Clinical trial NCT05170412: Dietary Intake and Dietary Behaviors in Adults With Sickle Cell Disease
Official title: Observational Study of Dietary Intake and Dietary Behaviors in Adults With Sickle Cell Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sickle Cell Disease
Keywords: cross-sectional design
Nutritional Status
physical health
psychosocial health
clinical phenotypes
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: National Human Genome Research Institute (NHGRI)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-12-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male and female; age: \>= 18 years of age; health status: diagnosis of Sickle Cell Disease

Brief summary: Background:

Sickle Cell Disease (SCD) causes blood cells form a crescent shape. It is caused by a genetic mutation in the hemoglobin gene. People with SCD are at increased risk for illnesses like stroke, chronic pain, and heart problems, as well as decreased overall health and well-being. Researchers want to learn more about how nutrition and diet can help relieve or reduce the symptoms of SCD.

Objective:

To understand how diet, dietary patterns and behaviors, nutrition, and other related factors in adults with SCD affect their overall health.

Eligibility:

Adults aged 18 and older with SCD.

Design:

Participants will be screened with a review of their medical records. They will take a pregnancy test if needed.

Participants will have a physical exam and medical history. Their height, weight, and waist and hip circumference will be measured. They can complete this exam (1) via telehealth along with a visit to an outpatient laboratory center or (2) by going to the NIH Clinical Center.

Participants will complete 2 interviews about their diet. They will talk about the foods they ate in the past 24 hours. They will also complete 1 interview about diet-related behaviors such as food shopping and cooking. They can complete the interviews in person, by phone, or by telehealth visit.

Participants will complete surveys about their demographics (such as age and gender), SCD pain, mood, stress, diet, and nutrition. It may take about 1 hour to complete all of the surveys.

Participants will give blood and urine samples. They will need to fast for at least 8 hours overnight before giving blood samples.

Participation will last for about 2 weeks.

Detailed description: Study Description:

This study seeks to determine dietary intake and behaviors of adults with Sickle Cell Disease through the use of a cross-sectional design using mixed methods. The premise for the study is based on the potential role of nutritional status in sickle cell disease outcomes in physical health and psychosocial health. The study will recruit outpatient adults with the diagnosis of Sickle Cell Disease, and will include patients with multiple clinical phenotypes and genotypes.

Objectives:

Primary Objective: The primary objective is to assess the dietary intake and behaviors of outpatient adults with SCD within the context of social determinants of health.

Secondary Objective 1: Identify associations between dietary intake and behaviors with clinical severity outcomes.

Secondary objective 2: Identify associations between dietary intake and behaviors with psychosocial variables.

Secondary objective 3: Identify associations between food access and dietary intake and behaviors.

Endpoints:

Primary Endpoint: Measure dietary intake and behaviors using 24-hour dietary recall data, participant survey responses and diet-related laboratory results

Secondary Endpoints: Identify associations between dietary intake and behaviors with: 1) social determinants of health (related to socioeconomic status, birthplace, neighborhood disadvantage, food environment); 2) clinical variables SCD of genotype, clinical phenotype (SCD related diagnoses and complications), clinical severity (chronic pain severity and frequency), medication use and

history of treatments, and SCD related laboratory studies; 3) psychosocial variables of mood, self-esteem, perceived stress, social support, self-mastery, self-compassion, racial identity, and stigmatization as measured by self-reported responses.

Eligibility criteria: * INCLUSION CRITERIA:

In order to be eligible to participate in this study, the participant must:

1. State their willingness to complete all study procedures for the duration of the study
2. 18 years of age or older at the time of screening
3. Have a documented clinical diagnosis (upon review of medical records) of SCD or presence of a SCD hemoglobinopathy genotype HbSS, HgSC, HbSB 0 or HBSB+

EXCLUSION CRITERIA:

The following criteria will exclude any individual from participating in the study:

1. Less than 18 years of age
2. Unable to speak, read, write, and/or understand English
3. Presence of a condition or illness that will hamper the individual from giving informed consent (e.g. cognitive impairment)
4. SCD trait genotype
5. Currently undergoing inpatient treatment in any hospital for SCD at the time of screening
6. Pregnancy at the time of screening

Primary outcomes:
measure: assess the dietary intake and behaviors of outpatient adults with SCD
timeFrame: 24 months
Secondary outcomes:
measure: demographic variables related to socioeconomic status, sex, age, birthplace
timeFrame: 24 months
measure: SCD genotype, clinical phenotype (SCD related diagnoses and complications), clinical severity (chronic pain severity and frequency), medication use and history of treatments, and SCD related laboratory studies.
timeFrame: 24 months
measure: psychosocial variables of mood, self-esteem, perceived stress, social support, self-mastery, self-compassion, racial identity, and stigmatization as measured by self-reported responses
timeFrame: 24 months
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institutes of Health Clinical Center (CC)
name: Nicole M Farmer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: