DiabetesCBLINCT03358797
Community-Based Lifestyle Intervention for Diabetes Prevention in Arab Women
A study testing Community based intervention with resilience training, intervention-HPP and Pilot in people with Diabetes and Health Behaviors, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Arab women present increased risk for diabetes, with a 70% greater risk for adult-onset diabetes and a significantly younger age at onset compared with Jewish Israelis. In fact, the rate of diabetes for Arab women in Jerusalem is 4 times higher compared with their Jewish counterparts. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Health Behaviors
- What is being tested?
- Community based intervention with resilience training, intervention-HPP and Pilot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- 29 Dec 2016to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over age 18
- Able to commit to the intervention timetable
Who cannot join
- Younger than age 18
- Unable to commit to the intervention timetable
- Were not pregnant with expected delivery during the intervention
- Were suffering from other serious mental or physical illness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Beit-Safafa community center
Jerusalem, 95822
director of the center, 02690717, beitzafa@matnasim.org.il
About this study
Official title: Community-Based Lifestyle and Leadership Intervention for Primary, Secondary, and Tertiary Prevention of Diabetes in Women in the Arab Community
Arab women present increased risk for diabetes, with a 70% greater risk for adult-onset diabetes and a significantly younger age at onset compared with Jewish Israelis. In fact, the rate of diabetes for Arab women in Jerusalem is 4 times higher compared with their Jewish counterparts. Group lifestyle interventions such as the Diabetes Prevention Program (DPP) have documented effectiveness in preventing diabetes; however, many fail to demonstrate outcome maintenance. We predict that integrating leadership skills training into the gold standard DPP would improve the long-term outcome maintenance.
Stage 1: A pre-post study design will be utilized, where all community participants will be exposed to intervention components. The sample was selected from pre-existing groups in the local community center, based on their leadership potential.
phase 2: The second stage of the trial will not include the leadership component, but instead it will incorporate resiliency training and it aims to evaluate the effect of increased resiliency on the main outcomes including improvement in healthy behaviors such as adherence to Mediterranean diet and as well as a reduction in sedentary lifestyle and increased engagement in physical activity. In addition, resiliency training is likely to improve the maintenance of these behaviors.
Read the detailed description
The purpose of this study is to design, implement and evaluate a community based lifestyle intervention that integrates a leadership skills training for Palestinian women living in East Jerusalem.
Stage 1: A pre-post study design will be utilized, where all community participants will be exposed to intervention components. The sample was selected from pre-existing groups in the local community center, based on their leadership potential. The Community-Based Lifestyle Intervention (CBLI) was developed by integrating leadership skill training to the gold standard Diabetes Prevention Program (DPP). According to social cognitive theory, engaging in lay leadership can help maintain health behaviors by providing leaders with social support, behavioral reinforcement, outcome expectancies, reciprocal determinism, and building self-efficacy. Fostering social change and empowering individuals, mobilizing community members is also an effective, low cost method for widespread impact on health behavior and health outcomes within the members' community. This is particularly true for women and minority populations. All intervention components were adapted to the specific culture, language, gender, and religious sensitivities of Palestinian female society.
The program will consist of 22 sessions presented by multiple professionals (nutritionists, exercise trainers, health coaches, and psychotherapists). Session content includes Mediterranean diet education, social support, food tasting and cooking, goal setting, self-monitoring, planning, conscious eating, leadership and lay leader training, initiative-taking, group dynamics, project design, community needs assessment, and project evaluation. The study is implemented in partnership with local community centers.
It is hypothesized that Arab women who participate in this community intervention will have improved - and maintained- healthy eating behaviors (i.e. Mediterranean Diet), reduced unhealthy eating behaviors (i.e. Western diet), increased engagement in physical activity and reduced risk of obesity (weight, BMI).
The second stage of the trial will not include the leadership component, but instead it will incorporate resiliency training and it aims to evaluate the effect of increased resiliency on the main outcomes including improvement in healthy behaviors such as adherence to Mediterranean diet and as well as a reduction in sedentary lifestyle and increased engagement in physical activity. In addition, resiliency training is likely to improve the maintenance of these behaviors.
