Chronic PainTheraFastNCT02113111
Effects of Fasting on Self Efficacy
An observational study of Chronic Pain and Fibromyalgia, run by Universität Duisburg-Essen at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Fibromyalgia, Rheumatoid Arthritis
- What is being tested?
- Fasting
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients being treated in an integrative clinic for internal medicine Patients recommended for fasting therapy during the inpatient treatment
Who may be able to join
- 18 years or older
- eligible for fasting, i.e. normal weight (no anorexia, no nutritional deficiency, no BMI<18 or >35, no eating disorder)
Who cannot join
- psychiatric disorder
- type 1 diabetes
- hepatitis
- severe somatic disorder (oncological disease, hepatological or nephrological)
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Essen, 45276
About this study
Official title: 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
Read the detailed description
see above
- Conditions
- Chronic Pain, Fibromyalgia, Rheumatoid Arthritis, Gout, Headache, Arthritis
- Being tested
- Fasting
- Medical subject headings
- Chronic Pain, Fibromyalgia, Arthritis, Rheumatoid, Gout, Headache, Arthritis, Gastrointestinal Diseases, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Fasting | Patients being admitted to an internal integrative medicine hospital and referred to therapeutic fasting therapy Receives: Behavioral: Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self efficacy questionnaire
Self efficacy questionnaire (SWE) by Schwarzer and Jerusalem, 1999
Measured: up to 6 months
Bodily self-efficacy
Bodily self-efficacy (Schützler and Witt, 2013)
Measured: up to 6 months
Secondary outcomes (9)
Ability and will to change
Ability and will to change (Büssing, 2008)
Measured: 2 weeks, 6 months
Easiness of life
Questionnaire on emotional and physical reactions
Measured: 2 weeks, 6 months
Health-related quality of life
Short Form (36) Health Survey
Measured: 2 weeks, 6 months
Body responsiveness
Body Responsiveness Scale (BRS)(Daubenmier 2005)
Measured: 2 weeks, 6 months
Body awareness and dissociation
Scale of Body Connection (SBC) (Price and Thompson 2007)
Measured: 2 weeks, 6 months
Body Awareness
Body Awareness Questionnaire (BAQ) (Shields 1989)
Measured: 2 weeks, 6 months
Symptoms
MYMOP questionnaire (Paterson)
Measured: 2 weeks, 6 months
Depression
Becks Depression Inventory (BDI)
Measured: 2 weeks, 6 months
Safety
Any adverse effect during the study period
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romy Lauche, Universität Duisburg-Essen
- Investigators
- Gustav Dobos, Prof, Study director, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-EssenRomy Lauche, PhD, Principal investigator, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113111
- Sponsor's protocol ID
- 13-5522 TheraFast
- Acronym
- TheraFast
- Status last verified
- Sep 2015
- First submitted
- 10 Apr 2014
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Therapeutic Fasting on Self Efficacy Measures - a Prospective Observational Trial
- ClinicalTrials.gov ID
- NCT02113111
- Acronym / sponsor ID
- TheraFast / 13-5522 TheraFast
- Conditions
- Chronic Pain, Fibromyalgia, Rheumatoid Arthritis, Gout, Headache, Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
see above
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fasting | – | Behavioral: FastingPatients being admitted to an internal integrative medicine hospital and referred to therapeutic fasting therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being treated in an integrative clinic for internal medicine Patients recommended for fasting therapy during the inpatient treatment
Key inclusion criteria (2 listed)
- 18 years or older
- eligible for fasting, i.e. normal weight (no anorexia, no nutritional deficiency, no BMI<18 or >35, no eating disorder)
Key exclusion criteria (5 listed)
- psychiatric disorder
- type 1 diabetes
- hepatitis
- severe somatic disorder (oncological disease, hepatological or nephrological)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FastingFasting 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. | Behavioural | Fasting |
Primary outcome
Self efficacy questionnaire
Time frame: up to 6 months
Self efficacy questionnaire (SWE) by Schwarzer and Jerusalem, 1999
Bodily self-efficacy
Time frame: up to 6 months
Bodily self-efficacy (Schützler and Witt, 2013)
9 secondary outcomes
Ability and will to change
Time frame: 2 weeks, 6 months
Easiness of life
Time frame: 2 weeks, 6 months
Health-related quality of life
Time frame: 2 weeks, 6 months
Body responsiveness
Time frame: 2 weeks, 6 months
Body awareness and dissociation
Time frame: 2 weeks, 6 months
Body Awareness
Time frame: 2 weeks, 6 months
Symptoms
Time frame: 2 weeks, 6 months
Depression
Time frame: 2 weeks, 6 months
Safety
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2015.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustav Dobos, Prof study director
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
Romy Lauche, PhD principal investigator
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Fibromyalgia, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self efficacy questionnaire (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2015.