Ignite Creation Date:
2024-05-06 @ 4:07 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02457234
Status:
COMPLETED
Last Update Posted:
2015-05-29
First Post:
2015-05-27
Brief Title:
Influence of Cultural Immersion on Willingness to Try Fruits and Vegetables Among Children in Guam the Traditions Study
Sponsor:
University of Guam
Organization:
University of Guam
Study Overview
Official Title:
Examining the Influence of Cultural Immersion on Willingness to Try Fruits and Vegetables Among Children in Guam the Traditions Study
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Traditions
Brief Summary:
The purpose of the Traditions study was to examine the influence of cultural immersion on willingness to try fruits and vegetables among children 3-12 y in Guam The primary objective of this study was to examine willingness to try fruits and vegetables and fruit and vegetable intake among children attending three existing summer camp programs a cultural immersion camp a university day camp and a recreational sports camp The primary hypothesis was that children attending the cultural immersion camp would have higher willingness to try fruits and vegetables WillTry score and a higher intake of fruits and vegetables compared to children attending both the university day camp and recreational sports camp without cultural immersion
A pre-post quasi-experimental design was used to evaluate 3 summer camps with different exposure levels of cultural immersion High moderate and zero cultural exposure was provided by a cultural immersion camp CIC a university-based day camp UDC and a recreational sports camp RSC respectively CIC delivered 4 culturally adapted nutrition lessons within the context of Chamorro cultural traditions as part of the cultural immersion camp activities The UDC delivered the same lessons within a physiology framework The RSC was without nutrition lessons and cultural immersion Children 3-12 years old registered in any of the three summer camp programs were eligible to participate Data collection was primarily administered at two assessment periods before 2 weeks and after 1 week each summer camp program Childrens willingness to try fruits and vegetables the primary outcome was assessed with the interview-administered Adapted WillTry tool The secondary outcome was fruit and vegetable intake as servingsday in the CIC to UDC only Fruit and vegetable intake was assessed using the mobile food record mFR which is an app running on an iPod Touch based on the technology assisted dietary assessment TADA protocols Outcomes examined Adapted WillTry post-scores for local novel and local common fruits and vegetables and fruit and vegetable servingsday using multivariate regression models adjusting for the relevant pre-score sex age ethnicity dose BMI percentile and parents cultural affiliation Therefore additional measures like sociodemographic information anthropometry ie heights and weights and parents cultural affiliation were collected to account for potential confounders
A pre-post quasi-experimental design was used to evaluate 3 summer camps with different exposure levels of cultural immersion High moderate and zero cultural exposure was provided by a cultural immersion camp CIC a university-based day camp UDC and a recreational sports camp RSC respectively CIC delivered 4 culturally adapted nutrition lessons within the context of Chamorro cultural traditions as part of the cultural immersion camp activities The UDC delivered the same lessons within a physiology framework The RSC was without nutrition lessons and cultural immersion Children 3-12 years old registered in any of the three summer camp programs were eligible to participate Data collection was primarily administered at two assessment periods before 2 weeks and after 1 week each summer camp program Childrens willingness to try fruits and vegetables the primary outcome was assessed with the interview-administered Adapted WillTry tool The secondary outcome was fruit and vegetable intake as servingsday in the CIC to UDC only Fruit and vegetable intake was assessed using the mobile food record mFR which is an app running on an iPod Touch based on the technology assisted dietary assessment TADA protocols Outcomes examined Adapted WillTry post-scores for local novel and local common fruits and vegetables and fruit and vegetable servingsday using multivariate regression models adjusting for the relevant pre-score sex age ethnicity dose BMI percentile and parents cultural affiliation Therefore additional measures like sociodemographic information anthropometry ie heights and weights and parents cultural affiliation were collected to account for potential confounders
Detailed Description:
A pre-post quasi-experimental design was used to observe outcomes ie willingness to try FV and FV intake between three existing summer camp programs in Guam cultural immersion camp CIC university day camp UDC and recreational sports camp RSC This natural-setting multi-arm parallel design was used as an alternative to a resource intensive infrastructure and the organizations were willing to incorporate activities to answer the research question
The CIC and UDC programs were nearly matched for daily activities eg physical activity cooking demonstrationstaste testing crafts The same four Traditions lessons Figure 1 were incorporated into CIC and UDC and delivered by the same educators These lessons featured local FV and promoted positive associations with eating FV In CIC the context of Chamorro cultural traditions practices and values was tied to FV Chamorro is the language culture and ethnicity of Guam and the Marianas In UDC consuming healthy foods was introduced within a context of nutrition and human physiology The four lessons were adapted with permission from a culturally-relevant Hawaiian nutrition curriculum to make them relevant to Guam and the Chamorro culture This curriculum complemented Hawaii and Guam Department of Education K-12 Content and Performance Standards
