Stepping Into Lifestyle Changes (SILC)

The University of Alabama at Birmingham

Status: Active, not recruiting

Conditions: High Blood Pressure; Overweight and Obesity; Pre-Diabetes

Treatments: Behavioral: Home Gardening Intervention; Behavioral: Educational Group Weight Loss Classes

Study type: Interventional

Funder types: Other

Identifiers

NCT05625321

300009477

Details and patient eligibility

About

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.

Full 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.

Enrollment: 273 patients

Sex: Female

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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273 participants in 2 patient groups

Educational Group Weight Loss Classes

Active Comparator group

Description:

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.

Treatment:

Behavioral: Educational Group Weight Loss Classes

Educational Group Weight Loss Classes PLUS Home Gardening Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Educational Group Weight Loss Classes

Behavioral: Home Gardening Intervention