A Study of Brenipatide (LY3537031) Comparing Two Formulations in Healthy Adults

Participants assigned to this single-arm intervention will receive a culturally tailored, church-based foot health program delivered over 4-6 weeks. The program includes three structured educational sessions addressing diabetes-related foot complications, preventive foot care, recognition of warning signs, and healthcare navigation. Participants will also receive standardized foot risk screening, including sensory and vascular assessments when indicated, and facilitated referral to appropriate clinical services based on screening findings. Patient navigation will support referral coordination and follow-up. Participants will be assessed for completion of guideline-concordant foot evaluations within three months of enrollment.

A culturally tailored, church-based intervention integrating structured foot health education, standardized foot risk screening, and facilitated clinical referral for Black adults with diabetes. The intervention includes three interactive educational sessions delivered over 4-6 weeks covering diabetes-related foot complications, daily foot self-examination, preventive care, recognition of warning signs, and healthcare navigation. Participants undergo foot risk screening, including visual inspection, sensory testing, pedal pulse assessment, and ankle-brachial index measurement when indicated. Individuals requiring additional evaluation receive facilitated referrals supported by patient navigation, including care coordination and follow-up to assess completion of recommended foot evaluations.

The proportion of enrolled participants who complete a guideline-concordant foot evaluation within three months of baseline screening. A qualifying evaluation includes a podiatry visit, comprehensive primary care diabetic foot examination with documented risk stratification, wound clinic visit, or vascular evaluation when clinically indicated. Completion will be determined through participant self-report, referral tracking logs, and medical record confirmation when available. The outcome will be calculated as the number of participants completing a qualifying evaluation divided by the total number of enrolled participants, expressed as a percentage.

Change in foot health knowledge will be measured using a study-specific questionnaire assessing recognition of diabetic foot warning signs, appropriate care-seeking, daily foot self-examination, preventive footwear practices, and common misconceptions. Scores will be compared across assessment time points, with higher scores indicating greater knowledge.

Change in foot self-care behaviors will be assessed using the foot-care subscale of the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire or an equivalent measure. Behaviors assessed include daily foot inspection, appropriate footwear use, avoidance of walking barefoot, and timely reporting of foot problems. Scores will be compared between baseline and three-month follow-up, with higher scores indicating greater adherence to recommended foot self-care practices.

The proportion of enrolled participants who complete a standardized baseline foot risk assessment at a participating church event or linked clinical site. Screening completion will be documented using study assessment records. The measure will be calculated as the number of participants completing the assessment divided by the total number enrolled, expressed as a percentage.

Among participants classified as Tier 2 or Tier 3 based on standardized foot risk screening and referred for additional clinical evaluation, the proportion who complete the recommended evaluation within three months of baseline screening. Referral completion will be assessed using patient navigation records, participant self-report, and clinical documentation when available. The denominator will include all participants receiving a qualifying referral.

Change in participants' confidence in performing daily foot self-examinations, recognizing warning signs, and seeking appropriate professional care will be assessed using study-specific Likert-scale items or a validated self-efficacy instrument. Scores will be compared at baseline, immediately following the educational intervention, and at three-month follow-up. Higher scores will indicate greater confidence in managing foot health.