Influence of a Modified Ramadan Fasting on Health and Well-being in Healthy Muslims - a Randomised Controlled Trial

Study Overview
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Brief Summary
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In this study the investigators will test the impact of a modified Ramadan Fasting regimen on health and well-being. The 2016 Ramadan is around summer solstice in Germany making it one of the most challenging fasting periods for participating Muslims. The modified Ramadan Fasting consists of educational components around fasting, and advice for nutritional modifications in order to support health and well-being during Ramadan, while the control group will continue to fast as usual. The investigators will measure not only body weight/fat but also include measures of psychological well-being, and spiritual practice, and serum markers for blood lipids, and blood sugar. With this trial the investigators aim to determine, whether such modifications around Ramadan will be beneficial for health and well-being.

Detailed Description
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see above

Official Title
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The Influence of a Modified Ramadan Fasting Regimen on Health and Well-being in Healthy Muslims - a Randomised Controlled Trial

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Behavioral: Modified Ramadan Fasting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Muslims participating in Ramadan Fasting No first time fasting Exclusion Criteria: Untreated or malign hypertension Eating disorder psychological disorder (e.g. depression, schizophrenia, addiction) co-morbid disease (e.g. diabetes, cancer, gout) pregnancy breastfeeding women BMI under 20 or above 40 recently on a diet

