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.
see above
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
114
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.
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Essen, Germany
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/.
Time frame: 4 weeks
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/.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Body weight
Body weight in kg
Time frame: 4 weeks
Body weight
Body weight in kg
Time frame: 12 weeks
Body fat
Body fat, measured using a Bioelectrical impedance analysis scale
Time frame: 4 weeks
Body fat
Body fat, measured using a Bioelectrical impedance analysis scale
Time frame: 12 weeks
Waist circumference
Waist circumference in cm
Time frame: 4 weeks
Waist circumference
Waist circumference in cm
Time frame: 12 weeks
Hip circumference
Hip circumference
Time frame: 4 weeks
Hip circumference
Hip circumference
Time frame: 12 weeks
Blood pressure
Blood pressure, measured using an automatic device
Time frame: 4 weeks
Blood pressure
Blood pressure, measured using an automatic device
Time frame: 12 weeks
Heart rate
Heart rate, measured using an automatic device
Time frame: 4 weeks
Heart rate
Heart rate, measured using an automatic device
Time frame: 12 weeks
Compliance
Compliance, measured using a structured interview about nutrition during Ramadan
Time frame: 4 weeks
Adverse events
adverse events during the study period
Time frame: 4 weeks
Blood lipid level
Blood lipid level, including serum measures triglycerides, cholesterol, HDL and LDL cholesterol
Time frame: 4 weeks
Blood glucose level
Blood glucose level, serum measure
Time frame: 4 weeks
AST/SGOT
AST/SGOT, as measure of liver function
Time frame: 4 weeks
ALT/SGPT
ALT/SGPT, as measure of liver function
Time frame: 4 weeks
GGT
GGT, as measure of liver function
Time frame: 4 weeks
Uric acid level
Uric acid level, serum measure
Time frame: 4 weeks
Creatinine
Creatinine level, serum measure
Time frame: 4 weeks
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