Status:
RECRUITING
Eatit's Obesity Intervention: Effects on Weight, Eating Habits and Health
Lead Sponsor:
Eatit AB
Collaborating Sponsors:
Sahlgrenska University Hospital
Karolinska University
Conditions:
Overweight and Obese Adults
Obese Patients (BMI ≥ 30 kg/m²)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Obesity is a growing public health problem in Sweden, but access to care varies depending on geographical location. Eatit´s multimodal digitally dietitian-supported lifestyle intervention offers an ac...
Detailed Description
Study design: \- Open-label interventional study conducted within Eatit's routine patient flow, where each participant serves as their own control. Data sources: \- Data collection to address the r...
Eligibility Criteria
Inclusion
- 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 heading Comorbidities below).
- Has central obesity, defined as waist circumference \> 80 cm for women or \> 94 cm for men.
- Kostindex score of 4 or lower - eligible for treatment due to increased risk of rapid future weight gain. Dietitian-led intervention may significantly impact weight 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 the dietitian assesses that the need for care is too great, and that Eatit's treatment cannot meet the patient's needs.
- Comorbidities:
- Cardiovascular disease This is a large group of diagnoses, e.g. previous myocardial infarction or stroke, angina pectoris, heart failure, etc.
- Hypertension
- Elevated blood pressure, above 130/85 mmHg or ongoing treatment for previously diagnosed 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 \<40 mg/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
- BMI: Patients with BMI \< 27 are excluded from treatment.
- Medical conditions: Patients with conditions where weight loss or weight gain may worsen the disease are excluded. For example: cancer or chronic obstructive pulmonary disease, COPD.
- Multimorbidity: Individuals with extensive comorbidities may have complex healthcare needs requiring more comprehensive medical support than Eatit can provide.
- Untreated depression may hinder participation in the program and should be managed with medical or psychological support.
- Untreated or ongoing eating disorder (bulimia nervosa, binge eating disorder, anorexia, atypical anorexia, ARFID) should be treated in a specialized eating disorder unit.
- Severe psychiatric illness (such as psychosis or schizophrenia) without ongoing support.
- Ongoing substance abuse (alcohol, narcotics, or medication) is a contraindication for participation and requires specialized addiction care.
- Suicidal behavior or self-harm in the past six months. Acute mental illness requires immediate and specialized interventions.
- Requires individual assessment. Certain conditions require individual evaluation as they may negatively affect treatment outcomes. This means that the treating dietitians should ask follow-up questions to ensure that participation in the program is feasible.
- Symptoms of binge eating not meeting criteria for binge eating disorder: Ensure that the person is willing to work with the program, not skip meals, and will inform you if the binge eating worsens.
- Depression under psychiatric care: Ask follow-up questions about what support the person is receiving and his or her current mental state.
- Bipolar disorder: Ask follow-up questions about what support the person is receiving and his or her current mental state.
- Exhaustion syndrome/stress: Ask follow-up questions to determine whether treatment is feasible at this time or if the patient needs to manage the stress in other ways first.
- Neuropsychiatric disorders: To benefit from the program, sufficient concentration ability and capacity for structure/planning in daily life are required. In case of a neuropsychiatric diagnosis, follow-up questions should be asked about whether the person 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 a complicating 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 her current mental state.
- Severe sleep problems: Sleep deprivation may lead to increased appetite and reduced cognitive capacity, making it difficult to engage with treatment. Ask follow-up questions about possible undiagnosed sleep apnea or potential need for other care to address the sleep problems.
Key Trial Info
Start Date :
September 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT07183228
Start Date
September 3 2025
End Date
August 1 2026
Last Update
September 19 2025
Active Locations (1)
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1
Eatit AB
Stockholm, Stockholm County, Sweden, 120 30