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Impaired MobilityNIFOA-RTNCT07898085

Nutrition Intervention for Older Adults and Research Training

A study testing Nutrition Intervention in people with Impaired Mobility, run by University of Maryland, Baltimore at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Lack of effective interventions to improve diet quality among older urban adults represents a significant health problem. Simultaneously, enhancing the biomedical workforce is needed to meet growing US demands in research and science fields to address disparities in chronic disease outcomes. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Impaired Mobility
What is being tested?
Nutrition Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteUnited States
Study dates
27 Nov 2026to 31 Mar 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Age 65 and older
  • Access to an internet-accessible device
  • Lives in a healthy food priority area (locations with low access to healthy food, low median household income (at/below 185% of federal poverty level), high rates of vehicle-free households (over 30%), and a distance of more than 1/4 mile to a supermarket)

Who cannot join

  • 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
  • Currently participating in a diet or weight loss intervention
  • Volatile behavioral issues or unable to work successfully in a group environment/setting

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ranyah Almardawi, M.B.B.S, M.P.H contact

410

ralmardawi@som.umaryland.edu

Elizabeth Dennis, PhD, RD contact

elizabeth.dennis@som.umaryland.edu

United States1 site
  • University of Maryland

    Baltimore, Maryland, 21201

    Ranyah Almardawi, MBBS, MPH, 410, ralmardawi@som.umaryland.edu

Other trials in United States

About this study

Official title: Empowering Baltimore Youth Through Applied Research Experiences to Improve Diet Quality in Older Adults Living in Healthy Food Priority Areas

Lack of effective interventions to improve diet quality among older urban adults represents a significant health problem. Simultaneously, enhancing the biomedical workforce is needed to meet growing US demands in research and science fields to address disparities in chronic disease outcomes. This project meets these demands by expanding research training opportunities for younger students to build confidence and self-efficacy that they belong in an academic research environment, while providing a relatively low-cost nutrition intervention to disseminate to help narrow these gaps.

Read the detailed description

Certain populations are disproportionately affected by nutrition-related chronic diseases. In Baltimore, disparities in healthy food access contribute to poor dietary intake. One-third of Black residents and nearly 25% of older adults live in Healthy Food Priority Areas (HFPA), urban areas where the availability of unhealthy foods exceeds that of healthy foods. Common self-care tasks like food shopping, meal preparation, and cooking can also be barriers to a healthy diet. Poor dietary intake contributes to chronic disease risk and loss of muscle mass and strength, resulting in frailty and impaired functional mobility. Impaired functional mobility impacts >11 million community-dwelling older adults,5 with related complications resulting in an important public health concern. Improving diet by increasing healthy food access and teaching older adults to address barriers limiting diet-related self-care tasks is important to maintain functional independence.

Ensuring that the next generation of researchers reflects the population is essential to address all aspects of disparities, but there is a need to engage students at early education levels. UMB RAMP is a summer research training program that exposes high school (HS) students to translational research concepts and teaches basic lab techniques and clinical skills. Pilot data demonstrate a positive impact on HS students' research career interest, but year-round paid experiences to engage and mentor these students in research labs are lacking for this age group. Additional research is needed to assess the longer-term impact of applied research experiences on the HS students' overall perceptions of research as a professional occupation and matriculation to biomedical science/STEM fields.

Our preliminary data demonstrate feasibility and older adult participant satisfaction of implementing in-person and virtual group nutrition classes with optional participation in a free farmer's market as a strategy to improve dietary quality. In this proposed randomized controlled trial, we will build upon that data to determine if a 3-month virtual group nutrition education and virtual teaching kitchen cooking demonstrations paired with free produce (NUT) tailored for older adults (>65 yrs) living in HFPA will improve diet and health-related outcomes compared to contact control (CON). Our overarching hypothesis is that this intervention, inclusive of attention to this older adult population's barriers to consuming a healthy diet, will improve dietary quality and functional mobility while providing an applied clinical and aging-focused research experience for HS students. As paid research assistants, UMB RAMP students will be integral to this project's delivery.

