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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03441594
Other study ID # 2017-060-PBRC
Secondary ID U54GM104940
Status Completed
Phase
First received
Last updated
Start date February 5, 2018
Est. completion date December 31, 2019

Study information

Verified date January 2020
Source Pennington Biomedical Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date December 31, 2019
Est. primary completion date May 28, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria:

- Age 18-49 years

- BMI = 20.0 kg/m2

- Able to read and write using the English language

- Willing to provide written informed consent

Exclusion Criteria:

- Pregnancy

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Pennington Biomedical Research Center Baton Rouge Louisiana

Sponsors (2)

Lead Sponsor Collaborator
Pennington Biomedical Research Center National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Through study completion, an average of 1 hour and 30 minutes at Study Visit 1
Secondary 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). Through study completion, an average of 1 hour and 30 minutes at Study Visit 1
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