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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Food Insecurity

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

African American women aged 18-65 with obesity

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Change in body weight	22 weeks

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Investigators: Principal Investigator: Candice A Myers, PhD, Pennington Biomedical Research; Principal Investigator: John W Apolzan, PhD, Pennington Biomedical Research

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): November 29, 2023
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: September 30, 2021
• First Submitted That Met QC Criteria: September 30, 2021
• First Posted (Actual): October 13, 2021

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Stress; Body Weight; Food Insecurity
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: PBRC 2021-022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No