What side effects are associated with this type of intervention?

Behavioral and lifestyle modifications for obesity, including diet changes and increased physical activity, generally have minimal side effects, such as muscle soreness and gastrointestinal changes. Pharmacologic treatments like GLP-1 receptor agonists (e.g., liraglutide, semaglutide) can cause gastrointestinal side effects such as nausea, vomiting, and diarrhea. Naltrexone-bupropion may lead to insomnia, dizziness, and dry mouth. Patients should discuss these potential side effects with their healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including semaglutide, liraglutide, phentermine-topiramate, orlistat, and bupropion-naltrexone. Semaglutide and liraglutide are GLP-1 receptor agonists that have shown significant weight loss benefits, especially when combined with lifestyle interventions. Phentermine-topiramate is a combination drug that also aids in weight loss, while orlistat works by inhibiting fat absorption. Bupropion-naltrexone is another combination drug that targets the brain's reward system to reduce hunger and cravings. These medications are often used alongside behavioral and lifestyle modifications to enhance weight loss outcomes.

What other types of research exist?

Promising novel alternatives to traditional behavioral and lifestyle modification programs for obesity treatment in 2024 include: 1) Pharmacotherapy options such as naltrexone/bupropion combination therapy, which has shown efficacy in weight loss and obesity-related risk factors. 2) Bariatric surgery, including newer techniques like the silastic ring Roux-en-Y gastric bypass, which has demonstrated long-term weight loss and improvement in obesity-related conditions. 3) Emerging therapies like the compuLsive Exercise Activity TheraPy (LEAP) for addressing compulsive exercise behaviors in anorexia nervosa, which may have implications for obesity treatment. These alternatives offer additional options for patients who may not respond adequately to traditional programs.

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Lifestyle Changes for Obesity (SILC Trial)

N/A

Waitlist Available

Led By Monica Baskin, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Lives, works, or worships in one of the 12 intervention communities and expresses no intentions to move outside of that community in the 18 months following enrollment

A measured BMI >25 kg/m2 and at least one other cardiometabolic risk factor (physician diagnosis of pre-diabetes and/or hypertension within past 2 years)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 6, and 12 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the interventions involve lifestyle changes like education and gardening, side effects may include muscle soreness from physical activity or skin irritation from outdoor work. No severe medical side effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am 30 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 6, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 6, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 6, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

BMI

Dietary Intake

Waist Circumference

+1 more

Secondary study objectives

Cholesterol Levels

Diastolic and Systolic Blood Pressure

Fasting Glucose

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Educational Group Weight Loss Classes PLUS Home Gardening InterventionExperimental Treatment2 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 ClassesActive Control1 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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for obesity, particularly those involving behavioral and lifestyle modifications, work through several key mechanisms. Dietary interventions aim to reduce caloric intake by promoting healthier eating patterns, such as low-calorie or balanced macronutrient diets. Physical activity increases energy expenditure, helping to create a caloric deficit necessary for weight loss. Behavioral strategies, including self-monitoring, goal setting, and group support, enhance adherence to diet and exercise plans by addressing psychological and social factors that influence eating and activity behaviors. These mechanisms are crucial for obesity patients as they not only facilitate weight loss but also improve overall health, reduce the risk of comorbidities, and enhance long-term weight maintenance.

The impact of child and adolescent obesity treatment interventions on physical activity: a systematic review.