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DiabetesNCT04143737

Community-Based Lifestyle Intervention for Primary and Secondary Prevention of Diabetes in Arab Women in East-Jerusalem

A study testing Healthy lifestyle intervention in people with Diabetes and Cardiovascular Diseases, run by Hadassah Medical Organization.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Given the extremely high incidence of diabetes in Arab women and the current lack of interventions, all non-diabetic women can be considered "at risk" and warrant secondary prevention. Read more about this study

Who is it for?
Ages 25 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Diabetes, Cardiovascular Diseases, Health Behavior
What is being tested?
Healthy lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
7 Mar 2016to 17 Jan 2017
Phase
Interventional
Are there results?
None posted in the registry

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 25 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 25 and above
  • Able to commit to the program timetable

Who cannot join

  • Age younger than25
  • Unable to commit to the intervention timetable
  • Pregnant with expected delivery during the intervention
  • Women with serious mental or physical illness

About this study

Official title: Community-Based Lifestyle Intervention for Primary and Secondary Prevention of Diabetes in Arab Women in East-Jerusalem, A Quasi-experimental Study.

Given the extremely high incidence of diabetes in Arab women and the current lack of interventions, all non-diabetic women can be considered "at risk" and warrant secondary prevention. Creating an effective community-based primary and secondary diabetes prevention program has the potential for nationwide reduction of health disparities for Arab women.

The purpose of this study was to investigate the effectiveness of a lifestyle intervention in reducing risky health behaviors and thus reducing modifiable risk factors associated with diabetes and cardiovascular diseases, through dietary modification, adherence to healthy low-caloric, low-fat diet and engaging in physical activity.

Read the detailed description

Given the extremely high incidence of diabetes in Arab women and the current lack of interventions, all non-diabetic women can be considered "at risk" and warrant secondary prevention.

The purpose of this study was to investigate the effectiveness of lifestyle intervention in reducing risky health behaviors and thus reducing modifiable risk factors associated with diabetes and cardiovascular diseases, through dietary modification, adherence to healthy low-caloric, low-fat diet and engaging in physical activity.

Methods: The invistigators will conduct a quasi-experimental, pre-post intervention study between to investigate the effectiveness of community based intervention to change lifestyle habits and consequently reduce the modifiable risk factors for developing diabetes at all levels of prevention. All members of two targeted Arab women's community centers in East-Jerusalem will be invited to participate in the study. Potential participants will be interviewed for eligibility (over age 25, able to commit to the intervention timetable, and precluding pregnancy or serious mental and physical illness).

Participants who will be included in the control group will not receive any intervention. The intervention group will be located in one community center in Zur-Baher neighborhood, and the control group will be located in one community center in the old city of Jerusalem.

Data will be collected from both groups. Intervention: The Community-Based Lifestyle Intervention (CBLI) was developed based on the gold standard Diabetes Prevention Program (DPP) and adapting all intervention components to the specific culture, language, gender, and religious sensitivities of Palestinian female society. The intervention consisted of 20 weekly sessions and will be taught by professional facilitators (nutritionists, exercise trainers, health coaches, and psychotherapists). The DPP's lifestyle curriculum includes sessions on nutrition, physical activity, stress management skills, and self-monitoring and was culturally adapted, translated into Arabic, and gender tailored.

Being tested
Healthy lifestyle intervention
Keywords
Community-based intervention, Arab women, East jerusalem, Diabetes prevention, Lifestyle intervention, Quasi-Experiment
Medical subject headings
Diabetes Mellitus, Cardiovascular Diseases, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Healthy lifestyle interventionBehavioural

    38 women participated in the intervention group which was located in a community center in Zur-Baher neighborhood. The intervention consisted of 20 weekly sessions on nutrition, physical activity, stress management skills, and self-monitoring. All taught by professional facilitators (nutritionists, exercise trainers, health coaches, and psychotherapists). Baseline data was collected

Study groups in NCT04143737
Study groupRoleWhat they receive
InterventionOther38 women participated in the intervention group which was located in a community center in Zur-Baher neighborhood. The intervention consisted of 20 weekly sessions on nutrition, physical activity, stress management skills, and self-monitoring. All taught by professional facilitators (nutritionists, exercise trainers, health coaches, and psychotherapists). Baseline data was collected
Receives: Behavioral: Healthy lifestyle intervention
ControlNo intervention22 women participated in the control group. They were recruited from a community center in the old city of Jerusalem and did not receive any intervention. Baseline data was collected.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence to Mediterranean diet

    Adherence to Mediterranean Diet- Eating behaviors will be assessed through self-reported questionnaire adapted from the Attica study. The questions include an assessment of daily average consumption of whole grains, vegetables, fruits, legumes, and low-fat dairy products. The questionnaire includes also food items assessing the consumption of western diet including sweets, sweet drinks and salty snacks. These questions were adapted from the following study: "A Western dietary pattern is associated with higher blood pressure in Iranian adolescents." European Journal of Nutrition 2017 Feb:56(1)399-408.

    Measured: 6 months after intervention initiation

  2. Change in average daily steps- measured by Pedometer

    The participants in the intervention group were given a pedometer and weekly step data were collected by the research team.

