A Trial to Increase Child Vegetable Intake Through Behavioral Strategies

July 10, 2019 updated by: University of Minnesota

A Controlled-intervention Trial to Increase Child Vegetable Intake Through Parent-implemented Behavioral Strategies

A community nutrition trial among a diverse low-income population that tested the effect of parent-child cooking nutrition intervention on vegetable intake among 9-12 children.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study was a nonrandomized, controlled trial to determine whether a series of 6 weekly parent-child vegetable cooking skills classes and parent-led strategies informed by behavioral economics (1/week) (intervention group) improved dietary and non-dietary outcomes of a racially and ethnically diverse sample of low-income children (ages 9-12) more than a vegetable cooking skills program alone (control group).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
103

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant child must be 9-12 years old
  • Parent must be the main food preparer for the household
  • The family must qualify for some form of public assistance
  • Have a phone
  • Must not have participated in a previous Cooking Matters for Families in the past 3 years
  • Be able to read, speak, and understand English (or Spanish for Spanish-only courses).

Exclusion criteria:

*No exclusions other than those that do not meet inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Intervention
The intervention consisted of an enhanced Cooking Matters® for Families program that included behavioral strategies derived from behavioral economics, to be implemented by parents at home for increasing vegetable intake of low-income 9-12 year old children
Behavioral: Parent-led behavioral strategies
Intervention parents participated in an additional 20-25-min segment led by the nutrition educator during which the week's behavioral strategy was introduced. The following six behavioral strategies were introduced (one each week) as a segment of each cooking skills session: 1) have your child help prepare vegetables for meals (Child Help), 2) use a plate that shows the amount of vegetables to include for a meal (My Plate), 3) make vegetables visible and accessible by removing other foods from the dining area during the meal and leaving the vegetables (Make Avail/Visible), 4) serve at least 2 vegetables with the meal (Serve 2), 5) serve vegetables before the meal (Serve First), and 6) use a bigger spoon to serve the vegetables (Big Spoon).
NO_INTERVENTION: Control
The control arm consisted of the enhanced Cooking Matters® for Families program alone--without lessons about the behavioral strategies for the parents

