Obesity is a growing public health problem in Sweden, but access to care varies dependingon geographical location. Eatit´s multimodal digitally dietitian-supported lifestyleintervention offers an accessible treatment alternative, but its clinical effects inpractice need to be documented.The aim of this pilot study is to evaluate the effect of Eatit´s multimodal digitallydietitian-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 theirweight, waist size, eating habits and health. The program integrates behavior changetechniques 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.
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.
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.
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 heading
Comorbidities below).
3. Has central obesity, defined as waist circumference > 80 cm for women or > 94
cm for men.
4. 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
- 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 Criteria:
- 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.
- Severe sleep problems: Sleep deprivation may lead to increased appetite and reduced
cognitive capacity, making it difficult to engage with treatment. Ask follow-up
questions about possible undiagnosed sleep apnea or potential need for other care to
address the sleep problems.
Eatit AB
Stockholm 2673730, Stockholm County 2673722, Sweden
Investigator: Agnes Thiel, MSc in Psychology
Contact: +46 707463118
agnes@eatitcare.com
Investigator: Agnes C Thiel, MSc in Psychology
Agnes C Thiel, MSc in Psychology
+46 707 46 31 18
agnes@eatitcare.com
Moa Olson, B.Sc.in Dietetics
moa@eatitcare.com
Not Provided