RESPONSES: Effects of Episodic Food Insecurity in African American Women With Obesity
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 Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Study Design
Arms and Interventions
| Arm | Intervention/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
- Body weight [22 weeks]
Change in body weight
Eligibility Criteria
Criteria
Inclusion Criteria:
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willing to provide written informed consent
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female
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self-reported race of African American or more than one race in which African American is identified
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18 to 65 years of age
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BMI 30 to 50 kg/m2
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reported income ≤ 200% of the federal poverty level
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ability to complete questionnaires in English
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willing to archive blood and urine samples
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willing to fast for a minimum of 8-10 hours prior to clinic visits
Exclusion Criteria:
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male
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self-reported race other than African American or more than one race in which African America is not identified
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reported income > 200% of the federal poverty level
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given birth within the past 6 months, currently pregnant, or plans to become pregnant within 6 months
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currently breastfeeding
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currently participating in a weight loss program
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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
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past bariatric surgery or plans for bariatric surgery within 3 months
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active cancer or cancer treatment
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cognitive impairment as to interfere with study participation
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serious digestive disorders that significantly alter metabolism and weight (like uncontrolled inflammatory bowel disease)
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other conditions that affect metabolism or body weight
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current diagnosis and active treatment for alcoholism or other illicit drugs of abuse
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uncontrolled significant thyroid disorder (controlled = 6 months of medication)
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uncontrolled significant diabetes (FBS >250) or hypertension (BP >180/100)
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current diagnosis or treatment for heart failure
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serious psychiatric illness, including bipolar disorder and schizophrenia
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current or recent diagnosis (within last 5 years) of an eating disorder persons who weigh more than 380 pounds (due to scale).
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not willing to be able to re-contacted
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are unable to utilize devices and/or applications as required for device study participation
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have another member of the household (same address) that is a participant in RESPONSES
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other conditions that affect metabolism or body weight as determined by the PIs and MI
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pennington Biomedical Research | Baton Rouge | Louisiana | United States | 70808 |
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.- 2021-022-PBRC