Resiliency can be defined as a personal trait that contributes to the individual's ability to recover from stressful events. It is the ability to achieve, retain, or regain a level of physical or emotional health after illness or loss (bounce back). This characteristic is also considered a protective strength against mental problems, and the ability to effectively adapt to changes and recover from stressful events. Psychological stress is associated with increased risk of non-communicable diseases pose the greatest burden to public health, including heart disease. Additionally, people experiencing psychosocial challenges like isolation and life stress, are found to be less physically active, which is considered an independent risk factor for heart disease. Therefore, effective interventions that aim to reduce stress and anxiety and improve social connectedness are potential means of preventing and managing chronic diseases.
The present study (stage 2) will employ a cluster-randomized trial in which community centers will be assigned to either intervention group or attention control group. The intervention group will receive the CBLI content curriculum (as described above) in addition to the resiliency training (hence CBLI+RT). The attention control group will receive the core curriculum of the CBLI (CBLI-) only without the resiliency training. The sessions of the resiliency training will be replaced with sessions on health topics that do not contribute to our outcome (increased resiliency).
All intervention components were adapted to the specific culture, language, gender, and religious sensitivities of Palestinian female society.
It is hypothesized that Arab women who participate in this community intervention will have improved - and maintained- healthy eating behaviors (i.e. Mediterranean Diet), reduced unhealthy eating behaviors (i.e. Western diet), increased engagement in physical activity and reduced risk of obesity (weight, BMI).
The integration of positive psychology which focuses on individual's strengths through the resiliency training in the second stage of this trial, is hypothesized to be associated with improving-and maintain- healthy behaviors such as healthy diet, increased engagement in physical activity, and reducing unhealthy behaviors such as the consumption of western diet.
The first group will be assigned as a pilot study. This group will not be randomized but will receive the CBLI+RT in order to develop a resiliency training manual to be implemented in the following groups that will be assigned to receive RT in addition to the CBLI core curriculum.
- Conditions
- Diabetes, Health Behaviors
- Being tested
- Attention-control, Community based intervention with resilience training, intervention-HPP, Pilot
- Keywords
- Community-based Intervention, Lifestyle intervention, Diabetes prevention, Leadership, Resilience, Women's health
- Medical subject headings
- Diabetes Mellitus, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention-controlBehavioural
Lifestyle intervention with presentations by multiple professionals (nutritionists, exercise trainers, and psychotherapists), this intervention will include Mediterranean diet education, physical activity, social support, food tasting and cooking, goal setting,and women's health topics
Community based intervention with resilience trainingBehavioural
Lifestyle intervention with presentations by multiple professionals (nutritionists, exercise trainers, and psychotherapists), this intervention will include Mediterranean diet education, physical activity, social support, food tasting and cooking, goal setting, and women's health topics. In addition, there will be content targeting resilience training including: positive emotions, cognitive flexibility, life meaning, and active coping strategies.
intervention-HPPBehavioural
Lifestyle intervention with presentations by multiple professionals (nutritionists, exercise trainers, and psychotherapists), this intervention will include Mediterranean diet education, physical activity, social support, food tasting and cooking, goal setting,and women's health topics. In addition, there will be training in leadership skills, community interventions, community needs assessment, intervention planning and outcomes assessment.
PilotBehavioural
Lifestyle intervention with presentations by multiple professionals (nutritionists, exercise trainers, and psychotherapists), this intervention will include Mediterranean diet education, physical activity, social support, food tasting and cooking, goal setting, and women's health topics. In addition, there will be content targeting resilience training including: positive emotions, cognitive flexibility, life meaning, and active coping strategies.
