Addressing Food Access and Physical Activity to Improve Diabetes Prevention Outcomes Among Underserved African Americans
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
- Attend DPP sessions delivered in community settings (e.g., churches)
- Receive lifestyle education focused on diet, physical activity, and weight loss
- Engage in physical activity (including in-class exercise sessions [E-DPP only] and community-based options)
- Receive support for healthy eating, including food deliveries ([E-DPP only]), food selection guidance, and referrals to food assistance programs
- Receive information and support for accessing community resources for food and physical activity
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Jenifer E Allsworth, PhD
- 전화번호: 816-235-1781
- 이메일: allsworthj@umkc.edu
연구 연락처 백업
- 이름: Jannette E Berkley-Patton, PhD
- 전화번호: 816-235-1781
- 이메일: berkleypattonj@umkc.edu
연구 장소
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Missouri
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Kansas City, Missouri, 미국, 64108
- University of Missouri-Kansas City
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연락하다:
- Jenifer E Allsworth, PhD
- 전화번호: 816-235-1781
- 이메일: allsworthj@umkc.edu
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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.
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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.
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실험적: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Weight loss
기간: Baseline, 6 months, 12 months
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Percent weight loss measured as percent change in weight (in pounds) from baseline at 6 and 12 months
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Baseline, 6 months, 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Nutrition security
기간: Baseline, 6 months, 12 months
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Self-reported nutrition security
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Baseline, 6 months, 12 months
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Dietary intake
기간: Baseline, 6 months, 12 months
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Self-reported dietary quality that assesses alignment with US dietary guidelines
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Baseline, 6 months, 12 months
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DPP Attendance
기간: 6 months
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Number of DPP sessions attended
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6 months
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Physical activity (subjective)
기간: Baseline, 6 months, 12 months
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Self-reported physical activity
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Baseline, 6 months, 12 months
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Physical activity (objective)
기간: Baseline, 6 months
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Physical activity measured by accelerometer
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Baseline, 6 months
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Use of community resources for food access
기간: Baseline, 6 months, 12 months
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Self-reported use of food access community resources
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Baseline, 6 months, 12 months
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Use of community resources for physical activity
기간: Baseline, 6 months, 12 months
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Self-reported use of physical activity community resources
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Baseline, 6 months, 12 months
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Blood pressure
기간: Baseline, 6 months, 12 months
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Measured systolic and diastolic blood pressure
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Baseline, 6 months, 12 months
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Glycosylated hemoglobin
기간: Baseline, 6 months, 12 months
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Measured A1c categorized via American Diabetes Association guidelines
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Baseline, 6 months, 12 months
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Food security
기간: Baseline, 6 months, 12 months
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Self-reported measure of household food security
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Baseline, 6 months, 12 months
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Jenifer E Jenifer, PhD, University of Missouri, Kansas City
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2130354
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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