The CIC activities perpetuated the Chamorro culture and language through songchanting dance prayer arts and crafts cooking outdoor activities and gardening based on traditional and contemporary practices Chamorro was spoken about 80 of the time including the delivery of key messages in the Traditions lessons All activities operated on indigenous values of respect love humility reciprocity and camaraderie The UDC activities focused on promoting healthful present-day recreational activities and global foods The activities were an extension of the Expanded Food and Nutrition Education Program mission RSC was exclusively physical activity Upon completion of the last assessments educators provided one Traditions lesson for registrants at RSC
Data collection occurred at two assessment periods before 2 weeks and after 1 week each program The first assessment was completed at each camp setting The second was also completed at camp or at a pre-arranged location such as the childrens home or a child-friendly public space eg the mall Children completed the interview-administered Adapted WillTry tool which measures childrens willingness to try FV and was previously validated for children 3-11 years old in Guam FV intake was assessed using the mobile food record mFR The mFR is an app that has been shown to be a useful method for dietary assessment with adolescents Only participants in CIC and UDC were asked to use the mFR due to a limited number of iPods
Other Measures Parents completed a questionnaire that included information about the childs age sex language spoken religion and birthplace Parents cultural affiliation was determined using their responses reported on a cultural affiliation questionnaire which assesses one of four modes of acculturation traditional integrated assimilated or marginalized The same scoring system was used as described by Kaholokula and others Anthropometric assessments were completed at a time designated as least disruptive to camp activities Height and weight were measured using a portable Seca scale and stadiometer PE-AIM 101 using centimeters and kilograms respectively These measurements were converted to body mass index BMI as kgheight m2 Dose was assessed by recording attendance at camp and at each Traditions lesson
For participation all children were given a gift card in 5 or 10 denominations one before and one after camp assessments Remuneration varied due to the different types and lengths of involvement for participants depending on camp program
Sample size was determined using estimates for the Adapted WillTry local novel and local common FV scores from data representing children similar to children recruited for this study The main outcomes model 1 and model 2 were powered at 08 for a minimum detectable difference MDD of 043 for the local novel score and 041 for the local common score which corresponded to proposed sample sizes of n60 for CIC n30 for UDC and n30 for RSC For Model 3 based on the UDC and RSC sample sizes MDD was 049 and 047 for local novel and local common respectively For the secondary outcome post-FV intake the MDDs were 0877 03132 and 06265 per day dependent on the baseline FV consumption being 2 1 or 15 which yielded sample sizes for CIC n60 and UDC n30
Data were entered using a Microsoft Access Microsoft Corp tool specifically designed for this study Double-data entry procedures were used and PROC COMPARE in SAS 93 SAS Institute Inc was performed until both data entries achieved 100 matching A trained analyst examined images identified all whole FV eg FV mixed dishes fruits vegetables and amounts consumed FV 100 juices were excluded FV intake was calculated by dividing the total FV by the total number of days eating occasions were captured using the mFR
Categorical variables were examined using frequencies and for quantitative variables means and standard deviations were used Differences between camps in Adapted WillTry FV post-scores ie local novel local common and imported were examined using univariate ANOVA adjusted for pre-scores To examine the previously observed incremental trend of the Adapted WillTry FV scores where each score was statistically significantly different from one another the paired t-tests for each pre- and post-assessment score in all camps were performed Analytical analyses were conducted using IBM SPSS Statistics version 21 IBM Corporation Armonk NY
Potential confounders were included in models using indicator variables for age ie 3-6y 7-8y 9-12y ethnicity ie Chamorro Chamorro Mixed Other and sex Categories of parents cultural affiliation were analyzed as traditional and integrated In these models children whose parents were categorized as marginalized n2 or assimilated n1 were eliminated due to small numbers Lesson and camp attendance dose for CIC and UDC were calculated using the sum of days participants attended lessons and camp days divided by the total possible lesson and camp days respectively A dichotomous variable was created for high and low dose using the 50th percentile cut-point for lessons and camp dose BMI was modeled as a continuous variable
To examine the primary hypothesis indicator variables were created for each camp for relevant comparisons in Models 1 2 and 3 Multiple linear regression models for the three Adapted WillTry post-scores dependent variables were fit separately to examine whether and how much the Adapted WillTry scores differed by camp program accounting for potential confounders ie pre-scores participants age sex ethnicity BMI parents cultural affiliation and lesson and camp days dose The final model included Adapted WillTry pre-scores sex age and ethnicity For whole FV intake multiple linear regression models were used to examine differences in post-FV intakeday dependent variable between UDC and CIC The final model included pre-FV intakeday age ethnicity and parents cultural affiliation independent variables
The CIC and UDC programs were nearly matched for daily activities eg physical activity cooking demonstrationstaste testing crafts The same four Traditions lessons Figure 1 were incorporated into CIC and UDC and delivered by the same educators These lessons featured local FV and promoted positive associations with eating FV In CIC the context of Chamorro cultural traditions practices and values was tied to FV Chamorro is the language culture and ethnicity of Guam and the Marianas In UDC consuming healthy foods was introduced within a context of nutrition and human physiology The four lessons were adapted with permission from a culturally-relevant Hawaiian nutrition curriculum to make them relevant to Guam and the Chamorro culture This curriculum complemented Hawaii and Guam Department of Education K-12 Content and Performance Standards