| Study group | Role | What they receive |
|---|---|---|
| intervention-HPP | Experimental | Community participants will participate in a group-based lifestyle intervention based on the CDC Diabetes Prevention Program, and adapted to the Arabic language, Arab culture, Mediterranean Diet, and adapted to include empowerment, leadership and emotion regulation. Receives: Behavioral: intervention-HPP |
| CBLI+RT | Experimental | based on randomization, group that will be assigned to CBLI+RT will receive the CBLI curriculum (as described in the intervention-HPP arm) in addition to the resiliency training Receives: Behavioral: Community based intervention with resilience training |
| Attention control (CBLI-) | Experimental | The attention control group will receive the core curriculum of the CBLI (as described in the intervention-HPP arm) only without the resiliency training. The sessions of the resiliency training will be replaced with sessions on health topics that do not contribute to our outcome (increased resiliency) (i.e. breast cancer, osteoporosis) Receives: Behavioral: Attention-control |
| Pilot | Experimental | This group will not be randomized. The group will receive the CBLI content (as described in the intervention-HPP arm) in addition to the resiliency training. The aim of this pilot is to create a resiliency training manual to be implemented in the following groups that will be assigned to receive the CBLI+RT Receives: Behavioral: Pilot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mediterranean Diet adherence
Will be assessed through Panagiotakos' Mediterranean Diet score (an 11 item self-report measure of adherence to the Mediterranean food pattern) which was adapted to Israeli diet and the Arab culture. Items assessing potato and alcohol consumption were removed and an item assessing nut consumption was added
Measured: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in physical activity engagement
Will be assessed through self report of minutes engaged in vigorous and moderate physical via questionnaires.
Measured: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Secondary outcomes (13)
Change in Plasma levels of Hemoglobin A1c (HbA1c)
The participants will be referred to their national health insurance in order to conduct a blood test for plasma levels of Hemoglobin A1c (HbA1c)
Measured: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Plasma levels of total cholesterol
The participants will be referred to their national health insurance in order to conduct a blood test for plasma levels of total cholesterol
Measured: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Plasma levels of HDL
The participants will be referred to their national health insurance in order to conduct a blood test for plasma levels of HDL
Measured: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Plasma levels of LDL
The participants will be referred to their national health insurance in order to conduct a blood test for plasma levels of LDL
Measured: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Plasma levels of triglycerides
The participants will be referred to their national health insurance in order to conduct a blood test for plasma levels of triglycerides
Measured: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Body Mass Index (BMI)
BMI will be calculated by measuring weight and height for each participant.
Measured: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Blood Pressure (BP)
Will be measured using standard procedures with an electronic BP apparatus and the recorded measurement is the average of 2 measurements taken in the seated position
Measured: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Cardiovascular Disease Knowledge
Will be assessed through self report questionnaire based on the American Heart Association's knowledge survey items
Measured: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Stages of Change for targeted health behaviors
Will be assessed through self report questionnaire
Measured: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Leadership Self-Efficacy
Will be assessed through self report questionnaire
Measured: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Resilience
Resilience will be measured through the validated 10 items Connor-Davidson Resilience Scale (CD-RISC-10)
Measured: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Sense of Coherence
Sense of coherence will be measured through the Sense of Coherence 13-item scale
Measured: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Self-Rated health
Self reported status of health will be measured using the Self-Rated health questionnaire
Measured: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start29 Dec 2016
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stage 1: interventional, Pre - Post study, with quasi-experimental comparison group Stage 2: interventional, Pre - Post study, with cluster randomization (Pilot study to develop the resiliency training manual will be part of stage 2)
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donna R Zwas, Hadassah Medical Organization
- Investigators
- Donna Zwas, MD, MPH, Principal investigator, Hadassah University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358797
- Sponsor's protocol ID
- 123NDP-HMO-CTIL
- Acronym
- CBLI
- Status last verified
- Apr 2023
- First submitted
- 25 Jun 2017
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: yes, to investigators with certified GCP upon request
Publications
Anderson ES, Winett RA, Wojcik JR. Self-regulation, self-efficacy, outcome expectations, and social support: social cognitive theory and nutrition behavior. Ann Behav Med. 2007 Nov-Dec;34(3):304-12. doi: 10.1007/BF02874555.
PubMed 18020940Lorig KR, Mazonson PD, Holman HR. Evidence suggesting that health education for self-management in patients with chronic arthritis has sustained health benefits while reducing health care costs. Arthritis Rheum. 1993 Apr;36(4):439-46. doi: 10.1002/art.1780360403.
