NCT01983891

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 7, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2013

Completed
Last Updated

July 10, 2015

Status Verified

July 1, 2015

Enrollment Period

6 months

First QC Date

November 7, 2013

Last Update Submit

July 8, 2015

Conditions

Keywords

food shelfnutrition educationcooking course

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (1)

  • Meal preparations skills and self-efficacy

    3 months

Study Arms (1)

Intervention

EXPERIMENTAL

6-week nutrition education and cooking course

Other: Cooking course

Interventions

6-week nutrition education and cooking course

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Department of Family Medicine and Community Health

Minneapolis, Minnesota, 55455, United States

Location

Study Officials

  • Caitlin Caspi, ScD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2013

First Posted

November 14, 2013

Study Start

April 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

July 10, 2015

Record last verified: 2015-07

Locations