AzTrials
AzTrials

OverweightAD01NCT02308176

Effectiveness of a Mobile Application as an Adjunct to Medical Advice to Promote Healthy Habits

A study testing APP + health advice and health advice in people with Overweight and Obesity, run by Basque Health Service at 3 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

INTRODUCTION: Obesity is the most common metabolic problem and its genesis and maintenance there is always a positive energy balance, with less energy expenditure than that obtained from the intake. Low physical activity is often an important factor in this lower spending. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Overweight, Obesity
What is being tested?
APP + health advice and health advice
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
107 participants
Where
3 sitesSpain
Study dates
Sep 2015to Nov 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • BMI> = 25 mg / kg
  • Holder smartphone
  • Sign informed consent

Who cannot join

  • Presence of physical or mental illnesses that prevent the realization of physical activity
  • Be participating in another research project
  • Pregnancy or lactation
  • Patients who are on diet or drug treatment for weight loss
  • History of myocardial infarction or stroke

Trial locations and contacts

3 sites in 1 country.

Spain3 sites

  • Comarca Araba (Salburua Health Center)

    Vitoria-Gasteiz, Alava, 01003

  • Comarca Araba (Lakubizkarra Health Center)

    Vitoria-Gasteiz, Alava, 01010

  • Comarca Araba (Zabalgana Health Center)

    Vitoria-Gasteiz, Alava, 01015

Other trials in Spain

About this study

Official title: Effectiveness of a Mobile Application as an Adjunct to Medical Advice to Promote Healthy Habits (Diet and Sport) in a Population of Patients Obese or Overweight Adults Patients

INTRODUCTION: Obesity is the most common metabolic problem and its genesis and maintenance there is always a positive energy balance, with less energy expenditure than that obtained from the intake. Low physical activity is often an important factor in this lower spending. Medical advice is useful for determining changes in the habits of life of patients, however, the changes produced by the council do not last over time, so it would be necessary to establish enforcement mechanisms as with mobile technology, because it could improve the adhesion of obese patients to therapy. OBJECTIVE: Primary: To evaluate the effectiveness of an app as an adjunct to medical advice to promote healthy living habits (sport and diet) to lose weight in a population of obese or overweight adult patients. MATERIAL AND METHODS: Open randomized controlled clinical trial with clinical practice (health advice for physical activity and sport). STUDY POPULATION: Obese or overweight adults patients of Araba aged between 18-45 years who be in Contemplation stage with smartphone. Variables: Primary endpoint: Weight (kg); Secondary variables: BMI (kg/cm2); blood pressure (mm Hg); heart rate; Plasma cholesterol (mg / dl); HbA1c; score on the satisfaction questionnaire; index of physical exercise (IPAQ) (METs); quitting tobacco (yes / no); Waist circumference (cm). Statistical analysis: The primary endpoint (weight reduction) will be evaluated by covariance analysis adjusting by baseline weight, and other confounding variables (sex, age, level of education..) Simple size: 48 patients by arm plus 20% to cover losses to follow.

Conditions
Overweight, Obesity
Being tested
APP + health advice, health advice
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APP + health adviceBehavioural

    health advice and reinforcement to it

  • health adviceBehavioural

    health advice

Study groups in NCT02308176
Study groupRoleWhat they receive
intervention groupExperimentalhealth advice and app installation in patient's mobile
Receives: Behavioral: APP + health advice
control groupPlacebo comparatorhealth advice
Receives: Behavioral: health advice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. weight reduction

    reduction of weight

    Measured: at 6 months

Secondary outcomes (8)

  1. BMI

    Measured: at 6 and 12 months

  2. blood pressure

    Measured: at 6 and 12 months

  3. heart rate

    Measured: at 6 and 12 months

  4. smoking cessation

    quitting tobacco (yes / no)

    Measured: at 6 and 12 months

  5. waist circumference

    Measured: at 6 and 12 months

  6. plasma cholesterol

    Measured: at 12 months

  7. satisfaction

    satisfaction questionnaire

    Measured: at 12 months

  8. index of physical exercise

    index of physical exercise (IPAQ) (METs)

    Measured: at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2014 (estimated)
  2. Study startSep 2015
  3. Primary completionMay 2017 (estimated)
  4. Study completionNov 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02308176
Sponsor's protocol ID
AKTIDIET
Acronym
AD01
Status last verified
Jan 2017
First submitted
2 Dec 2014
Last updated
11 Jan 2017
Results posted
No
Data monitoring committee
No

Publications

  • Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.

    PubMed 38375882

  • Apinaniz A, Cobos-Campos R, Saez de Lafuente-Morinigo A, Parraza N, Aizpuru F, Perez I, Goicoechea E, Trapaga N, Garcia L. Effectiveness of randomized controlled trial of a mobile app to promote healthy lifestyle in obese and overweight patients. Fam Pract. 2019 Nov 18;36(6):699-705. doi: 10.1093/fampra/cmz020.

    PubMed 31093681

Questions about this trial

What is this clinical trial studying?

A study testing APP + health advice and health advice in people with Overweight and Obesity, run by Basque Health Service at 3 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

weight reduction (time frame: at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02308176, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.

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