PubMed 8457219Heath GW. The role of the public health sector in promoting physical activity: national, state, and local applications. J Phys Act Health. 2009 Nov;6 Suppl 2:S159-67.
PubMed 20120125Kim K, Choi JS, Choi E, Nieman CL, Joo JH, Lin FR, Gitlin LN, Han HR. Effects of Community-Based Health Worker Interventions to Improve Chronic Disease Management and Care Among Vulnerable Populations: A Systematic Review. Am J Public Health. 2016 Apr;106(4):e3-e28. doi: 10.2105/AJPH.2015.302987. Epub 2016 Feb 18.
PubMed 26890177Koniak-Griffin D, Brecht ML, Takayanagi S, Villegas J, Melendrez M, Balcazar H. A community health worker-led lifestyle behavior intervention for Latina (Hispanic) women: feasibility and outcomes of a randomized controlled trial. Int J Nurs Stud. 2015 Jan;52(1):75-87. doi: 10.1016/j.ijnurstu.2014.09.005. Epub 2014 Sep 22.
PubMed 25307195Walton JW, Snead CA, Collinsworth AW, Schmidt KL. Reducing diabetes disparities through the implementation of a community health worker-led diabetes self-management education program. Fam Community Health. 2012 Apr-Jun;35(2):161-71. doi: 10.1097/FCH.0b013e31824651d3.
PubMed 22367263Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Panagiotakos DB, Pitsavos C, Stefanadis C. Dietary patterns: a Mediterranean diet score and its relation to clinical and biological markers of cardiovascular disease risk. Nutr Metab Cardiovasc Dis. 2006 Dec;16(8):559-68. doi: 10.1016/j.numecd.2005.08.006. Epub 2006 Feb 9.
PubMed 17126772The National Diabetes Registry (Total Population). (n.d.). Retrieved from https://www.health.gov.il/English/MinistryUnits/ICDC/disease_Registries/Pages/diabetes_reg.aspx.
Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. doi: 10.2337/diacare.25.12.2165.
PubMed 12453955Idler EL, Angel RJ. Self-rated health and mortality in the NHANES-I Epidemiologic Follow-up Study. Am J Public Health. 1990 Apr;80(4):446-52. doi: 10.2105/ajph.80.4.446.
PubMed 2316767Eriksson M, Mittelmark MB. The Sense of Coherence and Its Measurement. 2016 Sep 3. In: Mittelmark MB, Sagy S, Eriksson M, Bauer GF, Pelikan JM, Lindstrom B, Espnes GA, editors. The Handbook of Salutogenesis [Internet]. Cham (CH): Springer; 2017. Chapter 12. Available from http://www.ncbi.nlm.nih.gov/books/NBK435830/
PubMed 28590637Cheng C, Dong D, He J, Zhong X, Yao S. Psychometric properties of the 10-item Connor-Davidson Resilience Scale (CD-RISC-10) in Chinese undergraduates and depressive patients. J Affect Disord. 2020 Jan 15;261:211-220. doi: 10.1016/j.jad.2019.10.018. Epub 2019 Oct 12.
PubMed 31654919
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Lifestyle and Leadership Intervention for Primary, Secondary, and Tertiary Prevention of Diabetes in Women in the Arab Community
- ClinicalTrials.gov ID
- NCT03358797
- Acronym / sponsor ID
- CBLI / 123NDP-HMO-CTIL
- Conditions
- Diabetes, Health Behaviors
- Keywords
- Community-based Intervention, Lifestyle intervention, Diabetes prevention, Leadership, Resilience, Women's health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 29 Dec 2016 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Arab women present increased risk for diabetes, with a 70% greater risk for adult-onset diabetes and a significantly younger age at onset compared with Jewish Israelis. In fact, the rate of diabetes for Arab women in Jerusalem is 4 times higher compared with their Jewish counterparts. Group lifestyle interventions such as the Diabetes Prevention Program (DPP) have documented effectiveness in preventing diabetes; however, many fail to demonstrate outcome maintenance. We predict that integrating leadership skills training into the gold standard DPP would improve the long-term outcome maintenance.
