. [2021]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Psychiatric adverse events in randomized, double-blind, placebo-controlled clinical trials of varenicline: a pooled analysis. [2022]

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

Understanding Primary Care Patients' Self-weighing Habits: Cohort Analysis from the PaTH Clinical Data Research Network. [2020]

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

The daily Self-Weighing for Obesity Management in Primary Care Study: Rationale, design and methodology. [2022]

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

Experiences of Daily Weighing Among Successful Weight Loss Individuals During a 12-Month Weight Loss Study. [2018]

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

Overeat today, skip the scale tomorrow: An examination of caloric intake predicting nonadherence to daily self-weighing. [2018]

15. England pubmed.ncbi.nlm.nih.gov

Is self-weighing an effective tool for weight loss: a systematic literature review and meta-analysis. [2022]