Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575465
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-25
Brief Title:
Evaluating Family Community-Based Interventions to Improve Treatment Adherence in Metabolic Health Among Negev Bedouins EFIT-BED
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Examining the Effectiveness of Family and Community-Based Intervention Programs to Improve Treatment Adherence for Overweight Obesity Prediabetes Metabolic Syndrome and Type 2 Diabetes in the Bedouin Community in the Negev
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:
EFIT-BED
Brief Summary:
Background
The Bedouin community in the Negev faces high rates of type 2 diabetes low treatment adherence and increased disease complications Transition to urban living and changing dietary patterns have exacerbated these issues Current interventions often overlook the potential of culturally tailored approaches leveraging kinship ties and community resources This study seeks to address these gaps by examining the impact of a family-centered intervention program
Objectives
Primary Assess the effect of community intervention on Mediterranean diet adherence
Secondary Evaluate changes in fasting glucose HbA1c lipid profiles BMI physical activity and quality of life
Methodology
Study Design Controlled community intervention trial with two groups intervention and control
Participants 170 Bedouin adults diagnosed with overweight obesity metabolic syndrome prediabetes or type 2 diabetes
Intervention 10 sessions over 12 months focusing on nutrition physical activity and behavioral changes tailored to cultural norms
Control Routine care without added intervention Outcome Measures Lab tests HbA1c lipid profiles anthropometric measures Mediterranean diet adherence physical activity quality of life and social belonging
Recruitment and Data Collection
Participants will be recruited via Clalit clinics in Rahat with the support of local community leaders Data will be collected through medical records questionnaires and physical assessments at baseline 6 and 12 months
Data Analysis
Statistical analysis will be performed using SASSPSS employing ANOVA Chi-square tests and regression models for outcome prediction
Ethical Considerations
Participants privacy will be ensured through coded data storage The study will comply with Helsinki guidelines and participants can withdraw at any time
Conclusion
This study aims to provide culturally tailored interventions to improve health outcomes in the Bedouin community potentially serving as a model for similar minority groups globally
The Bedouin community in the Negev faces high rates of type 2 diabetes low treatment adherence and increased disease complications Transition to urban living and changing dietary patterns have exacerbated these issues Current interventions often overlook the potential of culturally tailored approaches leveraging kinship ties and community resources This study seeks to address these gaps by examining the impact of a family-centered intervention program
Objectives
Primary Assess the effect of community intervention on Mediterranean diet adherence
Secondary Evaluate changes in fasting glucose HbA1c lipid profiles BMI physical activity and quality of life
Methodology
Study Design Controlled community intervention trial with two groups intervention and control
Participants 170 Bedouin adults diagnosed with overweight obesity metabolic syndrome prediabetes or type 2 diabetes
Intervention 10 sessions over 12 months focusing on nutrition physical activity and behavioral changes tailored to cultural norms
Control Routine care without added intervention Outcome Measures Lab tests HbA1c lipid profiles anthropometric measures Mediterranean diet adherence physical activity quality of life and social belonging
Recruitment and Data Collection
Participants will be recruited via Clalit clinics in Rahat with the support of local community leaders Data will be collected through medical records questionnaires and physical assessments at baseline 6 and 12 months
Data Analysis
Statistical analysis will be performed using SASSPSS employing ANOVA Chi-square tests and regression models for outcome prediction
Ethical Considerations
Participants privacy will be ensured through coded data storage The study will comply with Helsinki guidelines and participants can withdraw at any time
Conclusion
This study aims to provide culturally tailored interventions to improve health outcomes in the Bedouin community potentially serving as a model for similar minority groups globally
Detailed Description:
Research Initiator Prof Vered Kaufman-Shriqui Department of Nutrition Sciences Ariel University Ariel Email veredksarielacil Clalit HMO Principal Investigator Dr Muflah Ataika Rahat Counseling Clinic Southern District Clalit Health Services
Co-Investigators
Dr Walid El Huzayel Rahat A Clinic Southern District Clalit Health Services
Ms Malak Oubra Abu Alasal Regional Diabetes Nurse Southern District Clalit Health Services
External Co-Investigators
Prof Mona Boaz Head of the Department of Nutrition Sciences at Ariel University in Samaria
Dr Maya Maor Department of Sociology and Anthropology Ariel University
Dr Samira Alfayoumi Ziadna Ashkelon College
Scientific Background and Rationale for the Study The health status of populations is shaped by social political economic and cultural factors that influence individual behaviors Social and cultural patterns are especially relevant in the context of diabetes where lifestyle choices diet and physical activity play critical roles Inoyue 2012 A comprehensive approach targeting all sectors is essential for effective health promotion However despite widespread health initiatives little is known about their long-term impact and sustainability
