MPI: Peter T. Katzmarzyk, Ph.D., FTOS

Professor, Assoc Executive Director for Population & Public Health Sciences, Pennington Biomedical Research Center

MPI: Eboni Price-Haywood, MD, MPH

OXIHER Director, Associate Professor, Oschner Health

Type 2 diabetes is a major health concern in the United States, and underserved and minority populations share a disproportionate amount of the burden. Further, the Deep South has higher rates of obesity, diabetes, and other chronic conditions than other regions. Modest weight loss can significantly improve cardiometabolic risk and several health outcomes in patients with diabetes. Promoting Successful Weight Loss in Primary Care in Louisiana Using Information Technology (PROPEL-IT) study will examine the effectiveness of integrating primary care with a health coach who remotely delivers care, facilitated by the patient portal of an electronic medical record (EMR), in Black patients with obesity and type 2 diabetes. We will also assess the contextual factors of the intervention settings that may influence utilization and dissemination of the weight loss intervention.

The study group will include Black primary care patients aged 18-70 years with obesity and type 2 diabetes. We will randomly assign 352 individuals equally to an EMR-facilitated behavioral weight loss intervention and a usual care group for 24 months. Patients in the weight loss group will receive a comprehensive, high-intensity behavioral weight loss program delivered by a health coach using interactive electronic health (eHealth) technology including video conferencing, with a strong emphasis on bi-directional communication. Through an EMR patient portal, patients will have access to program materials and personalized weight loss graphs to track their progress. Patients in the usual care group will continue to receive routine medical care by their primary care practitioner.

We hypothesize that patients in the weight loss group will have greater and clinically significant percent reductions in body weight compared to patients in the usual care group. We further hypothesize that patients in the weight loss group will have greater improvements in secondary outcomes, including fasting plasma glucose, hemoglobin A1c, cardiovascular disease risk factors, and patient-reported outcomes such as medication use, sleep quality, mobility, dietary intake, physical activity, and quality of life. Finally, we will study the implementation of the intervention using focus groups, semi- structured interviews, and cost-effectiveness analysis in order to better understand external validity and implementation outcomes. PROPEL-IT study will significantly advance the translation of evidence-based weight loss strategies into primary care that are widely applicable to the growing diabetes population in the United States, particularly in the Deep South.

Disease focus: obesity treatment, diabetes management
Disparity population: Black Americans with obesity and diabetes in a large urban health system
Study setting & non-academic partner: Ochsner Health System, a safety net care provider for >950,000 patients in and around New Orleans, a majority of whom are low-income and racial/ethnic minority
Study design: Hybrid type 1 implementation trial; Intervention description: Remotely-delivered weight loss program using patient portals through the EMR and augmented with health coaches embedded in primary care
Levels of action:
1) individual (transportation, support for healthy behaviors)
2) interpersonal/ organizational (communication with the health care team, remote monitoring capacity, systematized outreach and education), and
3) Community (access to health care services)

PROPEL-IT Research Project Status (NCT05523375): Recruiting participants. For more information, visit clinicaltrials.gov..

MPI: Tapan Mehta, Ph.D.

Professor, Vice Chair of Research, Department of Family and Community Medicine, University of Alabama at Birmingham  

MPI: Michael E. Hall, M.D.

Associate Professor, Chair, Department of Medicine, The University of Mississippi Medical Center

Deep South states, including Alabama (AL) and Mississippi (MS), have the highest rates of type 2 diabetes mellitus (T2DM) and some of the worst outcomes due to T2DM-related cardiovascular disease (CVD) and chronic kidney disease (CKD). T2DM and related cardiorenal diseases disproportionately burden Black Americans. Over half of the racial health disparities related to T2DM can be attributed to social determinants of health (SDoH), including reduced healthcare access, poverty, transportation barriers, and food insecurity. There is a need for effective and sustainable intervention packages that address T2DM-related outcomes and improve health equity.

The overall goal of the Food Delivery, Remote Monitoring, and Coaching-Enhanced EDucation for Optimized Diabetes Management (FREEDOM) study (Project 3) is to develop an optimized, multilevel, and scalable intervention to improve T2DM control in low-income Black adults with T2DM and cardiorenal complications in the Deep South by targeting relevant SDoH. The FREEDOM study will enroll 304 Black adults with suboptimal SDoH through three health systems in AL and MS. A randomized factorial optimization design using a multiphase optimization strategy (MOST) will evaluate three intervention components: 1) digital health coaching, 2) food box delivery, and 3) remote patient monitoring (RPM). Thus, this project will evaluate multilevel interventions that address changes at the individual (patient), interpersonal (patient-care team communication), organizational (healthcare system–delivered RPM), and community (food box delivery) levels to improve T2DM management among socially vulnerable Black adults with cardiorenal comorbidities (CVD or CKD).

Aim 1 will identify the combination(s) of the three intervention components that reduce HbA1c (primary outcome) at 12 months. Aim 2 includes within-trial cost-utility analyses of intervention components. Aim 3 will identify contextual factors that impact implementation of these different interventions using a Consolidated Framework for Implementation (CFIR) approach, and the implementation outcomes will be assessed via the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The FREEDOM study will leverage multi-healthcare system and healthcare system–industry partnerships to develop optimized, sustainable intervention strategies to improve T2DM outcomes in socially vulnerable Black adults living in the Deep South.