The CIC activities perpetuated the Chamorro culture and language through songchanting dance prayer arts and crafts cooking outdoor activities and gardening based on traditional and contemporary practices Chamorro was spoken about 80 of the time including the delivery of key messages in the Traditions lessons All activities operated on indigenous values of respect love humility reciprocity and camaraderie The UDC activities focused on promoting healthful present-day recreational activities and global foods The activities were an extension of the Expanded Food and Nutrition Education Program mission RSC was exclusively physical activity Upon completion of the last assessments educators provided one Traditions lesson for registrants at RSC
Data collection occurred at two assessment periods before 2 weeks and after 1 week each program The first assessment was completed at each camp setting The second was also completed at camp or at a pre-arranged location such as the childrens home or a child-friendly public space eg the mall Children completed the interview-administered Adapted WillTry tool which measures childrens willingness to try FV and was previously validated for children 3-11 years old in Guam FV intake was assessed using the mobile food record mFR The mFR is an app that has been shown to be a useful method for dietary assessment with adolescents Only participants in CIC and UDC were asked to use the mFR due to a limited number of iPods
Other Measures Parents completed a questionnaire that included information about the childs age sex language spoken religion and birthplace Parents cultural affiliation was determined using their responses reported on a cultural affiliation questionnaire which assesses one of four modes of acculturation traditional integrated assimilated or marginalized The same scoring system was used as described by Kaholokula and others Anthropometric assessments were completed at a time designated as least disruptive to camp activities Height and weight were measured using a portable Seca scale and stadiometer PE-AIM 101 using centimeters and kilograms respectively These measurements were converted to body mass index BMI as kgheight m2 Dose was assessed by recording attendance at camp and at each Traditions lesson
For participation all children were given a gift card in 5 or 10 denominations one before and one after camp assessments Remuneration varied due to the different types and lengths of involvement for participants depending on camp program
Sample size was determined using estimates for the Adapted WillTry local novel and local common FV scores from data representing children similar to children recruited for this study The main outcomes model 1 and model 2 were powered at 08 for a minimum detectable difference MDD of 043 for the local novel score and 041 for the local common score which corresponded to proposed sample sizes of n60 for CIC n30 for UDC and n30 for RSC For Model 3 based on the UDC and RSC sample sizes MDD was 049 and 047 for local novel and local common respectively For the secondary outcome post-FV intake the MDDs were 0877 03132 and 06265 per day dependent on the baseline FV consumption being 2 1 or 15 which yielded sample sizes for CIC n60 and UDC n30
Data were entered using a Microsoft Access Microsoft Corp tool specifically designed for this study Double-data entry procedures were used and PROC COMPARE in SAS 93 SAS Institute Inc was performed until both data entries achieved 100 matching A trained analyst examined images identified all whole FV eg FV mixed dishes fruits vegetables and amounts consumed FV 100 juices were excluded FV intake was calculated by dividing the total FV by the total number of days eating occasions were captured using the mFR
Categorical variables were examined using frequencies and for quantitative variables means and standard deviations were used Differences between camps in Adapted WillTry FV post-scores ie local novel local common and imported were examined using univariate ANOVA adjusted for pre-scores To examine the previously observed incremental trend of the Adapted WillTry FV scores where each score was statistically significantly different from one another the paired t-tests for each pre- and post-assessment score in all camps were performed Analytical analyses were conducted using IBM SPSS Statistics version 21 IBM Corporation Armonk NY
Potential confounders were included in models using indicator variables for age ie 3-6y 7-8y 9-12y ethnicity ie Chamorro Chamorro Mixed Other and sex Categories of parents cultural affiliation were analyzed as traditional and integrated In these models children whose parents were categorized as marginalized n2 or assimilated n1 were eliminated due to small numbers Lesson and camp attendance dose for CIC and UDC were calculated using the sum of days participants attended lessons and camp days divided by the total possible lesson and camp days respectively A dichotomous variable was created for high and low dose using the 50th percentile cut-point for lessons and camp dose BMI was modeled as a continuous variable
To examine the primary hypothesis indicator variables were created for each camp for relevant comparisons in Models 1 2 and 3 Multiple linear regression models for the three Adapted WillTry post-scores dependent variables were fit separately to examine whether and how much the Adapted WillTry scores differed by camp program accounting for potential confounders ie pre-scores participants age sex ethnicity BMI parents cultural affiliation and lesson and camp days dose The final model included Adapted WillTry pre-scores sex age and ethnicity For whole FV intake multiple linear regression models were used to examine differences in post-FV intakeday dependent variable between UDC and CIC The final model included pre-FV intakeday age ethnicity and parents cultural affiliation independent variables
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None