Community-Based Lifestyle Intervention for Diabetes Prevention in Arab Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHadassah Medical Organization
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Over age 18
Able to commit to the intervention timetable
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Attention-control
BehavioralLifestyle 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
BehavioralLifestyle 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
BehavioralLifestyle 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
BehavioralLifestyle 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.
Treatment groups
300 Participants
are divided into 4 treatment groupsGroup A: intervention-HPPExperimental treatment 1 intervention
Group B: CBLI+RTExperimental treatment 1 intervention
Group C: Attention control (CBLI-)Experimental treatment 1 intervention
Group D: PilotExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)2
Change in physical activity engagement
Will be assessed through self report of minutes engaged in vigorous and moderate physical via questionnaires.
Time frame
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)Secondary outcomes
1
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)
Time frame
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)2
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
Time frame
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)3
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
Time frame
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)4
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
Time frame
Baseline, 6 months after intervention initiation and 6 months following project completion (1 year later)Sponsors and contacts
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Source ClinicalTrials.gov