ObesityNCT05424367
Food Environment, Food Insecurity, and Health Behaviors in NH Hispanics
An observational study of Obesity and Food Insecurity, run by University of New Hampshire at 1 site in United States.
Trial summary
This telephone-based survey included adults of Hispanic/Latino background residing in New Hampshire (NH). Information on food security and access, food environment, and health status and behaviors was collected through validated questionnaires. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Food Insecurity
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 10 Oct 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study included a convenience sample in which participants were primarily recruited by past participants (without prompting by study staff). Unique participants (excluding participants who completed both surveys, N=139) were mostly female (81.3%). Of those who reported age (N=138), as well as weight and height information (N=132), the average age was 45.6 years (SD=14.9) and the average BMI was overweight (M=28.6, SD=5.2).
Who may be able to join
- Hispanic or Latino cultural background
- Current New Hampshire Resident
Who cannot join
- Previous participation (cannot complete the survey more than once unless re-contacted for follow-up)
Trial locations and contacts
1 site in 1 country.
United States1 site
Dao Research Lab, University of New Hampshire
Durham, New Hampshire, 03824
About this study
Official title: Assessment of Food Environment, Food Insecurity, and Health Behaviors Throughout the COVID-19 Pandemic in NH Hispanics
This telephone-based survey included adults of Hispanic/Latino background residing in New Hampshire (NH). Information on food security and access, food environment, and health status and behaviors was collected through validated questionnaires. This project addresses the need for assessment of barriers to nutrition and health during COVID-19 in this population.
Read the detailed description
This telephone-based survey included a convenience sample of Hispanic/Latino adults (>18 years) with cultural origin in a Spanish-speaking country and residing in NH. A subgroup of the study population was assessed at baseline and 6-months following baseline. Validated questionnaires assessing the following outcomes were included:
- Demographics
- Food Access
- Food Security
- Physical Activity
- Dietary Intake
- Eating Behaviors
- Weighing Behaviors
- Psychology
- Sleep Behaviors
- Acculturation
- Gastrointestinal Symptoms
- COVID-19 Vaccine Behaviors
Objective food access will be assessed through mapping and calculation of proximity of subjects' residential addresses to various food sources.
- Conditions
- Obesity, Food Insecurity
- Keywords
- Hispanic/Latino, Psychosocial Wellbeing, Overweight and obesity, Food Insecurity, COVID-19 pandemic
- Medical subject headings
- Obesity, Overweight, COVID-19
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 |
|---|---|---|
| NH Hispanic/Latino Adults | New Hampshire adults(at least 18 years of age) with cultural background in a Spanish-speaking Latin American country or territory surveyed between March 2021 - March 2022. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between weight status and indicators of physical and psychological wellbeing during the COVID-19 pandemic.
Physical activity will be assessed with the Global Physical Activity Questionnaire (GPAQ - possible scores for physical activity level at work, recreation, or transport: sedentary, moderate, or vigorous). Eating behavior will be examined with the Pennington Biomedical Research Center (PBRC) Impacts of COVID-19 on Dietary Intake survey. Results from linear regression analysis will reveal the relationship between weight status (BMI) and lifestyle (physical activity, eating behavior) and psychological characteristics during the COVID-19 pandemic. Linear regression models will be adjusted for age, gender, month of survey completion, and other demographic characteristics as needed.
Measured: March 2021 - September 2021
Correlation between food insecurity, psychosocial factors, and weight status.
Severity of depressive, anxiety, and stress symptoms will be assessed with the 21-item Depression, Anxiety, Stress Scale (DASS-21 - possible scores for symptoms: normal, mild, moderate, severe, extremely severe). The USDA Household Food Sufficiency Questionnaire will be used to calculate food insecurity scores at both the household and the individual level (possible food security levels: high, marginal, low, and very low). The PBRC Impacts of COVID-19 on Sleep survey will assess sleeping behavior. Analysis will generate information on how food insecurity during the pandemic is associated with psychological wellbeing (stress, anxiety, depression), sleeping patterns, degree of acculturation, and weight status. Linear regression models will be used to ascertain the correlation between lifestyle and psychosocial factors with weight status. Models will be adjusted for age, gender, month of survey completion, and other demographic characteristics as appropriate.
Measured: March 2021 - September 2021
Role of lifestyle and psychosocial factors in dietary fiber intake.
Intake of fiber-rich foods during the month prior to the data collection date will be assessed using the National Health and Nutrition Examination Survey (NHANES) Dietary Screener. The correlation between fiber intake, food access and insecurity, weight status, and gastrointestinal symptoms will be examined using linear regression models adjusted for age, gender, month of survey completion, and other demographic characteristics as appropriate.
Measured: March 2021 - September 2021
Updated New Hampshire (NH) food access database and characterization of barriers to healthy nutrition in NH Hispanics.