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Fasting as Usual<br>This group will continue to practice their usual fasting regimen during Ramadan | |
| Experimental: Modified Ramadan Fasting<br>This group will receive an educational intervention providing knowledge about fasting and its effects on the body/mind, and health advice around nutrition to support health and well-being of participants during Ramadan. | Behavioral: Modified Ramadan Fasting<br>* The intervention aims to provide knowledge about fasting and its effects on the body/mind, and health advice around nutrition to support health and well-being of participants during Ramadan.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life, measured by the WHO-5 (World Health Organisation, Allgaier et al., 2011, WHO-5, 1998) WHO-5, Fragebogen zum Wohlbefinden (Version 1998), Psychiatric Research Unit, WHO Collaborating Centre in Mental Health, http://www.who-5.org/. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life, measured by the WHO-5 (World Health Organisation, Allgaier et al., 2011, WHO-5, 1998) WHO-5, Fragebogen zum Wohlbefinden (Version 1998), Psychiatric Research Unit, WHO Collaborating Centre in Mental Health, http://www.who-5.org/. | 16 weeks | 
| Satisfaction with life | Satisfaction with life, measured by the BMLSS-10 (Brief Multidimensional Life Satisfaction Scale) Büssing A, Fischer J, Haller A, Heusser P, Ostermann T, Matthiessen PF: Validation of the brief multidimensional life satisfaction scale in patients with chronic diseases. European Journal of Medicine Research 2009; 14: 171-177 | 4 weeks | 
| Satisfaction with life | Satisfaction with life, measured by the BMLSS-10 (Brief Multidimensional Life Satisfaction Scale) Büssing A, Fischer J, Haller A, Heusser P, Ostermann T, Matthiessen PF: Validation of the brief multidimensional life satisfaction scale in patients with chronic diseases. European Journal of Medicine Research 2009; 14: 171-177 | 12 weeks | 
| Spirituality | Spirituality, measured by the SpREUK-P SF17 (Spiritual and Religious Attitudes in Dealing with Illness) Büssing A, Reiser F, Michalsen A, Baumann K: Engagement of patients with chronic diseases in spiritual and secular forms of practice: Results with the shortened SpREUK-P SF17 Questionnaire. Integrative Medicine: A Clinician´s Journal 2012; 11(1):28-38 | 4 weeks | 
| Spirituality | Spirituality, measured by the SpREUK-P SF17 (Spiritual and Religious Attitudes in Dealing with Illness) Büssing A, Reiser F, Michalsen A, Baumann K: Engagement of patients with chronic diseases in spiritual and secular forms of practice: Results with the shortened SpREUK-P SF17 Questionnaire. Integrative Medicine: A Clinician´s Journal 2012; 11(1):28-38 | 12 weeks | 
| Sleep quality | Sleep quality, measured by the PROMIS Sleep Disturbances and Sleep-related impairment questionnaires Yu L, Buysse DJ, Germain A, Moul DE, Stover A, Dodds NE, Johnston KL, Pilkonis PA. Development of short forms from the PROMIS™ sleep disturbance and Sleep-Related Impairment item banks. Behav Sleep Med. 2011 Dec 28;10(1):6-24. | 4 weeks | 
| Sleep quality | Sleep quality, measured by the PROMIS Sleep Disturbances and Sleep-related impairment questionnaires Yu L, Buysse DJ, Germain A, Moul DE, Stover A, Dodds NE, Johnston KL, Pilkonis PA. Development of short forms from the PROMIS™ sleep disturbance and Sleep-Related Impairment item banks. Behav Sleep Med. 2011 Dec 28;10(1):6-24. | 12 weeks | 
| Mindfulness | Mindfulness, measured by the Conscious Presence and Self Control Instruments Büssing A, Walach H, Kohls N, Zimmermann F, Trousselard M. Conscious Presence and Self Control as a measure of situational awareness in soldiers - A validation study. International Journal of Mental Health Systems 2013, 7:1 | 4 weeks | 
| Mindfulness | Mindfulness, measured by the Conscious Presence and Self Control Instruments Büssing A, Walach H, Kohls N, Zimmermann F, Trousselard M. Conscious Presence and Self Control as a measure of situational awareness in soldiers - A validation study. International Journal of Mental Health Systems 2013, 7:1 | 12 weeks | 
| Inner Peace | Inner Peace, measured by the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale (FACIT-Sp) Peterman AH, Fitchett G, Brady MJ, Hernandez L, Cella D: Measuring spiritual well-being in people with cancer: the functional assessment of chronic illness therapy - Spiritual Well-being Scale (FACIT-Sp). Ann Behav Med 2002, 24:49-58. | 4 weeks | 
| Inner Peace | Inner Peace, measured by the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale (FACIT-Sp) Peterman AH, Fitchett G, Brady MJ, Hernandez L, Cella D: Measuring spiritual well-being in people with cancer: the functional assessment of chronic illness therapy - Spiritual Well-being Scale (FACIT-Sp). Ann Behav Med 2002, 24:49-58. | 12 weeks | 
| Ease of life | Ease of life, measured by the Emotional and rational disease acceptance questionnaire (ERDA) Büssing A, Matthiessen PF, Mundle G. Emotional and rational disease acceptance in patients with depression and alcohol addiction. BMC Health and Quality of Life Outcomes 2008; 6:4. | 4 weeks | 
| Ease of life | Ease of life, measured by the Emotional and rational disease acceptance questionnaire (ERDA) Büssing A, Matthiessen PF, Mundle G. Emotional and rational disease acceptance in patients with depression and alcohol addiction. BMC Health and Quality of Life Outcomes 2008; 6:4. | 12 weeks | 
| Body weight | Body weight in kg | 4 weeks | 
| Body weight | Body weight in kg | 12 weeks | 
| Body fat | Body fat, measured using a Bioelectrical impedance analysis scale | 4 weeks | 
| Body fat | Body fat, measured using a Bioelectrical impedance analysis scale | 12 weeks | 
| Waist circumference | Waist circumference in cm | 4 weeks | 
| Waist circumference | Waist circumference in cm | 12 weeks | 
| Hip circumference | Hip circumference | 4 weeks | 
| Hip circumference | Hip circumference | 12 weeks | 
| Blood pressure | Blood pressure, measured using an automatic device | 4 weeks | 
| Blood pressure | Blood pressure, measured using an automatic device | 12 weeks | 
| Heart rate | Heart rate, measured using an automatic device | 4 weeks | 
| Heart rate | Heart rate, measured using an automatic device | 12 weeks | 
| Compliance | Compliance, measured using a structured interview about nutrition during Ramadan | 4 weeks | 
| Adverse events | adverse events during the study period | 4 weeks | 
| Blood lipid level | Blood lipid level, including serum measures triglycerides, cholesterol, HDL and LDL cholesterol | 4 weeks | 
| Blood glucose level | Blood glucose level, serum measure | 4 weeks | 
| AST/SGOT | AST/SGOT, as measure of liver function | 4 weeks | 
| ALT/SGPT | ALT/SGPT, as measure of liver function | 4 weeks | 
| GGT | GGT, as measure of liver function | 4 weeks | 
| Uric acid level | Uric acid level, serum measure | 4 weeks | 
| Creatinine | Creatinine level, serum measure | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ramadan, Fasting, Nutrition, Quality of Life