NCT07183228Recruiting
Eatit's Obesity Intervention: Effects on Weight, Eating Habits and Health
Eatit's Multimodal Digital Lifestyle Intervention for Obesity: A Clinical Pilot Study on Effects on Weight, Self-Rated Eating Habits and Self-Rated Health
Source: ClinicalTrials.gov · Last updated 19 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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. The aim of this pilot study is to evaluate the effect of Eatit´s multimodal digitally dietitian-supported lifestyle intervention for weight loss in adults with obesity. The main question is: \- Does body weight change after six months of using the program? Secondary questions are: * Does waist size change after six months of using the program? * Do self-rated eating habits improve after six months of using the program? * Does self-rated health improve after six months of using the program? Participants will use the Eatit program for six months and answer questions about their weight, waist size, eating habits and health. The program integrates behavior change techniques with individualized nutrition counseling provided by licensed dietitians. * During the first three months, participants use Eatit's core program through the app, with weekly support by a dietitian via video calls and text messages. * The core program consists of a weekly reading section combined with a related homework assignment. * After completing the core program, participants continue with monthly video sessions with a dietitian, focusing on the skills that were most helpful during the initial phase or on areas such as receiving support to initiate physical activity. * Weight and waist size are recorded in the app every week. * Questionnaires on eating habits and health are completed at baseline, after three months, and after six months.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 93 (estimated)
- First submitted
- 9 Sept 2025
- Start date
- 3 Sept 2025
- Primary completion date
- 1 Aug 2026
- Lead sponsor
- Eatit AB
- Diseases
- Obesity
- NCT number
- NCT07183228
What you commit to
- Study type: Interventional
- Planned participants: 93
- From 3 Sept 2025 to the primary completion date, 1 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ongoing substance abuse (alcohol, narcotics, or medication) is a contraindication for participation and requires specialized addiction care.
- 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.
- 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.
Other illness
- 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.
- 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.
- 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.
- 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.
Other
- BMI: Patients with BMI \< 27 are excluded from treatment.
- 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.
- 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.
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Eatit AB Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.