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Addressing Food Access and Physical Activity to Improve Diabetes Prevention Outcomes Among Underserved African Americans

24 aprile 2026 aggiornato da: Jenifer Allsworth, University of Missouri, Kansas City

The goal of this clinical trial is to learn if an enhanced, culturally, socially, and structurally tailored Diabetes Prevention Program (E-DPP) can improve weight loss and related diabetes risk factors in African American adults with prediabetes living in low-income, socially vulnerable communities.

The main questions it aims to answer are:

  • Does the enhanced DPP (E-DPP) lead to greater percent weight loss at 6 and 12 months compared to the standard culturally tailored DPP (S-DPP)?
  • How do social determinants (e.g., food insecurity, stigma, access to resources) influence weight loss and engagement in lifestyle behaviors?

Researchers will compare a standard culturally tailored DPP (S-DPP) to an enhanced DPP (E-DPP) to see if improving access to healthy food, physical activity, and community resources increases weight loss and improves diabetes-related outcomes.

Participants will

  1. Attend DPP sessions delivered in community settings (e.g., churches)
  2. Receive lifestyle education focused on diet, physical activity, and weight loss
  3. Engage in physical activity (including in-class exercise sessions [E-DPP only] and community-based options)
  4. Receive support for healthy eating, including food deliveries ([E-DPP only]), food selection guidance, and referrals to food assistance programs
  5. Receive information and support for accessing community resources for food and physical activity

Panoramica dello studio

Descrizione dettagliata

This study is a cluster-randomized clinical trial designed to evaluate the effectiveness of an enhanced, culturally, socially, and structurally tailored Diabetes Prevention Program (E-DPP) compared to a standard culturally tailored DPP (S-DPP) among African American adults with prediabetes residing in low-income, socially vulnerable communities. The trial will enroll approximately 408 participants across 12 community-based sites (churches), which will be randomized to deliver either S-DPP or E-DPP to minimize contamination across intervention conditions.

Both intervention arms are grounded in the evidence-based DPP lifestyle intervention and incorporate cultural tailoring strategies to improve relevance and acceptability in African American communities. The enhanced intervention builds upon this foundation by explicitly addressing multilevel social determinants that influence engagement in healthy eating and physical activity. Specifically, E-DPP integrates structural supports to improve access to healthy foods and safe, low-cost physical activity opportunities, alongside strategies to address social stigma related to obesity, poverty, and food insecurity.

The E-DPP includes additional components delivered during and between sessions. These include provision of fruits and vegetables during sessions, experiential activities focused on healthy food selection and budgeting, and facilitated linkage to community food resources such as food pantries and assistance programs. Physical activity support includes structured in-session exercise and guidance on accessing community-based physical activity programs. Participants in the E-DPP arm will also receive tailored text messaging designed to reinforce behavior change, promote utilization of community resources, and reduce stigma-related barriers to engagement.

The intervention is delivered over a 12-month period, with assessments conducted at baseline, 6 months, and 12 months. A community-engaged approach informs intervention design and implementation, ensuring alignment with local context and resources. The study is guided by theoretical frameworks that emphasize the role of social and structural determinants in shaping health behaviors and outcomes.

In addition to evaluating intervention effects, the study will examine potential mediators and moderators of weight loss, including social determinant-related stressors, access to resources, and psychosocial factors. A concurrent process evaluation will assess intervention fidelity, dose, participant engagement, acceptability, and feasibility, as well as cost-related considerations. These data will inform identification of key intervention components and support future scalability and dissemination of the enhanced program in underserved communities.

Tipo di studio

Interventistico

Iscrizione (Stimato)

408

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

    • Missouri
      • Kansas City, Missouri, Stati Uniti, 64108
        • University of Missouri-Kansas City
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Members of a participating church or user of a participating church's outreach services
  • Age 18 years or older
  • Prediabetic (score of 5 or higher in the National Diabetes Prevention Program Risk Score or ([body mass index > 24 or history of gestational diabetes] and (5.7-6.4 A1v, 100-125 mg/dL fasting plasma glucose, or 140-149 mg/dL oral glucose tolerance test)

Exclusion Criteria:

  • Individuals who are pregnant, breastfeeding or planning to become pregnant in the next year
  • Individuals with unsafe blood pressure levels (160 systolic or higher or 100 diastolic or higher) without a medical clearance firn
  • Individuals who are not able to engage in low-impact physical activity
  • Individuals who do not speak English
  • Individuals who live in a household with a participant in this study at a different church