The Bedouin community in the Negev has some of the highest rates of type 2 diabetes in Israel with 40 of those over 50 affected internal district data Despite high disease prevalence there are low success rates in disease management and high rates of complications The Bedouin society is experiencing a cultural shift from a semi-nomadic lifestyle to permanent housing which is altering traditional dietary habits eg home-cooked meals vs ready-made food The extent to which these changes contribute to rising obesity and diabetes rates is unclear Additionally most research on diabetes in the Bedouin community focuses on adherence to standard interventions without considering how cultural norms could serve as unique coping resources Maor et al 2023 Studies on other minority groups suggest that community experiences and worldviews can enhance disease management strategies Chard 2017 Duwe 2016 Sanderson 2012
Given the Bedouin societys strong clan ties strategies involving collective actions eg family-wide physical activities may boost participation and treatment adherence Maor et al 2023 Therefore tailored health promotion programs are essential for reducing health disparities in this community
In Israel despite overall high life expectancy minority groups-especially those in lower socioeconomic strata-experience significantly shorter life spans This gap is largely due to higher rates of chronic conditions like obesity and heart disease among Arab populations Swinburn et al 2011 ICDC 2012 A 1999-2000 survey found that obesity rates BMI 30 in the Arab sector are notably high Abdeen et al 2012 A subsequent study involving 17044 Arab participants 49 men average age 394 and 16012 Jewish participants 50 men average age 405 confirmed significantly higher BMI and other risk factors eg HDL-C triglycerides SBP in the Arab population Abdeen et al 2012 Kalter-Leibovici et al 2012
The prevalence of type 2 diabetes in the Arab sector is roughly double that of the Jewish sector Kalter-Leibovici et al 2012 Abdeen et al 2012 Adherence to treatment is particularly low among Bedouins with over 70 of patients non-compliant leading to severe complications such as kidney failure and blindness Chard 2017 Duwe 2016 This highlights an urgent need to understand how Bedouin patients manage their condition
Research Objectives General Objective This study aims to evaluate whether a community-based intervention targeting healthy lifestyle practices within Bedouin clans can improve physical activity glycemic control anthropometric measures and dietary habits in individuals with metabolic syndrome prediabetes and type 2 diabetes beyond routine medical care provided by physicians and clinic staff
Primary Objective
To examine the effect of the intervention on the Mediterranean diet score among patients with obesity metabolic syndrome prediabetes and type 2 diabetes over a period of up to one year from their entry into the study
Secondary Objectives Among people with overweight obesity metabolic syndrome prediabetes and type 2 diabetes over a period of up to one year to examine the effect of the community intervention on
1 Fasting blood sugar levels FPG and glycosylated hemoglobin levels HBA1c
2 Blood lipid profile LIPID PROFILE
3 Anthropometric measures weight BODY MASS INDEX BMI waist circumference blood pressure
4 Nutritional intake quality
5 Health habits and physical activity level
6 Quality of life
7 Sense of social belonging We aim to examine whether a healthy lifestyle intervention program within the clan in the research group compared to the control group will lead to improvements in these outcome measures
Number of Participants and Planned Study Centers
Number of participants in the study 170 participants Each intervention group requires 70 people total 140 participants 15 participants in each group in case of dropout total 170 participants The intervention group will receive a program to promote a healthy lifestyle The intervention will be given separately to men and women There will be 10 meetings The meeting topics are detailed in the research timeline table The control group will not receive an intervention program
The sample size was based on the following assumptions The sample size was calculated to demonstrate a difference of 051 in HbA1c levels in a two-sided test α005
Participant Recruitment Method Patients insured by Clalit Health Services from two selected clans in Rahat whose elders agreed to participate in the study from the Southern District men and women aged 18 and above will be recruited by the researchers in the study who are the primary treating physicians identifying suitable patients for participation in the study according to inclusion and exclusion criteria Recruited patients will be referred for further testing and treatment
Study Design and Methodology
Study Design The study is designed as a controlled community intervention trial Participants will be divided into two groups an intervention group and a control group The intervention group will receive a comprehensive community-based intervention program while the control group will receive routine care All outcome measures will be measured at baseline 6 months from baseline and 12 months from baseline
Reporting of Adverse Events Serious Adverse Events
o At each visit patients will be questioned about changes in their medical condition and changes in their regular medications If an adverse event or serious adverse event occurs it will be reported to the principal investigator and the study initiator according to the requirements of the Helsinki Committee and GCP procedures The principal investigator will complete an Adverse Event or Serious Adverse Event report form as required
The principal investigator will compile data from all participating clinics
Each patient will be assigned a coded number in a sequential order consisting of the initials of the patients name and their recruitment order in the study Identifying details will be omitted
The encrypted data file will be stored on the principal investigators computer in the office of Dr Muflah Ataika at the Clalit Health Services district management in Beer Sheva
