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

80 Participants Needed

Trial Summary

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 data supports the idea that Lifestyle Intervention for Obesity is an effective treatment?

The available research shows that Lifestyle Intervention for Obesity can lead to significant weight loss. For example, one study found that people who completed the program lost an average of 8-10% of their initial body weight in about 30 weeks. Another study reported an average weight loss of 10 kg by the end of a short-term program, with some weight still lost after a year. These results suggest that the treatment is effective in helping people lose weight. Additionally, lifestyle interventions have been shown to improve quality of life and reduce health risks associated with obesity. Compared to other methods, such as Internet-based programs, on-site lifestyle interventions tend to result in greater weight loss. Overall, these findings indicate that lifestyle interventions are a promising approach for managing obesity. ^{1 2 3 4 5}

What safety data exists for the lifestyle intervention for obesity?

The provided research abstracts do not specifically mention safety data for the lifestyle intervention for obesity. They focus on the effectiveness, challenges, and implementation of lifestyle interventions for weight loss and obesity management. To find specific safety data, further detailed studies or clinical trial reports would be needed. ^{1 5 6 7 8}

Is the 12-week lifestyle intervention a promising treatment for obesity?

Yes, the 12-week lifestyle intervention is promising for treating obesity. It helps people adopt healthier habits, like better eating and more exercise, which can lead to weight loss and improved health. Studies show that lifestyle changes can be effective in managing obesity and can be adapted to fit different people's needs. ^{1 5 8 9 10}

What is the purpose of this trial?

African American adults that live in economically disadvantaged areas are at an increased risk for obesity and cardiometabolic disease. The treatment program being tested in this research study aims to address these factors and increase outcomes for the study population. The purpose of this research study is to find out about the feasibility and acceptability of using house chats (HC) as a model for a weight loss program in a real-world, community-based setting.

Research Team

Moghboeba Mosavel

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Lifestyle modification in the management of obesity: achievements and challenges. [2022]

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

Behavioral treatment of severe obesity. [2018]

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

Beyond weight reduction: improvements in quality of life after an intensive lifestyle intervention in subjects with severe obesity. [2015]

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

Lifestyle modification for the management of obesity. [2022]

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

Behavior therapy for obesity: where are we now? [2022]

6. United States 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. [2023]

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

Development of an online diabetes prevention lifestyle intervention coaching protocol for use in primary care practice. [2018]

8. United States 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. [2019]

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

The implementation of the coaching on lifestyle (CooL) intervention: lessons learnt. [2020]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Prevention and treatment of obesity with lifestyle interventions: review and meta-analysis. [2022]