Development of an mHealth Tool (ANíMATE) to Assess Self-management, Self-care and Adherence in People With Obesity
- Conditions
- Obesity
- Interventions
- Device: ANíMATE mobile application
- Registration Number
- NCT05236881
- Lead Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Brief Summary
This trial main purpose is to develop and test an mHealth app aimed at improving self-management, self-care and adherence of people with obesity.
The study population are type I or II obese people, aged more than 18 years old, with or without comorbidities, who have a smartphone or tablet compatible with the app (Android version 9.0 or higher) and access to a scale for regular weight monitoring.
Control group will follow standard care protocol and patients in the intervention group will also be provided with the app. Follow-up will be done for 16 weeks. Both groups will attend 3 face-to-face visits (baseline, 2 and 4 months).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 36
- Patients over 18 years of age.
- People with BMI 30-39.9 kg/m2.
- Have a smartphone or tablet compatible with the app (Android version 9.0 or higher) and have sufficient capabilities to use it.
- Have access to a scale for regular weight monitoring.
- Presence of serious major comorbidities: High blood pressure treated with > 3 drugs, diabetes mellitus treated with insulin, dyslipidemia treated with PCSK9 inhibitors, sleep apnea-hypopnea syndrome treated with CPAP, ischemic heart disease or stroke.
- Use of pharmacological treatment with influence on weight started in the 6 months prior to study entry.
- History of weight loss intervention (diet, exercise) in the 6 months prior to study entry.
- History of eating disorder.
- History of bariatric surgery.
- Use of any other app or treatment to lose weight in the 6 months prior to study entry.
- Pregnancy, short-term gestational desire or lactation.
- Any other disease or condition that may interfere with compliance with the protocol or completion of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ANíMATE mobile application ANíMATE mobile application Standard care protocol (3 face-to-face visits: basal, 2 and 4 months) + ANíMATE mobile application
- Primary Outcome Measures
Name Time Method %TWL at 4 months 4 months Percentage of total weight loss (%TWL) at 4 months
- Secondary Outcome Measures
Name Time Method Blood pressure change at 2 and 4 months Baseline, 2 and 4 months Change in systolic and diastolic blood pressure (mmhg) from baseline to 2 and 4 months
%TWL at 2 months 2 months Percentage of total weight loss (%TWL) at 2 months
%EWL at 2 and 4 months 2 and 4 months Percentage of excess weight loss (%EWL) at 2 and 4 months
BMI change at 2 and 4 months Baseline, 2 and 4 months Change in body mass index (BMI) (kg/m\^2) from baseline to 2 and 4 months
Waist change at 2 and 4 months Baseline, 2 and 4 months Change in waist circumference (cm) from baseline to 2 and 4 months
HbA1c change at 2 and 4 months Baseline, 2 and 4 months Change in HbA1c percent from baseline to 2 and 4 months
Mediterranean diet adherence change at 4 months Baseline and 4 months Change in mediterranean diet adherence questionnaire score (0\*-14, \*indicates worse questionnaire results) from baseline to 4 months
IPAQ change at 4 months Baseline and 4 months Change in International Physical Activity Questionnaire (IPAQ) score (cathegory results: low/inactive\*, moderate or high, \*indicates worse questionnaire results) from baseline to 4 months
ACTA change at 4 months Baseline and 4 months Change in attitudes towards change in eating disorders (ACTA) questionnaire score (0\*-236, \*indicates worse questionnaire results) from baseline to 4 months
Adherence to records 2 and 4 months Percentage of records (weight, diet) at 2 and 4 months
Adherence to recommendations 2 and 4 months Percentage of recommendations given by the medical team followed at next visit
Adherence to visits 2 and 4 months Percentage of face-to-face visits attended
Adherence to the app 2 months after the end of the study Percentage of patients who continue using the 2 months app after the end of the study
Quality of life change at 4 months Baseline and 4 months Change in Short-Form Health Survey SF-36 questionnaire score (0\*-100, \*indicates worse questionnaire results) from baseline to 4 months
Satisfaction with the app 4 months Satisfaction questionnaire in relation to the use of the app score (0\*-20, \*indicates worse questionnaire results) in the intervention group at the end of the study
Trial Locations
- Locations (1)
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain