NCT02308176

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

1.7 years

First QC Date

December 2, 2014

Last Update Submit

January 10, 2017

Conditions

OverweightObesity

Outcome Measures

Primary Outcomes (1)

  • weight reduction

    reduction of weight

    at 6 months

Secondary Outcomes (8)

  • BMI

    at 6 and 12 months

  • blood pressure

    at 6 and 12 months

  • heart rate

    at 6 and 12 months

  • smoking cessation

    at 6 and 12 months

  • waist circumference

    at 6 and 12 months

  • +3 more secondary outcomes

Study Arms (2)

intervention group

EXPERIMENTAL

health advice and app installation in patient's mobile

Behavioral: APP + health advice

control group

PLACEBO COMPARATOR

health advice

Behavioral: health advice

Interventions

APP + health adviceBEHAVIORAL

health advice and reinforcement to it

intervention group
health adviceBEHAVIORAL

health advice

control group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Comarca Araba (Salburua Health Center)

Vitoria-Gasteiz, Alava, 01003, Spain

Location

Comarca Araba (Lakubizkarra Health Center)

Vitoria-Gasteiz, Alava, 01010, Spain

Location

Comarca Araba (Zabalgana Health Center)

Vitoria-Gasteiz, Alava, 01015, Spain

Location

Related Publications (2)

  • 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.

    PMID: 38375882DERIVED

  • 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.

    PMID: 31093681DERIVED

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MAIN RESEARCHER

Study Record Dates

First Submitted

December 2, 2014

First Posted

December 4, 2014

Study Start

September 1, 2015

Primary Completion

May 1, 2017

Study Completion

November 1, 2017

Last Updated

January 11, 2017

Record last verified: 2017-01

Locations

ES(3)