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

Study acronym: FREEDOM
StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Eligibility criteria expanded, about 23 words · Publications: details revised at 1 of 1 entry · Study description expanded, about 5 words Show 3 more changesShow less
    • Eligibility criteria expanded, about 23 words
    • Publications: details revised at 1 of 1 entry
    • Study description expanded, about 5 words
  2. Completion pushed from Jul 18, 2026 to Aug 30, 2026 Primary completion date changed from estimate of Jul 18, 2026 to Jul 21, 2026v17 Show 1 more changeShow less
    • Primary completion date changed from estimate of Jul 18, 2026 to Jul 21, 2026
  3. Primary and study completion dates: Jun 30, 2026 to Jul 18, 2026 Start date: Jan 1, 2023 to Jan 5, 2023v16 Show 1 more changeShow less
    • Start date: Jan 1, 2023 to Jan 5, 2023
  4. Re-verified, no change to tracked fieldsv15
  5. Trial status: Recruiting to Active, Not Recruiting Site details revisedv14 Show 1 more changeShow less
    • Site details revised
Show 12 earlier versionsHide 12 earlier versions
  1. Eligibility criteria shortened, about 7 words Site contact updatedv13 Show 1 more changeShow less
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  2. Eligibility criteria shortened, about 8 wordsv12 See this version in full on ClinicalTrials.gov ↗
  3. Primary completion date: Jul 1, 2026 to Jun 30, 2026 Completion date: Dec 1, 2027 to Jun 30, 2026v11 Show 1 more changeShow less
    • Completion date: Dec 1, 2027 to Jun 30, 2026
  4. Eligibility criteria revised Collaborators: 3 to 4v10 Show 1 more changeShow less
    • Collaborators: 3 to 4

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Dec 1, 2025 to Jul 1, 2026 Primary endpoints: 1 to 2 · Eligibility criteria expanded, about 67 words · Study description expanded, about 179 words · 1 morev9 Show 4 more changesShow less
    • Primary endpoints: 1 to 2
    • Eligibility criteria expanded, about 67 words
    • Study description expanded, about 179 words
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  6. Interventions: Core Intervention: Diabetes Self-Management Education and Support (DSMES) Program (Behavioral), Digital Health Coaching (Behavioral), Food… to Diabetes Education Class (Behavioral), Digital Health Coaching (Behavioral), Food Box Delivery (Dietary Supplement), Remote Patient… Eligibility criteria shortened, about 22 wordsv8 Show 1 more changeShow less
    • Eligibility criteria shortened, about 22 words

    See this version in full on ClinicalTrials.gov ↗

  7. Primary completion date: Dec 1, 2024 to Dec 1, 2025 Completion date: Dec 1, 2026 to Dec 1, 2027v7 Show 1 more changeShow less
    • Completion date: Dec 1, 2026 to Dec 1, 2027
  8. Site contact updatedv6
  9. Trial status: Not Yet Recruiting to Recruiting Start date: Nov 15, 2022 to Jan 1, 2023 · Study sites: 0 to 1v5 Show 2 more changesShow less
    • Start date: Nov 15, 2022 to Jan 1, 2023
    • Study sites: 0 to 1
  10. Start date: Sep 6, 2022 to Nov 15, 2022v4
  11. Start date: Aug 15, 2022 to Sep 6, 2022v3
  12. Start date: Jul 1, 2022 to Aug 15, 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05288452
Lead Sponsor University of Alabama at Birmingham
Collaborators: University of Mississippi Medical Center, Cooper Green Mercy Health Services, Pack Health, National Institute on Minority Health and Health Disparities (NIMHD)
Conditions Diabetes Mellitus, Type 2
Enrollment 304 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov