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

NCT07183228 | Recruiting

• 1 other identifier: 2025-04645-01
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Overweight and Obese Adults; Obese Patients (BMI ≥ 30 kg/m²)

Keywords

Obesity; Weight Reduction Programs

Outcome Measures

Primary Outcomes (1)

• Change in body weight (kg)

  Body weight measured in kilograms by participant self-weighing at home. Participants weigh themselves weekly according to standardized instructions (in the morning, after voiding bowels, without clothes, before breakfast) and enter values in the Eatit app.

  Change from baseline weight to six months.

Secondary Outcomes (3)

• Change in waist circumference (cm)

  Change from baseline waist circumference to six months.

• Change in self-reported eating habits

  Change in Kostindex score from baseline to six months.

• Change in self-reported health and disability

  Change in WHODAS 2.0 score from baseline to six months.

Study Arms (1)

Eatit's Obesity Intervention

EXPERIMENTAL

Digital dietitian-led lifestyle Intervention for Obesity.

Behavioral: Lifestyle Intervention for Obesity

Interventions

Lifestyle Intervention for Obesity BEHAVIORAL

A multimodal obesity lifestyle program delivered via the Eatit app. The dietitian-led intervention consists of 11 structured modules with weekly dietitian support (video consultations and messaging) during the first 11 weeks, followed by monthly video consultations up to six months. The program integrates behavior change techniques with individualized nutrition counseling provided by licensed dietitians.

Eatit's Obesity Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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).
• 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

You may not qualify 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 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.

Sponsors & Collaborators

• Eatit AB: lead
• Sahlgrenska University Hospital: collaborator
• Karolinska University: collaborator

Study Sites (1)

Eatit AB

Stockholm, Stockholm County, 120 30, Sweden

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Adiposity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Body Fat Distribution; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Body Composition; Biochemical Phenomena; Chemical Phenomena; Metabolism; Physiological Phenomena

Central Study Contacts

Agnes C Thiel, MSc in Psychology

CONTACT

+46 707 46 31 18; agnes@eatitcare.com

Moa Olson, B.Sc.in Dietetics

CONTACT

moa@eatitcare.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 19, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)