ObesityNCT03441594
Psychological Mechanisms Linking Food Insecurity and Obesity
An observational study of Obesity and Psychological, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The current pilot study will examine emergent hypotheses by investigating the role of psychological mechanisms in the relationship between food insecurity and obesity. This objective will be achieved via a cross-sectional, observational pilot study collecting quantitative and qualitative data. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Psychological
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The target study sample will be 56 food secure and food insecure women and men aged 18 to 49 years with a BMI of 20.0 kg/m2 or greater.
Who may be able to join
- Age 18-49 years
- BMI ≥ 20.0 kg/m2
- Able to read and write using the English language
- Willing to provide written informed consent
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808-4124
About this study
Official title: Psychological Mechanisms Linking Food Insecurity and Obesity (Food Mind Pilot Study)
The current pilot study will examine emergent hypotheses by investigating the role of psychological mechanisms in the relationship between food insecurity and obesity. This objective will be achieved via a cross-sectional, observational pilot study collecting quantitative and qualitative data.
Read the detailed description
This pilot study will investigate an emergent risk factor for obesity: food insecurity, which is defined as the limited or uncertain availability of nutritionally adequate and safe foods. While paradoxically linked, numerous studies have shown a significant association between food insecurity and obesity. Moreover, recent narrative works have developed new, untested hypotheses linking food insecurity and obesity positing the causal role of psychological mechanisms. Given this, this mixed method pilot study will collect new psychological data in a sample of food secure and food insecure adults with and without obesity to examine the connections between food insecurity, body weight, and psychological constructs. The overarching objective of the study is to gather pilot data to identify potentially new intervention targets that will be used in future studies to more rigorously investigate the relationship between food insecurity and obesity.
- Conditions
- Obesity, Psychological
- Keywords
- Food Insecurity
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay Discounting
Assessed via the 27-Item Monetary Choice Questionnaire, which measures bias toward smaller, immediate rewards versus larger, delayed rewards. This questionnaire presents participants with a set of 27 choices between smaller, immediate monetary rewards and larger, delayed monetary rewards. Participants who discount the value of the delayed rewards more steeply are considered to be more impulsive. An estimate of a participant's discounting rate (k) is calculated from the pattern of choices. Values of k range from 0.00016 (ln transformation -8.74) to 0.25 (ln transformation -1.39), with higher values indicating a greater preference for smaller, immediate rewards over larger, delayed rewards. K tends to be skewed, so a natural log (ln) transformation is utilized to approximate a normal distribution for statistical analyses.
Measured: Through study completion, an average of 1 hour and 30 minutes at Study Visit 1
Secondary outcomes (1)
Grit
Assessed using the 8-item Short Grit Scale, which measures trait-level perseverance and passion for long-term goals. Scores range from 1 (not at all gritty) to 5 (extremely gritty).
Measured: Through study completion, an average of 1 hour and 30 minutes at Study Visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start5 Feb 2018
- Primary completion28 May 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Candice A. Myers, Ph.D., Pennington Biomedical Research Center
- Investigators
- Candice A Myers, Ph.D., Principal investigator, Pennington Biomedicial Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441594
- Sponsor's protocol ID
- 2017-060-PBRC
- Other IDs
- U54GM104940
- Status last verified
- Jan 2020
- First submitted
- 26 Jan 2018
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Myers CA, Beyl RA, Martin CK, Broyles ST, Katzmarzyk PT. Psychological mechanisms associated with food security status and BMI in adults: a mixed methods study. Public Health Nutr. 2020 Oct;23(14):2501-2511. doi: 10.1017/S1368980020000889. Epub 2020 Jun 29.
PubMed 32597739
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Mechanisms Linking Food Insecurity and Obesity (Food Mind Pilot Study)
- ClinicalTrials.gov ID
- NCT03441594
- Acronym / sponsor ID
- 2017-060-PBRC
- Conditions
- Obesity, Psychological
- Keywords
- Food Insecurity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 28 May 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current pilot study will examine emergent hypotheses by investigating the role of psychological mechanisms in the relationship between food insecurity and obesity. This objective will be achieved via a cross-sectional, observational pilot study collecting quantitative and qualitative data.
Detailed description
This pilot study will investigate an emergent risk factor for obesity: food insecurity, which is defined as the limited or uncertain availability of nutritionally adequate and safe foods. While paradoxically linked, numerous studies have shown a significant association between food insecurity and obesity. Moreover, recent narrative works have developed new, untested hypotheses linking food insecurity and obesity positing the causal role of psychological mechanisms. Given this, this mixed method pilot study will collect new psychological data in a sample of food secure and food insecure adults with and without obesity to examine the connections between food insecurity, body weight, and psychological constructs. The overarching objective of the study is to gather pilot data to identify potentially new intervention targets that will be used in future studies to more rigorously investigate the relationship between food insecurity and obesity.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The target study sample will be 56 food secure and food insecure women and men aged 18 to 49 years with a BMI of 20.0 kg/m2 or greater.
Key inclusion criteria (4 listed)
- Age 18-49 years
- BMI ≥ 20.0 kg/m2
- Able to read and write using the English language
- Willing to provide written informed consent
Key exclusion criteria (1 listed)
- Pregnancy
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
Delay Discounting
Time frame: Through study completion, an average of 1 hour and 30 minutes at Study Visit 1
Assessed via the 27-Item Monetary Choice Questionnaire, which measures bias toward smaller, immediate rewards versus larger, delayed rewards. This questionnaire presents participants with a set of 27 choices between smaller, immediate monetary rewards and larger, delayed monetary rewards. Participants who discount the value of the delayed rewards more steeply are considered to be more impulsive. An estimate of a participant's discounting rate (k) is calculated from the pattern of choices. Values of k range from 0.00016 (ln transformation -8.74) to 0.25 (ln transformation -1.39), with higher values indicating a greater preference for smaller, immediate rewards over larger, delayed rewards. K tends to be skewed, so a natural log (ln) transformation is utilized to approximate a normal distribution for statistical analyses.
1 secondary outcome
Grit
Time frame: Through study completion, an average of 1 hour and 30 minutes at Study Visit 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32597739Myers CA, Beyl RA, Martin CK, Broyles ST, Katzmarzyk PT. Psychological mechanisms associated with food security status and BMI in adults: a mixed methods study. Public Health Nutr. 2020 Oct;23(14):2501-2511. doi: 10.1017/S1368980020000889. Epub 2020 Jun 29.
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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, Ph.D. principal investigator
Pennington Biomedicial Research Center
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 Psychological, 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 4 inclusion and 1 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 5 Feb 2020. 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?
Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Delay Discounting (time frame: Through study completion, an average of 1 hour and 30 minutes at Study Visit 1). 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 NCT03441594, 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 5 Feb 2020.