Perceived (Perceived Nutrition Environment Survey or NEMS-P) and objective food access (food sources) will be compared to characterize personal and geographical barriers to food access. NH food sources will be aggregated and geo-located using publicly available data from the State of NH (e.g., the USDA Economic Research Service (ERS) Food Access and Food Environment Research Atlases). ArcGIS software will be used to calculate measures of food access and to map sources in conjunction with participants' addresses to inspect for high-level spatial patterning in proximity gaps. For each participant, a count of the food sources can be tallied and constrained to a specified, geographically-dependent radius (e.g., within 1 mile of urban residents, 10 miles of rural residents), used for calculating a binary measure of access (e.g., access within zip code, yes/no), or used for measures of access for exploratory research.
Measured: October 2021 - March 2022
Assessment of the physical and psychosocial burden of food insecurity.
A questionnaire assessing health history and sociodemographic characteristics will be administered as well as the Short Acculturation Scale for Hispanics (language acculturation score range=1-6, high=more acculturation). Other health-related constructs include psychological symptoms, sleep patterns, gastrointestinal symptoms, and food insecurity (possible food security levels: high, marginal, low, and very low). Changes in these constructs from baseline to follow-up will be assessed with a dependent t-test for paired samples, and their association with food insecurity through repeated measures ANOVA including only repeat subjects. The cross-sectional correlation between food insecurity and health behavior will be determined through bivariate linear regression models and chi square analyses. Covariate adjustment will include age and sex, and other relevant sociodemographic characteristics.
Measured: March 2021 - March 2022
Characterization of the impact of the COVID-19 pandemic on health behaviors and their correlation with food insecurity and weight status.
Food insecurity will be assessed with the USDA Food Sufficiency Questionnaire (possible food security levels: high, marginal, low, and very low). Weighing behaviors will be evaluated with the Early Adult Reduction of weight through Lifestyle intervention (EARLY) Self-Weighing Questionnaire and a modified version of NHANES Weight History Questionnaire. Vaccine receipt will be assessed with questions from the Census Bureau's Household Pulse Survey. COVID-19 vaccination rate will be calculated, and attitudes to vaccination will be analyzed qualitatively through deductive coding. The predictive power of health behaviors on food insecurity and weight status will be assessed by logistic regression. Covariate adjustment will include age and sex.
Measured: October 2021 - March 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Oct 2021
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Hampshire
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Carlota Dao, University of New Hampshire
- Investigators
- Maria C Dao, PhD, Principal investigator, University of New Hampshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424367
- Sponsor's protocol ID
- UNH-09-FY2021_45
- Status last verified
- Mar 2025
- First submitted
- 12 Jun 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kamdar N, Rozmus CL, Grimes DE, Meininger JC. Ethnic/Racial Comparisons in Strategies Parents Use to Cope with Food Insecurity: A Systematic Review of Published Research. J Immigr Minor Health. 2019 Feb;21(1):175-188. doi: 10.1007/s10903-018-0720-y.
PubMed 29549476Mousa TY, Freeland-Graves JH. Food security of food recipients of a food pantry and soup kitchen. Public Health Nutr. 2019 Jun;22(8):1451-1460. doi: 10.1017/S1368980018003658. Epub 2019 Feb 8.
PubMed 30732673Carlson SJ, Andrews MS, Bickel GW. Measuring food insecurity and hunger in the United States: development of a national benchmark measure and prevalence estimates. J Nutr. 1999 Feb;129(2S Suppl):510S-516S. doi: 10.1093/jn/129.2.510S.
PubMed 10064320Hernandez DC, Reesor LM, Murillo R. Food insecurity and adult overweight/obesity: Gender and race/ethnic disparities. Appetite. 2017 Oct 1;117:373-378. doi: 10.1016/j.appet.2017.07.010. Epub 2017 Jul 22.
PubMed 28739148Alarcon RD, Parekh A, Wainberg ML, Duarte CS, Araya R, Oquendo MA. Hispanic immigrants in the USA: social and mental health perspectives. Lancet Psychiatry. 2016 Sep;3(9):860-70. doi: 10.1016/S2215-0366(16)30101-8.
PubMed 27568273Ogden CL, Fakhouri TH, Carroll MD, Hales CM, Fryar CD, Li X, Freedman DS. Prevalence of Obesity Among Adults, by Household Income and Education - United States, 2011-2014. MMWR Morb Mortal Wkly Rep. 2017 Dec 22;66(50):1369-1373. doi: 10.15585/mmwr.mm6650a1.
PubMed 29267260Forrest KYZ, Leeds MJ, Ufelle AC. Epidemiology of Obesity in the Hispanic Adult Population in the United States. Fam Community Health. 2017 Oct/Dec;40(4):291-297. doi: 10.1097/FCH.0000000000000160.
