Change in Dietary OutcomesNCT01983891
Improving Nutritional Outcomes Among Food Insecure Twin Cities Residents
A study testing Cooking course in people with Change in Dietary Outcomes, run by University of Minnesota at 1 site in United States.
Trial summary
This is a pilot intervention study conducted in four food shelves in the Twin Cities area. The aims of the study are to improve nutritional outcomes and client skills and self-efficacy among a culturally diverse group of food shelf clients through a nutrition education and meal preparation program. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Change in Dietary Outcomes
- What is being tested?
- Cooking course
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Oct 2013
- Phase
- Interventional
- 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
Who may be able to join
- English-speaking
- Age 18 and older
- Required food assistance from a participating food shelf in the last 30 days
- Must be willing to give verbal consent
Who cannot join
- Not able to speak and understand English
- Potential participants who have an apparent or self-reported physical or mental disability that would prohibit them from participating in a cooking course
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Department of Family Medicine and Community Health
Minneapolis, Minnesota, 55455
About this study
This is a pilot intervention study conducted in four food shelves in the Twin Cities area. The aims of the study are to improve nutritional outcomes and client skills and self-efficacy among a culturally diverse group of food shelf clients through a nutrition education and meal preparation program. This study will also identify opportunities to expand the supply of healthy and culturally relevant foods in food shelves. The goal is to inform a larger-scale intervention to improve the nutritional quality and cultural relevance of food shelf items as well as client outcomes. The primary outcome is participant change in Health Eating Index scores from pre-intervention to post-intervetion.
Read the detailed description
Food insecurity disproportionately affects low-income, minority, and foreign-born families, resulting in a disproportionate burden of nutrition-related chronic conditions affecting these groups. In Minnesota, over a half a million food insecure families relied on food shelves (also known as food pantries) for emergency food assistance in 2009. Yet reliance on food shelves in a culturally diverse population may present nutritional challenges for two main reasons. First, unlike many food assistance programs (e.g., school nutritional programs, WIC), there are currently no existing standards on the nutritional quality of food shelf offerings. Inventory data collected from a sample of Twin Cities food shelves in the summer of 2012 began to identity priority areas for the improvement of the nutritional quality of food shelves items, but such recommendations have yet to be implemented. Second, securing healthy meals for the large population of immigrants and refugees families who rely on food shelves in the Twin Cities may be particularly challenging. Among these clients, unfamiliarity with "American" foods and cooking practices for foods that are most affordable or available may serve as barriers to healthy meal preparation. Very little research has examined the potential for cooking skills and the incorporation of new foods in improving dietary outcomes among a group of culturally diverse food insecure families.
Recognizing that nutritional outcomes are driven by influence at both the food systems level and the individual level, the long-term goal of this research is to improve nutritional outcomes among food insecure families through enhancements at both the food shelf level and the client level. Because of the complexity in making systemic improvements in the quality of the emergency food supply, this pilot study will conduct formative research on improving food supply at the food shelf level, while primarily focusing on testing strategies to improve nutrition-related behaviors at the client level.
This intervention will focus primarily on promoting cooking skills using healthier "American" items along with culturally appropriate ingredients. Cooking classes will occur through a partnership with the Cooking Matters™ program, which leads hands-on 6-week cooking based nutrition education programs at a variety of venues in the greater Twin Cities area, and is conducted by the University of Minnesota Extension.
- Conditions
- Change in Dietary Outcomes
- Being tested
- Cooking course
- Keywords
- food shelf, nutrition education, cooking course
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooking courseOther
6-week nutrition education and cooking course
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 6-week nutrition education and cooking course Receives: Other: Cooking course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Healthy Eating Index score
The Healthy Eating Index is scored on a scale of 0 to 100 and will be analyzed as a continuous outcome. Mean change in index score T1 to T2 will be assessed using a paired t-test with each individual serving as his or her own control.