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change in # of vegetable servings consumed by child measured by averaging vegetable serving data extracted from 3, 24-hr recalls.
Time Frame: change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention)
Number of vegetable servings were assessed from 3, 24-hr dietary recalls, collected by trained study personnel in-person and over the phone from each child, using Nutrition Data System for Research (NDSR®)software). The 3, 24-hr recalls were averaged to come up with an aggregate # of vegetable servings.
change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention)
change in # of vegetable servings consumed by child measured by averaging vegetable serving data extracted from 3, 24-hr recalls.
Time Frame: change from baseline to 6 months post-baseline
Number of vegetable servings were assessed from 3, 24-hr dietary recalls, collected by trained study personnel in-person and over the phone from each child, using Nutrition Data System for Research (NDSR®)software). The 3, 24-hr recalls were averaged to come up with an aggregate # of vegetable servings.
change from baseline to 6 months post-baseline
change in # of vegetable servings consumed by child measured by averaging vegetable serving data extracted from 3, 24-hr recalls.
Time Frame: change from baseline to 12 months post-baseline
Number of vegetable servings were assessed from 3, 24-hr dietary recalls, collected by trained study personnel in-person and over the phone from each child, using Nutrition Data System for Research (NDSR®)software). The 3, 24-hr recalls were averaged to come up with an aggregate # of vegetable servings.
change from baseline to 12 months post-baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in liking of vegetables by child (liking rating scale was comprised of values across a 10-point labeled hedonic scale (1 -"Hate it" to 5 - "It's okay" to 10 - "Love it"))
Time Frame: change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention)
Each child rated his/her liking of 37 different vegetables.The liking rating scale was comprised of values across a 10-point labeled hedonic scale (1 -"Hate it" to 5 - "It's okay" to 10 - "Love it"). This type of liking rating scale has been validated for testing with children. (Kroll, B.J. 1990. Evaluating rating scales for sensory testing with children. Food Technology, 44(11), 78-86.) An aggregate vegetable liking score representing mean liking rating across all vegetables was calculated for each child.
change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention)
change in liking of vegetables by child ( liking rating scale was comprised of values across a 10-point labeled hedonic scale (1 -"Hate it" to 5 - "It's okay" to 10 - "Love it"))
Time Frame: change from baseline to 6-months post baseline
Each child rated his/her liking of 37 different vegetables.The liking rating scale was comprised of values across a 10-point labeled hedonic scale (1 -"Hate it" to 5 - "It's okay" to 10 - "Love it"). This type of liking rating scale has been validated for testing with children. (Kroll, B.J. 1990. Evaluating rating scales for sensory testing with children. Food Technology, 44(11), 78-86.) An aggregate vegetable liking score representing mean liking rating across all vegetables was calculated for each child.
change from baseline to 6-months post baseline
change in liking of vegetables by child ( liking rating scale was comprised of values across a 10-point labeled hedonic scale (1 -"Hate it" to 5 - "It's okay" to 10 - "Love it"))
Time Frame: change from baseline to 12-months post baseline
Each child rated his/her liking of 37 different vegetables.The liking rating scale was comprised of values across a 10-point labeled hedonic scale (1 -"Hate it" to 5 - "It's okay" to 10 - "Love it"). This type of liking rating scale has been validated for testing with children. (Kroll, B.J. 1990. Evaluating rating scales for sensory testing with children. Food Technology, 44(11), 78-86.) An aggregate vegetable liking score representing mean liking rating across all vegetables was calculated for each child.
change from baseline to 12-months post baseline
change in number different of vegetables tried by child
Time Frame: change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention)
Each child was asked the question "Have you ever tried (name of vegetable)" with following response options: Yes/No/Don't know. An aggregate score per child was tabulated by summing all "yes" answers.
change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention)
change in number different of vegetables tried by child
Time Frame: change from baseline to 6-months post-baseline
Each child was asked the question "Have you ever tried (name of vegetable)" with following response options: Yes/No/Don't know. An aggregate score per child was tabulated by summing all "yes" answers.
change from baseline to 6-months post-baseline
change in number different of vegetables tried by child
Time Frame: change from baseline to 12-months post-baseline
Each child was asked the question "Have you ever tried (name of vegetable)" with following response options: Yes/No/Don't know. An aggregate score per child was tabulated by summing all "yes" answers.
change from baseline to 12-months post-baseline
change in number of available vegetables in the child's home
Time Frame: change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention)
Each of the child's parent was asked to complete a validated Home Food Inventory developed by Fulkerson and colleagues [Fulkerson JA, Nelson MC, Lytle L, Moe S, Heitzler C, Pasch KE. The validation of a home food inventory. Int J Behav Nutr Phys Act. 2008;5:55. doi:10.1186/1479-5868-5-55], to self-report the availability of different vegetables currently in their home. Response options for each question asking if the vegetable was currently in the home were "yes /no/ don't know" . Final number of available vegetables in the home was calculated by summing the number of vegetables for which the parent answered "yes."
change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention)
change in number of available vegetables in the child's home
Time Frame: change from baseline to 6-months post baseline
Each of the child's parent was asked to complete a validated Home Food Inventory developed by Fulkerson and colleagues [Fulkerson JA, Nelson MC, Lytle L, Moe S, Heitzler C, Pasch KE. The validation of a home food inventory. Int J Behav Nutr Phys Act. 2008;5:55. doi:10.1186/1479-5868-5-55], to self-report the availability of different vegetables currently in their home. Response options for each question asking if the vegetable was currently in the home were "yes /no/ don't know" .Final number of available vegetables in the home was calculated by summing the number of vegetables for which the parent answered "yes."
change from baseline to 6-months post baseline
change in number of available vegetables in the child's home
Time Frame: change from baseline to 12-months post baseline
Each of the child's parent was asked to complete a validated Home Food Inventory developed by Fulkerson and colleagues [Fulkerson JA, Nelson MC, Lytle L, Moe S, Heitzler C, Pasch KE. The validation of a home food inventory. Int J Behav Nutr Phys Act. 2008;5:55. doi:10.1186/1479-5868-5-55], to self-report the availability of different vegetables currently in their home. Response options for each question asking if the vegetable was currently in the home were "yes /no/ don't know" . Final number of available vegetables in the home was calculated by summing the number of vegetables for which the parent answered "yes."
change from baseline to 12-months post baseline
change in child's body mass index (as measured by collected height (m) and weight (kg) from child)
Time Frame: change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention)
