Lifestyle Changes for Obesity

(SILC Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help African American women, aged 30 or older, with pre-diabetes or high blood pressure achieve healthy weight loss. The study focuses on women living, working, or worshipping in specific rural areas of Alabama and Mississippi. Participants will join educational group weight loss classes and may also try a home gardening program to support their weight loss journey. Women with a body mass index over 25 who meet these criteria might be a good fit for this trial.

As an unphased study, this trial offers a unique opportunity to contribute to important research and potentially improve personal health outcomes.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Past research has found group-based weight loss programs to be safe and effective. Studies showed that participants in these programs lost about 3 kilograms more than those in education-only programs, without any harm. This indicates that structured group classes are generally safe and well-received.

Regarding home gardening, studies have shown it can aid in weight control. One study found that people who garden are less likely to be obese compared to those who don't. Another study showed that gardening encourages increased consumption of fruits and vegetables, which is a healthy change. These findings suggest that gardening is a safe and beneficial activity.

Overall, both educational classes and home gardening activities are safe and linked to positive health outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer a fresh approach to tackling obesity by combining education with practical lifestyle changes. Unlike traditional methods that often rely solely on diet and exercise plans, this program includes educational weight loss classes led by lay health educators, which focus on promoting healthy weight loss, dietary changes, and increased physical activity. Additionally, one treatment arm introduces a unique home gardening intervention, where participants are guided by Master Gardeners to grow their own food, potentially fostering a deeper connection to healthy eating and sustainable lifestyle changes. This hands-on, holistic approach aims to empower individuals with practical skills and knowledge, potentially leading to more sustainable weight loss and overall health improvement.

What evidence suggests that this trial's treatments could be effective for obesity?

Research shows that group weight loss classes, which participants in this trial may attend, effectively aid weight loss. One study found that people who attended at least eight classes lost a significant amount of weight. Another study showed that participants lost at least 5% of their body weight, with some groups losing even more.

In this trial, some participants will also receive a home gardening intervention alongside the educational group weight loss classes. Adding a home gardening activity can further enhance weight loss. Community gardening has been linked to a reduction in body mass index (BMI) by up to 1.84 in women and an increase in vegetable consumption. Another study found a 3.5% weight loss and a 9.9% decrease in waist size. These findings suggest that both educational classes and gardening can support healthy weight loss. ^{6 7 8 9 10}

Who Is on the Research Team?

Monica Baskin, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

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]

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 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 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]

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7537736/

A Retrospective Analysis of Employee Education Level on ...

Individuals attending more than or equal to eight classes achieved a greater percentage of clinically beneficial and clinically significant weight loss. Those ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3987437/

The Impact of Education on Weight Loss in Overweight and ...

The initial weight decreased at least 5% in 21.5%, 26.0%, and 34.9% of the participants in the three groups, respectively (13).

3.

cardio.jmir.org

cardio.jmir.org/2024/1/e42402/

Effects of a Web-based Weight Management Education ...

This study found that the group receiving education and tailored feedback showed significant weight loss and improvements in several psychological factors.

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1744388123000026

Additional health education and nutrition management ...

Additional health education and nutrition management cause more weight loss than concurrent training in overweight young females · Abstract · Introduction.

5.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2795182

Efficacy of a Commercial Weight Management Program ...

At 3 months, participants in the commercial program had a mean (SD) weight loss of −3.8 (4.1) kg vs −1.8 (3.7) kg among those in the DIY group.

6.

cdc.gov

cdc.gov/pcd/issues/2017/16_0605.htm

Obesity Prevention Interventions in US Public Schools

Thirty-seven schools (15.0%) reported developing intervention programs that focused primarily on individual students' or staff members' weight ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5276726/

School-based obesity prevention policies and practices ...

Results suggest obesity prevention policies/practices do not have unintended consequences for student weight-control behaviors and support the importance of ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6444501/

Comparison of Education-Only versus Group-Based ...

Group-based intervention further increased weight loss by 3.0 kg compared with the education-only intervention. In weight loss intervention trials, well- ...

9.

publications.aap.org

publications.aap.org/pediatrics/article/116/1/73/72939/Children-s-Residential-Weight-Loss-Programs-Can

Children's Residential Weight-Loss Programs Can Work: A ...

Results. Campers, who stayed for a mean of 29 days, lost 6.0 kg, reduced their BMI by 2.4 units, and reduced their BMI SD scores by 0.28 ...

10.

ijbnpa.biomedcentral.com

ijbnpa.biomedcentral.com/articles/10.1186/s12966-020-01065-9

A systematic review and meta-analysis of school-based ...

However, previous reviews of school-based interventions have shown mixed results for BMI outcomes [72, 73]. These reviews suggest that, for ...