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Active, Not Recruiting

NCT Number: NCT05625321

Stepping Into Lifestyle Changes

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Overweight and Obesity Body Weight Cardiovascular Diseases Glucose Intolerance Glucose Metabolism Disorders High Blood Pressure Hyperglycemia Hypertension Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pre-diabetes Signs and Symptoms Vascular Diseases

Age range

30 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Group Weight Loss Classes

Behavioral

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 Intervention

Behavioral

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

Primary outcomes

  1. Weight

    Time frame: 0, 6, and 12 months

    Changes in Weight, measured in pounds

  2. BMI

    Time frame: 0, 6, and 12 months

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

  3. Waist Circumference

    Time frame: 0, 6, and 12 months

    Changes in waist circumference, measured in centimeters

  4. Dietary Intake

    Time frame: 0, 6, and 12 months

    Changes in diet, measured using a questionnaire

Secondary outcomes

  1. Diastolic and Systolic Blood Pressure

    Time frame: 0, 6, and 12 months

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

  2. Fasting Glucose

    Time frame: 0, 6, and 12 months

    Changes in glucose readings, collected by finger-stick

  3. Cholesterol Levels

    Time frame: 0, 6, and 12 months

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

  4. Physical Activity

    Time frame: 0, 6, and 12 months

    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.

  5. Physical Activity

    Time frame: 0, 6, and 12 months

    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.

  6. Perceived Quality of Life

    Time frame: 0, 6, and 12 months

    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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)
  • University of Mississippi Medical Center

Registry information

Official study title

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

Acronym: SILC

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 22, 2022
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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