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

Obesity Clinical Trial

— ANíMATE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05236881
• Other study ID #: IIBSP-ANI-2020-10
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2022
• Est. completion date: June 2023

Study information

• Verified date: April 2022
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: June 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• ANíMATE mobile application
mHealth tool ANíMATE (Adherence, Nutrition, PhysIcal Activity, Motivation, medicAtion, Technology and Empowerment) allows the recording of data related to diet and exercise and feedback on behavior through an intelligent data analysis system.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	%TWL at 4 months	Percentage of total weight loss (%TWL) at 4 months	4 months
Secondary	%TWL at 2 months	Percentage of total weight loss (%TWL) at 2 months	2 months
Secondary	%EWL at 2 and 4 months	Percentage of excess weight loss (%EWL) at 2 and 4 months	2 and 4 months
Secondary	BMI change at 2 and 4 months	Change in body mass index (BMI) (kg/m^2) from baseline to 2 and 4 months	Baseline, 2 and 4 months
Secondary	Waist change at 2 and 4 months	Change in waist circumference (cm) from baseline to 2 and 4 months	Baseline, 2 and 4 months
Secondary	Blood pressure change at 2 and 4 months	Change in systolic and diastolic blood pressure (mmhg) from baseline to 2 and 4 months	Baseline, 2 and 4 months
Secondary	HbA1c change at 2 and 4 months	Change in HbA1c percent from baseline to 2 and 4 months	Baseline, 2 and 4 months
Secondary	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	Baseline and 4 months
Secondary	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	Baseline and 4 months
Secondary	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	Baseline and 4 months
Secondary	Adherence to records	Percentage of records (weight, diet) at 2 and 4 months	2 and 4 months
Secondary	Adherence to recommendations	Percentage of recommendations given by the medical team followed at next visit	2 and 4 months
Secondary	Adherence to visits	Percentage of face-to-face visits attended	2 and 4 months
Secondary	Adherence to the app	Percentage of patients who continue using the 2 months app after the end of the study	2 months after the end of the study
Secondary	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	Baseline and 4 months
Secondary	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	4 months