Child Body Mass Index (BMI) was calculated from collected height and weight of child that were combined to report BMI in kg/m^2
change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention)
change in child's body mass index (as measured by collected height (m) and weight (kg) from child)
Time Frame: change from baseline to 6-months post baseline
Child Body Mass Index (BMI) was calculated from collected height and weight of child that were combined to report BMI in kg/m^2
change from baseline to 6-months post baseline
change in child's body mass index (as measured by collected height (m) and weight (kg) from child)
Time Frame: change from baseline to 12-months post baseline
Child Body Mass Index (BMI) was calculated from collected height and weight of child that were combined to report BMI in kg/m^2
change from baseline to 12-months post baseline
change in child's Healthy Eating Index 2010 score (a measure of dietary quality)
Time Frame: change from baseline to immediate post-intervention (i.e, 9 weeks post-baseline)
Child dietary data was assessed through from 3, 24-hr dietary recalls, collected by trained study personnel in-person and over the phone using Nutrition Data System for Research (NDSR) software.The 3, 24-hr recalls were averaged to come up with an aggregate score for each nutrient. NDSR data was imported into a SAS® program (version 9.4) (SAS Institute Inc. Cary, NC 2014), created by National Institutes of Health-NCI, Division of Cancer Control & Population Studies that calculated a Healthy Eating Index 2010 score, a validated measure of dietary quality, for each child (Guenther PM, Casavale KO, Reedy J, Kirkpatrick SI, Hiza HAB, Kuczynski KJ, et al. Update of the Healthy Eating Index: HEI-2010. J Acad Nutr Diet. 2013;113:569-80..
change from baseline to immediate post-intervention (i.e, 9 weeks post-baseline)
change in child's Healthy Eating Index 2010 score (a measure of dietary quality)
Time Frame: change from baseline to 6-months post baseline
Child dietary data was assessed through from 3, 24-hr dietary recalls, collected by trained study personnel in -person and over the phone using Nutrition Data System for Research (NDSR) software.The 3, 24-hr recalls were averaged to come up with an aggregate score for each nutrient. NDSR data was imported into a SAS® program (version 9.4) (SAS Institute Inc. Cary, NC 2014), created by National Institutes of Health-NCI, Division of Cancer Control & Population Studies that calculated a Healthy Eating Index 2010 score, a validated measure of dietary quality, for each child.
change from baseline to 6-months post baseline
change in child's Healthy Eating Index 2010 score (a measure of dietary quality)
Time Frame: change from baseline to 12-months post baseline
Child dietary data was assessed through from 3, 24-hr dietary recalls, collected by trained study personnel in -person and over the phone using Nutrition Data System for Research (NDSR) software.The 3, 24-hr recalls were averaged to come up with an aggregate score for each nutrient. NDSR data was imported into a SAS® program (version 9.4) (SAS Institute Inc. Cary, NC 2014), created by National Institutes of Health-NCI, Division of Cancer Control & Population Studies that calculated a Healthy Eating Index 2010 score, a validated measure of dietary quality, for each child.
change from baseline to 12-months post baseline
change in child's dietary energy (in kilocalories) intake
Time Frame: change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention)
Child dietary data was assessed through from 3, 24-hr dietary recalls, collected by trained study personnel in -person and over the phone using Nutrition Data System for Research (NDSR) software.The 3, 24-hr recalls were averaged to come up with an aggregate score for each nutrient (e.g., dietary energy in kilocalories)
change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention)
change in child's dietary energy (in kilocalories) intake
Time Frame: change from baseline to 6-months post-baseline
Child dietary data was assessed through from 3, 24-hr dietary recalls, collected by trained study personnel in -person and over the phone using Nutrition Data System for Research (NDSR) software.The 3, 24-hr recalls were averaged to come up with an aggregate score for each nutrient (e.g., dietary energy in kilocalories)
change from baseline to 6-months post-baseline
change in child's dietary energy (in kilocalories) intake
Time Frame: change from baseline to 12-months post-baseline
Child dietary data was assessed through from 3, 24-hr dietary recalls, collected by trained study personnel in -person and over the phone using Nutrition Data System for Research (NDSR) software.The 3, 24-hr recalls were averaged to come up with an aggregate score for each nutrient (e.g., dietary energy in kilocalories)
change from baseline to 12-months post-baseline
change in child cooking skills self-efficacy as measured by a validated survey to measure child cooking self-efficacy
Time Frame: change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention)
Child cooking skills self-efficacy was measured using scales that have shown internal consistency and test-retest reliability in a psychometric evaluation of a cooking-based nutrition education intervention among low-income 9-11 year old children (Cronbach α = ≥ 0.74, test-retest r ≥ 0.66).(Lohse B, Cunningham-Sabo L, Walters LM, Stacey JE. Valid and Reliable Measures of Cognitive Behaviors toward Fruits and Vegetables for Children Aged 9 to 11 Years. J Nutr Educ Behav. 2011;43:42-49. doi:10.1016/j.jneb.2009.12.006). Response options for the child self-efficacy questions: 1 = YES! - 5 = NO!). The child-self-efficacy scale was calculated by summing 8 items measuring self-efficacy. A lower score indicated greater self-efficacy and more positive attitudes toward cooking.
change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention)
change in adult cooking skills confidence as measured by a validated survey to measure adult cooking confidence. Response options for the cooking confidence questions: (4 items, 1 = not at all confident - 5 = very confident).
Time Frame: change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention)
Parents completed the Cooking Matters for Families Before and After Course Survey to assess change in cooking skills confidence. Internal consistency and ability of the scales to reflect positive self-reported changes were previously among low-income adults (Pinard CA, Uvena LM, Quam JB, Smith TM, Yaroch AL. Development and testing of a revised cooking matters for adults survey. Am J Health Behav. 2015;39(6):866-873. doi:10.5993/AJHB.39.6.14). Response options for the 4 cooking confidence questions: (4 items, 1 = not at all confident - 5 = very confident). An aggregate score for each parent was tabulated by averaging the 4 questions. A higher score indicated greater cooking skills confidence.
change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marla Reicks, PhD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 24, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 2, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 2, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1111S06501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Although there is no formal plan in place, the investigative team will share any of the information with other researchers (study protocol, statistical analysis plan, informed consent form, analytic code/data). We are in the process of publishing the results of our trial in a peer-reviewed journal.

IPD Sharing Time Frame

No time frame

IPD Sharing Access Criteria

Email Study Contact

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity, Childhood

Clinical Trials on Parent-led behavioral strategies

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings