Obesity, ChildhoodNCT03641521
A Trial to Increase Child Vegetable Intake Through Behavioral Strategies
A study testing Parent-led behavioral strategies in people with Obesity, Childhood, run by University of Minnesota.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Parent-led behavioral strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- 24 Sep 2014to 2 May 2017
- 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 9 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- No exclusions other than those that do not meet inclusion criteria
About this study
Official title: 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.
Read the 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).
- Conditions
- Obesity, Childhood
- Being tested
- Parent-led behavioral strategies
- Keywords
- child vegetable intake, behavioral strategy, intervention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-led behavioral strategiesBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Behavioral: Parent-led behavioral strategies |
| Control | No intervention | The control arm consisted of the enhanced Cooking Matters® for Families program alone--without lessons about the behavioral strategies for the parents |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in # of vegetable servings consumed by child measured by averaging vegetable serving data extracted from 3, 24-hr recalls.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: change from baseline to 12 months post-baseline
Secondary outcomes (20)
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"))
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.
Measured: 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"))
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.
Measured: 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"))
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.
Measured: change from baseline to 12-months post baseline
change in number different of vegetables tried by child
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.
Measured: change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention)
change in number different of vegetables tried by child
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.
Measured: change from baseline to 6-months post-baseline
change in number different of vegetables tried by child
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.
Measured: change from baseline to 12-months post-baseline
change in number of available vegetables in the child's home
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."
Measured: change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention)
change in number of available vegetables in the child's home
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."
Measured: change from baseline to 6-months post baseline
change in number of available vegetables in the child's home
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."
Measured: 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)
Child Body Mass Index (BMI) was calculated from collected height and weight of child that were combined to report BMI in kg/m^2
Measured: 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)
Child Body Mass Index (BMI) was calculated from collected height and weight of child that were combined to report BMI in kg/m^2
Measured: 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)
Child Body Mass Index (BMI) was calculated from collected height and weight of child that were combined to report BMI in kg/m^2
Measured: change from baseline to 12-months post baseline
change in child's Healthy Eating Index 2010 score (a measure of dietary quality)
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..
Measured: 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)
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.
Measured: change from baseline to 6-months post baseline
change in child's Healthy Eating Index 2010 score (a measure of dietary quality)
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.
Measured: change from baseline to 12-months post baseline
change in child's dietary energy (in kilocalories) intake
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)
Measured: change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention)
change in child's dietary energy (in kilocalories) intake
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)
Measured: change from baseline to 6-months post-baseline
change in child's dietary energy (in kilocalories) intake
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)
Measured: 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
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.
Measured: 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).
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.
Measured: change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start24 Sep 2014
- Primary completion2 May 2017
- Study completion2 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- controlled, non-randomized community nutrition intervention
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marla Reicks, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641521
- Sponsor's protocol ID
- 1111S06501
- Status last verified
- Jul 2019
- First submitted
- 14 Aug 2018
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Overcash F, Ritter A, Mann T, Mykerezi E, Redden J, Rendahl A, Vickers Z, Reicks M. Impacts of a Vegetable Cooking Skills Program Among Low-Income Parents and Children. J Nutr Educ Behav. 2018 Sep;50(8):795-802. doi: 10.1016/j.jneb.2017.10.016. Epub 2017 Dec 12.
PubMed 29242140Overcash FM, Reicks M, Ritter A, Leak TM, Swenson A, Vickers Z. Children Residing in Low-Income Households Like a Variety of Vegetables. Foods. 2018 Jul 20;7(7):116. doi: 10.3390/foods7070116.
PubMed 30036932Overcash FM, Vickers Z, Ritter AE, Mann T, Mykerezi E, Redden J, Rendahl AK, Davey C, Reicks M. An in-home intervention of parent-implemented strategies to increase child vegetable intake: results from a non-randomized cluster-allocated community trial. BMC Public Health. 2019 Jul 4;19(1):881. doi: 10.1186/s12889-019-7079-4.
PubMed 31272404
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled-intervention Trial to Increase Child Vegetable Intake Through Parent-implemented Behavioral Strategies
- ClinicalTrials.gov ID
- NCT03641521
- Acronym / sponsor ID
- 1111S06501
- Conditions
- Obesity, Childhood
- Keywords
- child vegetable intake, behavioral strategy, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 24 Sep 2014 (actual)
- Primary completion
- 2 May 2017 (actual)
- Study completion
- 2 May 2017 (actual)
- First posted
- 22 Aug 2018 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- controlled, non-randomized community nutrition intervention
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Parent-led behavioral strategiesThe 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 |
| Control | No intervention | –The control arm consisted of the enhanced Cooking Matters® for Families program alone--without lessons about the behavioral strategies for the parents |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- No exclusions other than those that do not meet inclusion criteria
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 |
|---|---|---|
| Parent-led behavioral strategiesIntervention 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). | Behavioural | Intervention |
Primary outcome
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 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 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.
20 secondary outcomes
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)
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
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
change in number different of vegetables tried by child
Time frame: 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
change in number different of vegetables tried by child
Time frame: 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)
change in number of available vegetables in the child's home
Time frame: 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
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)
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
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
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)
change in child's Healthy Eating Index 2010 score (a measure of dietary quality)
Time frame: 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
change in child's dietary energy (in kilocalories) intake
Time frame: 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
change in child's dietary energy (in kilocalories) intake
Time frame: 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)
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)
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 12 Jul 2019.
- Results publication: PubMed 29242140Overcash F, Ritter A, Mann T, Mykerezi E, Redden J, Rendahl A, Vickers Z, Reicks M. Impacts of a Vegetable Cooking Skills Program Among Low-Income Parents and Children. J Nutr Educ Behav. 2018 Sep;50(8):795-802. doi: 10.1016/j.jneb.2017.10.016. Epub 2017 Dec 12.
- Results publication: PubMed 30036932Overcash FM, Reicks M, Ritter A, Leak TM, Swenson A, Vickers Z. Children Residing in Low-Income Households Like a Variety of Vegetables. Foods. 2018 Jul 20;7(7):116. doi: 10.3390/foods7070116.
- Derived from this study: PubMed 31272404Overcash FM, Vickers Z, Ritter AE, Mann T, Mykerezi E, Redden J, Rendahl AK, Davey C, Reicks M. An in-home intervention of parent-implemented strategies to increase child vegetable intake: results from a non-randomized cluster-allocated community trial. BMC Public Health. 2019 Jul 4;19(1):881. doi: 10.1186/s12889-019-7079-4.
- Individual participant dataSharing planned: Yes. 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.
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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.
Marla Reicks, PhD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A study testing Parent-led behavioral strategies in people with Obesity, Childhood, run by University of Minnesota.
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 6 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 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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 # 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)). The study lists 3 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 NCT03641521, which also lists 3 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 12 Jul 2019.