ACTIVE_NOT_RECRUITING

Food Delivery, Remote Monitoring, and Coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Brief Summary: The FREEDOM study aims to develop a scalable intervention to improve type 2 diabetes mellitus control in low-income Black adults in the Deep South. The intervention targets social determinants of health (SDoH) such as reduced healthcare access, poverty, transportation barriers, and food insecurity.

Official Title

Food Delivery, Remote Monitoring, and Coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM)

Quick Facts

Study Start:2023-01-01

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05288452

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Self-identified as Black/African American 2. ICD diagnosis of T2DM 3. ≥18 years of age 4. Ongoing insulin treatment 5. HbA1c ≥8% within 6 weeks of study screening 6. has the ability to converse in and read English 7. must provide written informed consent prior to enrollment	1. Current enrollment in any diabetes-related interventional study 2. Cognitive impairment 3. End-stage kidney disease (CKD-5) 4. Pregnant or plans to become pregnant within 12 months 5. Currently enrolled in a structured lifestyle change program 6. Enrolled in remote patient monitoring or health coaching within 60 days of the study or intervention 1. ≥ 18 years of age 2. ICD diagnosis of T2DM 3. HbA1c ≥ 7% 4. Confirmed HIV+ diagnosis 5. Prescribed HIV ART therapy as part of care 1. Current enrollment in any diabetes-related interventional study or structured lifestyle change program 2. Enrolled in RPM or health coaching (except for coaching on smoking cessation) within 60 days of the intervention 3. Cognitive impairment 4. End-stage kidney disease (CKD-5) 5. Pregnant or plans to become pregnant within 12 months

Inclusion Criteria

Exclusion Criteria

1. Self-identified as Black/African American
2. ICD diagnosis of T2DM
3. ≥18 years of age
4. Ongoing insulin treatment
5. HbA1c ≥8% within 6 weeks of study screening
6. has the ability to converse in and read English
7. must provide written informed consent prior to enrollment

1. Current enrollment in any diabetes-related interventional study
2. Cognitive impairment
3. End-stage kidney disease (CKD-5)
4. Pregnant or plans to become pregnant within 12 months
5. Currently enrolled in a structured lifestyle change program
6. Enrolled in remote patient monitoring or health coaching within 60 days of the study or intervention
1. ≥ 18 years of age
2. ICD diagnosis of T2DM
3. HbA1c ≥ 7%
4. Confirmed HIV+ diagnosis
5. Prescribed HIV ART therapy as part of care
1. Current enrollment in any diabetes-related interventional study or structured lifestyle change program
2. Enrolled in RPM or health coaching (except for coaching on smoking cessation) within 60 days of the intervention
3. Cognitive impairment
4. End-stage kidney disease (CKD-5)
5. Pregnant or plans to become pregnant within 12 months

Contacts and Locations

Study Locations (Sites)

UAB Hospital and UMMC Cardiology Clinics

Birmingham, Alabama, 35205

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-01

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2023-01-01

Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

Diabetes Mellitus, Type 2
HIV

Additional Relevant MeSH Terms

Diabetes Mellitus, Type 2