Healthy Volunteers
Conditions
Keywords
Ramadan, Fasting, Nutrition, Quality of Life
Brief summary
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
see above
Interventions
BEHAVIORALModified Ramadan Fasting
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.
Sponsors
Universität Duisburg-Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 4 weeks | 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/. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with life | 4 weeks | 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 |
| Spirituality | 4 weeks | 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 |
| Sleep quality | 4 weeks | 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. |
| Mindfulness | 4 weeks | 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 |
| Inner Peace | 4 weeks | 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. |
| Ease of life | 4 weeks | 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. |
| Body weight | 4 weeks | Body weight in kg |
| Body fat | 4 weeks | Body fat, measured using a Bioelectrical impedance analysis scale |
| Waist circumference | 4 weeks | Waist circumference in cm |
| Hip circumference | 4 weeks | Hip circumference |
| Quality of life | 16 weeks | 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/. |
| Heart rate | 4 weeks | Heart rate, measured using an automatic device |
| Compliance | 4 weeks | Compliance, measured using a structured interview about nutrition during Ramadan |
| Adverse events | 4 weeks | adverse events during the study period |
| Blood lipid level | 4 weeks | Blood lipid level, including serum measures triglycerides, cholesterol, HDL and LDL cholesterol |
| Blood glucose level | 4 weeks | Blood glucose level, serum measure |
| AST/SGOT | 4 weeks | AST/SGOT, as measure of liver function |
| ALT/SGPT | 4 weeks | ALT/SGPT, as measure of liver function |
| GGT | 4 weeks | GGT, as measure of liver function |
| Uric acid level | 4 weeks | Uric acid level, serum measure |
| Creatinine | 4 weeks | Creatinine level, serum measure |
| Blood pressure | 4 weeks | Blood pressure, measured using an automatic device |
Countries
Germany
Outcome results
None listed