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

Primary Purpose

Obesity

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

ANíMATE mobile application

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, mHealth, mobile application, self-management, self-care, adherence

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital de la Santa Creu i Sant PauRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ANíMATE mobile application

Standard care

Arm Description

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

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

Outcomes

Primary Outcome Measures

%TWL at 4 months

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

Secondary Outcome Measures

%TWL at 2 months

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

%EWL at 2 and 4 months

Percentage of excess weight loss (%EWL) at 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

Waist change at 2 and 4 months

Change in waist circumference (cm) from baseline to 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

HbA1c change at 2 and 4 months

Change in HbA1c percent from baseline to 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

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

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

Adherence to records

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

Adherence to recommendations

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

Adherence to visits

Percentage of face-to-face visits attended

Adherence to the app

Percentage of patients who continue using the 2 months app 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

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

Full Information

NCT ID

NCT05236881

First Posted

January 24, 2022

Last Updated

April 20, 2022

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT05236881

Brief Title

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

Acronym

ANíMATE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 20, 2022 (Actual)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ANíMATE mobile application

Arm Type

Experimental

Arm Description

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

Arm Title

Standard care

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

ANíMATE mobile application

Intervention Description

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.

Primary Outcome Measure Information:

Title

%TWL at 4 months

Description

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

Time Frame

4 months

Secondary Outcome Measure Information:

Title

%TWL at 2 months

Description

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

Time Frame

2 months

Title

%EWL at 2 and 4 months

Description

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

Time Frame

2 and 4 months

Title

BMI change at 2 and 4 months

Description

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

Time Frame

Baseline, 2 and 4 months

Title

Waist change at 2 and 4 months

Description

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

Time Frame

Baseline, 2 and 4 months

Title

Blood pressure change at 2 and 4 months

Description

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

Time Frame

Baseline, 2 and 4 months

Title

HbA1c change at 2 and 4 months

Description

Change in HbA1c percent from baseline to 2 and 4 months

Time Frame

Baseline, 2 and 4 months

Title

Mediterranean diet adherence change at 4 months

Description

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

Time Frame

Baseline and 4 months

Title

IPAQ change at 4 months

Description

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

Title

ACTA change at 4 months

Description

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

Title

Adherence to records

Description

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

Time Frame

2 and 4 months

Title

Adherence to recommendations

Description

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

Time Frame

2 and 4 months

Title

Adherence to visits

Description

Percentage of face-to-face visits attended

Time Frame

2 and 4 months

Title

Adherence to the app

Description

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

Title

Quality of life change at 4 months

Description

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

Title

Satisfaction with the app

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Hospital de la Santa Creu i Sant Pau

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cintia Gonzalez Blanco, MD, PhD

Phone

+34610898918

cgonzalezb@santpau.cat

First Name & Middle Initial & Last Name & Degree

Cintia Gonzalez Blanco, MD, PhD

First Name & Middle Initial & Last Name & Degree

Gemma Cuixart Carruesco, MD

12. IPD Sharing Statement

Learn more about this trial

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

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