PubMed 28820783
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Food Environment, Food Insecurity, and Health Behaviors Throughout the COVID-19 Pandemic in NH Hispanics
- ClinicalTrials.gov ID
- NCT05424367
- Acronym / sponsor ID
- UNH-09-FY2021_45
- Conditions
- Obesity, Food Insecurity
- Keywords
- Hispanic/Latino, Psychosocial Wellbeing, Overweight and obesity, Food Insecurity, COVID-19 pandemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- University of New HampshireUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 21 Jun 2022 (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.
This telephone-based survey included adults of Hispanic/Latino background residing in New Hampshire (NH). Information on food security and access, food environment, and health status and behaviors was collected through validated questionnaires. This project addresses the need for assessment of barriers to nutrition and health during COVID-19 in this population.
Detailed description
This telephone-based survey included a convenience sample of Hispanic/Latino adults (>18 years) with cultural origin in a Spanish-speaking country and residing in NH. A subgroup of the study population was assessed at baseline and 6-months following baseline. Validated questionnaires assessing the following outcomes were included:
- Demographics
- Food Access
- Food Security
- Physical Activity
- Dietary Intake
- Eating Behaviors
- Weighing Behaviors
- Psychology
- Sleep Behaviors
- Acculturation
- Gastrointestinal Symptoms
- COVID-19 Vaccine Behaviors
Objective food access will be assessed through mapping and calculation of proximity of subjects' residential addresses to various food sources.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NH Hispanic/Latino Adults | – | –New Hampshire adults(at least 18 years of age) with cultural background in a Spanish-speaking Latin American country or territory surveyed between March 2021 - March 2022. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study included a convenience sample in which participants were primarily recruited by past participants (without prompting by study staff). Unique participants (excluding participants who completed both surveys, N=139) were mostly female (81.3%). Of those who reported age (N=138), as well as weight and height information (N=132), the average age was 45.6 years (SD=14.9) and the average BMI was overweight (M=28.6, SD=5.2).
Key inclusion criteria (2 listed)
- Hispanic or Latino cultural background
- Current New Hampshire Resident
Key exclusion criteria (1 listed)
- Previous participation (cannot complete the survey more than once unless re-contacted for follow-up)
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
The correlation between weight status and indicators of physical and psychological wellbeing during the COVID-19 pandemic.
Time frame: March 2021 - September 2021
Physical activity will be assessed with the Global Physical Activity Questionnaire (GPAQ - possible scores for physical activity level at work, recreation, or transport: sedentary, moderate, or vigorous). Eating behavior will be examined with the Pennington Biomedical Research Center (PBRC) Impacts of COVID-19 on Dietary Intake survey. Results from linear regression analysis will reveal the relationship between weight status (BMI) and lifestyle (physical activity, eating behavior) and psychological characteristics during the COVID-19 pandemic. Linear regression models will be adjusted for age, gender, month of survey completion, and other demographic characteristics as needed.
Correlation between food insecurity, psychosocial factors, and weight status.
Time frame: March 2021 - September 2021
Severity of depressive, anxiety, and stress symptoms will be assessed with the 21-item Depression, Anxiety, Stress Scale (DASS-21 - possible scores for symptoms: normal, mild, moderate, severe, extremely severe). The USDA Household Food Sufficiency Questionnaire will be used to calculate food insecurity scores at both the household and the individual level (possible food security levels: high, marginal, low, and very low). The PBRC Impacts of COVID-19 on Sleep survey will assess sleeping behavior. Analysis will generate information on how food insecurity during the pandemic is associated with psychological wellbeing (stress, anxiety, depression), sleeping patterns, degree of acculturation, and weight status. Linear regression models will be used to ascertain the correlation between lifestyle and psychosocial factors with weight status. Models will be adjusted for age, gender, month of survey completion, and other demographic characteristics as appropriate.
Role of lifestyle and psychosocial factors in dietary fiber intake.
Time frame: March 2021 - September 2021
Intake of fiber-rich foods during the month prior to the data collection date will be assessed using the National Health and Nutrition Examination Survey (NHANES) Dietary Screener. The correlation between fiber intake, food access and insecurity, weight status, and gastrointestinal symptoms will be examined using linear regression models adjusted for age, gender, month of survey completion, and other demographic characteristics as appropriate.
Updated New Hampshire (NH) food access database and characterization of barriers to healthy nutrition in NH Hispanics.
