Eatit's Obesity Intervention: Effects on Weight, Eating Habits and Health

Last updated: September 18, 2025
Sponsor: Eatit AB
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Obesity

Hypertriglyceridemia

Treatment

Lifestyle Intervention for Obesity

Clinical Study ID

NCT07183228
2025-04645-01
  • Ages > 18
  • All Genders

Study 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 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.

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:

  1. Has received a diagnosis of obesity from another healthcare provider.

  2. Has a comorbidity (according to the defined diagnosis list under the headingComorbidities below).

  3. Has central obesity, defined as waist circumference > 80 cm for women or > 94cm for men.

  4. 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

Total Participants: 93
Treatment Group(s): 1
Primary Treatment: Lifestyle Intervention for Obesity
Phase:
Study Start date:
September 03, 2025
Estimated Completion Date:
August 01, 2026

Study 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 research questions regarding treatment effects will be obtained from Eatit's database.

Data to be collected:

-Sex, age, weight, waist circumference, number of completed modules in the digital treatment program, number of completed dietitian visits, as well as results from the self-administered questionnaires Kostindex (Diet Index, developed by the Swedish National Board of Health and Welfare) and World Health Organization Disability Assessment Schedule 2.0, 12-item self-administered version (WHODAS 2.0 12-item).

Recruitment and study participants:

-Five study dietitians will recruit 93 participants through Eatit's routine patient flow. The study population will consist of all eligible individuals who schedule an appointment with a study dietitian, as the aim is to evaluate the treatment effect within Eatit's normal patient population.

Informed consent process:

-The request for study participation is made during Assessment Visit 1, which is conducted by video. If the potential participant expresses interest, the dietitian provides written study information. Inclusion in the study occurs during Assessment Visit 2, after the participant has received both written and verbal information. Participants will be enrolled in the study according to the inclusion criteria, provided that no exclusion criteria are met (see Eligibility). If the participant agrees to take part, informed consent will be obtained digitally.

Intervention:

  • Standard care with Eatit's multimodal digital lifestyle intervention program according to routine practice, delivered over six months with dietitian support via chat and video.

Analysis and statistics:

  • Descriptive statistics will be used to characterize the study population. Treatment effects will be evaluated using appropriate regression and correlation analyses. Subgroup and dropout analyses are planned. Both intention-to-treat (ITT) and per-protocol (PP) approaches will be applied.

Connect with a study center

  • Eatit AB

    Stockholm 2673730, Stockholm County 2673722 120 30
    Sweden

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.