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临床试验/NCT06173804
NCT06173804已完成不适用

A Senior Center-Based Multilevel Lifestyle Intervention to Improve Physical Function in Older Adults With Type 2 Diabetes (RESILIENT)

The University of Texas Health Science Center at San Antonio1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年7月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Feasibility of conducting study

研究概览

简要总结

The purpose of this study is to explore strategies to effectively implement senior-center-based multilevel lifestyle interventions adapted from evidence-based lifestyle interventions to promote physical function and quality of life in diverse older adults with Type 2 Diabetes (T2D).

详细描述

Aim 1: Work with community stakeholders including individuals with T2D, family members, and senior center staff to adapt evidence-based lifestyle interventions, and develop implementation strategies.

Aim 2: Conduct a senior-center-based 6-month pre- and post-pilot study and collect recruitment, enrollment, retention rate, fidelity, program satisfaction and experience, and stakeholder acceptance using quantitative and qualitative data.

Aim 3: Assess the preliminary health-related responses to the intervention in older adults with T2D in the 6-month trial.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults aged ≥60 years
  • •Self-reported T2D diagnosis with verification from a health report
  • •Live within the census tract of the selected senior center, or a member of the senior center
  • •No significant cognitive impairment as defined by MMSE (score≥20) (46) which may influence diabetes self-management
  • •Can speak and understand either English or Spanish
  • •Agree to participate in the study procedures

排除标准

  • •Severe chronic conditions without physician's permission to participate (e.g., severe heart disease and end-stage renal disease);
  • •Unwillingness to sign the consent form; and
  • •Enrollment in other diabetes management programs

研究组 & 干预措施

Lifestyle intervention group

Experimental

The study team will assess improvements in physical function assessed by the short physical performance battery and other health-related measures (diabetes knowledge, self-efficacy, social support, physical activity, diet consumption, HbA1c, and quality of life).

干预措施: Adapted Look Ahead Lifestyle Intervention (Other)

结局指标

主要结局

Feasibility of conducting study

时间窗: Baseline, 3, 6, and 12 months

Feasibility refers to how feasible to conduct the study. In this study, feasibility will be assessed by data such as participant recruitment, enrollment, education session attendance, and retention rate.

Acceptability

时间窗: Baseline, 3, 6, and 12 months

Acceptability refers to how well an intervention will be received by the target population and the extent to which an intervention might meet the needs of the target population. Acceptability will be assessed through qualitative interview with participants to explore their experience, and perceptions with the intervention.

次要结局

  • Glycated Hemoglobin (HbA1c)(Baseline, 3, 6, and 12 months)
  • Short Physical Performance Battery (SPPB)(Baseline, 3, 6, and 12 months)
  • Body Weight(Baseline, 3, 6, and 12 months)
  • Systolic Blood Pressure(Baseline, 3, 6, and 12 months)
  • Diastolic Blood Pressure(Baseline, 3, 6, and 12 months)
  • Grip Strength(Baseline, 3, 6, and 12 months)
  • Lipid profile(Baseline, 3, 6, and 12 months)
  • IPAQ-12(Baseline, 3, 6, and 12 months)
  • MoCA(Baseline, 3, 6, and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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