Disease focus: Medically complex patients (i.e., those with DM on insulin and with existing cardiorenal disease);
Disparity population: Socially vulnerable Black individuals; Setting: two university health systems (UMMC and UAB Family Medicine) and a safety net health system in Birmingham (Cooper Green);
Study design: MOST trial testing three intervention components;
Intervention description:
1) Digital health coaching
2) Remote patient monitoring
3) Grocery delivery
Levels of action:
1) Individual-level (health behaviors, food insecurity, transportation barriers),
2) Interpersonal (Household environment) and
3) Community/system level (access to health care services, food environment)
Non-academic partner: Pack Health (AL) with a digital platform for chronic disease management

FREEDOM Research Project Status (NCT05288452): Recruiting participants. For more information, visit clinicaltrials.gov.

PI: Abigail Gamble, PhD

Associate Professor, Preventive Medicine, The University of Mississippi Medical Center

Primary aim of study: Determine the effect of #BabyLetsMove compared to usual WIC care on objective moderate-to-vigorous physical activity & blood pressure at 26- and 36-gestational weeks using a two-arm cluster randomized trial

• #BabyLetsMove is a multi-level, multicomponent digital health intervention including interactive self-monitoring, tailored skills, virtual peer health coaching, & commercialwearable device (ex. Fitbit, Apple Watch)

Diseases or Conditions Being Studied: cardiometabolic disease prevention
Communities of Focus: pregnant, Black adolescents enrolled in WIC
Study Sites: select counties in Mississippi select counties in Mississippi
Study Population: Enroll 144 pregnant (<16 weeks gestation), Black adolescents (15 – 19 years) currently receiving WIC
Community or non-academic partners (if applicable): WIC, MS Urban League, Catholic Charities, Black Women’s Health Imperative, SHE Project
Primary outcome: moderate-to-vigorous physical activity min/week; sedentary min/day
Outcome measures collected at: baseline (<16 weeks), 26 and 36 weeks gestation
Levels of action:
1) Individual-level (health behaviors)
2) Community (parks, gyms, & recreation)
3) Societal (government & social services – WIC Program)

PI: Amber Kinsey, PhD

Primary study aim: Examine the feasibility, acceptability, and preliminary efficacy of the remotely-delivered resistance training (RT) intervention

• Leverage remote delivery using a commercially available platform to provide foundational skills for RT to overcome barriers to traditional RT

Diseases/Conditions Being Studied: overweight/obesity, prediabetes/diabetes, prehypertension/hypertension
Communities of Focus: Black women with elevated cardiometabolic risk living in Birmingham-metro area
Study Sites: Birmingham, AL
Study Population: Enroll 36 Black women (30-64 years) with elevated cardiometabolic risk (has ≥1 of the following conditions: overweight or obesity; prediabetes or type 2 diabetes; or prehypertension or hypertension; or taking medications for any of these conditions)
Primary outcome: feasibility, acceptability, patient-reported outcomes
Outcome measures collected at: 0 and 4 months
Community or non-academic partners: Collaborate to recruit via local organizations
Levels of action:
1) Individual-level (health behaviors)
2) Interpersonal (communication and education with trainer, household environment)

PI: Caroline Presley, MD

Assistant Professor, Preventive Medicine, University of Alabama at Birmingham  

Primary aim of study: Test intervention of Integrated Mindfulness-Based Stress Reduction and Diabetes Self-Management Education program

• Delivered remotely in group setting

Diseases or Conditions Being Studied: Type 2 diabetes, Diabetes distress

Communities of Focus: Rural Black adults living with Type 2 Diabetes

Study Sites: Federally Qualified Health Centers in Black Belt region in Alabama

Study Population: Enroll 80 Black participants living with Type 2 diabetes who have a

hemoglobin A1c lab result of equal to or greater than 8.0%

Community or non-academic partners: Alabama Primary Health Care Association

Primary outcome: Feasibility, acceptability

Outcome measures collected at: Baseline, 6 Months

Levels of action:

1) Individual-level (health behaviors)

2) Community (access to education, health care services)

PI: Drew Sayer, PhD

Assistant Professor, Medicine,  Family & Community Medicine, University of Alabama at Birmingham  

Primary aim of study: Determine the feasibility and preliminary effectiveness of a SMART to compare weight-focused and weight-neutral biobehavioral interventions for improving cardiometabolic health.

• Participants receive 6-months of either weight-focused (i.e., behavioral weight loss) or weight-neutral (not emphasizing weight loss) health coaching
• Sub-optimal responders to initial strategies will be re-randomized to either an intensified lifestyle intervention or PCP-led enhanced medical management

Diseases or Conditions Being Studied: Overweight or obesity with concomitant prehypertension/hypertension, prediabetes/diabetes, and/or dyslipidemia
Communities of Focus: Black adults with overweight or obesity and weight-related cardiometabolic conditions residing in the Birmingham metro area
Study Sites: Birmingham, AL
Study Population: Enroll 60 Black adults with Stage 1 Obesity as defined by the AACE/ACE Guidelines
Community or non-academic partners (if applicable): YMCA of Greater Birmingham
Primary outcome: Clinical trial/SMART feasibility, treatment acceptability & credibility, estimates of treatment effect sizes and variances
Outcome measures collected at: Baseline, week 8, and week 26
Levels of action:
1) Individual level (health behaviors),
2) Community (access to education, parks, gyms, & recreation)