Effects of Fasting on Self Efficacy

Cardiovascular Diseases Clinical Trial

— TheraFast  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02113111
• Other study ID #: 13-5522 TheraFast
• Status: Completed
• Phase: N/A
• First received: April 10, 2014
• Last updated: September 3, 2015
• Start date: April 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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

Description:

see above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Cardiovascular Diseases
• Chronic Pain
• Digestive System Diseases
• Fibromyalgia
• Gastrointestinal Diseases
• Gout
• Headache
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Irritable Bowel Syndrome
• Rheumatoid Arthritis

Intervention

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.

Locations

Country	Name	City	State
Germany	Department of Internal and Integrative Medicine, Kliniken Essen-Mitte	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Well-being	Daily log, visual analogue scales (VAS) on positive or negative physical or psychological states, side effects, daily rating	2 weeks	Yes
Other	Diagnosis according to traditional Chinese medicine	Assessment of traditional Chinese medicine type will be used for correlational analysis	day 1	No
Other	Experiences	gathered by qualitative interviews	2 weeks	No
Primary	Self efficacy questionnaire	Self efficacy questionnaire (SWE) by Schwarzer and Jerusalem, 1999	up to 6 months	No
Primary	Bodily self-efficacy	Bodily self-efficacy (Schützler and Witt, 2013)	up to 6 months	No
Secondary	Ability and will to change	Ability and will to change (Büssing, 2008)	2 weeks, 6 months	No
Secondary	Easiness of life	Questionnaire on emotional and physical reactions	2 weeks, 6 months	No
Secondary	Health-related quality of life	Short Form (36) Health Survey	2 weeks, 6 months	No
Secondary	Body responsiveness	Body Responsiveness Scale (BRS)(Daubenmier 2005)	2 weeks, 6 months	No
Secondary	Body awareness and dissociation	Scale of Body Connection (SBC) (Price and Thompson 2007)	2 weeks, 6 months	No
Secondary	Body Awareness	Body Awareness Questionnaire (BAQ) (Shields 1989)	2 weeks, 6 months	No
Secondary	Symptoms	MYMOP questionnaire (Paterson)	2 weeks, 6 months	No
Secondary	Depression	Becks Depression Inventory (BDI)	2 weeks, 6 months	No
Secondary	Safety	Any adverse effect during the study period	2 weeks	Yes

External Links

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