Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565455
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
La CASA Comunidad Alimentación Seguridad y Amén Healthy Eating Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
La CASA Comunidad Alimentación Seguridad y Amén Program Healthy Eating Intervention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Childhood obesity is a national problem with racial and ethnic disparities specifically among Hispanic children The primary purpose of this study is to develop and implement a culturally appropriate healthy eating intervention called CASA Comunidad Alimentacion Seguridad y Amen
Specific Aim SA 1 To develop a culturally appropriate healthy eating promotion intervention the CASA in collaboration with Hispanic churches and their congregants
SA2 To conduct the CASA intervention in eight churches four churches in the intervention vs four in the controlattention group and to assess the feasibility and acceptability of implementing the intervention
SA3 To assess the impact of the CASA intervention on healthy food preparation mothers and intake of fruits and vegetables child
The investigators will compare between the intervention group 16 mother-child dyads versus the controlattention group 16 mother-child dyad to see if the intervention is effective in improving diet quality and changing cooking behaviors
Participants will
1 Participate in cooking workshops and one to one learning activities
2 Report on diet and physical activity
3 Will measure fruit and vegetable intake
Specific Aim SA 1 To develop a culturally appropriate healthy eating promotion intervention the CASA in collaboration with Hispanic churches and their congregants
SA2 To conduct the CASA intervention in eight churches four churches in the intervention vs four in the controlattention group and to assess the feasibility and acceptability of implementing the intervention
SA3 To assess the impact of the CASA intervention on healthy food preparation mothers and intake of fruits and vegetables child
The investigators will compare between the intervention group 16 mother-child dyads versus the controlattention group 16 mother-child dyad to see if the intervention is effective in improving diet quality and changing cooking behaviors
Participants will
1 Participate in cooking workshops and one to one learning activities
2 Report on diet and physical activity
3 Will measure fruit and vegetable intake
Detailed Description:
The primary purpose of this study is to develop and implement a culturally appropriate healthy eating intervention called CASA Comunidad Alimentacion Seguridad y Amen to be delivered in the home and church setting by lay Community Health workers CHWpromotoras
Specific Aim SA 1 To develop a culturally appropriate healthy eating promotion intervention the CASA in collaboration with Hispanic churches and their congregants formative
SA2 To conduct the CASA intervention in eight churches four churches in the intervention vs four in the controlattention group and to assess the feasibility and acceptability of implementing the intervention implementation
SA3 To assess the impact of the CASA intervention on healthy food preparation mothers and intake of fruits and vegetables child
To achieve Aim 1 Healthy eating culturally adapted modules will be developed from existing sources The healthy eating modules will consist of Cause and long-term consequences of childhood obesity Importance of hydration Hidrátate Physical Activity Muévete Recommended meal portions and meal planning Mídete Sugar Smart Azúcar Ultra-processed foods Conoce Fruits and vegetables Frescas
The investigators will recruit up to 15 women to participate in focus groups FGs to participate in an iterative process of culturally adapting the healthy eating modules FGs will be audio-recorded on Zoom or on an encrypted iPad and professionally transcribed for data analysis A moderator will lead the FGs and a note taker will be present during the FGs
To achieve aim 2 the investigators will recruit and train 10 lay CHWspromotoras to deliver the intervention Priest pastors sisters andor church staff will approach women who are active in the church setting to discuss the program goals and assess their interest in becoming CHWspromotoras The training will consist of learning the 7 learning modules and how to effect and motivate behavior change
Hispanic mother and-child dyads will be recruited to participate in the CASA intervention via word or mouth from priests sisters and church staff and via fliers being posted in the churches The objective is to recruit a total of 16 mother-child dyad for the intervention group and 16 mother-child dyads for the controlattention group The total sample size will be 64 participants
Randomization will occur at the level of the church Each dyad will be assigned to either the CASA intervention group or the control group The CASA intervention group will be implemented at home by the lay CHW bi-weekly for 14 weeks Participants within the CASA intervention will also attend two Cooking DemonstrationsTasting Workshops The workshops will be led by the CHW Specialist and the dietitian The workshops are projected to last 2-3 hrs 60 minutes for teaching nutrition facts healthy ingredient selection portion sizes and the nutritional value of typical Hispanic dishes The remaining 60-90 minutes will be dedicated to cooking
The control group will receive seven bi-weekly messaging videos for 12 weeks via FacebookwhatsApp The messaging videos will last 5-15 minutes and will be delivered in Spanish or English The topics of the messaging videos are as follows Mental health issues that affect the Hispanic community childhood vaccinations Cord blood banking recommended adult vaccinations common childhood diseases dental care for adults and children common behavioral problems in children
