Lifestyle Intervention for Obesity

Overseen By Jessica LaRose

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Must not be taking: Weight loss medication

Disqualifiers: Type 1 diabetes, Cancer, Psychiatric, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help African American adults in economically disadvantaged areas manage obesity and related health risks. It involves a 12-week lifestyle program using "house chats" to encourage weight loss in a community setting. Participants will either start the program immediately or have a delayed start. Adults living in Petersburg, VA, who are not dealing with certain medical conditions like type 1 diabetes or cancer, might be a good fit.

As an unphased trial, this study offers a unique opportunity to participate in innovative research aimed at improving community health.

Do I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are currently using weight loss medication, you cannot participate in the trial.

What prior data suggests that this lifestyle intervention is safe?

Research has shown that a 12-week lifestyle program is generally safe for adults with obesity. In previous studies, participants handled these programs well, with no reports of serious side effects. Many participants saw health improvements, such as better weight control and reduced risks for heart disease. This suggests the program is safe and could assist those seeking to manage their weight and health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike typical treatments for obesity that often rely on medication or surgery, this lifestyle intervention focuses on behavior changes. Researchers are excited about this approach because it empowers individuals to adopt healthier habits over a 12-week period, potentially leading to sustainable weight loss without medical intervention. This method emphasizes personalized guidance and support, making it a promising alternative for those seeking long-term solutions to manage obesity.

What evidence suggests that this 12-week lifestyle intervention is effective for obesity?

Research has shown that a 12-week lifestyle program can help people lose a significant amount of weight. For instance, one study found that participants lost at least 5% of their body weight, a meaningful reduction for those with obesity. Another study demonstrated that these programs improved health by promoting regular exercise and healthy eating. These programs often include group meetings or online platforms to support participants, making them accessible and effective. In this trial, participants will either receive the 12-week lifestyle intervention immediately or join a delayed intervention control group, with both groups receiving the same program. Overall, evidence suggests that a 12-week lifestyle program can effectively manage weight and improve health. ^{1 6 7 8 9}

Who Is on the Research Team?

Moghboeba Mosavel

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for African American adults who are at least 18 years old and live in Petersburg, VA. It's designed to help those living in economically disadvantaged areas reduce obesity and improve heart health through a community-based program.

Inclusion Criteria

You live in Petersburg, VA.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week lifestyle intervention delivered via weekly group meetings in the HCL's homes

12 weeks

Weekly group meetings

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 12 and 24 weeks post-treatment

12 weeks

In-person assessment visits at 12 and 24 weeks

Long-term follow-up

Mixed methods approach to assess factors that might promote and/or interfere with sustainability over long-term follow-up

What Are the Treatments Tested in This Trial?

Interventions

• 12-week lifestyle intervention

Trial Overview

The study is testing a 12-week lifestyle intervention that includes 'house chats' as a method of delivering weight loss coaching. The goal is to see if this approach is practical and well-received in the community setting.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Participants will be randomized to intervention and will receive the 12-week program.

Group II: Delayed Intervention Control Active Control 1 Intervention

Participants will be randomized to delayed intervention control and will receive the same 12-week program.

12-week lifestyle intervention is already approved in United States for the following indications:

Approved in United States as 12-week lifestyle intervention for:

• Weight loss
• Obesity prevention
• Cardiometabolic disease prevention

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A comprehensive lifestyle modification program can lead to a significant weight loss of about 10% of initial body weight within 16 to 26 weeks, especially when delivered through group or individual on-site treatments.

Long-term weight control is enhanced by ongoing contact with healthcare providers, high physical activity levels, and the use of medications alongside lifestyle changes, which also help in reducing cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle modification for the management of obesity. Wadden, TA., Butryn, ML., Wilson, C.[2022]

Comprehensive lifestyle modification programs delivered in person can lead to an average weight loss of about 10% over 16-26 weeks, while web-based interventions typically result in around 5% weight loss, highlighting the effectiveness of in-person support.

Combining lifestyle changes with long-term medication use may enhance initial weight loss and help maintain weight loss over time, suggesting a multi-faceted approach could be beneficial for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior therapy for obesity: where are we now? Sarwer, DB., von Sydow Green, A., Vetter, ML., et al.[2022]

The Healthy Weight for Living (HWL) intervention resulted in similar weight loss outcomes compared to the modified Diabetes Prevention Program (m-DPP) after 12 months, with both groups losing around 7.5 kg on average, indicating that both approaches are effective for weight management.

Participants in both groups experienced similar improvements in cardiometabolic health markers, such as blood pressure and cholesterol levels, suggesting that both lifestyle interventions are beneficial for overall health beyond just weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of a novel lifestyle intervention compared with the Diabetes Prevention Program for weight loss in adult dependents of military service members. Das, SK., Bukhari, AS., Taetzsch, AG., et al.[2023]

Short-term behavioral interventions for obesity typically result in an average weight loss of 10 kg during the program and 6.6 kg at one year follow-up, indicating some effectiveness in the short term.

To improve long-term weight management, a chronic disease model of obesity treatment is suggested, emphasizing the need for ongoing care and potentially incorporating highly structured diets and supervised exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral treatment of severe obesity. Wing, RR.[2018]

Lifestyle modification therapy can lead to a significant weight loss of 8-10% over approximately 30 weeks for overweight and obese patients, combining diet, exercise, and behavioral strategies.

