Clinical trial NCT05076487: Effects of Episodic Food Insecurity in African American Women With Obesity
Official title: Effects of Episodic Food Insecurity on Psychological and Physiological Responses in African American Women With Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Food Insecurity
Keywords: Food Insecurity
Stress
Body Weight
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: African American women aged 18-65 with obesity

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Body weight
timeFrame: 22 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research
name: Candice A Myers, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pennington Biomedical Research
name: John W Apolzan, PhD
role: PRINCIPAL_INVESTIGATOR
References: