Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629610
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Diet and Active Lifestyle - Yuuyaraq The Yupik Way of Life
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Community-led Intervention DAiLY Promoting a Heart-healthy Diet and Active Lifestyle The Yup39ik Way
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
DAiLY
Brief Summary:
Heart disease is the leading cause of death for Alaska Native men and the second leading cause of death after cancer among women and Alaska Native people overall The overarching goal of the proposed multilevel multicomponent intervention Diet and Active Lifestyle - Yuuyaraq DAiLY is to reduce consumption of highly processed store-bought foods while promoting intake of subsistence foods healthy store-bought foods and a more active lifestyle to reduce heart disease risk The Yupampamp39ik word Yuuyaraq means the Yupik way of life and encompasses a worldview in which living in harmony with the environment as well as sharing of subsistence foods and traditional knowledge is central The proposed DAiLY intervention is grounded in the Yupik worldview and Indigenous Food Sovereignty and supported by a foundation of trust resulting from 22 years of continuous Community Based Participatory Research on heart disease risk andprotective factors with Yupik communities DAiLY is a direct response to the intervention research requests of community partners and input from Yupik Community Research Associates and a Yupik Community Planning Group during the formative research and community engagement process shaping this proposal The proposed intervention based on the Warnecke model of health disparities and social cognitive theory includes three components 1 home-based workshops framed in the Yupik worldview led by Community Research Associates to facilitate interactive discussions with community members about healthy market foods as well as the health benefits of locally harvested traditional foods and increased physical activity 2 local food store interventions to increase access to and help build demand for healthy food options and 3 traditional community activities including Yuraq Yupik traditional dance Native sports events and berry festivals that provide opportunities to increase physical activity The three components will be supported and reinforced via community media including Facebook text messaging and visual materials A continuous metabolic syndrome score will be used as the primary outcome to assess changes in heart disease risk and objective stable isotope biomarkers of diet and a validated food frequency questionnaire will be used to measure intake of traditional and market foods We will test the DAiLY intervention in four Yupik communities randomized to immediate and delayed intervention Aim 1 will determine the effectiveness of the DAiLY intervention on heart disease risk by measuring change in a continuous metabolic syndrome risk score primary outcome Aim 2 will assess implementation of the DAiLY intervention using a mixed methods process evaluation to determine fidelity dose and reach as well as barriers and facilitators to implementation of program activities and participant satisfaction and engagement Aim 3 will determine the impact of the DAiLY intervention on community-level outcomes including access to and sales of healthy foods in local stores as well as opportunities for physical activity at community venues
Detailed Description:
Background Heart disease HD is the leading cause of death for Alaska Native men and the second leading cause of death among women HD mortality among the Yupamp39ik Alaska Native people is 30 higher than that for all races in the US The traditional Yupamp39ik diet is associated with a reduction in multiple risk factors for HD but over the past 60 years this dietary pattern has been replaced by a shift toward ultra-processed foods high in saturated fat salt and sugar which have been linked to increased risk for HD At the same time there has been a shift to a more sedentary lifestyle The goal of this project is to determine the effectiveness of a culturally adapted intervention to reduce HD risk among Yupampamp39ik Alaska Native people by encouraging increased consumption of heart healthy traditional and market foods as well as increased physical activity
Intervention Approach This work adheres to a Community-Based Participatory Research CBPR framework which depends heavily upon community engagement and partnership throughout the entire research process and Indigenous Food Sovereignty IFS a concept that represents Indigenous peoples39 ability to control their food systems including the production distribution and consumption of food The Yupampamp39ik word Yuuyaraq means ampamp39the Yupampamp39ik way of lifeampamp39 and it encompasses the Yupampamp39ik worldview which is founded on traditional values of respect for humans animals and the environment in which they live sharing of resources including subsistence foods sharing stories and knowledge and an interpersonal relationship with nature as a source of wellness The proposed intervention Diet and Active Lifestyle- Yuuyaraq DAiLY is based on Yupampamp39ik worldview principles
DAiLY Intervention Components The intervention will be delivered through three complementary components each supported and reinforced by community media including social media Facebook texting and visual materials
1 Home-Based Workshops HBWs will be delivered by trained members of the local community The aim of the HBWs is to increase knowledge skills and confidence related to to food eg understanding nutrition labels the benefits of traditional foods supporting traditional subsistence and harvesting practices making healthy market food choices and healthy food preparation and serving methods as well as participantsampamp39 awareness of the importance of physical activity and maintaining a healthy weight An emphasis is placed on understanding the benefits of consuming traditional subsistence foods as well as heart-healthy foods from the local stores to complement the traditional diet