To enhance the effectiveness and sustainability of this therapy, new strategies such as individualized treatment, remote delivery via phone or internet, and integration with community programs or bariatric surgery have shown promising results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle modification in the management of obesity: achievements and challenges. Dalle Grave, R., Calugi, S., El Ghoch, M.[2022]

A 10-14 week inpatient intensive lifestyle intervention (ILI) for 100 severely obese individuals led to significant improvements in quality of life, including reductions in binge eating, anxiety, and depression, as well as enhancements in physical and mental health.

The study found that improvements in binge eating and physical health were directly associated with weight loss, indicating that the ILI not only helped participants lose weight but also positively impacted their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond weight reduction: improvements in quality of life after an intensive lifestyle intervention in subjects with severe obesity. Danielsen, KK., Sundgot-Borgen, J., Mæhlum, S., et al.[2015]

The CooL intervention, a combined lifestyle program in the Netherlands, was found to be accessible and effective in helping obese individuals adopt healthier lifestyles, as evaluated by both participants and stakeholders.

Despite its positive reception, the program's success relies on increasing the recognition and integration of lifestyle coaches within the healthcare system, highlighting the need for better networking and communication about their role.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The implementation of the coaching on lifestyle (CooL) intervention: lessons learnt. van Rinsum, C., Gerards, S., Rutten, G., et al.[2020]

An online lifestyle intervention coaching protocol was developed based on the Diabetes Prevention Program, aiming to provide effective obesity treatment in primary care settings.

This e-counseling approach allows for high-quality lifestyle advice to be accessible to patients who cannot attend in-person sessions due to scheduling or geographic limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an online diabetes prevention lifestyle intervention coaching protocol for use in primary care practice. Simkin-Silverman, LR., Conroy, MB., Bhargava, T., et al.[2018]

A 12-month study involving 147 obese patients with type 2 diabetes showed that a lifestyle intervention program led by dietitians resulted in significantly greater weight loss (3.0 kg) and reduced waist circumference (-4.2 cm) compared to usual care.

Participants in the lifestyle case management group also experienced improved HbA1c levels, reduced use of diabetes medications by 0.8 medications per day, and enhanced health-related quality of life across multiple domains, indicating the program's effectiveness in managing diabetes and obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating lifestyle intervention to practice in obese patients with type 2 diabetes: Improving Control with Activity and Nutrition (ICAN) study. Wolf, AM., Conaway, MR., Crowther, JQ., et al.[2019]

A systematic review of 30 studies (13 on prevention and 17 on treatment) showed that lifestyle interventions significantly reduced body weight, body mass index, waist circumference, blood pressure, blood lipids, and blood glucose in overweight and obese individuals.

These positive effects of lifestyle changes were maintained for up to three years, indicating that such interventions are effective for long-term management of obesity and related cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention and treatment of obesity with lifestyle interventions: review and meta-analysis. Galani, C., Schneider, H.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8835149/

Health Effects of a 12-Week Web-Based Lifestyle Intervention ...

A 12-week web-based lifestyle intervention for physically inactive and overweight or obese adults: study protocol of two randomized controlled clinical trials.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06172582

WE Project: 2.0 Grassroots Wellness Coaching (Phase 2)

Behavioral : 12-week lifestyle intervention. A 12-week lifestyle intervention delivered via weekly group meetings in the House Chat Leaders (HCL's) homes.

3.

jmir.org

jmir.org/2023/1/e43426/

Effects of a Web-Based Lifestyle Intervention on Weight ...

Health Effects of a 12-Week Web-Based Lifestyle Intervention for Physically Inactive and Overweight or Obese Adults: Study Protocol of Two ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5556301/

A randomized controlled trial of a 12-week intensive ...

The 12-week primary care-based ILI program was effective in achieving a clinically meaningful weight reduction (≥5%) among Saudi and Arab patients with obesity.

5.

nature.com

nature.com/articles/s41387-018-0034-0

Evaluation of a 12-week lifestyle education intervention ...

Evaluation of a 12-week lifestyle education intervention with or without partial meal replacement in Thai adults with obesity and metabolic ...

6.

frontiersin.org

frontiersin.org/journals/public-health/articles/10.3389/fpubh.2022.868255/full

Effects of a 12-Week Web-Based Weight Loss Program for ...

The results demonstrated that adults with overweight and obesity can improve their COVIDAge and specific cardiometabolic risk factors by using this interactive ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S2667368124000354

Efficacy of in-person versus digital enhanced lifestyle ...

Several studies have shown that with behavioral interventions, participants achieved maximal weight loss between 6 and 12 months [5,27,28]. Real-world data with ...

8.

nature.com

nature.com/articles/s41366-023-01415-0

Efficacy of an app-based multimodal lifestyle intervention ...

This study aimed to examine the effect of a digital multimodal weight loss intervention program delivered by an app on body weight in persons with obesity.

9.

academic.oup.com

academic.oup.com/ptj/article/105/9/pzaf097/8233084

Lifestyle Intervention in People With Overweight and Obesity ...

The primary outcome is pain intensity (assessed using the Brief Pain Inventory). Secondary outcomes include other pain-related outcomes, body composition ...