Eatit's Obesity Intervention: Effects on Weight, Eating Habits and Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEatit AB
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Body mass index (BMI) ≥ 30
Has received a diagnosis of obesity from another healthcare provider.
Has a comorbidity (according to the defined diagnosis list under the heading Comorbidities below).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Lifestyle Intervention for Obesity
BehavioralA 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.
Treatment groups
93 Participants
are divided into 1 treatment groupGroup A: Eatit's Obesity InterventionExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Change from baseline weight to six months.Secondary outcomes
1
Change in waist circumference (cm)
Waist circumference measured in centimeters by participant through self-assessment at home. Participants measure weekly using standardized instructions (measured in the morning after voiding bowels, standing upright, without clothes, tape placed horizontally between the lower rib margin and iliac crest, after exhalation without tightening the tape). Values are entered in the Eatit app.
Time frame
Change from baseline waist circumference to six months.2
Change in self-reported eating habits
Self-reported eating habits assessed with Kostindex (Diet Index, developed by the Swedish National Board of Health and Welfare). Kostindex is a screening tool used to estimate eating habits. Scores range from 0 to 12, with higher scores indicating healthier eating habits. Scoring is divided as follows: 0-4 points: Unhealthy eating habits 5-8 points: Less healthy eating habits 9-12 points: Healthy eating habits The questionnaire is self-administered digitally via the Eatit app.
Time frame
Change in Kostindex score from baseline to six months.3
Change in self-reported health and disability
Change in self-reported health and disability, assessed with the World Health Organization Disability Assessment Schedule 12-item version self-administered (WHODAS 12). Each of the 12 items is scored from 0 to 4 (0 = No difficulty, 4 = Extreme difficulty/cannot do), yielding a raw total score ranging from 0 to 48. Raw scores are transformed into a value between 0 and 100, expressed as a percentage to indicate degree of disability. Higher scores represent greater disability (worse outcome), with 0% = no disability and 100% = complete disability. The questionnaire is self-administered digitally via the Eatit app.
Time frame
Change in WHODAS 2.0 score from baseline to six months.Sponsors and contacts
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Source ClinicalTrials.gov