Effects of Episodic Food Insecurity in African American Women With Obesity

Overview

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.

Full Title of Study: “Effects of Episodic Food Insecurity on Psychological and Physiological Responses in African American Women With Obesity”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2023

Arms, Groups and Cohorts

  • African American Women with Food Security
    • 30 African American women with obesity who are food secure
  • African American Women with Food Insecurity
    • 30 African American women with obesity who are food insecure

Clinical Trial Outcome Measures

Primary Measures

  • Body weight
    • Time Frame: 22 weeks
    • Change in body weight

Participating in This Clinical Trial

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 ≤ 200% 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 > 200% 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 weight loss medication, or recent weight loss (>10lbs in last 6 months). If ppt is on a prescription medication that impacts weight but meets weight stability criteria (weight stable or loss of <10 lbs in the last 6 months), ppt will be deemed eligible – past bariatric surgery or plans for bariatric surgery within 3 months – active cancer or cancer treatment – cognitive impairment as to interfere with study participation – 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 – other conditions that affect metabolism or body weight as determined by the PIs and MI

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pennington Biomedical Research Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Candice A. Myers, Ph.D., Assistant Professor – Pennington Biomedical Research Center
  • Overall Official(s)
    • Candice A Myers, PhD, Principal Investigator, Pennington Biomedical Research
    • John W Apolzan, PhD, Principal Investigator, Pennington Biomedical Research
  • Overall Contact(s)
    • Jenny Ricks, 225-763-0939, jenny.ricks@pbrc.edu

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