ObesityRESPONSESNCT05076487
Effects of Episodic Food Insecurity in African American Women With Obesity
An observational study of Obesity and Food Insecurity, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Food Insecurity
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 29 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: African American women aged 18-65 with obesity
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research
Baton Rouge, Louisiana, 70808
About this study
Official title: 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.
- Conditions
- Obesity, Food Insecurity
- Keywords
- Food Insecurity, Stress, Body Weight
- Medical subject headings
- Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Change in body weight
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start1 Nov 2021
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Candice A. Myers, Ph.D., Pennington Biomedical Research Center
- Investigators
- Candice A Myers, PhD, Principal investigator, Pennington Biomedical ResearchJohn W Apolzan, PhD, Principal investigator, Pennington Biomedical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076487
- Sponsor's protocol ID
- PBRC 2021-022
- Acronym
- RESPONSES
- Status last verified
- Dec 2023
- First submitted
- 30 Sep 2021
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38117554
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Episodic Food Insecurity on Psychological and Physiological Responses in African American Women With Obesity
- ClinicalTrials.gov ID
- NCT05076487
- Acronym / sponsor ID
- RESPONSES / PBRC 2021-022
- Conditions
- Obesity, Food Insecurity
- Keywords
- Food Insecurity, Stress, Body Weight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- African American women aged 18-65 with obesity
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body weight
Time frame: 22 weeks
Change in body weight
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Derived from this study: PubMed 38117554Myers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Candice A Myers, PhD principal investigator
Pennington Biomedical Research
John W Apolzan, PhD principal investigator
Pennington Biomedical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Food Insecurity, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 22 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05076487, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.