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Lifestyle Changes for Obesity (SILC Trial)

N/A
Recruiting
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

SILC Trial Summary

This trial aims to reduce obesity, diabetes, and high blood pressure in African American women over 30 in Alabama and Mississippi by promoting healthy weight loss with evidence-based programs.

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.Check my eligibility
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.See study design
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.

SILC Trial 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.

SILC Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
BMI
Dietary Intake
Waist Circumference
+1 more
Secondary outcome measures
Cholesterol Levels
Diastolic and Systolic Blood Pressure
Fasting Glucose
+2 more

SILC 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.

Find a Location

Who is running the clinical trial?

University of Mississippi Medical CenterOTHER
173 Previous Clinical Trials
194,823 Total Patients Enrolled
10 Trials studying Obesity
579 Patients Enrolled for Obesity
University of Alabama at BirminghamLead Sponsor
1,586 Previous Clinical Trials
2,279,968 Total Patients Enrolled
73 Trials studying Obesity
474,130 Patients Enrolled for Obesity
Monica Baskin, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Educational Group Weight Loss Classes Clinical Trial Eligibility Overview. Trial Name: NCT05625321 — N/A
Obesity Research Study Groups: Educational Group Weight Loss Classes, Educational Group Weight Loss Classes PLUS Home Gardening Intervention
Obesity Clinical Trial 2023: Educational Group Weight Loss Classes Highlights & Side Effects. Trial Name: NCT05625321 — N/A
Educational Group Weight Loss Classes 2023 Treatment Timeline for Medical Study. Trial Name: NCT05625321 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor still open to new participants?

"According to clinicaltrials.gov, this specific research endeavour is no longer actively searching for individuals to participate in its trials. The study was launched on February 1st 2023 and last updated November 21st 2022; however, there are many other studies with open recruitment periods presently available."

Answered by AI

What is the chief aspiration of this research endeavor?

"This trial, which will have measurements taken at 0, 6, 12, and 18 months is focused on Waist Circumference. Secondary metrics to be tracked include Diastolic & Systolic Blood Pressure (measured with a calibrated sphygmomanometer), Fasting Glucose (finger-stick readings) and Cholesterol Levels (LDL/HDL values collected by finger-stick)."

Answered by AI

Who else is applying?

What state do they live in?
Mississippi
What site did they apply to?
The University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I have not tried anything for pre-diabetes. I have recently been diagnosed type 2 diabetes and nee help learning how to control it and lose weight. Can I please get a screening appointment 205-807-6798.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Stepping Into Lifestyle Changes
Monica L Baskin 2023. "Stepping Into Lifestyle Changes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05625321.
~163 spots leftby Feb 2026
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