Measured: 3 months
Secondary outcomes (1)
Meal preparations skills and self-efficacy
Meal preparation skills and self-efficacy will be measured by 10 Likert scale items.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Change in Dietary OutcomesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caitlin Caspi, ScD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983891
- Sponsor's protocol ID
- 2013NTLS011
- Status last verified
- Jul 2015
- First submitted
- 7 Nov 2013
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Nutritional Outcomes Among Food Insecure Twin Cities Residents
- ClinicalTrials.gov ID
- NCT01983891
- Acronym / sponsor ID
- 2013NTLS011
- Conditions
- Change in Dietary Outcomes
- Keywords
- food shelf, nutrition education, cooking course
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 14 Nov 2013 (estimated)
- 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 is a pilot intervention study conducted in four food shelves in the Twin Cities area. The aims of the study are to improve nutritional outcomes and client skills and self-efficacy among a culturally diverse group of food shelf clients through a nutrition education and meal preparation program. This study will also identify opportunities to expand the supply of healthy and culturally relevant foods in food shelves. The goal is to inform a larger-scale intervention to improve the nutritional quality and cultural relevance of food shelf items as well as client outcomes. The primary outcome is participant change in Health Eating Index scores from pre-intervention to post-intervetion.
Detailed description
Food insecurity disproportionately affects low-income, minority, and foreign-born families, resulting in a disproportionate burden of nutrition-related chronic conditions affecting these groups. In Minnesota, over a half a million food insecure families relied on food shelves (also known as food pantries) for emergency food assistance in 2009. Yet reliance on food shelves in a culturally diverse population may present nutritional challenges for two main reasons. First, unlike many food assistance programs (e.g., school nutritional programs, WIC), there are currently no existing standards on the nutritional quality of food shelf offerings. Inventory data collected from a sample of Twin Cities food shelves in the summer of 2012 began to identity priority areas for the improvement of the nutritional quality of food shelves items, but such recommendations have yet to be implemented. Second, securing healthy meals for the large population of immigrants and refugees families who rely on food shelves in the Twin Cities may be particularly challenging. Among these clients, unfamiliarity with "American" foods and cooking practices for foods that are most affordable or available may serve as barriers to healthy meal preparation. Very little research has examined the potential for cooking skills and the incorporation of new foods in improving dietary outcomes among a group of culturally diverse food insecure families.
Recognizing that nutritional outcomes are driven by influence at both the food systems level and the individual level, the long-term goal of this research is to improve nutritional outcomes among food insecure families through enhancements at both the food shelf level and the client level. Because of the complexity in making systemic improvements in the quality of the emergency food supply, this pilot study will conduct formative research on improving food supply at the food shelf level, while primarily focusing on testing strategies to improve nutrition-related behaviors at the client level.
This intervention will focus primarily on promoting cooking skills using healthier "American" items along with culturally appropriate ingredients. Cooking classes will occur through a partnership with the Cooking Matters™ program, which leads hands-on 6-week cooking based nutrition education programs at a variety of venues in the greater Twin Cities area, and is conducted by the University of Minnesota Extension.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Cooking course6-week nutrition education and cooking course |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English-speaking
- Age 18 and older
- Required food assistance from a participating food shelf in the last 30 days
- Must be willing to give verbal consent
Key exclusion criteria (2 listed)
- Not able to speak and understand English
- Potential participants who have an apparent or self-reported physical or mental disability that would prohibit them from participating in a cooking course
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cooking course6-week nutrition education and cooking course | Other | Intervention |
Primary outcome
Change in Healthy Eating Index score
Time frame: 3 months
The Healthy Eating Index is scored on a scale of 0 to 100 and will be analyzed as a continuous outcome. Mean change in index score T1 to T2 will be assessed using a paired t-test with each individual serving as his or her own control.
1 secondary outcome
Meal preparations skills and self-efficacy
Time frame: 3 months
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 10 Jul 2015.
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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.
Caitlin Caspi, ScD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooking course in people with Change in Dietary Outcomes, run by University of Minnesota 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 2 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 10 Jul 2015. 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?
Change in Healthy Eating Index score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2015.