2 Food store modifications will increase access to heart-healthy foods in local stores by working with store managers to stock and promote affordable healthy food options which will in turn provide participants with the opportunity to implement what they have learned in the HBWs Point of purchase promotions in stores including educational displays taste tests and cooking demonstrations and temporary price reductions to build demand will identify and promote these foods to community members
3 Physical Activity PA opportunities will be increased and will include community-based activities that have been identified by community members These will emphasize traditional activities such as Yuraq traditional Yupampamp39ik Dance Native sports events and berry festivals Fitbits will be given to participants and used as a motivational tool to encourage and allow participants to track their PA progress during and after the intervention
Implementation and Assessment Community research associates CRAs will implement the DAiLY intervention after being trained by the study team with follow-up booster trainings as needed The intervention will be carried out in four communities two of which will participate first immediate intervention allowing for comparison of outcomes among those who have and have not yet received the intervention Once the follow-up data collection is complete the second two communities delayed intervention will receive the intervention Throughout all phases of the intervention data will be collected about how well and to what extent the DAiLY intervention was implemented by the study team in each community
The impact of the DAiLY intervention will be measured through changes in individual participants heart disease risk factors as well as in the community food stores and in terms of access to increased PA opportunities at the community level Participants will be asked to donate a fasting blood sample to measure the different factors that affect risk for heart disease and study investigators Boyer and Hopkins will measure participantsampamp39 weight blood pressure and waist circumference ActiGraph GT3X high-resolution triaxial accelerometers will be used to measure physical activity levels in addition to completing a Yupampamp39ik Wellness Questionnaire to assess participation in traditional and community activities and confidence to adopt healthy behaviors In addition a Yupampamp39ik Food Frequency Questionnaire will be used to assess how participants report changes in dietary patterns and knowledge of healthy dietary behaviors In community food stores data will be collected on stocking and sales of promoted foods in store as well as food store ownersampamp39 and managersampamp39 expectations of sales of healthy food before and after the DAiLY intervention We will also monitor changes in the availability use people PA quality and duration of community traditional PA opportunities Physical activity opportunities in the community will be coordinated with the HBW modules and will include communityevents and subsistence activites CRAs will receive 2000 per community to sponsor community-wide events These activities will be initiated and promoted as part of the DAiLY including community campaigns to ampamp34park it and walkampamp34 to limit use of of snow machines and ATVs in the community Fitbit step challenges initiation of womenampamp39s ampamp34walking groupsampamp34 to gather their children at evening curfew promotion of cultural events such as Yuraq traditional Yupampamp39ik dance holding berry festivals including picking competitions and supporting additional sports events basketball volleyball and Native games in the school gyms All of these community-level activities were suggested by our CPG
Overall Project Aims Aim 1 Determine the effectiveness of the DAiLY intervention on HD risk by measuring 1 change in a continuous metabolic syndrome cMS risk score primary outcome in Yupampamp39ik adults and 2 secondary outcomes including PA using accelerometry dietary change using objectively measured biomarkers as well as dietary consumption and change in psychosocial measures ie knowledge self-efficacy and intentions
Aim 2 Assess implementation of the DAiLY intervention using a mixed methods process evaluation using a sequential explanatory design to determine 1 reach dose delivered and fidelity 2 barriers and facilitators to implementing program activities and 3 participant satisfaction and engagement Aim 3 Determine the impact of the DAiLY intervention on community-level outcomes including 1 access to and sales of healthy foods in local stores 2 access to community venues eg school gyms and community halls for PA and 3 frequency and level of engagement in subsistence activities and community-wide events
Sharing Results and Dissemination of Program Materials A major objective of DAiLY is to share the results with the participating communities as well as others who develop health promotion programs The study team will continuously share the progress and results of the intervention with local community Tribal governments and healthcare leaders in order to ensure the communities that participated can determine next steps in their best interest After completion of the trial all intervention materials will be made available and freely downloadable from the study website
Intervention Approach This work adheres to a Community-Based Participatory Research CBPR framework which depends heavily upon community engagement and partnership throughout the entire research process and Indigenous Food Sovereignty IFS a concept that represents Indigenous peoples39 ability to control their food systems including the production distribution and consumption of food The Yupampamp39ik word Yuuyaraq means ampamp39the Yupampamp39ik way of lifeampamp39 and it encompasses the Yupampamp39ik worldview which is founded on traditional values of respect for humans animals and the environment in which they live sharing of resources including subsistence foods sharing stories and knowledge and an interpersonal relationship with nature as a source of wellness The proposed intervention Diet and Active Lifestyle- Yuuyaraq DAiLY is based on Yupampamp39ik worldview principles
