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New treatment option for Overweight and Obese Adults
Official title Eatit's Obesity Intervention: Effects on Weight, Eating Habits and Health
ClinicalTrials.gov ID: NCT07183228
What this study is testing
- What it's testing
- 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 accessible treatment alternative, but its clinical effects in practice need to be documented.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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).
You likely can't join if
- 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...
- Multimorbidity: Individuals with extensive comorbidities may have complex healthcare needs requiring more comprehensive medical support than Eatit...
- 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...
- Severe psychiatric illness (such as psychosis or schizophrenia) without ongoing support.
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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)
What rules you out
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Stockholm, Stockholm County, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stockholm, Stockholm County, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.