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

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 Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Device: ANíMATE mobile application

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau
    • Contact: Cintia Gonzalez Blanco, MD, PhD; Phone Number: +34610898918; Email: cgonzalezb@santpau.cat
    • Principal Investigator: Cintia Gonzalez Blanco, MD, PhD
    • Sub-Investigator: Gemma Cuixart Carruesco, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ANíMATE mobile application; Standard care protocol (3 face-to-face visits: basal, 2 and 4 months) + ANíMATE mobile application	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.
No Intervention: Standard care; Standard care protocol (3 face-to-face visits: basal, 2 and 4 months)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
%TWL at 4 months	Percentage of total weight loss (%TWL) at 4 months	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
%TWL at 2 months	Percentage of total weight loss (%TWL) at 2 months	2 months
%EWL at 2 and 4 months	Percentage of excess weight loss (%EWL) at 2 and 4 months	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	Baseline, 2 and 4 months
Waist change at 2 and 4 months	Change in waist circumference (cm) from baseline to 2 and 4 months	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	Baseline, 2 and 4 months
HbA1c change at 2 and 4 months	Change in HbA1c percent from baseline to 2 and 4 months	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	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	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	Baseline and 4 months
Adherence to records	Percentage of records (weight, diet) at 2 and 4 months	2 and 4 months
Adherence to recommendations	Percentage of recommendations given by the medical team followed at next visit	2 and 4 months
Adherence to visits	Percentage of face-to-face visits attended	2 and 4 months
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
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
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

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Obesity; adherence; self-management; mHealth; mobile application; self-care
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: IIBSP-ANI-2020-10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No