Family dyad-focused diabetes self-management intervention (FDSMI) for African American adults with type 2 diabetes: Study protocol

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-07-22 DOI:10.1016/j.cct.2025.108029

Jie Hu , Lorraine C. Mion , Alai Tan , Suzanne Bartle-Haring , Carla Miller , Joshua J. Joseph

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引用次数: 0

Abstract

Background

Type 2 diabetes is a major risk factor for serious long-term complications; African Americans (AAs) are especially vulnerable as compared to other racial groups. Multiple factors at individual, interpersonal, community, societal, and healthcare system levels contribute to greater difficulty in diabetes self-management. Social support can be a mediating factor.

Objective

We will examine a family-dyad-focused intervention to facilitate family support to promote diabetes self-management among middle-aged and older adult AAs with type 2 diabetes (T2D).

Methods

We propose a small phase I/II randomized controlled trial (RCT) using virtual group sessions to examine: (1) the feasibility, acceptability and preliminary efficacy of a 10-session dyad-focused diabetes intervention for AA adults with T2D and their family members; and (2) the associations of dyadic lifestyle behaviors and relationships to healthy behaviors and health outcomes over time in patients with T2D. We will recruit 208 AA adult participants (104 patient-family member dyads). Adults with diabetes and A1C > 7.0 % paired with their designated family members will be randomized 1:1 to the intervention or control arm (52 dyads per arm). Each dyad randomized to the intervention arm will receive 1) group sessions focusing on diabetes self-management, behavioral changes and strategies to cope with stress; 2) family dyadic-focused support component in each session; and 3) three individual family telephone feedback sessions. We will collect data at baseline, post-intervention (Month 3) and six-month post-intervention follow-up (Month 9).

Conclusion

Findings will provide foundational data to guide future implementation studies of family-dyad interventions for adult AAs with T2D.

Trial registration

ClinicalTrials.gov registry, NCT05905575.

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针对非裔美国成人2型糖尿病的以家族为中心的糖尿病自我管理干预（FDSMI）：研究方案

背景：2型糖尿病是严重长期并发症的主要危险因素；与其他种族群体相比，非洲裔美国人（AAs）尤其脆弱。个人、人际、社区、社会和卫生保健系统层面的多重因素导致糖尿病自我管理的难度加大。社会支持可能是一个中介因素。目的：我们将研究一种以家庭为中心的干预措施，以促进家庭支持，促进中老年2型糖尿病（T2D）的糖尿病自我管理。方法：我们提出了一项小型的I/II期随机对照试验（RCT），采用虚拟小组会议来检验：(1)对AA成年T2D及其家庭成员进行10次以双代为中心的糖尿病干预的可行性、可接受性和初步效果；(2) t2dm患者二元生活方式行为与健康行为和健康结局的关系。我们将招募208名AA成年参与者（104名患者-家庭成员对）。患有糖尿病和A1C > 7.0 %的成年人与其指定的家庭成员配对，将以1:1的比例随机分配到干预组或对照组（每组52对）。随机分配到干预组的每一组将接受1)小组会议，重点是糖尿病自我管理、行为改变和应对压力的策略；2)每次会议中以家庭为中心的支持组件；3)三个家庭电话反馈会议。我们将在基线、干预后（第3个月）和干预后6个月的随访（第9个月）收集数据。结论：研究结果将为指导未来成人AAs合并T2D的家庭双干预实施研究提供基础数据。试验注册：ClinicalTrials.gov注册中心，NCT05905575。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.