RECRUITING

SUSTAIN: Behavior Change and Nutrition Security for CKMS

Conditions

Stage 2 Cardiovascular-Kidney-Metabolic Syndrome Cardiovascular Disease Other CKMS Cardiometabolic Health Cardiovascular-Kidney-Metabolic Health Cardiovascular-Kidney-Metabolic Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To determine the feasibility and engagement of participants in the SUSTAIN intervention compared to enhanced usual care over 24 weeks through mixed-methods measurement of participant enrollment, adherence, retention, and engagement (counseling, screenings, referrals, and uptake). Methods: Leveraging rigorous quantitative and qualitative evaluation, the study team will identify mechanisms driving intervention feasibility and engagement. Hypothesis: SUSTAIN will be feasible with a high degree of engagement among Medicaid-enrolled participants with Stage 2 CKMS in comparison to enhanced usual care.

Official Title

SUSTAIN: Promoting Sustained Behavior Change and Nutrition Security in Medicaid-Enrolled Individuals With Stage 2 Cardiovascular-Kidney-Metabolic Syndrome (CKMS)

Quick Facts

Study Start:2024-08-26

Study Completion:2025-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06589336

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients must be Medicaid enrolled, and/or dual enrolled in Medicaid * Patients must be diagnosed with at least one of the following diseases: hypertension, type 2 diabetes mellitus, hyperlipidemia, chronic kidney disease and/or metabolic syndrome * Patients must at least 18 years of age or older at the time of signing consent * Patient must have access to internet-enabled device * Patient has no objections to online grocery shopping, home food deliveries, or nutrition counseling * Patient lives in setting able to receive Instacart deliveries (e.g., non-institutionalized) * Patient is willing to use a credit card for Instacart back-up payments	* Have any condition that impacts digestion, metabolism, or food intake (e.g., surgical loss of esophagus, stomach, or colon, pancreatic dysfunction, bariatric surgery, brain surgery that alters cognition, etc.) * Have active digestive illnesses (i.e., Celiac disease, irritable bowel syndrome, chronic malabsorption) * Any comorbidity such as psychiatric or general illness that may put the subject at risk as determined by investigator * Any other factor which, in the investigator's opinion, is likely to compromise the subject's ability to participate in the study * Recent (e.g., 6 months) participation in other behavioral nutrition trials * Are currently pregnant or are planning to become pregnant during the study

Inclusion Criteria

Exclusion Criteria

* Patients must be Medicaid enrolled, and/or dual enrolled in Medicaid
* Patients must be diagnosed with at least one of the following diseases: hypertension, type 2 diabetes mellitus, hyperlipidemia, chronic kidney disease and/or metabolic syndrome
* Patients must at least 18 years of age or older at the time of signing consent
* Patient must have access to internet-enabled device
* Patient has no objections to online grocery shopping, home food deliveries, or nutrition counseling
* Patient lives in setting able to receive Instacart deliveries (e.g., non-institutionalized)
* Patient is willing to use a credit card for Instacart back-up payments

* Have any condition that impacts digestion, metabolism, or food intake (e.g., surgical loss of esophagus, stomach, or colon, pancreatic dysfunction, bariatric surgery, brain surgery that alters cognition, etc.)
* Have active digestive illnesses (i.e., Celiac disease, irritable bowel syndrome, chronic malabsorption)
* Any comorbidity such as psychiatric or general illness that may put the subject at risk as determined by investigator
* Any other factor which, in the investigator's opinion, is likely to compromise the subject's ability to participate in the study
* Recent (e.g., 6 months) participation in other behavioral nutrition trials
* Are currently pregnant or are planning to become pregnant during the study

Contacts and Locations

Study Contact

Erin Frey

CONTACT

614-293-8973

Erin.Frey@osumc.edu

Principal Investigator

Joshua Joseph, MD

PRINCIPAL_INVESTIGATOR

The Ohio State University Wexner Medical Center

Study Locations (Sites)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Ohio State University

Joshua Joseph, MD, PRINCIPAL_INVESTIGATOR, The Ohio State University Wexner Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-26

Study Completion Date2025-12-01

Study Record Updates

Study Start Date2024-08-26

Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

CKMS
Cardiometabolic Health
Cardiovascular-Kidney-Metabolic Health
Cardiovascular-Kidney-Metabolic Syndrome

Additional Relevant MeSH Terms

Stage 2 Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular Disease Other