Effects of Episodic Food Insecurity in African American Women With Obesity

Obesity Clinical Trial

— RESPONSES  

Official title:

Effects of Episodic Food Insecurity on Psychological and Physiological Responses in African American Women With Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05076487
• Other study ID #: PBRC 2021-022
• Status: Completed
• Start date: November 1, 2021
• Est. completion date: November 29, 2023

Study information

• Verified date: December 2023
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 29, 2023
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Insecurity
• Obesity

Locations

Country	Name	City	State
United States	Pennington Biomedical Research	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Change in body weight	22 weeks