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临床试验/NCT06726083
NCT06726083招募中不适用

Improving Dietary Quality and Social Engagement Through a Virtual Nutrition and Teaching Kitchen Intervention Among Older Veterans With Impaired Mobility

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2026年3月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
180
试验地点
2
主要终点
Diet quality

研究概览

简要总结

Compared to non-Veterans, Veterans demonstrate an increased risk for obesity and multimorbidity. Thus, interventions to improve overall health are warranted in this population. Healthy diets that include fruits and vegetables are linked to a reduced risk of chronic disease including mobility disability, and are associated with higher muscle mass, strength and physical performance potentially slowing further disability progression later in life. The investigators will determine if a three-month virtual group nutrition intervention paired with produce delivery and virtual teaching kitchen cooking demonstrations tailored for older Veterans with impaired mobility will improve diet, health-related quality of life and muscle strength.

详细描述

There are >8 million older Veterans (>65 years) in the United States, and nearly half of them self-report having a disability such as impaired mobility that impacts their ability to perform self-care. Among older Veterans with mobility disability, common self-care tasks like food shopping, meal preparation, and cooking are barriers to consuming a healthy diet, resulting in poor dietary intake. Poor dietary intake contributes to chronic disease risk and loss of muscle mass and strength, consequently limiting function and increasing immobility. Teaching older Veterans with impaired mobility how to overcome barriers limiting these diet-related self-care tasks provides an opportunity to significantly impact this group's dietary intake. Lack of social support has also been associated with negative health outcomes and poor nutritional intake; thus, effective, age-friendly intervention strategies to improve dietary quality as a strategy to delay further progression of disability and maintain functional independence among this population are needed.

In this randomized controlled trial, the investigators will determine if a 3-month virtual group nutrition intervention paired with produce delivery and virtual teaching kitchen cooking demonstrations tailored for older Veterans will improve diet and functional mobility. The overarching hypothesis is that virtual group nutrition education classes and cooking demos, personalized to include considerations of this population's physical limitations, age-related taste changes and technological barriers, will result in favorable improvements in dietary quality and functional mobility while promoting social interaction.

Specific Aim 1: determine the impact of the virtual intervention paired with produce delivery and virtual cooking demonstrations on objective measures of diet quality compared to contact control among a diverse sample of older Veterans with impaired mobility. Additionally, the investigators will assess the sustained effects of the program on dietary quality at a 6-month follow-up, 3-months after the virtual intervention ends. If no treatment effects are observed at the end of the 3-month intervention, the investigators will explore reasons why the intervention was ineffective.

Specific Aim 2: determine the impact of the 3-month virtual nutrition intervention on measures of social isolation, health-related quality of life and mental health using validated questionnaires.

Specific Aim 3: determine associations with changes in dietary quality and frailty-related physical function outcomes and body composition among those who benefit from a virtual nutrition education and cooking program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The outcomes assessor will be blinded to study participant group assignment.

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Veterans >65 years with reduced gait speed (gait speed <1.0 m/s) or elevated four square step test
  • •use of an assistive device who also indicate that they would like to improve their eating habits, defined by response of <3 on a scale of 1 to 5 to the question, 'Do you consider your eating habits to be healthy'

排除标准

  • •Uncontrolled diabetes mellitus (HbA1c >10) or Current renal replacement therapy (e.g. dialysis)
  • •Other medical condition precluding patient participation in this study as per medical judgment of study team
  • •dementia as self-reported or found on medical record review
  • •currently participating in a diet or weight loss intervention
  • •Volatile behavior issues or unable to work successfully in a group environment/setting

研究组 & 干预措施

Nutrition Intervention

Experimental

Weekly virtual live group sessions led by a trained study team member will be held twice weekly for 1 hour/week over 12 weeks using a HIPAA compliant online platform. The first class of each week will include the teaching kitchen cooking demonstration (~30 min) and the remainder of the class will focus on dietary education. The second class each week will provide an opportunity for group discussion to have Veterans share to their peers about how they used the weekly produce

干预措施: Nutrition Intervention (Behavioral)

Contact Control

Active Comparator

Weekly virtual live group health education sessions led by staff will be held for two hours/week over 12 weeks. We will enroll up to 15 participants into each virtual class cohort and run multiple different group sessions for a total sample size of 90 participants. The content follows the LIFE study structured successful aging health education curriculum80,81 which was designed to increase self-efficacy and empower older Veterans to take control of their own healthcare. Topics focus on a broad range of healthy aging, such as importance of sleep, safe travel, goal setting, self-care, and common comorbidities

干预措施: Contact Control (Behavioral)

结局指标

主要结局

Diet quality

时间窗: 3 month and 6 month compared to baseline

Habitual dietary intake will be assessed using three 24-h recalls via the online Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool, version (2022), developed by the National Cancer Institute, Bethesda, MD. The dietary recalls will be used to calculate diet quality using the HEI; scores range from 0 to 100; higher scores indicate better adherence to the Dietary Guidelines for Americans.

Social Isolation

时间窗: 3 month and 6 month compared to baseline

The Lubben Social Network Scale, is a 12-item scale to assess self-reported social engagement including family and friends (Cronbach's =0.70). The total score is calculated by finding the sum of the all items. The score ranges between 0 and 60, with a higher score indicating more social engagement. The UCLA Loneliness Scale is a 20-item scale to measure subjective feelings of loneliness \& social isolation (Cronbach's 0.89\<0.94). Using a 4-point rating scale (1= never; 4 = always), participants answer 20 questions, such as "How often do you feel left out?" and "How often do you feel part of a group of friends?" Researchers later reverse-code the positively worded items so that high values mean more loneliness, and then calculate a score for each respondent by averaging their ratings. Both measures are included because they assess complementary but separate constructs

次要结局

  • Health-related Quality of Life(3 month and 6 month compared to baseline)
  • Body Composition(3 month)
  • Modified Physical Performance Test (MPPT)(3 month and 6 month compared to baseline)
  • Functional Gait Assessment (FGA)(3 month and 6 month compared to baseline)
  • Falls-Efficacy Scale-International (FES-I)(3 month and 6 month compared to baseline)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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