    Measured: 6 months after intervention initiation

Secondary outcomes (6)

  1. Change in body Mass Index (BMI)

    BMI will be calculated by measuring weight and height for each participant. weight will be measured in kilograms. Height was measured to the nearest 0.1 cm. Body Mass Index (BMI) will be calculated using the formula of weight in kg divided by height in m2 (kg/m2).

    Measured: 6 months after intervention initiation

  2. Change in Plasma levels of Hemoglobin A1c (HbA1c)

    measured using capillary whole blood obtained on finger stick, through a cartridge-based latex agglutination inhibition assay through finger stick on the Cobas B101 point of care device

    Measured: 6 months after intervention initiation

  3. Change in Plasma levels of Glucose, HDL, LDL, triglycerides, and total cholesterol

    The participants will be referred to their national health insurance in order to conduct a blood test for plasma levels of HDL, LDL, triglycerides, and total cholesterol

    Measured: 6 months after intervention initiation

  4. 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: 6 months after intervention initiation

  5. Change in Cardiovascular disease knowledge

    Will be assessed through self report questionnaire based on the American Heart Association's knowledge survey items

    Measured: 6 months after intervention initiation

  6. Change in Leadership self-efficacy scale

    Leadership self-efficacy will be assessed through self report questionnaire. This questionnaire was adapted from a scale used in previous study by the Brookdale Institute in Israel, with similar objectives of empowering and promoting female lay health leaders in the community to advance women's health. The questionnaire consists of 9 items. Participants were asked to rate their level of confidence that they can perform the tasks defined by the leadership component objectives. Respondents select from a 4-point scale varying from 1 = a little confident to 4 = very confident. The sub-scales will be summed and average score will be calculated. higher values represent a better outcome.

    Measured: 6 months after intervention initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2019
  2. Study start7 Mar 2016
  3. Primary completion21 Sep 2016
  4. Study completion17 Jan 2017

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
Quasi-experimental, pre-post study
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04143737
Sponsor's protocol ID
ZU456-HMO-CTIL
Status last verified
Jun 2017
First submitted
29 Nov 2018
Last updated
29 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Plan is to share de-identified IPD

Publications

  • Ackermann RT. Bridging the why and the how of clinical-community integration. Am J Prev Med. 2013 Oct;45(4):526-9. doi: 10.1016/j.amepre.2013.07.003. No abstract available.

    PubMed 24050431

  • 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 12453955

  • Chiuve SE, Cook NR, Shay CM, Rexrode KM, Albert CM, Manson JE, Willett WC, Rimm EB. Lifestyle-based prediction model for the prevention of CVD: the Healthy Heart Score. J Am Heart Assoc. 2014 Nov 14;3(6):e000954. doi: 10.1161/JAHA.114.000954.

    PubMed 25398889

  • Chan JC, Malik V, Jia W, Kadowaki T, Yajnik CS, Yoon KH, Hu FB. Diabetes in Asia: epidemiology, risk factors, and pathophysiology. JAMA. 2009 May 27;301(20):2129-40. doi: 10.1001/jama.2009.726.

    PubMed 19470990

  • Fianu A, Bourse L, Naty N, Le Moullec N, Lepage B, Lang T, Favier F. Long-Term Effectiveness of a Lifestyle Intervention for the Primary Prevention of Type 2 Diabetes in a Low Socio-Economic Community--An Intervention Follow-Up Study on Reunion Island. PLoS One. 2016 Jan 5;11(1):e0146095. doi: 10.1371/journal.pone.0146095. eCollection 2016.

    PubMed 26731676

  • Kalter-Leibovici O, Chetrit A, Lubin F, Atamna A, Alpert G, Ziv A, Abu-Saad K, Murad H, Eilat-Adar S, Goldbourt U. Adult-onset diabetes among Arabs and Jews in Israel: a population-based study. Diabet Med. 2012 Jun;29(6):748-54. doi: 10.1111/j.1464-5491.2011.03516.x.

    PubMed 22050554

  • Idilbi NM, Barhana M, Milman U, Carel RS. [Diabetes mellitus and cancer: the different expression of these diseases in Israeli Arabs and Jews]. Harefuah. 2012 Nov;151(11):625-8, 654. Hebrew.

    PubMed 23367733

  • Panagiotakos DB, Chrysohoou C, Pitsavos C, Stefanadis C. Association between the prevalence of obesity and adherence to the Mediterranean diet: the ATTICA study. Nutrition. 2006 May;22(5):449-56. doi: 10.1016/j.nut.2005.11.004. Epub 2006 Feb 2.

    PubMed 16457990

  • Hojhabrimanesh A, Akhlaghi M, Rahmani E, Amanat S, Atefi M, Najafi M, Hashemzadeh M, Salehi S, Faghih S. A Western dietary pattern is associated with higher blood pressure in Iranian adolescents. Eur J Nutr. 2017 Feb;56(1):399-408. doi: 10.1007/s00394-015-1090-z. Epub 2015 Nov 3.

    PubMed 26534856

Questions about this trial

What is this clinical trial studying?

A study testing Healthy lifestyle intervention in people with Diabetes and Cardiovascular Diseases, run by Hadassah Medical Organization.

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: finished, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to Mediterranean diet (time frame: 6 months after intervention initiation). 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 NCT04143737, which also lists 9 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 29 Oct 2019.

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