DAiLY Intervention Components The intervention will be delivered through three complementary components each supported and reinforced by community media including social media Facebook texting and visual materials
1 Home-Based Workshops HBWs will be delivered by trained members of the local community The aim of the HBWs is to increase knowledge skills and confidence related to to food eg understanding nutrition labels the benefits of traditional foods supporting traditional subsistence and harvesting practices making healthy market food choices and healthy food preparation and serving methods as well as participantsampamp39 awareness of the importance of physical activity and maintaining a healthy weight An emphasis is placed on understanding the benefits of consuming traditional subsistence foods as well as heart-healthy foods from the local stores to complement the traditional diet
2 Food store modifications will increase access to heart-healthy foods in local stores by working with store managers to stock and promote affordable healthy food options which will in turn provide participants with the opportunity to implement what they have learned in the HBWs Point of purchase promotions in stores including educational displays taste tests and cooking demonstrations and temporary price reductions to build demand will identify and promote these foods to community members
3 Physical Activity PA opportunities will be increased and will include community-based activities that have been identified by community members These will emphasize traditional activities such as Yuraq traditional Yupampamp39ik Dance Native sports events and berry festivals Fitbits will be given to participants and used as a motivational tool to encourage and allow participants to track their PA progress during and after the intervention
Implementation and Assessment Community research associates CRAs will implement the DAiLY intervention after being trained by the study team with follow-up booster trainings as needed The intervention will be carried out in four communities two of which will participate first immediate intervention allowing for comparison of outcomes among those who have and have not yet received the intervention Once the follow-up data collection is complete the second two communities delayed intervention will receive the intervention Throughout all phases of the intervention data will be collected about how well and to what extent the DAiLY intervention was implemented by the study team in each community
The impact of the DAiLY intervention will be measured through changes in individual participants heart disease risk factors as well as in the community food stores and in terms of access to increased PA opportunities at the community level Participants will be asked to donate a fasting blood sample to measure the different factors that affect risk for heart disease and study investigators Boyer and Hopkins will measure participantsampamp39 weight blood pressure and waist circumference ActiGraph GT3X high-resolution triaxial accelerometers will be used to measure physical activity levels in addition to completing a Yupampamp39ik Wellness Questionnaire to assess participation in traditional and community activities and confidence to adopt healthy behaviors In addition a Yupampamp39ik Food Frequency Questionnaire will be used to assess how participants report changes in dietary patterns and knowledge of healthy dietary behaviors In community food stores data will be collected on stocking and sales of promoted foods in store as well as food store ownersampamp39 and managersampamp39 expectations of sales of healthy food before and after the DAiLY intervention We will also monitor changes in the availability use people PA quality and duration of community traditional PA opportunities Physical activity opportunities in the community will be coordinated with the HBW modules and will include communityevents and subsistence activites CRAs will receive 2000 per community to sponsor community-wide events These activities will be initiated and promoted as part of the DAiLY including community campaigns to ampamp34park it and walkampamp34 to limit use of of snow machines and ATVs in the community Fitbit step challenges initiation of womenampamp39s ampamp34walking groupsampamp34 to gather their children at evening curfew promotion of cultural events such as Yuraq traditional Yupampamp39ik dance holding berry festivals including picking competitions and supporting additional sports events basketball volleyball and Native games in the school gyms All of these community-level activities were suggested by our CPG
Overall Project Aims Aim 1 Determine the effectiveness of the DAiLY intervention on HD risk by measuring 1 change in a continuous metabolic syndrome cMS risk score primary outcome in Yupampamp39ik adults and 2 secondary outcomes including PA using accelerometry dietary change using objectively measured biomarkers as well as dietary consumption and change in psychosocial measures ie knowledge self-efficacy and intentions
Aim 2 Assess implementation of the DAiLY intervention using a mixed methods process evaluation using a sequential explanatory design to determine 1 reach dose delivered and fidelity 2 barriers and facilitators to implementing program activities and 3 participant satisfaction and engagement Aim 3 Determine the impact of the DAiLY intervention on community-level outcomes including 1 access to and sales of healthy foods in local stores 2 access to community venues eg school gyms and community halls for PA and 3 frequency and level of engagement in subsistence activities and community-wide events
Sharing Results and Dissemination of Program Materials A major objective of DAiLY is to share the results with the participating communities as well as others who develop health promotion programs The study team will continuously share the progress and results of the intervention with local community Tribal governments and healthcare leaders in order to ensure the communities that participated can determine next steps in their best interest After completion of the trial all intervention materials will be made available and freely downloadable from the study website
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