Stage 1: A pre-post study design will be utilized, where all community participants will be exposed to intervention components. The sample was selected from pre-existing groups in the local community center, based on their leadership potential.
phase 2: The second stage of the trial will not include the leadership component, but instead it will incorporate resiliency training and it aims to evaluate the effect of increased resiliency on the main outcomes including improvement in healthy behaviors such as adherence to Mediterranean diet and as well as a reduction in sedentary lifestyle and increased engagement in physical activity. In addition, resiliency training is likely to improve the maintenance of these behaviors.
Detailed description
The purpose of this study is to design, implement and evaluate a community based lifestyle intervention that integrates a leadership skills training for Palestinian women living in East Jerusalem.
Stage 1: A pre-post study design will be utilized, where all community participants will be exposed to intervention components. The sample was selected from pre-existing groups in the local community center, based on their leadership potential. The Community-Based Lifestyle Intervention (CBLI) was developed by integrating leadership skill training to the gold standard Diabetes Prevention Program (DPP). According to social cognitive theory, engaging in lay leadership can help maintain health behaviors by providing leaders with social support, behavioral reinforcement, outcome expectancies, reciprocal determinism, and building self-efficacy. Fostering social change and empowering individuals, mobilizing community members is also an effective, low cost method for widespread impact on health behavior and health outcomes within the members' community. This is particularly true for women and minority populations. All intervention components were adapted to the specific culture, language, gender, and religious sensitivities of Palestinian female society.
The program will consist of 22 sessions presented by multiple professionals (nutritionists, exercise trainers, health coaches, and psychotherapists). Session content includes Mediterranean diet education, social support, food tasting and cooking, goal setting, self-monitoring, planning, conscious eating, leadership and lay leader training, initiative-taking, group dynamics, project design, community needs assessment, and project evaluation. The study is implemented in partnership with local community centers.
It is hypothesized that Arab women who participate in this community intervention will have improved - and maintained- healthy eating behaviors (i.e. Mediterranean Diet), reduced unhealthy eating behaviors (i.e. Western diet), increased engagement in physical activity and reduced risk of obesity (weight, BMI).
The second stage of the trial will not include the leadership component, but instead it will incorporate resiliency training and it aims to evaluate the effect of increased resiliency on the main outcomes including improvement in healthy behaviors such as adherence to Mediterranean diet and as well as a reduction in sedentary lifestyle and increased engagement in physical activity. In addition, resiliency training is likely to improve the maintenance of these behaviors.
Resiliency can be defined as a personal trait that contributes to the individual's ability to recover from stressful events. It is the ability to achieve, retain, or regain a level of physical or emotional health after illness or loss (bounce back). This characteristic is also considered a protective strength against mental problems, and the ability to effectively adapt to changes and recover from stressful events. Psychological stress is associated with increased risk of non-communicable diseases pose the greatest burden to public health, including heart disease. Additionally, people experiencing psychosocial challenges like isolation and life stress, are found to be less physically active, which is considered an independent risk factor for heart disease. Therefore, effective interventions that aim to reduce stress and anxiety and improve social connectedness are potential means of preventing and managing chronic diseases.
The present study (stage 2) will employ a cluster-randomized trial in which community centers will be assigned to either intervention group or attention control group. The intervention group will receive the CBLI content curriculum (as described above) in addition to the resiliency training (hence CBLI+RT). The attention control group will receive the core curriculum of the CBLI (CBLI-) only without the resiliency training. The sessions of the resiliency training will be replaced with sessions on health topics that do not contribute to our outcome (increased resiliency).
All intervention components were adapted to the specific culture, language, gender, and religious sensitivities of Palestinian female society.
It is hypothesized that Arab women who participate in this community intervention will have improved - and maintained- healthy eating behaviors (i.e. Mediterranean Diet), reduced unhealthy eating behaviors (i.e. Western diet), increased engagement in physical activity and reduced risk of obesity (weight, BMI).
The integration of positive psychology which focuses on individual's strengths through the resiliency training in the second stage of this trial, is hypothesized to be associated with improving-and maintain- healthy behaviors such as healthy diet, increased engagement in physical activity, and reducing unhealthy behaviors such as the consumption of western diet.
