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Completed

NCT Number: NCT02113111

Effects of Fasting on Self Efficacy

The study aims to investigate

* if a 7 day therapeutic fasting regimen will affect self-efficacy of patients with chronic diseases * the effects of fasting on physical and mental well-being, quality of life and body awareness/image * the association between patients characteristics and the perceived health benefit after fasting * the association between Diagnosis according to traditional Chinese medicine and physical and mental well-being during the course of fasting * experiences and perceptions of patients during fasting therapy

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Key information

Conditions

Chronic Pain Arthritis Arthritis, Rheumatoid Autoimmune Diseases Cardiovascular Diseases Colonic Diseases Colonic Diseases, Functional Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Crystal Arthropathies Digestive System Diseases Fibromyalgia Gastroenteritis Gastrointestinal Diseases Genetic Diseases, Inborn Gout Headache Immune System Diseases Inflammatory Bowel Disease Inflammatory Bowel Diseases Intestinal Diseases Irritable Bowel Syndrome Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases Rheumatoid Arthritis Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Essen, 45276, Germany

About this study

see above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • eligible for fasting, i.e. normal weight (no anorexia, no nutritional deficiency, no BMI<18 or >35, no eating disorder)

Exclusion criteria

  • psychiatric disorder
  • type 1 diabetes
  • hepatitis
  • severe somatic disorder (oncological disease, hepatological or nephrological)
  • pregnancy

Treatment and study plan

Fasting

Behavioral

Fasting therapy was adapted from Buchinger, including a fasting period of 7 days. After 2 prefasting days with 800kcal per day from vegetables and rice/potatoes, fasting starts with the ingestion of an oral laxative. During fasting patients receive small quantities of juice and herbal teas, and a vegetable broth for lunch, altogether no more than 350kcal per day. At the end, fasting is broken by an apple or cooked potato, and for the following 3 days nutrition returns to normocaloric diet.

Primary outcomes

  1. Self efficacy questionnaire

    Time frame: up to 6 months

    Self efficacy questionnaire (SWE) by Schwarzer and Jerusalem, 1999

  2. Bodily self-efficacy

    Time frame: up to 6 months

    Bodily self-efficacy (Schützler and Witt, 2013)

Secondary outcomes

  1. Ability and will to change

    Time frame: 2 weeks, 6 months

    Ability and will to change (Büssing, 2008)

  2. Easiness of life

    Time frame: 2 weeks, 6 months

    Questionnaire on emotional and physical reactions

  3. Health-related quality of life

    Time frame: 2 weeks, 6 months

    Short Form (36) Health Survey

  4. Body responsiveness

    Time frame: 2 weeks, 6 months

    Body Responsiveness Scale (BRS)(Daubenmier 2005)

  5. Body awareness and dissociation

    Time frame: 2 weeks, 6 months

    Scale of Body Connection (SBC) (Price and Thompson 2007)

  6. Body Awareness

    Time frame: 2 weeks, 6 months

    Body Awareness Questionnaire (BAQ) (Shields 1989)

  7. Symptoms

    Time frame: 2 weeks, 6 months

    MYMOP questionnaire (Paterson)

  8. Depression

    Time frame: 2 weeks, 6 months

    Becks Depression Inventory (BDI)

  9. Safety

    Time frame: 2 weeks

    Any adverse effect during the study period

Other outcomes

  1. Well-being

    Time frame: 2 weeks

    Daily log, visual analogue scales (VAS) on positive or negative physical or psychological states, side effects, daily rating

  2. Diagnosis according to traditional Chinese medicine

    Time frame: day 1

    Assessment of traditional Chinese medicine type will be used for correlational analysis

  3. Experiences

    Time frame: 2 weeks

    gathered by qualitative interviews

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

The Effects of Therapeutic Fasting on Self Efficacy Measures - a Prospective Observational Trial

Acronym: TheraFast

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 14, 2014
Registry last updated
Sep 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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