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

NCT05236881 | Completed

• 1 other identifier: IIBSP-ANI-2020-10
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity

Keywords

Obesity; mHealth; mobile application; self-management; self-care; adherence

Outcome Measures

Primary Outcomes (1)

• %TWL at 4 months

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

  4 months

Secondary Outcomes (15)

• %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

Study Arms (2)

ANíMATE mobile application

EXPERIMENTAL

Standard care protocol (3 face-to-face visits: basal, 2 and 4 months) + ANíMATE mobile application

Device: ANíMATE mobile application

Standard care

NO INTERVENTION

Standard care protocol (3 face-to-face visits: basal, 2 and 4 months)

Interventions

ANíMATE mobile application DEVICE

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.

ANíMATE mobile application

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 11, 2022
• Study Start: April 20, 2022
• Primary Completion: November 13, 2024
• Study Completion: January 31, 2025
• Last Updated: November 18, 2025

Record last verified: 2024-09

Locations

ES (1)