Objectives are presented at the RCT intervention participant level and the student trainee/staff level.

RCT intervention participant objectives:

One part of the study seeks to determine the impact of the randomized controlled trial intervention on health-related outcomes of older adult participants.

Aim 1: To determine differences in diet quality between the NUT and CON group at 3- month post-randomization. We hypothesize higher diet quality scores (Healthy Eating Index via three 24-hr diet recalls) after 3 months in NUT compared to CON (N= 90/group).

Aim 2: To determine differences in key metabolic health outcomes (blood pressure; lipids; hemoglobin A1C) and functional mobility (via functional assessments; questionnaires) at 3-month post-randomization. We hypothesize greater improvements in metabolic and functional outcomes after 3 months in NUT versus CON.

Aim 3. To determine the sustained effects on primary and secondary outcomes at 6 months post-randomization. If no treatment effects are observed 6 months post-randomization, we will conduct focus groups to explore barriers and facilitators of the intervention.

Student trainee/staff level objectives:

One part of our study seeks to assess the impact of participating in a paid research internship on the high school students' trajectory in STEM fields, and is not a clinical trial.

Aim 1: To determine the impact of participation in a year-long applied research opportunity on HS students using a mixed-methods approach. 1a. Quantitatively, we will track student matriculation to undergraduate STEM majors and future participation in structured research programs. We hypothesize that students in this program will matriculate to undergraduate STEM majors and engage in research opportunities within the first two years of college. 1b. Qualitative interviews will explore students' sense of belonging, confidence, and motivation for pursuing undergraduate/career research experiences, and perceptions about both the aging field and the community impact of their research experience. We hypothesize that introducing them to shifting demographics, mobility issues, and increasing awareness of the impact of chronic conditions and barriers to healthy nutrition could also broaden their perspective about research areas and disparities in aging fields.

One part seeks to assess the staff and older adult participants' perceptions of working with younger students. This is also not a clinical trial.

Exploratory Aim: To explore the impact of tri-generational research engagement, from the perceptions of research staff and older research participants working with HS students through the intervention. We will explore perceived impact from the older adult research participants related to working with young student researchers and how it may change their perceptions of research through qualitative interviews. Staff will complete a pre/post survey related to their perceived mentorship self-efficacy to help us refine HS student roles in this setting

Being tested
Nutrition Intervention, Contact Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutrition InterventionBehavioural

    A trained study team member will lead weekly virtual live group sessions once a week for 1 hour over 12 weeks. The first part of class each week will include the teaching kitchen cooking demonstration, and the remainder of the class will focus on dietary education. We will enroll up to 15 participants in a virtual cohort and run multiple different group sessions for 90 participants.

  • Contact ControlBehavioural

    Staff will lead weekly virtual live group health education sessions for one hour/week over 12 weeks. We will enroll up to 15 participants in each virtual class cohort and run multiple different group sessions for a total sample size of 90 participants. Health education sessions are designed to increase self-efficacy and empower older adults to take control of their own healthcare. Topics cover a broad range of healthy aging, including the importance of sleep, goal setting, self-care, and common comorbidities.

Study groups in NCT07898085
Study groupRoleWhat they receive
Nutrition InterventionExperimentalA trained study team member will lead weekly live virtual group sessions for 1 hour over 12 weeks using a HIPAA-compliant online platform. The first part of each week's class will include the teaching kitchen cooking demonstration (~30 min), and the remainder of the class will focus on dietary education. We will hold weekly meetings with the study staff to ensure standardized data collection and intervention implementation. We will enroll up to 15 participants in a virtual cohort and run multiple group sessions to reach a sample size of 90 participants. Follow-up focus groups will provide key information on intervention sustainability and discern barriers and facilitators to virtual intervention implementation and continued adherence after intervention completion.
Receives: Behavioral: Nutrition Intervention
Contact ControlActive comparatorStaff will lead weekly virtual live group health education sessions for one hour/week over 12 weeks. We will enroll up to 15 participants in each virtual class cohort and run multiple different group sessions for a total sample size of 90 participants. Health education sessions are designed to increase self-efficacy and empower older adults to take control of their own healthcare. Topics cover a broad range of healthy aging, including the importance of sleep, goal setting, self-care, and common comorbidities.
Receives: Behavioral: Contact Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dietary quality

