NCT05076487Completed
Effects of Episodic Food Insecurity in African American Women With Obesity
Effects of Episodic Food Insecurity on Psychological and Physiological Responses in African American Women With Obesity
Source: ClinicalTrials.gov · Last updated 13 Dec 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 60 (actual)
- First submitted
- 30 Sept 2021
- Start date
- 1 Nov 2021
- Primary completion date
- 29 Nov 2023
- Lead sponsor
- Pennington Biomedical Research Center
- Diseases
- Obesity
- NCT number
- NCT05076487
What you commit to
- Study type: Observational
- Participants enrolled: 60
- From 1 Nov 2021 to the primary completion date, 29 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- current diagnosis and active treatment for alcoholism or other illicit drugs of abuse
Other illness
- 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
- 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
- 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
Other
- 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
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pennington Biomedical Research Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.