Study documents including informed consent forms research questionnaires and other related materials will be stored in a locked cabinet at the research site with restricted access to the research team only according to good clinical practice GCP procedures
Identifying details will not be transferred to the study initiator outside of Clalit facilities only coded data will be transferred
Laboratory Tests and Any Other Relevant Tests to be Conducted During the Study and Follow-Up Period and Where They Will Be Performed
Laboratory tests will not be specifically conducted for the study but will be extracted from the participants medical records during each clinic visit Anthropometric measurements will be actively checked at each meeting
Method of Analyzing and Processing Results
Descriptive and inferential statistical analyses will be performed using SAS andor SPSS software
For continuous variables a normal distribution analysis will be conducted and if necessary a logarithmic transformation
Comparisons between continuous variables will be performed using appropriate statistical tests such as ANOVA general comparison and if necessary between all groups and between each pair of groups
Comparisons of categorical variables will be performed using the Chi-square test and if possible the Fisher Exact test
For continuous outcome variables a multivariate prediction model will be built including demographic background factors of the participants and the intervention group they were part of
Multivariate comparisons will be conducted using logistic regression or multivariate linear regression as appropriate
Role of the Sub-Investigators in the Study
The sub-investigators will oversee all stages of the study implementation and intervention including training research assistants on research questionnaires and medical teams dietitians and physiotherapists to integrate the intervention among the population Additionally they will supervise data collection oversee the work of research assistants conduct statistical analyses on de-identified data and write the research findings
7 Ethical Issues of the Trial
All subjects will sign an informed consent form prior to inclusion in the study
- Pregnant women special populations individuals lacking judgment capacity and children will not be recruited for the study
Participants can withdraw from the study at any time
Number of centers in the study This study involves one center the primary investigators clinic
Co-Investigators
Dr Walid El Huzayel Rahat A Clinic Southern District Clalit Health Services
Ms Malak Oubra Abu Alasal Regional Diabetes Nurse Southern District Clalit Health Services
External Co-Investigators
Prof Mona Boaz Head of the Department of Nutrition Sciences at Ariel University in Samaria
Dr Maya Maor Department of Sociology and Anthropology Ariel University
Dr Samira Alfayoumi Ziadna Ashkelon College
Scientific Background and Rationale for the Study The health status of populations is shaped by social political economic and cultural factors that influence individual behaviors Social and cultural patterns are especially relevant in the context of diabetes where lifestyle choices diet and physical activity play critical roles Inoyue 2012 A comprehensive approach targeting all sectors is essential for effective health promotion However despite widespread health initiatives little is known about their long-term impact and sustainability
The Bedouin community in the Negev has some of the highest rates of type 2 diabetes in Israel with 40 of those over 50 affected internal district data Despite high disease prevalence there are low success rates in disease management and high rates of complications The Bedouin society is experiencing a cultural shift from a semi-nomadic lifestyle to permanent housing which is altering traditional dietary habits eg home-cooked meals vs ready-made food The extent to which these changes contribute to rising obesity and diabetes rates is unclear Additionally most research on diabetes in the Bedouin community focuses on adherence to standard interventions without considering how cultural norms could serve as unique coping resources Maor et al 2023 Studies on other minority groups suggest that community experiences and worldviews can enhance disease management strategies Chard 2017 Duwe 2016 Sanderson 2012
Given the Bedouin societys strong clan ties strategies involving collective actions eg family-wide physical activities may boost participation and treatment adherence Maor et al 2023 Therefore tailored health promotion programs are essential for reducing health disparities in this community
In Israel despite overall high life expectancy minority groups-especially those in lower socioeconomic strata-experience significantly shorter life spans This gap is largely due to higher rates of chronic conditions like obesity and heart disease among Arab populations Swinburn et al 2011 ICDC 2012 A 1999-2000 survey found that obesity rates BMI 30 in the Arab sector are notably high Abdeen et al 2012 A subsequent study involving 17044 Arab participants 49 men average age 394 and 16012 Jewish participants 50 men average age 405 confirmed significantly higher BMI and other risk factors eg HDL-C triglycerides SBP in the Arab population Abdeen et al 2012 Kalter-Leibovici et al 2012
The prevalence of type 2 diabetes in the Arab sector is roughly double that of the Jewish sector Kalter-Leibovici et al 2012 Abdeen et al 2012 Adherence to treatment is particularly low among Bedouins with over 70 of patients non-compliant leading to severe complications such as kidney failure and blindness Chard 2017 Duwe 2016 This highlights an urgent need to understand how Bedouin patients manage their condition
Research Objectives General Objective This study aims to evaluate whether a community-based intervention targeting healthy lifestyle practices within Bedouin clans can improve physical activity glycemic control anthropometric measures and dietary habits in individuals with metabolic syndrome prediabetes and type 2 diabetes beyond routine medical care provided by physicians and clinic staff