    Habitual dietary intake (energy, fat, added sugar, and fiber intakes; fruit and vegetable intakes) will be assessed using three 24-hour recalls using the online Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool, version (2020), developed by the National Cancer Institute, Bethesda, MD. A registered dietitian will collect recalls within a two-week period. The dietary recall will be used to calculate diet quality using the HEI. The score ranges from 0 to 100; higher scores indicate better adherence to the Dietary Guidelines for Americans.

    Measured: Baseline, 3 months, and 6 months

Secondary outcomes (9)
  1. Mobility and balance

    The Functional Gait Assessment (FGA) will be used to measure mobility and balance. 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 backward. Total scores range from 0 to 30, and scores below 22 are predictive of future falls

    Measured: Baseline, 3 months, and 6 months

  2. Metabolic health outcomes

    We will measure biomarkers of dietary changes(lipid profile; hemoglobin A1C) and cardiometabolic risk factors. We may measure new hormones, inflammatory proteins, and other biomarkers as new technologies for measuring diet- and muscle-health biomarkers emerge.

    Measured: Baseline, 3 months, and 6 months

  3. Physical function

    The Modified Physical Performance Test (MPPT) will assess function. 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 tasks such as donning and doffing a coat, picking a penny from the ground, and ascending the stairs. These scores are summed out of 36, and scores below 32 indicate at least mild frailty.

    Measured: Baseline, 3 months and 6 months

  4. Blood pressure

    Resting blood pressure will be measured in the seated position using a mercury sphygmomanometer after a 15-min period of rest.

    Measured: Baseline, 3 months, and 6 months

  5. Body Mass Index (BMI)

    1. Height will be measured by a stadiometer to the nearest ¼ inch without shoes.
    2. Body weight will be measured to the nearest ½ pound in light clothing without shoes using a beam balance scale.
    3. BMI= Weight (kg) / Height (m2)

    Measured: Baseline, 3 months, and 6 months

  6. Waist circumference

    Measure waist circumference with a standard tape measure.

    Measured: Baseline, 3 months, and 6 months

  7. Grip strength

    Grip strength: maximal isometric contraction of the biceps muscle measured with a hand dynamometer.

    Measured: Baseline, 3 months, and 6 months

  8. Gait speed

    Gait speed: the time it takes to walk 10 m at a normal/usual walking pace.

    Measured: Baseline, 3 months, and 6 months

  9. Falls-Efficacy Scale-International (FES-I)

    The FES-I is a 16-item self-report tool that measures fear of falling during routine activities such as preparing a meal, going shopping, getting dressed, visiting 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 to 64 points (high fear of falling >23 points).

    Measured: Baseline, 3 months, and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2026
  2. Study start27 Nov 2026 (estimated)
  3. Primary completion31 Mar 2030 (estimated)
  4. Study completion31 Mar 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial with an intervention group compared to a control group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07898085
Sponsor's protocol ID
HP-00118569
Other IDs
R01NR021713
Acronym
NIFOA-RT
Status last verified
Oct 2026
First submitted
13 Oct 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vasanth Kumar AB, McGinnis GG, Jones L, Hager ER, Wright SL, Felter C, Carey G, Hassel B, Livingston AW, Parker EA. A Feasibility Study Describing the Successes and Challenges of Implementing a Virtual Community Health Worker Training Among High School Students Participating in a Summer STEM Enrichment Program. J STEM Outreach. 2024;7(1):10.15695/jstem/v7i1.01. doi: 10.15695/jstem/v7i1.01. Epub 2024 Jan 22.

    PubMed 39329087

Questions about this trial

What is this clinical trial studying?

A study testing Nutrition Intervention in people with Impaired Mobility, run by University of Maryland, Baltimore at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ranyah Almardawi, M.B.B.S, M.P.H (410, ralmardawi@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dietary quality (time frame: Baseline, 3 months, and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07898085, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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