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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Jenifer E Allsworth, PhD
- 電話番号:816-235-1781
- メール:allsworthj@umkc.edu
研究連絡先のバックアップ
- 名前:Jannette E Berkley-Patton, PhD
- 電話番号:816-235-1781
- メール:berkleypattonj@umkc.edu
研究場所
-
-
Missouri
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Kansas City、Missouri、アメリカ、64108
- University of Missouri-Kansas City
-
コンタクト:
- Jenifer E Allsworth, PhD
- 電話番号:816-235-1781
- メール:allsworthj@umkc.edu
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ: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.
|
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実験的: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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Weight loss
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Nutrition security
時間枠: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
時間枠: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
時間枠:6 months
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Number of DPP sessions attended
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6 months
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Physical activity (subjective)
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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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協力者と研究者
協力者
捜査官
- 主任研究者:Jenifer E Jenifer, PhD、University of Missouri, Kansas City
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2130354
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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