To achieve Aim 3 the investigators will test differences between the intervention and control groups To determine if there is a change in food preparation in the home setting by the participant mother the investigators will measure home cooking quality at T0 and T1 The instrument to evaluate if there is a difference after implementation of the CASA intervention is the HCQ2 To assess if there is a change in intake of fruits and vegetables in children that participated in the CASA intervention and the controlattention group the investigators will use the Veggie Meter and the Block FFQ at T0 and T1
The investigators will use descriptive statistics to describe our sample and to make comparisons between the intervention and controlattention group For the primary outcomes of changes in dietary behaviors at the family level and change in diet quality the investigators will use pre-post data T0 and TI Secondary outcomes of consumption of fruits and vegetables consumption of sugar drinks and physical activity will be analyzed by using an analysis of covariance ANCOVA model from baseline T0 to T1 in children and mothers in both groups
Data analysis of the FGs qualitative data FGs transcripts will be uploaded to MAXQDA software for data management and to analyze the transcripts The investigators will use Rapid analytical techniques to code and uncover themes in the transcripts
Specific Aim SA 1 To develop a culturally appropriate healthy eating promotion intervention the CASA in collaboration with Hispanic churches and their congregants formative
SA2 To conduct the CASA intervention in eight churches four churches in the intervention vs four in the controlattention group and to assess the feasibility and acceptability of implementing the intervention implementation
SA3 To assess the impact of the CASA intervention on healthy food preparation mothers and intake of fruits and vegetables child
To achieve Aim 1 Healthy eating culturally adapted modules will be developed from existing sources The healthy eating modules will consist of Cause and long-term consequences of childhood obesity Importance of hydration Hidrátate Physical Activity Muévete Recommended meal portions and meal planning Mídete Sugar Smart Azúcar Ultra-processed foods Conoce Fruits and vegetables Frescas
The investigators will recruit up to 15 women to participate in focus groups FGs to participate in an iterative process of culturally adapting the healthy eating modules FGs will be audio-recorded on Zoom or on an encrypted iPad and professionally transcribed for data analysis A moderator will lead the FGs and a note taker will be present during the FGs
To achieve aim 2 the investigators will recruit and train 10 lay CHWspromotoras to deliver the intervention Priest pastors sisters andor church staff will approach women who are active in the church setting to discuss the program goals and assess their interest in becoming CHWspromotoras The training will consist of learning the 7 learning modules and how to effect and motivate behavior change
Hispanic mother and-child dyads will be recruited to participate in the CASA intervention via word or mouth from priests sisters and church staff and via fliers being posted in the churches The objective is to recruit a total of 16 mother-child dyad for the intervention group and 16 mother-child dyads for the controlattention group The total sample size will be 64 participants
Randomization will occur at the level of the church Each dyad will be assigned to either the CASA intervention group or the control group The CASA intervention group will be implemented at home by the lay CHW bi-weekly for 14 weeks Participants within the CASA intervention will also attend two Cooking DemonstrationsTasting Workshops The workshops will be led by the CHW Specialist and the dietitian The workshops are projected to last 2-3 hrs 60 minutes for teaching nutrition facts healthy ingredient selection portion sizes and the nutritional value of typical Hispanic dishes The remaining 60-90 minutes will be dedicated to cooking
The control group will receive seven bi-weekly messaging videos for 12 weeks via FacebookwhatsApp The messaging videos will last 5-15 minutes and will be delivered in Spanish or English The topics of the messaging videos are as follows Mental health issues that affect the Hispanic community childhood vaccinations Cord blood banking recommended adult vaccinations common childhood diseases dental care for adults and children common behavioral problems in children
To achieve Aim 3 the investigators will test differences between the intervention and control groups To determine if there is a change in food preparation in the home setting by the participant mother the investigators will measure home cooking quality at T0 and T1 The instrument to evaluate if there is a difference after implementation of the CASA intervention is the HCQ2 To assess if there is a change in intake of fruits and vegetables in children that participated in the CASA intervention and the controlattention group the investigators will use the Veggie Meter and the Block FFQ at T0 and T1
The investigators will use descriptive statistics to describe our sample and to make comparisons between the intervention and controlattention group For the primary outcomes of changes in dietary behaviors at the family level and change in diet quality the investigators will use pre-post data T0 and TI Secondary outcomes of consumption of fruits and vegetables consumption of sugar drinks and physical activity will be analyzed by using an analysis of covariance ANCOVA model from baseline T0 to T1 in children and mothers in both groups
Data analysis of the FGs qualitative data FGs transcripts will be uploaded to MAXQDA software for data management and to analyze the transcripts The investigators will use Rapid analytical techniques to code and uncover themes in the transcripts
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