Anthropometric and behavioural changes after an app-based multimodal treatment for patients with obesity

Anthropometric and behavioural changes after an app-based multimodal treatment for patients with obesity - ZANADIO-replication

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00029070

Enrollment

200

Registered

2022-05-17

Start date

2022-05-23

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E66.00 Obesity due to excess calories Grade 1 obesity (WHO) in patients aged 18 and over E66.01 Obesity due to excess calories Grade 2 obesity (WHO) in patients aged 18 and over E66.02 Obesity due to excess calories Grade 3 obesity (WHO) in patients aged 18 and over

Interventions

Group 1: Intervention Group (IG): Participants receive the intervention program zanadio (medical device of risk class 1 according to MDD) over a period of 12 months. Group 2: Control group (KG): Parti

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) patients of legal age with obesity (m/f/d) 2) BMI between 30 and 45 kg/m2 3) fluent written and spoken German 4) possession of a mobile device

Exclusion criteria

Exclusion criteria: 1) severe concomitant physical illnesses, lack of physical fitness, physical limitations that do not allow moderate independent physical activity. 2) currently diagnosed mental illness or mental problems, significant stress or limitations in everyday life due to mental illness or mental problems, currently ongoing psychotherapeutic treatments, taking medication (psychopharamaceuticals) 3) condition after bariatric surgery 4) secondary forms of obesity (Cushing's syndrome, Prader-Willi syndrome, hypothyroidism or hypogonadism) 5) pregnancy 6) people who are not able to give their consent

Design outcomes

Primary

Measure	Time frame
Percentage change in weight after 12 months in relation to baseline weight.	—

Secondary

Measure	Time frame
Reduction of 1) body fat distribution operationalized as waist-to-height ratio (waist circumference in cm divided by height in cm, measured with a tape measure) and improvements in 2) well-being (WHO-5 well-being index) and the 3) obesity-specific quality of life (IWQOL-Lite questionnaire) at 12 months compared with baseline. Moreover, (4) a health-promoting change in eating behavior (, i.e., less emotionally and externally driven but likely more restrictive eating behavior after 12 months of program participation (DEBQ)). Exploratory endpoints: 1) Gender differences in regarding the aboveabove-mentioned endpoints, especially in the primary endpoint. 2) Follow-up: changes in the above-mentioned endpoints at 12 and 24 months after the active study phase has been completed.	—

Measure

Time frame

Reduction of 1) body fat distribution operationalized as waist-to-height ratio (waist circumference in cm divided by height in cm, measured with a tape measure) and improvements in 2) well-being (WHO-5 well-being index) and the 3) obesity-specific quality of life (IWQOL-Lite questionnaire) at 12 months compared with baseline. Moreover, (4) a health-promoting change in eating behavior (, i.e., less emotionally and externally driven but likely more restrictive eating behavior after 12 months of program participation (DEBQ)). Exploratory endpoints: 1) Gender differences in regarding the aboveabove-mentioned endpoints, especially in the primary endpoint. 2) Follow-up: changes in the above-mentioned endpoints at 12 and 24 months after the active study phase has been completed.

—

Countries

Germany

Contacts

Public ContactLena Roth

Max-Planck Institut für Kognitions- und Neurowissenschaften

rothl@cbs.mpg.de040 285306251

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026