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

Sponsor
Pennington Biomedical Research Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05076487
Collaborator
(none)
60
Enrollment
1
Location
22
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effects of Episodic Food Insecurity on Psychological and Physiological Responses in African American Women With Obesity
    Anticipated Study Start Date :
    Nov 1, 2021
    Anticipated Primary Completion Date :
    May 1, 2023
    Anticipated Study Completion Date :
    Sep 1, 2023

    Arms and Interventions

    ArmIntervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Body weight [22 weeks]

      Change in body weight

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    • are unable to utilize devices and/or applications as required for device 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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Pennington Biomedical ResearchBaton RougeLouisianaUnited States70808

    Sponsors and Collaborators

    • Pennington Biomedical Research Center

    Investigators

    • Principal Investigator: Candice A Myers, PhD, Pennington Biomedical Research
    • Principal Investigator: John W Apolzan, PhD, Pennington Biomedical Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Candice A. Myers, Ph.D., Assistant Professor, Pennington Biomedical Research Center
    ClinicalTrials.gov Identifier:
    NCT05076487
    Other Study ID Numbers:
    • 2021-022-PBRC
    First Posted:
    Oct 13, 2021
    Last Update Posted:
    Oct 14, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Candice A. Myers, Ph.D., Assistant Professor, Pennington Biomedical Research Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 14, 2021