Primary Objective
To examine the effect of the intervention on the Mediterranean diet score among patients with obesity metabolic syndrome prediabetes and type 2 diabetes over a period of up to one year from their entry into the study
Secondary Objectives Among people with overweight obesity metabolic syndrome prediabetes and type 2 diabetes over a period of up to one year to examine the effect of the community intervention on
1 Fasting blood sugar levels FPG and glycosylated hemoglobin levels HBA1c
2 Blood lipid profile LIPID PROFILE
3 Anthropometric measures weight BODY MASS INDEX BMI waist circumference blood pressure
4 Nutritional intake quality
5 Health habits and physical activity level
6 Quality of life
7 Sense of social belonging We aim to examine whether a healthy lifestyle intervention program within the clan in the research group compared to the control group will lead to improvements in these outcome measures
Number of Participants and Planned Study Centers
Number of participants in the study 170 participants Each intervention group requires 70 people total 140 participants 15 participants in each group in case of dropout total 170 participants The intervention group will receive a program to promote a healthy lifestyle The intervention will be given separately to men and women There will be 10 meetings The meeting topics are detailed in the research timeline table The control group will not receive an intervention program
The sample size was based on the following assumptions The sample size was calculated to demonstrate a difference of 051 in HbA1c levels in a two-sided test α005
Participant Recruitment Method Patients insured by Clalit Health Services from two selected clans in Rahat whose elders agreed to participate in the study from the Southern District men and women aged 18 and above will be recruited by the researchers in the study who are the primary treating physicians identifying suitable patients for participation in the study according to inclusion and exclusion criteria Recruited patients will be referred for further testing and treatment
Study Design and Methodology
Study Design The study is designed as a controlled community intervention trial Participants will be divided into two groups an intervention group and a control group The intervention group will receive a comprehensive community-based intervention program while the control group will receive routine care All outcome measures will be measured at baseline 6 months from baseline and 12 months from baseline
Reporting of Adverse Events Serious Adverse Events
o At each visit patients will be questioned about changes in their medical condition and changes in their regular medications If an adverse event or serious adverse event occurs it will be reported to the principal investigator and the study initiator according to the requirements of the Helsinki Committee and GCP procedures The principal investigator will complete an Adverse Event or Serious Adverse Event report form as required
The principal investigator will compile data from all participating clinics
Each patient will be assigned a coded number in a sequential order consisting of the initials of the patients name and their recruitment order in the study Identifying details will be omitted
The encrypted data file will be stored on the principal investigators computer in the office of Dr Muflah Ataika at the Clalit Health Services district management in Beer Sheva
Study documents including informed consent forms research questionnaires and other related materials will be stored in a locked cabinet at the research site with restricted access to the research team only according to good clinical practice GCP procedures
Identifying details will not be transferred to the study initiator outside of Clalit facilities only coded data will be transferred
Laboratory Tests and Any Other Relevant Tests to be Conducted During the Study and Follow-Up Period and Where They Will Be Performed
Laboratory tests will not be specifically conducted for the study but will be extracted from the participants medical records during each clinic visit Anthropometric measurements will be actively checked at each meeting
Method of Analyzing and Processing Results
Descriptive and inferential statistical analyses will be performed using SAS andor SPSS software
For continuous variables a normal distribution analysis will be conducted and if necessary a logarithmic transformation
Comparisons between continuous variables will be performed using appropriate statistical tests such as ANOVA general comparison and if necessary between all groups and between each pair of groups
Comparisons of categorical variables will be performed using the Chi-square test and if possible the Fisher Exact test
For continuous outcome variables a multivariate prediction model will be built including demographic background factors of the participants and the intervention group they were part of
Multivariate comparisons will be conducted using logistic regression or multivariate linear regression as appropriate
Role of the Sub-Investigators in the Study
The sub-investigators will oversee all stages of the study implementation and intervention including training research assistants on research questionnaires and medical teams dietitians and physiotherapists to integrate the intervention among the population Additionally they will supervise data collection oversee the work of research assistants conduct statistical analyses on de-identified data and write the research findings
7 Ethical Issues of the Trial
All subjects will sign an informed consent form prior to inclusion in the study
- Pregnant women special populations individuals lacking judgment capacity and children will not be recruited for the study
Participants can withdraw from the study at any time
Number of centers in the study This study involves one center the primary investigators clinic
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