NCT06726083

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
48mo left

Started Apr 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Mar 2030

First Submitted

Initial submission to the registry

December 5, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2024

Completed
1.3 years until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2030

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

4 years

First QC Date

December 5, 2024

Last Update Submit

January 6, 2026

Conditions

Keywords

diet quality

Outcome Measures

Primary Outcomes (2)

  • Diet quality

    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.

    3 month and 6 month compared to baseline

  • Social Isolation

    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

    3 month and 6 month compared to baseline

Secondary Outcomes (5)

  • 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

Study Arms (2)

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

Behavioral: Nutrition Intervention

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

Behavioral: Contact Control

Interventions

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

Nutrition Intervention
Contact ControlBEHAVIORAL

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

Contact Control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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'

You may not qualify if:

  • uncontrolled diabetes mellitus or chronic kidney disease
  • contraindications to a nutrition intervention including physician prescribed diet (e.g. renal diet)
  • dementia (on medical record review or a mini-mental status exam score \<24)
  • currently participating in a diet or weight loss intervention
  • behavior that prevents group interaction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Elizabeth A Dennis, PhD RD

    Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey P Beans, BS

CONTACT

Elizabeth A Dennis, PhD RD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor will be blinded to study participant group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial with an intervention group compared to a control group
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2024

First Posted

December 10, 2024

Study Start

April 1, 2026

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

March 31, 2030

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations