Lifestyle Changes for Obesity

(SILC Trial)

Recruiting at 1 trial location

Overseen By Sharonda Hardy, MEd

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Pregnancy, Uncontrolled blood pressure, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 months

273 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to help African American women in rural Alabama and Mississippi lose weight and improve their health. It uses group classes on healthy living and a home gardening program to teach better eating habits and increase physical activity. The study will see how well these programs work and how easy they are to implement in these communities.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Educational Group Weight Loss Classes, Home Gardening Intervention for obesity?

Research shows that group-based interventions and educational measures can help people lose weight by teaching them healthy eating habits and providing regular follow-up. Group sessions reinforce commitment to treatment and help achieve weight loss goals. ^{1 2 3 4 5}

Is the lifestyle intervention for obesity safe for humans?

Lifestyle interventions for obesity, which include diet changes, exercise, and behavior therapy, have been shown to be safe in humans. Participants in studies generally report high satisfaction, and these interventions can lead to improvements in health markers like cholesterol and blood sugar levels. ^{6 7 8 9 10}

How is the Educational Group Weight Loss Classes treatment different from other obesity treatments?

The Educational Group Weight Loss Classes treatment is unique because it focuses on group-based education to promote weight loss and healthy lifestyle habits, which can be more effective in maintaining weight loss compared to usual care. This approach emphasizes learning and support in a group setting, which can enhance motivation and adherence to lifestyle changes. ^{11 12 13 14 15}

Research Team

Monica Baskin, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for African American women over 30 living in certain Alabama and Mississippi communities, who are overweight or obese with prediabetes or high blood pressure. Participants must be willing to stay in the study for 18 months and not plan to move or become pregnant during this time.

Inclusion Criteria

I live, work, or worship in one of the specified communities and don't plan to move for the next 18 months.

My BMI is over 25 and I have been diagnosed with pre-diabetes or hypertension in the last 2 years.

You identify yourself as Black and/or African American.

Exclusion Criteria

A baseline blood pressure and/or glucose that is outside of the normal range and a medical provider does not provide clearance to participate

Being or planning to become pregnant during the 18-month study duration

Medical contraindications

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will participate in a 12-month weight loss program, with weekly sessions for 6 months, bi-weekly for 3 months, and monthly for 3 months

12 months

Weekly sessions for 6 months, bi-weekly for 3 months, monthly for 3 months

Follow-up

Participants are monitored for changes in BMI, weight, fasting glucose, dietary intake, physical activity, perceived quality of life, waist circumference, cholesterol levels, and blood pressure

6 months

Treatment Details

Interventions

• Educational Group Weight Loss Classes
• Home Gardening Intervention

Trial Overview The study tests two weight loss programs: one involving educational group classes on weight loss, and another focusing on home gardening as a way to improve diet. The aim is to see which program better helps reduce obesity, diabetes, and high blood pressure.

Participant Groups

Group I: Educational Group Weight Loss Classes PLUS Home Gardening Intervention Experimental Treatment 2 Interventions

Participants will receive the educational group weight loss classes PLUS a home gardening intervention. The gardening intervention will be led by local Master Gardeners (MGs) who will help guide participants in setting-up and maintaining their garden.

Group II: Educational Group Weight Loss Classes Active Control 1 Intervention

Participants will participate in a 12-month weight loss program, taught by lay health educators, and designed to promote and encourage healthy weight loss, dietary changes, and increased physical activity. Participants will attend 90-minute sessions weekly for 6 months, bi-weekly for 3 months, and monthly for 3 months.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

University of Mississippi Medical Center

Collaborator

Trials

185

Recruited

200,000+

Findings from Research

In a study involving 116 patients over two years, educational measures and regular follow-ups significantly contributed to weight loss, with 5.1% achieving a weight reduction of at least 10%.

Patients who voluntarily discharged themselves showed the largest decrease in BMI (12.8), highlighting the importance of personal motivation in successful weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Results of educational intervention in obese patients]. Díaz Gómez, J., Armero Fuster, M., Calvo Viñuela, I., et al.[2013]

A qualitative study involving 10 adults with severe obesity revealed four key themes essential for maintaining weight loss over the long term: owning the decision, creating self-reinforcement, sustaining a lifestyle-forming identity, and selecting appropriate support.

The study suggests that successful weight loss maintenance is more about the intentional mindset behind behaviors rather than just the behaviors themselves, highlighting the importance of personal commitment and support in achieving lasting results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Experientially Derived Model of Flexible and Intentional Actions for Weight Loss Maintenance After Severe Obesity. Natvik, E., Råheim, M., Andersen, JR., et al.[2023]

Over 60% of US adults are overweight or obese, which increases their risk for chronic diseases like cardiovascular disease, highlighting the urgent need for effective weight management strategies.

Even small changes in physical activity and diet can lead to significant weight loss and help maintain a healthy body composition, yet many patients do not receive adequate guidance from healthcare providers on how to achieve these changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet, exercise, and the challenge of combating obesity in primary care. McInnis, KJ.[2019]

Weight loss of just 5-10% can significantly improve health issues related to obesity, such as hypertension and type II diabetes, as shown in studies like the Diabetes Prevention Program, which found a 7% weight reduction reduced diabetes risk by 58%.

Behavioral treatments, which include diet changes, increased physical activity, and behavior therapy, are effective in achieving and maintaining this level of weight loss, promoting long-term health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle modification in the treatment of obesity: an educational challenge and opportunity. Jones, LR., Wilson, CI., Wadden, TA.[2007]

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]

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]

Lifestyle interventions can lead to weight loss and health benefits, as shown in large randomized clinical trials, but not all participants achieve even a 5% reduction in body weight, and weight regain is a common issue.

Real-world studies show only modest weight loss from lifestyle changes, and there is currently no reimbursement model to support these interventions in medical office settings, highlighting the need for healthcare providers to understand both the potential and limitations of these approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle-Based Obesity Care. Ryan, DH.[2023]

Lifestyle interventions that combine dietary changes, physical activity support, and weight management education are the first-line treatment for obesity, emphasizing their importance in addressing the global obesity epidemic.

The chapter highlights the need for personalized weight management programs to enhance effectiveness and long-term adherence, given the significant health risks associated with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss Strategies. Roberts, SB., Anton, S., Dao, MC.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Importance of age for 3-year continuous behavioral obesity treatment success and dropout rate. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of education-only versus group-based intervention in promoting weight loss: a randomised controlled trial. [2021]

3. Spain pubmed.ncbi.nlm.nih.gov

[Results of educational intervention in obese patients]. [2013]

4. Switzerland pubmed.ncbi.nlm.nih.gov

An Experientially Derived Model of Flexible and Intentional Actions for Weight Loss Maintenance After Severe Obesity. [2023]

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

Diet, exercise, and the challenge of combating obesity in primary care. [2019]

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

Lifestyle modification in the treatment of obesity: an educational challenge and opportunity. [2007]

7. 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]

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

Narrative-focused Group Counseling Improves Intervention Outcomes in Women With Obesity. [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. United States pubmed.ncbi.nlm.nih.gov

Lifestyle-Based Obesity Care. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness to promote weight loss maintenance and healthy lifestyle habits of a group educational intervention program in adults with obesity: IGOBE program. [2021]

12. Germany pubmed.ncbi.nlm.nih.gov

Weight Loss Strategies. [2022]

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

The development of a program for treating obesity. [2019]

14. England pubmed.ncbi.nlm.nih.gov

A randomized trial comparing weight loss treatment delivered in large versus small groups. [2022]

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

Inner City Community Oriented Primary Care to Improve Medical Student Skills and Combat Obesity. [2019]