Community-Based Lifestyle Intervention for Diabetes Prevention in Arab Women

Diabetes Clinical Trial

— CBLI  

Official title:

Community-Based Lifestyle and Leadership Intervention for Primary, Secondary, and Tertiary Prevention of Diabetes in Women in the Arab Community

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03358797
• Other study ID #: 123NDP-HMO-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: December 29, 2016
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2023
• Source: Hadassah Medical Organization
• Contact: Nisreen Agbaria, RN, MSc
• Phone: +972 52-966-8796
• Email: nigbaria[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over age 18

• Able to commit to the intervention timetable

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Health Behaviors

Intervention

Behavioral:
• Attention-control
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 training
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-HPP
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.
• Pilot
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.

Locations

Country	Name	City	State
Israel	Beit-Safafa community center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (13)

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. — View Citation

Cheng 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. — View Citation

Craig 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. — View Citation

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. — View Citation

Eriksson 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/ — View Citation

Heath 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. — View Citation

Idler 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. — View Citation

Kim 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. — View Citation

Koniak-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. — View Citation

Lorig 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. — View Citation

Panagiotakos 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. — View Citation

The National Diabetes Registry (Total Population). (n.d.). Retrieved from https://www.health.gov.il/English/MinistryUnits/ICDC/disease_Registries/Pages/diabetes_reg.aspx.

Walton 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Primary	Change in physical activity engagement	Will be assessed through self report of minutes engaged in vigorous and moderate physical via questionnaires.	Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Secondary	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)	Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Secondary	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	Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Secondary	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	Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Secondary	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	Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Secondary	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	Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Secondary	Change in Body Mass Index (BMI)	BMI will be calculated by measuring weight and height for each participant.	Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Secondary	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	Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Secondary	Change in Cardiovascular Disease Knowledge	Will be assessed through self report questionnaire based on the American Heart Association's knowledge survey items	Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Secondary	Stages of Change for targeted health behaviors	Will be assessed through self report questionnaire	Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Secondary	Change in Leadership Self-Efficacy	Will be assessed through self report questionnaire	Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Secondary	Change in Resilience	Resilience will be measured through the validated 10 items Connor-Davidson Resilience Scale (CD-RISC-10)	Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Secondary	Change in Sense of Coherence	Sense of coherence will be measured through the Sense of Coherence 13-item scale	Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)
Secondary	Change in Self-Rated health	Self reported status of health will be measured using the Self-Rated health questionnaire	Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)