Community-Based Lifestyle Intervention for Diabetes Prevention in Arab Women

NCT03358797 | Recruiting

• 1 other identifier: 123NDP-HMO-CTIL
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes; Health Behaviors

Keywords

Community-based Intervention; Lifestyle intervention; Diabetes prevention; Leadership; Resilience; Women's health

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (13)

• Change in Plasma levels of Hemoglobin A1c (HbA1c)

  Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)

• Change in Plasma levels of total cholesterol

  Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)

• Change in Plasma levels of HDL

  Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)

• Change in Plasma levels of LDL

  Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)

• Change in Plasma levels of triglycerides

  Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)

Study Arms (4)

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.

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

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)

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

Behavioral: Pilot

Interventions

Attention-control BEHAVIORAL

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

Attention control (CBLI-)

Community based intervention with resilience training BEHAVIORAL

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.

CBLI+RT

intervention-HPP BEHAVIORAL

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.

intervention-HPP

Pilot BEHAVIORAL

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.

Pilot

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over age 18
• Able to commit to the intervention timetable

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Beit-Safafa community center

Jerusalem, 95822, Israel

RECRUITING

Related 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.

  PMID: 18020940 BACKGROUND

• 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.

  PMID: 8457219 BACKGROUND

• 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.

  PMID: 20120125 BACKGROUND

• 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.

  PMID: 26890177 BACKGROUND

• 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.

  PMID: 25307195 BACKGROUND

• 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.

  PMID: 22367263 BACKGROUND

• 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.

  PMID: 12900694 BACKGROUND

• 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.

  PMID: 17126772 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 12453955 BACKGROUND

• 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.

  PMID: 2316767 BACKGROUND

• 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/

  PMID: 28590637 BACKGROUND

• 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.

  PMID: 31654919 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Health Behavior

Interventions

Early Growth Response Protein 3

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Early Growth Response Transcription Factors; DNA-Binding Proteins; Proteins; Amino Acids, Peptides, and Proteins; Immediate-Early Proteins; Transcription Factors

Study Officials

• Donna Zwas, MD, MPH

  Hadassah University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nisreen Agbaria, RN, MSc

CONTACT

+972 52-966-8796; nigbaria@gmail.com

Donna Zwas, MD, MPH

CONTACT

+9722-677-9451; dannaz@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Linda Joy Pollin Cardiovascular Wellness Center for Women

Model Details: 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)

Study Record Dates

• First Submitted: June 25, 2017
• First Posted: December 2, 2017
• Study Start: December 29, 2016
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

IL (1)