NCT05236881
Completed
Not Applicable
Development of an mHealth Tool (ANíMATE) to Assess Self-management, Self-care and Adherence in People With Obesity
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 site in 1 country36 target enrollmentApril 20, 2022
ConditionsObesity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- %TWL at 4 months
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients over 18 years of age.
- •People with BMI 30-39.9 kg/m
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
%TWL at 4 months
Time Frame: 4 months
Percentage of total weight loss (%TWL) at 4 months
Secondary Outcomes
- %TWL at 2 months(2 months)
- %EWL at 2 and 4 months(2 and 4 months)
- BMI change at 2 and 4 months(Baseline, 2 and 4 months)
- Waist change at 2 and 4 months(Baseline, 2 and 4 months)
- Blood pressure change at 2 and 4 months(Baseline, 2 and 4 months)
- HbA1c change at 2 and 4 months(Baseline, 2 and 4 months)
- Mediterranean diet adherence change at 4 months(Baseline and 4 months)
- IPAQ change at 4 months(Baseline and 4 months)
- ACTA change at 4 months(Baseline and 4 months)
- Adherence to records(2 and 4 months)
- Adherence to recommendations(2 and 4 months)
- Adherence to visits(2 and 4 months)
- Adherence to the app(2 months after the end of the study)
- Quality of life change at 4 months(Baseline and 4 months)
- Satisfaction with the app(4 months)
Study Sites (1)
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