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Promoting Intergenerational Health in Rural Kentuckians With Diabetes (PIHRK'D) 75

募集中
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治験番号 NCT06080425 (PIHRK'D) は 介入研究 臨床試験 で、2型糖尿病 に関するものです。現在は 募集中 で、2023年9月1日 から開始しています。75 名の参加者 の募集が計画されています。この試験は The University of Texas Medical Branch, Galveston によって主導され、2026年5月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年1月9日 です。
概要

The goal of this feasibility study is to use family units as support to promote nutrition and physical activity of individuals with type 2 diabetes. The main question it aims to answer is:

• How does the family structure impact the health of its members living with type 2 diabetes?

Participants will be asked to;

  • Tell us about their access to food sources and places in the community to engage in physical activity...
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詳細説明
The proposed project is informed by the National Framework for Health Equity and Well Being, which was recently developed by the Cooperative Extension Service. This framework explicitly acknowledges the multiple levels of influence on health outcomes and the role of Cooperative Extension Service as a mitigator of community-level health inequities. The framework acknowledges factors that contribute to health inequitie...もっと見る
公式タイトル

Addressing Intergenerational Obesity and Promoting Healthy Eating and Physical Activity Among Individuals [PIHRK'D] Living With Diabetes in Rural Kentucky

疾患名
2型糖尿病
刊行物
この臨床試験について発表された科学記事と研究論文:
その他の研究識別子
  • PIHRK'D
  • 25-0225
  • 3048115811 (その他の助成金/資金番号) (American Diabetes Association)
NCT番号
開始日
2023-09-01
最終更新日
2026-01-09
終了予定日
2026-05-31
目標参加者数
75
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
主目的
支持療法
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし(非盲検)
群(アーム)/介入
参加グループ/群介入/治療法
その他Medical Nutrition Therapy
Medical Nutrition therapy is an intervention that will be administered to the participants for 6 months.
医療栄養療法
Counselling
主要評価項目
評価指標指標の説明時間枠
hemoglobin A1c values measured at the five post-baseline follow-up points
This is a test that measures average blood sugar levels over the past 3 months
baseline, 3 months, 6 months, 9 months and 12 months
body weight measured at the five post-baseline follow-up points
This is an indices used in the estimation of BMI
baseline, 3 months, 6 months, 9 months and 12 months
副次評価項目
評価指標指標の説明時間枠
Diabetes Knowledge
Diabetes knowledge of the participants will be assessed using a validated Diabetes Knowledge Questionnaire (DKQ). The DKQ is a 24-item questionnaire, designed by Starr County Diabetes Education Study, to elicit information about patients' understanding of the cause of their disease, its associated complications, blood glucose levels, diet, and physical activity. The DKQ has three response options "yes", "no", and "don't know". One point is awarded for each correct option, whereas, no point or negative scoring for the incorrect option. Its scoring involves summing-up the points obtained by each participant. A higher score represents better disease knowledge.
baseline, 3 months, 6 months, 9 months and 12 months
Diabetes self-management
Diabetes self-management/self-efficacy will be assessed using the Diabetes Empowerment Scale. Diabetes Empowerment Scale is a 28-item scale that measures diabetes-related psychosocial self-efficacy with an overall Cronbach's uses 3 subscales: Managing the Psychosocial Aspects of Diabetes, Assessing Dissatisfaction and Readiness to Change, and Setting and Achieving Diabetes Goals (Anderson et al, 2000). The questionnaires consist of 28 items with 3 subscales, with each item rated along a 5-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree). The range of score is divided in three subgroups as low (28-65 scores), middle (66-103) and high (104-140).
baseline, 3 months, 6 months, 9 months and 12 months
Dietary Intake
24-hour dietary will be used to estimate the dietary intake of the participants
baseline, 3 months, 6 months, 9 months and 12 months
Diabetes Distress
The Diabetes Distress Scale (DDS) is a 17-item scale that measures patient concerns about disease management, support, emotional burden and access to care. The response scale for each question ranges from "1" (not a problem) to "6" (a very serious problem). An average score of greater than or equal to 3 indicated moderate distress and discriminated between high and low distressed groups (Fisher et al, 2008)
baseline, 3 months, 6 months, 9 months and 12 months
参加アシスタント
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
  • must be diagnosed with type 2 diabetes
  • must be from rural Kentucky
  • must be living in rural Kentucky for at least 1 year

  • potential participants without consent
The University of Texas Medical Branch, Galveston logoThe University of Texas Medical Branch, Galveston
American Diabetes Association logoAmerican Diabetes Association
試験中央連絡先
連絡先: Kindness Akwari, (409)772-1011, [email protected]
1 1カ国の場所

Texas

University of Texas Medical Branch, Galveston, Galveston, Texas, 77566, United States
Kindness Setser, 連絡先, 409-772-1011, [email protected]
Brittany L. Smalls, PhD, MPH, 主任研究者
募集中