Obesity, Childhood Clinical Trial
Official title:
A Controlled-intervention Trial to Increase Child Vegetable Intake Through Parent-implemented Behavioral Strategies
Verified date | July 2019 |
Source | University of Minnesota - Clinical and Translational Science Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 103 |
Est. completion date | May 2, 2017 |
Est. primary completion date | May 2, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 9 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota - Clinical and Translational Science Institute |
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 — View Citation
Overcash 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). pii: E116. doi: 10.3390/foods7070116. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention) | |
Primary | 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. | change from baseline to 6 months post-baseline | |
Primary | 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. | change from baseline to 12 months post-baseline | |
Secondary | 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. | change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention) | |
Secondary | 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. | change from baseline to 6-months post baseline | |
Secondary | 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. | change from baseline to 12-months post baseline | |
Secondary | 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. | change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention) | |
Secondary | 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. | change from baseline to 6-months post-baseline | |
Secondary | 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. | change from baseline to 12-months post-baseline | |
Secondary | 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." | change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention) | |
Secondary | 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." | change from baseline to 6-months post baseline | |
Secondary | 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." | change from baseline to 12-months post baseline | |
Secondary | 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 | change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention) | |
Secondary | 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 | change from baseline to 6-months post baseline | |
Secondary | 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 | change from baseline to 12-months post baseline | |
Secondary | 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.. | change from baseline to immediate post-intervention (i.e, 9 weeks post-baseline) | |
Secondary | 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. | change from baseline to 6-months post baseline | |
Secondary | 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. | change from baseline to 12-months post baseline | |
Secondary | 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) | change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention) | |
Secondary | 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) | change from baseline to 6-months post-baseline | |
Secondary | 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) | change from baseline to 12-months post-baseline | |
Secondary | 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 a = = 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) | |
Secondary | 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. | change from baseline to 9 weeks post-baseline (i.e., immediate post-intervention) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT03994419 -
PErioperAtive CHildhood ObesitY
|
||
Active, not recruiting |
NCT06259539 -
A YouTube Curriculum for Children With Autism and Obesity
|
N/A | |
Completed |
NCT03533621 -
Gut Microbiome, Adiposity, and Probiotics (GMAP)
|
N/A | |
Completed |
NCT04009304 -
Effective Training Models for Implementing Health-Promoting Practices Afterschool
|
N/A | |
Completed |
NCT05563311 -
Functional Assessment and Sleep Apnea in Obese Children and Adolescents
|
N/A | |
Completed |
NCT03575884 -
Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers
|
N/A | |
Terminated |
NCT03586544 -
Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity
|
Phase 4 | |
Completed |
NCT04628897 -
Physical Activity and the Home Environment in Preschool-aged Children in Urban Bangladesh
|
||
Completed |
NCT03399617 -
SPOON: Sustained Program for Improving Nutrition - Guatemala
|
N/A | |
Enrolling by invitation |
NCT06265597 -
The Effect of Healthy Nutrition and Yoga Program on Obese Children
|
N/A | |
Active, not recruiting |
NCT03843424 -
Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents & Providers
|
N/A | |
Completed |
NCT03170700 -
Online Videos and New Feeding Content to Enhance a Current EFNEP Program
|
N/A | |
Not yet recruiting |
NCT06464497 -
Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity
|
N/A | |
Enrolling by invitation |
NCT05551650 -
El Sendero: Pathways to Health Study
|
||
Completed |
NCT04346433 -
Sleep and Stigma: Novel Moderators in the Relationship Between Weight Status and Cognitive Function
|
N/A | |
Recruiting |
NCT03963557 -
Cognitive Function and Body Mass Index in Children and Adolescents
|
||
Completed |
NCT03495310 -
Effect of Mindfulness on Stress, Appetite Hormones and Body Weight of Obese Schoolchildren. Controlled Clinical Trial
|
N/A | |
Recruiting |
NCT06028113 -
A Novel Obesity Prevention Program for High-Risk Infants in Primary Care
|
Phase 2 | |
Active, not recruiting |
NCT05465057 -
"HIIT Med Kiloene".
|
N/A | |
Completed |
NCT03069274 -
Sugar-sweetened Beverage Intake Substitution by Water to Prevent Overweight in Mexican Children
|
N/A |