Effects of Fasting on Self Efficacy (TheraFast)

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

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

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Diseases; Cardiovascular Diseases; Arthritis; Rheumatoid Arthritis; Chronic Pain; Irritable Bowel Syndrome; Fibromyalgia; Headache; Inflammatory Bowel Disease; Gout
• Intervention / Treatment: Behavioral: Fasting

Detailed Description

see above

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Germany
  • Essen, Germany, 45276
    • Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients being treated in an integrative clinic for internal medicine Patients recommended for fasting therapy during the inpatient treatment

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Fasting; Patients being admitted to an internal integrative medicine hospital and referred to therapeutic fasting therapy

Behavioral: Fasting; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self efficacy questionnaire	Self efficacy questionnaire (SWE) by Schwarzer and Jerusalem, 1999	up to 6 months
Bodily self-efficacy	Bodily self-efficacy (Schützler and Witt, 2013)	up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability and will to change	Ability and will to change (Büssing, 2008)	2 weeks, 6 months
Easiness of life	Questionnaire on emotional and physical reactions	2 weeks, 6 months
Health-related quality of life	Short Form (36) Health Survey	2 weeks, 6 months
Body responsiveness	Body Responsiveness Scale (BRS)(Daubenmier 2005)	2 weeks, 6 months
Body awareness and dissociation	Scale of Body Connection (SBC) (Price and Thompson 2007)	2 weeks, 6 months
Body Awareness	Body Awareness Questionnaire (BAQ) (Shields 1989)	2 weeks, 6 months
Symptoms	MYMOP questionnaire (Paterson)	2 weeks, 6 months
Depression	Becks Depression Inventory (BDI)	2 weeks, 6 months
Safety	Any adverse effect during the study period	2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Well-being	Daily log, visual analogue scales (VAS) on positive or negative physical or psychological states, side effects, daily rating	2 weeks
Diagnosis according to traditional Chinese medicine	Assessment of traditional Chinese medicine type will be used for correlational analysis	day 1
Experiences	gathered by qualitative interviews	2 weeks

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Investigators: Study Director: Gustav Dobos, Prof, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen; Principal Investigator: Romy Lauche, PhD, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: April 10, 2014
• First Submitted That Met QC Criteria: April 11, 2014
• First Posted (Estimate): April 14, 2014

Study Record Updates

• Last Update Posted (Estimate): September 4, 2015
• Last Update Submitted That Met QC Criteria: September 3, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Gastroenteritis; Muscular Diseases; Neuromuscular Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Cardiovascular Diseases; Arthritis; Irritable Bowel Syndrome; Chronic Pain; Inflammatory Bowel Diseases; Fibromyalgia; Gastrointestinal Diseases; Digestive System Diseases; Headache
• Other Study ID Numbers: 13-5522 TheraFast