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Standard Diabetes Prevention Program (S-DPP)
Standard DPP (S-DPP) is a 12-month, in-person lifestyle intervention based on the CDC PreventT2 curriculum, delivered by community peer coaches across 22 sessions (16 core, 6 maintenance). Coaches conduct pre-program outreach and a pre-session addressing diabetes disparities, goal setting, and attendance barriers. Each session includes weigh-ins with REDCap capture, review of self-monitoring logs for diet, activity, and goals, and guided delivery of the curriculum. Participants receive Wi-Fi scales and fitness trackers to support weight loss and physical activity tracking. Certain sessions provide information on local, low- or no-cost food and physical activity resources to support and maintain behavior change.
This intervention adapts the CDC PreventT2 Diabetes Prevention Program into two 12-month delivery models led by community peer coaches with student support across 22 sessions (16 core, 6 maintenance). Both arms include pre-program outreach, a pre-session addressing diabetes disparities, goal setting and barrier identification, structured sessions with weigh-ins captured in REDCap, review of self-monitoring logs, and guided curriculum delivery. Participants use Wi-Fi scales and fitness trackers to support behavior change. The enhanced arm adds tailored text messaging, resource navigation, food access supports, and culturally tailored physical activity to address barriers and improve engagement and sustainability.
Sperimentale: Enhanced Diabetes Prevention Program (E-DPP)
Enhanced DPP (E-DPP) is a 12-month intervention based on the CDC PreventT2 curriculum that integrates digital tools, community resources, and culturally tailored supports across 22 sessions (16 core, 6 maintenance). Coaches conduct pre-program outreach and a pre-session addressing diabetes disparities, goal setting, and attendance barriers. Sessions include weigh-ins with REDCap capture, review of self-monitoring logs, and guided curriculum delivery. Participants receive Wi-Fi scales and fitness trackers and access tailored text messages with DPP content and resource links. Coaches provide additional messaging support. The model also includes in-class healthy food distribution and culturally tailored physical activity sessions, as well as information on local low- or no-cost resources to support sustained behavior change.
This intervention adapts the CDC PreventT2 Diabetes Prevention Program into two 12-month delivery models led by community peer coaches with student support across 22 sessions (16 core, 6 maintenance). Both arms include pre-program outreach, a pre-session addressing diabetes disparities, goal setting and barrier identification, structured sessions with weigh-ins captured in REDCap, review of self-monitoring logs, and guided curriculum delivery. Participants use Wi-Fi scales and fitness trackers to support behavior change. The enhanced arm adds tailored text messaging, resource navigation, food access supports, and culturally tailored physical activity to address barriers and improve engagement and sustainability.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Weight loss
Lasso di tempo: Baseline, 6 months, 12 months
Percent weight loss measured as percent change in weight (in pounds) from baseline at 6 and 12 months
Baseline, 6 months, 12 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Nutrition security
Lasso di tempo: Baseline, 6 months, 12 months
Self-reported nutrition security
Baseline, 6 months, 12 months
Dietary intake
Lasso di tempo: Baseline, 6 months, 12 months
Self-reported dietary quality that assesses alignment with US dietary guidelines
Baseline, 6 months, 12 months
DPP Attendance
Lasso di tempo: 6 months
Number of DPP sessions attended
6 months
Physical activity (subjective)
Lasso di tempo: Baseline, 6 months, 12 months
Self-reported physical activity
Baseline, 6 months, 12 months
Physical activity (objective)
Lasso di tempo: Baseline, 6 months
Physical activity measured by accelerometer
Baseline, 6 months
Use of community resources for food access
Lasso di tempo: Baseline, 6 months, 12 months
Self-reported use of food access community resources
Baseline, 6 months, 12 months
Use of community resources for physical activity
Lasso di tempo: Baseline, 6 months, 12 months
Self-reported use of physical activity community resources
Baseline, 6 months, 12 months
Blood pressure
Lasso di tempo: Baseline, 6 months, 12 months
Measured systolic and diastolic blood pressure
Baseline, 6 months, 12 months
Glycosylated hemoglobin
Lasso di tempo: Baseline, 6 months, 12 months
Measured A1c categorized via American Diabetes Association guidelines
Baseline, 6 months, 12 months
Food security
Lasso di tempo: Baseline, 6 months, 12 months
Self-reported measure of household food security
Baseline, 6 months, 12 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Jenifer E Jenifer, PhD, University of Missouri, Kansas City

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

4 gennaio 2027

Completamento primario (Stimato)

28 febbraio 2031

Completamento dello studio (Stimato)

28 febbraio 2031

Date di iscrizione allo studio

Primo inviato

24 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 aprile 2026

Primo Inserito (Effettivo)

1 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano IPD

De-identified study data for participants will be shared in an NIH-approved repository or made available by request from the PIs.

Periodo di condivisione IPD

Data will be shared within 12 months of study completion.

Criteri di accesso alla condivisione IPD

De-identified data will be available to researchers who sign a data use agreement.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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