NCT Number: NCT06726083
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21201, United States
Location status: Recruiting
Elizabeth A Parker, PhD RD
PRINCIPAL_INVESTIGATOR
Jeffrey P Beans, BS
CONTACT
410-605-7000 ext. 4168
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: 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.
Time frame: 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
Time frame: 3 month and 6 month compared to baseline
The PROMIS Global Health (v1.2) consist of 10 items on a 5-pt Likert scale to measure an individual's physical (GPH) and mental health (GMH). The GPH score comprises 4 items on physical health, physical functioning, pain intensity, and fatigue. The GMH score includes 4 items on overall HRQoL, mental health, satisfaction with social activities/relationships, & emotional problems. Higher scores indicate better HRQoL.
Time frame: 3 month
Total and regional percentage body fat, absolute fat mass and fat-free mass will be measured using dual energy X-ray absorptiometry (DEXA).
Time frame: 3 month and 6 month compared to baseline
The MPPT is a nine-item standardized test used to identify frailty and mobility dysfunction in older individuals. It scores individuals on the time it takes to complete such tasks as donning and doffing a coat, picking a penny from the ground, and ascending the stairs. These scores are then summed out of 36 and scores of less than 32 indicate at least mild frailty.
Time frame: 3 month and 6 month compared to baseline
The FGA is a 10-item clinical gait test that is based on the dynamic gait index (DGI). It tests higher level dynamic gait activities that are part of daily functional mobility such as turning safely and ambulating backwards. Total scores ranging from 0 to 30 and scores below 22 are predictive of future falls.
Time frame: 3 month and 6 month compared to baseline
The FES-I is a 16-item self-reported tool that measures fear of falling when completing routine activities such as preparing a meal, going shopping, getting dressed, visiting with friends and family, and reaching up or bending down. The level of concern is measured on a four-point Likert scale (1=not at all concerned to 4=very concerned). It is scored from 16-64 points (high fear of falling >23 points)
Contact information is provided by the study sponsor or research team.
Elizabeth A Parker, PhD RD
CONTACT
(410) 605-7000 ext. 55393
Jeffrey P Beans, BS
CONTACT
(410) 605-7000 ext. 4168
VA Office of Research and Development
Fed
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07011446
Impaired Balance, Impaired Mobility
Pittsburgh, Pennsylvania, United States
View Trial Details