Effects of Episodic Food Insecurity in African American Women With Obesity

NCT05076487 | Completed

• 1 other identifier: PBRC 2021-022
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Food Insecurity

Keywords

Food Insecurity; Stress; Body Weight

Outcome Measures

Primary Outcomes (1)

• Body weight

  Change in body weight

  22 weeks

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

African American women aged 18-65 with obesity

You may qualify if:

• willing to provide written informed consent
• female
• self-reported race of African American or more than one race in which African American is identified
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

• Myers CA, Beyl RA, Hsia DS, Harris MN, Reed IJ, Eliser DD, Bagneris L, Apolzan JW. Effects of Episodic Food Insecurity on Psychological and Physiological Responses in African American Women With Obesity (RESPONSES): Protocol for a Longitudinal Observational Cohort Study. JMIR Res Protoc. 2023 Dec 20;12:e52193. doi: 10.2196/52193.

  PMID: 38117554 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood Urine

MeSH Terms

Conditions

Obesity; Body Weight

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Candice A Myers, PhD

  Pennington Biomedical Research

  PRINCIPAL INVESTIGATOR

• John W Apolzan, PhD

  Pennington Biomedical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 13, 2021
• Study Start: November 1, 2021
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Locations

US (1)