Time frame: October 2021 - March 2022
Perceived (Perceived Nutrition Environment Survey or NEMS-P) and objective food access (food sources) will be compared to characterize personal and geographical barriers to food access. NH food sources will be aggregated and geo-located using publicly available data from the State of NH (e.g., the USDA Economic Research Service (ERS) Food Access and Food Environment Research Atlases). ArcGIS software will be used to calculate measures of food access and to map sources in conjunction with participants' addresses to inspect for high-level spatial patterning in proximity gaps. For each participant, a count of the food sources can be tallied and constrained to a specified, geographically-dependent radius (e.g., within 1 mile of urban residents, 10 miles of rural residents), used for calculating a binary measure of access (e.g., access within zip code, yes/no), or used for measures of access for exploratory research.
Assessment of the physical and psychosocial burden of food insecurity.
Time frame: March 2021 - March 2022
A questionnaire assessing health history and sociodemographic characteristics will be administered as well as the Short Acculturation Scale for Hispanics (language acculturation score range=1-6, high=more acculturation). Other health-related constructs include psychological symptoms, sleep patterns, gastrointestinal symptoms, and food insecurity (possible food security levels: high, marginal, low, and very low). Changes in these constructs from baseline to follow-up will be assessed with a dependent t-test for paired samples, and their association with food insecurity through repeated measures ANOVA including only repeat subjects. The cross-sectional correlation between food insecurity and health behavior will be determined through bivariate linear regression models and chi square analyses. Covariate adjustment will include age and sex, and other relevant sociodemographic characteristics.
Characterization of the impact of the COVID-19 pandemic on health behaviors and their correlation with food insecurity and weight status.
Time frame: October 2021 - March 2022
Food insecurity will be assessed with the USDA Food Sufficiency Questionnaire (possible food security levels: high, marginal, low, and very low). Weighing behaviors will be evaluated with the Early Adult Reduction of weight through Lifestyle intervention (EARLY) Self-Weighing Questionnaire and a modified version of NHANES Weight History Questionnaire. Vaccine receipt will be assessed with questions from the Census Bureau's Household Pulse Survey. COVID-19 vaccination rate will be calculated, and attitudes to vaccination will be analyzed qualitatively through deductive coding. The predictive power of health behaviors on food insecurity and weight status will be assessed by logistic regression. Covariate adjustment will include age and sex.
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 2 Apr 2025.
- Background: PubMed 29549476Kamdar N, Rozmus CL, Grimes DE, Meininger JC. Ethnic/Racial Comparisons in Strategies Parents Use to Cope with Food Insecurity: A Systematic Review of Published Research. J Immigr Minor Health. 2019 Feb;21(1):175-188. doi: 10.1007/s10903-018-0720-y.
- Background: PubMed 30732673Mousa TY, Freeland-Graves JH. Food security of food recipients of a food pantry and soup kitchen. Public Health Nutr. 2019 Jun;22(8):1451-1460. doi: 10.1017/S1368980018003658. Epub 2019 Feb 8.
- Background: PubMed 10064320Carlson SJ, Andrews MS, Bickel GW. Measuring food insecurity and hunger in the United States: development of a national benchmark measure and prevalence estimates. J Nutr. 1999 Feb;129(2S Suppl):510S-516S. doi: 10.1093/jn/129.2.510S.
- Background: PubMed 28739148Hernandez DC, Reesor LM, Murillo R. Food insecurity and adult overweight/obesity: Gender and race/ethnic disparities. Appetite. 2017 Oct 1;117:373-378. doi: 10.1016/j.appet.2017.07.010. Epub 2017 Jul 22.
- Background: PubMed 27568273Alarcon RD, Parekh A, Wainberg ML, Duarte CS, Araya R, Oquendo MA. Hispanic immigrants in the USA: social and mental health perspectives. Lancet Psychiatry. 2016 Sep;3(9):860-70. doi: 10.1016/S2215-0366(16)30101-8.
- Background: PubMed 29267260Ogden CL, Fakhouri TH, Carroll MD, Hales CM, Fryar CD, Li X, Freedman DS. Prevalence of Obesity Among Adults, by Household Income and Education - United States, 2011-2014. MMWR Morb Mortal Wkly Rep. 2017 Dec 22;66(50):1369-1373. doi: 10.15585/mmwr.mm6650a1.
- Background: PubMed 28820783Forrest KYZ, Leeds MJ, Ufelle AC. Epidemiology of Obesity in the Hispanic Adult Population in the United States. Fam Community Health. 2017 Oct/Dec;40(4):291-297. doi: 10.1097/FCH.0000000000000160.
- Individual participant dataSharing planned: No
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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.
Maria C Dao, PhD principal investigator
University of New Hampshire
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 University of New Hampshire 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 2 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 2 Apr 2025. 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?
The correlation between weight status and indicators of physical and psychological wellbeing during the COVID-19 pandemic. (time frame: March 2021 - September 2021). The study lists 6 primary outcomes in all. 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 NCT05424367, which also lists 7 linked publications.
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 2 Apr 2025.