Effects of Episodic Food Insecurity in African American Women With Obesity
NCT ID: NCT05076487
Last Updated: 2023-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2021-11-01
2023-11-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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African American Women with Food Insecurity
30 African American women with obesity who are food insecure
No interventions assigned to this group
African American Women with Food Security
30 African American women with obesity who are food secure
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* female
* self-reported race of African American or more than one race in which African American is identified
* 18 to 65 years of age
* BMI 30 to 50 kg/m2
* reported income ≤ 250% of the federal poverty level
* ability to complete questionnaires in English
* willing to archive blood and urine samples
* willing to fast for a minimum of 8-10 hours prior to clinic visits
Exclusion Criteria
* self-reported race other than African American or more than one race in which African America is not identified
* reported income \> 250% of the federal poverty level
* given birth within the past 6 months, currently pregnant, or plans to become pregnant within 6 months
* currently breastfeeding
* currently participating in a weight loss program
* current use of prescription or OTC medication specifically for weight loss
* recent weight loss (+/-5% weight change in last 6 months by self-report). If ppt is on a prescription medication that impacts weight but meets weight stability criteria (+/-5% weight change in last 6 months by self-report), ppt will be deemed eligible
* past bariatric surgery within the past 5 years or plans for bariatric surgery within 3 months
* active cancer or cancer treatment
* serious digestive disorders that significantly alter metabolism and weight (like uncontrolled inflammatory bowel disease)
* other conditions that affect metabolism or body weight
* current diagnosis and active treatment for alcoholism or other illicit drugs of abuse
* uncontrolled significant thyroid disorder (controlled = 6 months of medication)
* uncontrolled significant diabetes (FBS \>250) or hypertension (BP \>180/100)
* current diagnosis or treatment for heart failure
* serious psychiatric illness, including bipolar disorder and schizophrenia
* current or recent diagnosis (within last 5 years) of an eating disorder
* persons who weigh more than 380 pounds (due to scale)
* not willing to be able to re-contacted
* are unable to utilize devices and/or applications as required for study participation
* have another member of the household (same address) that is a participant in RESPONSES
* other conditions that affect metabolism or body weight as determined by the PIs and MI
* presence of any cognitive, psychiatric, behavioral, or medical disorder that, in the opinion of the PIs or MI may interfere with study participation
18 Years
65 Years
FEMALE
Yes
Sponsors
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Pennington Biomedical Research Center
OTHER
Responsible Party
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Candice A. Myers, Ph.D.
Assistant Professor
Principal Investigators
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Candice A Myers, PhD
Role: PRINCIPAL_INVESTIGATOR
Pennington Biomedical Research
John W Apolzan, PhD
Role: PRINCIPAL_INVESTIGATOR
Pennington Biomedical Research
Locations
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Pennington Biomedical Research
Baton Rouge, Louisiana, United States
Countries
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References
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Myers CA, Beyl RA, Hsia DS, Harris MN, Reed IJ, Eliser DD, Bagneris L, Apolzan JW. Effects of Episodic Food Insecurity on Psychological and Physiological Responses in African American Women With Obesity (RESPONSES): Protocol for a Longitudinal Observational Cohort Study. JMIR Res Protoc. 2023 Dec 20;12:e52193. doi: 10.2196/52193.
Other Identifiers
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PBRC 2021-022
Identifier Type: -
Identifier Source: org_study_id