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OpenTrials
Completed

NCT Number: NCT05236881

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

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).

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. %TWL at 4 months

    Time frame: 4 months

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

Secondary outcomes

  1. %TWL at 2 months

    Time frame: 2 months

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

  2. %EWL at 2 and 4 months

    Time frame: 2 and 4 months

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

  3. BMI change at 2 and 4 months

    Time frame: Baseline, 2 and 4 months

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

  4. Waist change at 2 and 4 months

    Time frame: Baseline, 2 and 4 months

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

  5. Blood pressure change at 2 and 4 months

    Time frame: Baseline, 2 and 4 months

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

  6. HbA1c change at 2 and 4 months

    Time frame: Baseline, 2 and 4 months

    Change in HbA1c percent from baseline to 2 and 4 months

  7. Mediterranean diet adherence change at 4 months

    Time frame: Baseline and 4 months

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

  8. IPAQ change at 4 months

    Time frame: Baseline and 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

  9. ACTA change at 4 months

    Time frame: Baseline and 4 months

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

  10. Adherence to records

    Time frame: 2 and 4 months

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

  11. Adherence to recommendations

    Time frame: 2 and 4 months

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

  12. Adherence to visits

    Time frame: 2 and 4 months

    Percentage of face-to-face visits attended

  13. Adherence to the app

    Time frame: 2 months after the end of the study

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

  14. Quality of life change at 4 months

    Time frame: Baseline and 4 months

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

  15. Satisfaction with the app

    Time frame: 4 months

    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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: ANíMATE

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Feb 11, 2022
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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