NCT03845478

Brief Summary

This study aimed the effect of the Accupedo pedometer smartphone app intervention, with goal setting of walking prescription of 10,000 steps per day, in overweight adults.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

January 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

February 20, 2019

Status Verified

February 1, 2019

Enrollment Period

3 years

First QC Date

February 15, 2019

Last Update Submit

February 18, 2019

Conditions

OverweightObesity

Keywords

ObesityPhysical ActivityFat massFat free massPedometermHealth

Outcome Measures

Primary Outcomes (8)

  • Changes from baseline BMI

    Baseline mean BMI values will be measured and compared at 3, 6, 12 and 24 months. BMI will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale

    At baseline (0 years) and followed for 2 years

  • Changes from baseline Fatty mass

    Baseline mean Fatty mass values will be measured and compared at 3, 6, 12 and 24 months. Fatty mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a percentage.

    At baseline (0 years) and followed for 2 years

  • Changes from baseline Free-fatty mass

    Baseline mean Free-fatty mass values will be measured and compared at 3, 6, 12 and 24 months. Free-fatty mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a percentage.

    At baseline (0 years) and followed for 2 years

  • Changes from baseline Muscular Mass

    Baseline mean Muscular Mass values will be measured and compared at 3, 6, 12 and 24 months. Muscular Mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a Kg.

    At baseline (0 years) and followed for 2 years

  • Changes from baseline Corporal Water

    Baseline mean Corporal Water values will be measured and compared at 3, 6, 12 and 24 months. Corporal Water will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a Kg.

    At baseline (0 years) and followed for 2 years

  • Adherence to dietary pattern will be also measured through personal interview

    Participants will be subjected for an intervention based on nutritional (control group) and physical education (two intervention arms) during 24 months. Partial measures will be also taken every week. In the end of the trial, changes in dietary patterns will be measured comparing means differences between baselines, 3, 6, 12 and 24 months.

    At baseline (0 years) and followed for 2 years

  • Adherence to physical activity patterns will be also measured through IPAQ (International Physical Activity Questionnaire)

    Participants will be subjected for an intervention based on nutritional (control group) and physical education (two intervention arms) during 24 months. Partial measures will be also taken every week. In the end of the trial, changes in physical activity will be measured comparing means differences between baselines, 3, 6, 12 and 24 months.

    At baseline (0 years) and followed for 2 years

  • Changes from baseline in the number of steps per day

    Daily step-counts will be measured using Accupedo Pedometer app; this app can give feedback on distance, time and speed, and and average steps per day, week and month. Accupedo. Partial measures will be also taken every week. In the end of the trial, changes in physical activity patterns will be measured comparing means differences between baselines, 3, 6, 12 and 24 months.

    At baseline (0 years) and followed for 2 years

Study Arms (2)

Control Group (CG)

ACTIVE COMPARATOR

Education, modifying diet and physical activity

Behavioral: Control Group (CG)

Intervention Group (IG)

EXPERIMENTAL

Education and modifying diet and physical activity with prescription and goal setting

Behavioral: Intervention Group (IG)

Interventions

Control Group (CG)BEHAVIORAL

The control group is subjected to follow a hypocaloric diet and receives information about the benefits of achieving 10,000 steps a day in weight loss and improved body composition.

Control Group (CG)
Intervention Group (IG)BEHAVIORAL

This group in addition to fulfilling a hypocaloric diet identical to the control group, and receive identical information about physical activity that the control group, it has a system of prescription, monitoring and establishing an objective to achieve 10,000 steps a day.

Intervention Group (IG)

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having a IMC \>25,
  • Being sedentary and
  • Have not been submitted to a restrictive diet in the 6 months preceding this study.

You may not qualify if:

  • Suffered from type 2 diabetes or renal conditions
  • Being pregnancy or attempt at pregnancy,
  • Being in a maternal lactation period,
  • Being underage
  • Undergoing antidepressant pharmacological treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hernandez-Reyes A, Camara-Martos F, Molina-Luque R, Moreno-Rojas R. Effect of an mHealth Intervention Using a Pedometer App With Full In-Person Counseling on Body Composition of Overweight Adults: Randomized Controlled Weight Loss Trial. JMIR Mhealth Uhealth. 2020 May 27;8(5):e16999. doi: 10.2196/16999.

    PMID: 32348263DERIVED

MeSH Terms

Conditions

OverweightObesityMotor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Alberto Hernández-Reyes

    Universidad de Córdoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 15, 2019

First Posted

February 19, 2019

Study Start

January 1, 2016

Primary Completion

December 15, 2018

Study Completion

June 1, 2019

Last Updated

February 20, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share