NCT04237571

Brief Summary

Previous adult participants of the Tanglewood to Table walking program will be recruited to enroll in the CANE Meal Program. This program will encourage participants to pick up a healthy meal from the CANE Kitchen each week for five weeks. The meal will consist of at least one serving of fruit or vegetables. At each meal, educational materials will be distributed, including the recipe for healthy meals and nutrition handouts that are linked to the recipes. Additional information about the ways the nutrients in the meal may help protect from the negative effects of environmental pollutants will be included. Surveys, blood pressure, height, weight, waist circumference and carotenoid status will be assessed before and after the program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

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

First Submitted

Initial submission to the registry

January 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 23, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2020

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

January 17, 2020

Last Update Submit

July 21, 2020

Conditions

Keywords

fruitsvegetablesexercisecommunityeducation

Outcome Measures

Primary Outcomes (6)

  • Change in fruit and vegetable consumption.

    Fruit and vegetable consumption will be assessed with a food frequency questionnaire pre- and post-intervention. This questionnaire asks participants to estimate the frequency of consumption on a ten point scale (from never to three times per day) of 45 specific fruits or vegetables. Aggregate scores range from 0-450 with higher scores indicating increased consumption.

    Five weeks

  • Change in weight.

    Body weight will be measured on a digital scale pre- and post-intervention.

    Five weeks

  • Change in waist circumference

    Waist circumference will be measured with a tape measure pre- and post-intervention.

    Five weeks

  • Change in total blood pressure

    Systolic and diastolic blood pressure will be measured pre- and post-intervention using a digital blood pressure machine.

    Five weeks

  • Change in carotenoid status

    Carotenoid status will be measured via carotenoid RS scanner, an objective measure of diet-derived pigments in the skin.

    Five weeks

  • Change in knowledge of nutrition and environmental pollution.

    Knowledge of nutrition and environmental pollution will be assessed using a mixed 6-item survey containing 4 "yes" "no" "not sure" questions and two multiple choice knowledge questions. The questionnaire does not have an absolute range, but a higher percent of "not sure" responses indicates less knowledge of nutrition and pollution; while a higher percentage of absolutely correct responses indicates increased knowledge. Data will be reported as the change from pre- to post-intervention.

    Five weeks

Study Arms (1)

CANE Adult Participants

EXPERIMENTAL

This sample population consists of an active intervention group of prior Tanglewood to Table walking program adult participants.

Behavioral: CANE Meal Program

Interventions

Participants will be encouraged to pick up a healthy meal from the Community Agriculture Nutritional Experience (CANE) Kitchen in Whitesburg, Kentucky once a week for five weeks. The meals will consist of at least one serving of a fruit or a vegetable. At each meal, education materials will be distributed, including the recipe for the healthy meals and nutrition handouts that are linked to the recipes. Additional information about the ways the nutrients in the meal may help protect from the negative effects of environmental pollutants will be included.

CANE Adult Participants

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 18 years of age
  • previous participant in Tanglewood to Table Walking Program

You may not qualify if:

  • institutionalized adults
  • children under the age of 18
  • adults with impaired consent capacity
  • incarcerated adults

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Dawn Brewer

    University of Kentucky

    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 INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 17, 2020

First Posted

January 23, 2020

Study Start

January 23, 2020

Primary Completion

May 29, 2020

Study Completion

May 29, 2020

Last Updated

July 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations