NCT07183228

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (estimated)
• Sponsor: Eatit AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle Intervention for Obesity	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.

Timeline

• Start date: 2025-09-03
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-09-19
• Last updated: 2025-09-19

Locations

1 site across 1 country: Sweden