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Overweight and ObesitySILCNCT05625321

Stepping Into Lifestyle Changes

A study testing Educational Group Weight Loss Classes and Home Gardening Intervention in people with Overweight and Obesity and Pre-Diabetes, run by University of Alabama at Birmingham at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to promote healthy weight loss among African American women, age 30 or older, who are pre-diabetic and/or have high blood pressure and who live, work, or worship in select rural communities throughout Alabama and Mississippi. Read more about this study

Who is it for?
Ages 30 years and older, women onlyHealthy volunteers can take part
What is being tested?
Educational Group Weight Loss Classes and Home Gardening Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
273 participants
Where
2 sitesUnited States
Study dates
27 Mar 2023to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • self-identifies as Black and/or African American
  • ≥ 30 years old
  • 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)
  • 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 willingness to participate in the study for the 18-months duration.

Who cannot join

  • being or planning to become pregnant during the 18-month study duration
  • a baseline blood pressure and/or glucose that is outside of the normal range and a medical provider does not provide clearance to participate
  • medical contraindications

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • The University of Mississippi Medical Center

    Jackson, Mississippi, 39216

Other trials in United States

About this study

Official title: Community-Based Strategies to Reduce Cardiometabolic Disease in the Deep South

The purpose of this study is to promote healthy weight loss among African American women, age 30 or older, who are pre-diabetic and/or have high blood pressure and who live, work, or worship in select rural communities throughout Alabama and Mississippi. The goal of the study is to help reduce the burden of obesity, diabetes, and high blood pressure for these women and to collect information on the reach, effectiveness, adoption, implementation, maintenance, and cost effectiveness of our two evidence-base weight loss programs.

Read the detailed description

This study leverages two evidence-based interventions (EBIs) that have been culturally-adapted for the target population and have previously achieved clinically-relevant weight loss and other clinical outcomes (educational group weight loss intervention) along with improvements in diet and physical activity (home gardening intervention). Combining these EBIs addresses multiple domains (behavioral, personal environment, sociocultural) and levels (individual, interpersonal, community) of influence on risk factors for obesity and other cardiometabolic diseases prevalent in the Deep South. These interventions, delivered by local lay staff and non-academic partners, have a high potential for sustainability; however, there is a need to further evaluate the external validity and implementation-related barriers and facilitators to maximize reach, adoption and implementation. The investigators will employ a pragmatic, multilevel, cluster-randomized, type 1 hybrid effectiveness-implementation trial. A total of 264 Black women (age ≥ 30 years) with overweight or obesity and pre-diabetic or hypertensive from 12 rural counties (6 Alabama, 6 Mississippi) will receive either the combined educational group weight loss intervention plus a home gardening intervention or the educational group weight loss classes alone. The specific aims are to compare interventions on: (1) primary outcomes related to implementation effectiveness (reach, adoption, maintenance of health behaviors), (2) secondary outcomes on clinical effectiveness, and (3) cost effectiveness. Findings will inform discussions with coalition partners to achieve our long-term goal of widely disseminating and sustaining multi-level interventions to reduce the multiple chronic disease burden and health disparities in the Deep South.

Being tested
Educational Group Weight Loss Classes, Home Gardening Intervention
Medical subject headings
Overweight, Obesity, Glucose Intolerance, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational Group Weight Loss ClassesBehavioural

    Participants will be provided with educational materials on weight loss, and have opportunities to increase their exercise and make changes to their diet.

  • Home Gardening InterventionBehavioural

    Participants will receive tools to establish their own home garden, increasing their access to fresh fruits and vegetables.

Study groups in NCT05625321
Study groupRoleWhat they receive
Educational Group Weight Loss ClassesActive comparatorParticipants 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.
Receives: Behavioral: Educational Group Weight Loss Classes
Educational Group Weight Loss Classes PLUS Home Gardening InterventionExperimentalParticipants 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.
Receives: Behavioral: Educational Group Weight Loss Classes; Behavioral: Home Gardening Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight

    Changes in Weight, measured in pounds

    Measured: 0, 6, and 12 months

  2. BMI

    Changes in BMI, calculated as a person's weight in kilograms divided by the square of height in meters

    Measured: 0, 6, and 12 months

  3. Waist Circumference

    Changes in waist circumference, measured in centimeters

    Measured: 0, 6, and 12 months

  4. Dietary Intake

    Changes in diet, measured using a questionnaire

    Measured: 0, 6, and 12 months

Secondary outcomes (6)

  1. Diastolic and Systolic Blood Pressure

    Changes in values over time, using a calibrated automatic sphygmomanometer and following NHLBI protocols

    Measured: 0, 6, and 12 months

  2. Fasting Glucose

    Changes in glucose readings, collected by finger-stick

    Measured: 0, 6, and 12 months

  3. Cholesterol Levels

    Changes in LDL and HDL values/ratio, collected by finger-stick

    Measured: 0, 6, and 12 months

  4. Physical Activity

    Changes in physical activity, measured by the International Physical Activity Questionnaire (IPAQ).

    For the IPAQ survey, participants will be asked to indicate if they have completed low (sitting or walking) levels of activity, moderate levels of activity, and/or high levels of activity in the last 7 days.They will also be asked to provide the number of days they do each activity and the time, in minutes, they spend doing the activity.

    Measured: 0, 6, and 12 months

  5. Physical Activity

    Changes in physical activity, measured by the Stanford Leisure Time Activity Categorical Item (L-cat).

    The L-Cat is categorical and responses range from 1-6 with 1 indicating little to no physical activity, and 6 indicating vigorous activity for 5 or more days a week.

    Measured: 0, 6, and 12 months

  6. Perceived Quality of Life

    Changes in Quality of Life as measured by the EuroQol-5 Dimension survey (EQ-5D-5L). Condition states range from 1-5 with 1 meaning the participant has no problems or symptoms and 5 meaning they have are unable to perform the activity or are extremely impacted by the condition. Self reported health is measured on a 1 to 100 scale with 1 being the worst possible health and 100 being the best possible health.

    Measured: 0, 6, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2022
  2. Study start27 Mar 2023
  3. Primary completion30 Jun 2025
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
273 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05625321
Sponsor's protocol ID
300009477
Other IDs
P50MD017338
Acronym
SILC
Status last verified
Aug 2025
First submitted
2 Nov 2022
Last updated
27 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Educational Group Weight Loss Classes and Home Gardening Intervention in people with Overweight and Obesity and Pre-Diabetes, run by University of Alabama at Birmingham at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight (time frame: 0, 6, and 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05625321.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.

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