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

5 juin 2026 mis à jour par: 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

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

408

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Jenifer E Allsworth, PhD
  • Numéro de téléphone: 816-235-1781
  • E-mail: allsworthj@umkc.edu

Sauvegarde des contacts de l'étude

Lieux d'étude

  • États-Unis
    • Missouri
      • Kansas City, Missouri, États-Unis, 64108
        • University of Missouri-Kansas City
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Comportemental: Culturally-tailored, enhanced adaption of Diabetes Prevention Program
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.
Expérimental: 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.
Comportemental: Culturally-tailored, enhanced adaption of Diabetes Prevention Program
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Weight loss
Délai: 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

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Missouri, Kansas City

Collaborateurs

San Diego State University
Children's Mercy Hospital Kansas City
University of Massachusetts, Amherst
University of Kansas

Les enquêteurs

  • Chercheur principal: Jenifer E Jenifer, PhD, University of Missouri, Kansas City

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

4 janvier 2027

Achèvement primaire (Estimé)

28 février 2031

Achèvement de l'étude (Estimé)

28 février 2031

Dates d'inscription aux études

Première soumission

24 avril 2026

Première soumission répondant aux critères de contrôle qualité

24 avril 2026

Première publication (Réel)

1 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2130354

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Délai de partage IPD

Data will be shared within 12 months of study completion.

Critères d'accès au partage IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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