The first group will be assigned as a pilot study. This group will not be randomized but will receive the CBLI+RT in order to develop a resiliency training manual to be implemented in the following groups that will be assigned to receive RT in addition to the CBLI core curriculum.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Stage 1: interventional, Pre - Post study, with quasi-experimental comparison group Stage 2: interventional, Pre - Post study, with cluster randomization (Pilot study to develop the resiliency training manual will be part of stage 2)
| Arm | Type | Receives |
|---|---|---|
| intervention-HPP | Experimental | Behavioral: intervention-HPPCommunity participants will participate in a group-based lifestyle intervention based on the CDC Diabetes Prevention Program, and adapted to the Arabic language, Arab culture, Mediterranean Diet, and adapted to include empowerment, leadership and emotion regulation. |
| CBLI+RT | Experimental | Behavioral: Community based intervention with resilience trainingbased on randomization, group that will be assigned to CBLI+RT will receive the CBLI curriculum (as described in the intervention-HPP arm) in addition to the resiliency training |
| Attention control (CBLI-) | Experimental | Behavioral: Attention-controlThe attention control group will receive the core curriculum of the CBLI (as described in the intervention-HPP arm) only without the resiliency training. The sessions of the resiliency training will be replaced with sessions on health topics that do not contribute to our outcome (increased resiliency) (i.e. breast cancer, osteoporosis) |
| Pilot | Experimental | Behavioral: PilotThis group will not be randomized. The group will receive the CBLI content (as described in the intervention-HPP arm) in addition to the resiliency training. The aim of this pilot is to create a resiliency training manual to be implemented in the following groups that will be assigned to receive the CBLI+RT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over age 18
- Able to commit to the intervention timetable
Key exclusion criteria (4 listed)
- Younger than age 18
- Unable to commit to the intervention timetable
- Were not pregnant with expected delivery during the intervention
- Were suffering from other serious mental or physical illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attention-controlLifestyle intervention with presentations by multiple professionals (nutritionists, exercise trainers, and psychotherapists), this intervention will include Mediterranean diet education, physical activity, social support, food tasting and cooking, goal setting,and women's health topics | Behavioural | Attention control (CBLI-) |
| Community based intervention with resilience trainingLifestyle intervention with presentations by multiple professionals (nutritionists, exercise trainers, and psychotherapists), this intervention will include Mediterranean diet education, physical activity, social support, food tasting and cooking, goal setting, and women's health topics. In addition, there will be content targeting resilience training including: positive emotions, cognitive flexibility, life meaning, and active coping strategies. | Behavioural | CBLI+RT |
| intervention-HPPLifestyle intervention with presentations by multiple professionals (nutritionists, exercise trainers, and psychotherapists), this intervention will include Mediterranean diet education, physical activity, social support, food tasting and cooking, goal setting,and women's health topics. In addition, there will be training in leadership skills, community interventions, community needs assessment, intervention planning and outcomes assessment. | Behavioural | intervention-HPP |
| PilotLifestyle intervention with presentations by multiple professionals (nutritionists, exercise trainers, and psychotherapists), this intervention will include Mediterranean diet education, physical activity, social support, food tasting and cooking, goal setting, and women's health topics. In addition, there will be content targeting resilience training including: positive emotions, cognitive flexibility, life meaning, and active coping strategies. | Behavioural | Pilot |
Primary outcome
Change in Mediterranean Diet adherence
Time frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Will be assessed through Panagiotakos' Mediterranean Diet score (an 11 item self-report measure of adherence to the Mediterranean food pattern) which was adapted to Israeli diet and the Arab culture. Items assessing potato and alcohol consumption were removed and an item assessing nut consumption was added
Change in physical activity engagement
Time frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Will be assessed through self report of minutes engaged in vigorous and moderate physical via questionnaires.
