Eatit digital program to help adults with obesity lose weight and improve eating habits

Eatit's Multimodal Digital Lifestyle Intervention for Obesity: A Clinical Pilot Study on Effects on Weight, Self-Rated Eating Habits and Self-Rated Health

This pilot will see if using Eatit's six-month, dietitian-supported digital lifestyle program helps adults with obesity lose weight, reduce waist size, and improve eating habits and self-rated health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 93 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Eatit AB (industry)
• Locations: 1 site (Stockholm, Stockholm County)
• Trial ID: NCT07183228 on ClinicalTrials.gov

What this trial studies

This open-label pilot enrolls about 93 adults with obesity who use Eatit's multimodal, dietitian-supported digital program for six months while serving as their own controls. Data are collected from Eatit's routine database and include weight, waist circumference, completed program modules and dietitian visits, plus self-reported Kostindex and WHODAS 2.0 (12-item) outcomes. Five study dietitians recruit participants through Eatit's normal patient flow and obtain consent during video assessment visits. The main outcome is change in body weight at six months, with secondary outcomes of waist size, eating habits, and self-rated health.

Who should consider this trial

Good fit: Adults aged 18 or older with BMI ≥ 30 (or BMI 27–30 with specified comorbidity, prior obesity diagnosis, central obesity, or low Kostindex), who read Swedish, are not pregnant, and are not using or planning to start appetite-suppressing medication.

Not a fit: People who cannot engage with a digital program or video visits, those planning to use appetite-suppressing drugs, pregnant individuals, or patients with very complex needs that a dietitian judges require more intensive care may not benefit from this program.

Why it matters

Potential benefit: If successful, the program could provide a more accessible and scalable option for weight loss and healthier eating for adults with obesity in Sweden.

How similar studies have performed: Previous digital, dietitian-supported lifestyle programs have produced modest but meaningful weight loss in some trials, though evidence from routine clinical practice is still limited.

Eligibility criteria

Inclusion Criteria:

* Age 18 years or older
* Body mass index (BMI) ≥ 30
* BMI 27-30 in combination with at least one of the following:

  1. Has received a diagnosis of obesity from another healthcare provider.
  2. Has a comorbidity (according to the defined diagnosis list under the heading Comorbidities below).
  3. Has central obesity, defined as waist circumference \> 80 cm for women or \> 94 cm for men.
  4. 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 Criteria:

* 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.

Where this trial is running

Stockholm, Stockholm County

• Eatit AB — Stockholm, Stockholm County, Sweden (RECRUITING)

Study contacts

• Study coordinator: Agnes C Thiel, MSc in Psychology

Conditions: Overweight and Obese Adults, Obese Patients, Obesity, Weight Reduction Programs