Clinical trial NCT05625321: Stepping Into Lifestyle Changes
Official title: Community-Based Strategies to Reduce Cardiometabolic Disease in the Deep South
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Pre-Diabetes
High Blood Pressure
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: University of Mississippi Medical Center
First posted: 2022-11-22
Enrollment: 273
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight
timeFrame: 0, 6, and 12 months
measure: BMI
timeFrame: 0, 6, and 12 months
measure: Waist Circumference
timeFrame: 0, 6, and 12 months
measure: Dietary Intake
timeFrame: 0, 6, and 12 months
Secondary outcomes:
measure: Diastolic and Systolic Blood Pressure
timeFrame: 0, 6, and 12 months
measure: Fasting Glucose
timeFrame: 0, 6, and 12 months
measure: Cholesterol Levels
timeFrame: 0, 6, and 12 months
measure: Physical Activity
timeFrame: 0, 6, and 12 months
measure: Physical Activity
timeFrame: 0, 6, and 12 months
measure: Perceived Quality of Life
timeFrame: 0, 6, and 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Jackson
country: United States
facility: The University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Alabama at Birmingham
name: Monica Baskin, PhD
role: PRINCIPAL_INVESTIGATOR
References: