Intermittent fasting for obesity in general practice - a controlled, randomized implementation study within the Research Network Baden-Wuerttemberg

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 151

Inclusion Criteria

BMI 30-45 kg/m2,
- Regular care through recruiting 'research practice PLUS'
- Capacity to consent
- No objection to data processing for the purpose of identifying potential study participants (case finding)
- Signed study-specific informed consent and consent to data processing

Exclusion Criteria

- No regular primary care through 'research practice PLUS'
- Objection to data processing for the purpose of identifying potential study participants (case finding)
- No capacity to consent

Presence of any of the following:
o Pregnancy (up to 6 months post-partum) or lactation period.
o History for or presence of an eating disorder: anorexia, bulimia, binge eating disorder.
o Presence of uncontrolled hyper-/hypothyroidism, i.e. a TSH value outside the target range under hormone replacement or thyrostatic therapy, or newly diagnosed hypo-/hyperthyroidism in the past six months.
o Current presence of an organic or symptomatic mental disorder as assessed by the study physician.
o Diabetes mellitus type 1 or diabetes mellitus type 2 requiring insulin therapy
o Anamnestic evidence for:
> Cardiovascular event within the past 12 months (acute coronary syndrome, cardiac catheterization, bypass surgery, hospitalization due to heart
failure, stroke, transient ischemic attack) or uncontrolled arrhythmia, i.e. presence of a known brady/tachycardia or history of brady/tachycardia in the
past, if applicable, with persistent fail in rhythm/rate control, symptomatic AV block II° type Mobitz I, AV block II° (type Mobitz II)/III°.
> Active or therapeutically unstable (insufficiently achieved symptom control) or expected risk of worsening of the underlying disease under TRE in
diseases from the fields of rheumatology, oncology, hematology, infectiology, gastroenterology, psychiatry, nephrology or endocrinology.
> Uncontrolled arterial hypertension, i.e. blood pressure values outside the individual target range under therapy or initial diagnosis of arterial
hypertension in the course of the study.
> Current harmful use of illegal substances and/or alcohol
> Performed bariatric surgery
> Current or within the past 6 months use of medications which, according to the assessment of the study physician, favor obesity or influence body
weight and affect energy and glucose balance (e.g. steroids, antiepileptic drugs, psychotropic drugs, appetite suppressants) as well as
immunosuppressants.
o Pathological results of laboratory examination at screening:
> Advanced renal insufficiency (GFR <45 ml/min or assessed or known to be so by study physician).
> Advanced hepatic insufficiency (elevation of transaminases above 3 times normal or assessed or known to be so by study physician).
> Anemia
> Additional laboratory parameters assessed by the study physician as critical for study participation
o History of or existing retinal detachment
o Presence of any secondary form of obesity (incl. polycystic ovary syndrome, Cushing's syndrome, Prader-Willi syndrome, hypogonadism, Lauren-Moon-Biedl-Bardet syndrome, acromegaly, hypothalamic-pituitary hormone axis disorders).
o Physician-ordered other form of diet (e.g. for celiac disease).
o Active or recent participation in another weight loss program (with weight loss of more than 5% body weight in the past 3 months).
o Lack of suitability for study participation assessed by the study physician.
o Concurrent participation in another intervention study or participation in another intervention study within the last 3 months.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Goal criteria with focus on implementation - feasibility:<br>- Number of participating practices compared to the target number (n=50) of participating practices<br>- Participation rates at the patient level overall:<br> > Ratio of identified patients via case finding to approached patients<br> > Drop-out rate<br>- Participation rates at the practice level<br> > Participation rate per practice:<br> Target vs. achieved participant rate per practice<br> Ratio of identified patients via case finding to approached patients per practice<br> Ratio of patients addressed to participants<br> Drop-Out rate per practice<br><br>Goal criterion clinical study on TRE:<br>- Change in body weight/BMI t0 to t2 comparing the two study arms.

Secondary Outcome Measures