13 secondary outcomes
Change in Plasma levels of Hemoglobin A1c (HbA1c)
Time frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Plasma levels of total cholesterol
Time frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Plasma levels of HDL
Time frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Plasma levels of LDL
Time frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Plasma levels of triglycerides
Time frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Body Mass Index (BMI)
Time frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Blood Pressure (BP)
Time frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Cardiovascular Disease Knowledge
Time frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Stages of Change for targeted health behaviors
Time frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Leadership Self-Efficacy
Time frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Resilience
Time frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Sense of Coherence
Time frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Change in Self-Rated health
Time frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Background: PubMed 18020940Anderson ES, Winett RA, Wojcik JR. Self-regulation, self-efficacy, outcome expectations, and social support: social cognitive theory and nutrition behavior. Ann Behav Med. 2007 Nov-Dec;34(3):304-12. doi: 10.1007/BF02874555.
- Background: PubMed 8457219Lorig KR, Mazonson PD, Holman HR. Evidence suggesting that health education for self-management in patients with chronic arthritis has sustained health benefits while reducing health care costs. Arthritis Rheum. 1993 Apr;36(4):439-46. doi: 10.1002/art.1780360403.
- Background: PubMed 20120125Heath GW. The role of the public health sector in promoting physical activity: national, state, and local applications. J Phys Act Health. 2009 Nov;6 Suppl 2:S159-67.
- Background: PubMed 26890177Kim K, Choi JS, Choi E, Nieman CL, Joo JH, Lin FR, Gitlin LN, Han HR. Effects of Community-Based Health Worker Interventions to Improve Chronic Disease Management and Care Among Vulnerable Populations: A Systematic Review. Am J Public Health. 2016 Apr;106(4):e3-e28. doi: 10.2105/AJPH.2015.302987. Epub 2016 Feb 18.
- Background: PubMed 25307195Koniak-Griffin D, Brecht ML, Takayanagi S, Villegas J, Melendrez M, Balcazar H. A community health worker-led lifestyle behavior intervention for Latina (Hispanic) women: feasibility and outcomes of a randomized controlled trial. Int J Nurs Stud. 2015 Jan;52(1):75-87. doi: 10.1016/j.ijnurstu.2014.09.005. Epub 2014 Sep 22.
- Background: PubMed 22367263Walton JW, Snead CA, Collinsworth AW, Schmidt KL. Reducing diabetes disparities through the implementation of a community health worker-led diabetes self-management education program. Fam Community Health. 2012 Apr-Jun;35(2):161-71. doi: 10.1097/FCH.0b013e31824651d3.
- Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Background: PubMed 17126772Panagiotakos DB, Pitsavos C, Stefanadis C. Dietary patterns: a Mediterranean diet score and its relation to clinical and biological markers of cardiovascular disease risk. Nutr Metab Cardiovasc Dis. 2006 Dec;16(8):559-68. doi: 10.1016/j.numecd.2005.08.006. Epub 2006 Feb 9.
- BackgroundThe National Diabetes Registry (Total Population). (n.d.). Retrieved from https://www.health.gov.il/English/MinistryUnits/ICDC/disease_Registries/Pages/diabetes_reg.aspx.
- Background: PubMed 12453955Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. doi: 10.2337/diacare.25.12.2165.
- Background: PubMed 2316767Idler EL, Angel RJ. Self-rated health and mortality in the NHANES-I Epidemiologic Follow-up Study. Am J Public Health. 1990 Apr;80(4):446-52. doi: 10.2105/ajph.80.4.446.
- Background: PubMed 28590637Eriksson M, Mittelmark MB. The Sense of Coherence and Its Measurement. 2016 Sep 3. In: Mittelmark MB, Sagy S, Eriksson M, Bauer GF, Pelikan JM, Lindstrom B, Espnes GA, editors. The Handbook of Salutogenesis [Internet]. Cham (CH): Springer; 2017. Chapter 12. Available from http://www.ncbi.nlm.nih.gov/books/NBK435830/
- Individual participant dataSharing planned: Undecided. yes, to investigators with certified GCP upon request
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Donna Zwas, MD, MPH principal investigator
Hadassah University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community based intervention with resilience training, intervention-HPP and Pilot in people with Diabetes and Health Behaviors, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nisreen Agbaria, RN, MSc (+972 52-966-8796, nigbaria@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mediterranean Diet adherence (time frame: Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03358797, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.