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 Pau36 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity

Interventions

ANíMATE mobile application

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. 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

Percentage of total weight loss (%TWL) at 4 months

Time frame: 4 months

Secondary Outcomes

%TWL at 2 months

Percentage of total weight loss (%TWL) at 2 months

Time frame: 2 months

%EWL at 2 and 4 months

Percentage of excess weight loss (%EWL) at 2 and 4 months

Time frame: 2 and 4 months

BMI change at 2 and 4 months

Change in body mass index (BMI) (kg/m\^2) from baseline to 2 and 4 months

Time frame: Baseline, 2 and 4 months

Waist change at 2 and 4 months

Change in waist circumference (cm) from baseline to 2 and 4 months

Time frame: Baseline, 2 and 4 months

Blood pressure change at 2 and 4 months

Change in systolic and diastolic blood pressure (mmhg) from baseline to 2 and 4 months

Time frame: Baseline, 2 and 4 months

HbA1c change at 2 and 4 months

Change in HbA1c percent from baseline to 2 and 4 months

Time frame: Baseline, 2 and 4 months

Mediterranean diet adherence change at 4 months

Change in mediterranean diet adherence questionnaire score (0\*-14, \*indicates worse questionnaire results) from baseline to 4 months

Time frame: Baseline and 4 months

IPAQ change at 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

Time frame: Baseline and 4 months

ACTA change at 4 months

Change in attitudes towards change in eating disorders (ACTA) questionnaire score (0\*-236, \*indicates worse questionnaire results) from baseline to 4 months

Time frame: Baseline and 4 months

Adherence to records

Percentage of records (weight, diet) at 2 and 4 months

Time frame: 2 and 4 months

Adherence to recommendations

Percentage of recommendations given by the medical team followed at next visit

Time frame: 2 and 4 months

Adherence to visits

Percentage of face-to-face visits attended

Time frame: 2 and 4 months

Adherence to the app

Percentage of patients who continue using the 2 months app after the end of the study

Time frame: 2 months after the end of the study

Quality of life change at 4 months

Change in Short-Form Health Survey SF-36 questionnaire score (0\*-100, \*indicates worse questionnaire results) from baseline to 4 months

Time frame: Baseline and 4 months

Satisfaction with the app

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

Time frame: 4 months

Development of an mHealth Tool (ANíMATE) to Assess Self-management, Self-care and Adherence in People With Obesity

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes