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
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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)

Locations
Other Locations
Sweden
Eatit AB
RECRUITING
Stockholm
Contact Information
Primary
Agnes C Thiel, MSc in Psychology
agnes@eatitcare.com
+46 707 46 31 18
Backup
Moa Olson, B.Sc.in Dietetics
moa@eatitcare.com
Time Frame
Start Date: 2025-09-03
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 93
Treatments
Experimental: Eatit's Obesity Intervention
Digital dietitian-led lifestyle Intervention for Obesity.
Related Therapeutic Areas
Sponsors
Collaborators: Karolinska University, Sahlgrenska University Hospital
Leads: Eatit AB

This content was sourced from clinicaltrials.gov