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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
Participants will be provided with educational materials on weight loss, and have opportunities to increase their exercise and make changes to their diet.
Participants will receive tools to establish their own home garden, increasing their access to fresh fruits and vegetables.
The University of Alabama at Birmingham
Birmingham, Alabama, United States
The University of Mississippi Medical Center
Jackson, Mississippi, United States
Weight
Changes in Weight, measured in pounds
Time frame: 0, 6, and 12 months
BMI
Changes in BMI, calculated as a person's weight in kilograms divided by the square of height in meters
Time frame: 0, 6, and 12 months
Waist Circumference
Changes in waist circumference, measured in centimeters
Time frame: 0, 6, and 12 months
Dietary Intake
Changes in diet, measured using a questionnaire
Time frame: 0, 6, and 12 months
Diastolic and Systolic Blood Pressure
Changes in values over time, using a calibrated automatic sphygmomanometer and following NHLBI protocols
Time frame: 0, 6, and 12 months
Fasting Glucose
Changes in glucose readings, collected by finger-stick
Time frame: 0, 6, and 12 months
Cholesterol Levels
Changes in LDL and HDL values/ratio, collected by finger-stick
Time frame: 0, 6, and 12 months
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.
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PREVENTION
Masking
NONE
Enrollment
273
Time frame: 0, 6, and 12 months
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.
Time frame: 0, 6, and 12 months
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.
Time frame: 0, 6, and 12 months