Effects of Episodic Food Insecurity in African American Women With Obesity (RESPONSES)

Pennington Biomedical Research Center

Status

Completed

Conditions

Obesity

Food Insecurity

Study type

Observational

Funder types

Other

Identifiers

NCT05076487

PBRC 2021-022

Details and patient eligibility

About

The objective of this exploratory/developmental study is to investigate the episodic nature of food insecurity as a stressor via responses in body weight and psychological and physiological parameters longitudinally. Sixty African American women with obesity will be enrolled. Pennington Biomedical Research Center will coordinate this longitudinal study and measure 1) daily body weight remotely over 22 weeks and 2) psychological and physiological parameters via clinic assessments at the beginning and end of 22 weeks as well as assess episodes of food insecurity and stress on a weekly basis.

Enrollment

60 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

willing to provide written informed consent
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

male
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