Phase
Condition
Diabetes Prevention
Obesity
Hypertriglyceridemia
Treatment
Lifestyle Intervention for Obesity
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18 years or older
Body mass index (BMI) ≥ 30
BMI 27-30 in combination with at least one of the following:
Has received a diagnosis of obesity from another healthcare provider.
Has a comorbidity (according to the defined diagnosis list under the headingComorbidities below).
Has central obesity, defined as waist circumference > 80 cm for women or > 94cm for men.
Kostindex score of 4 or lower - eligible for treatment due to increased risk ofrapid future weight gain. Dietitian-led intervention may significantly impactweight development in this group.
Ability to read and understand Swedish
Does not currently use, and does not plan to initiate the use of,appetite-suppressing medication
Not pregnant
Patients with BMI > 40, As long as there is no contraindication for treatment,treatment is offered. A dietitian may deny the patient the Eatit program if thedietitian assesses that the need for care is too great, and that Eatit's treatmentcannot meet the patient's needs.
Comorbidities:
Cardiovascular disease This is a large group of diagnoses, e.g. previous myocardialinfarction or stroke, angina pectoris, heart failure, etc.
Hypertension
Elevated blood pressure, above 130/85 mmHg or ongoing treatment for previouslydiagnosed hypertension
Hyperlipidemia
Triglyceride levels ≥ 1.7 mmol/L or on treatment for elevated triglycerides, or LDL > 3.0 mmol/L at low risk, or on treatment for high cholesterol, or reduced HDL-C <40mg/dL for men, <50 mg/dL for women, or on treatment for HDL-C
Obstructive sleep apnea
Type 1 diabetes
Type 2 diabetes
Prediabetes (fasting glucose ≥ 6.1 or HbA1c > 42 without a diabetes diagnosis)
Fatty liver
Polycystic ovary syndrome, PCOS
Osteoarthritis in the lower body (e.g. hip, knee, or foot)
Exclusion
Exclusion Criteria:
BMI: Patients with BMI < 27 are excluded from treatment.
Medical conditions: Patients with conditions where weight loss or weight gain mayworsen the disease are excluded. For example: cancer or chronic obstructivepulmonary disease, COPD.
Multimorbidity: Individuals with extensive comorbidities may have complex healthcareneeds requiring more comprehensive medical support than Eatit can provide.
Untreated depression may hinder participation in the program and should be managedwith medical or psychological support.
Untreated or ongoing eating disorder (bulimia nervosa, binge eating disorder,anorexia, atypical anorexia, ARFID) should be treated in a specialized eatingdisorder unit.
Severe psychiatric illness (such as psychosis or schizophrenia) without ongoingsupport.
Ongoing substance abuse (alcohol, narcotics, or medication) is a contraindicationfor participation and requires specialized addiction care.
Suicidal behavior or self-harm in the past six months. Acute mental illness requiresimmediate and specialized interventions.
Requires individual assessment. Certain conditions require individual evaluation asthey may negatively affect treatment outcomes. This means that the treatingdietitians should ask follow-up questions to ensure that participation in theprogram is feasible.
Symptoms of binge eating not meeting criteria for binge eating disorder: Ensure thatthe person is willing to work with the program, not skip meals, and will inform youif the binge eating worsens.
Depression under psychiatric care: Ask follow-up questions about what support theperson is receiving and his or her current mental state.
Bipolar disorder: Ask follow-up questions about what support the person is receivingand his or her current mental state.
Exhaustion syndrome/stress: Ask follow-up questions to determine whether treatmentis feasible at this time or if the patient needs to manage the stress in other waysfirst.
Neuropsychiatric disorders: To benefit from the program, sufficient concentrationability and capacity for structure/planning in daily life are required. In case of aneuropsychiatric diagnosis, follow-up questions should be asked about whether theperson believes that he or she can manage texts and tasks that take approximately 2-3 hours per week.
High degree of psychiatric comorbidity has in some studies been shown to be acomplicating factor, and this should also be considered at the start of treatment.Ask follow-up questions about what support the person is receiving and his or hercurrent mental state.
Severe sleep problems: Sleep deprivation may lead to increased appetite and reducedcognitive capacity, making it difficult to engage with treatment. Ask follow-upquestions about possible undiagnosed sleep apnea or potential need for other care toaddress the sleep problems.
Study Design
Study Description
Connect with a study center
Eatit AB
Stockholm 2673730, Stockholm County 2673722 120 30
SwedenActive - Recruiting

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