Effect of the Prescription of 10,000 Steps Per Day Using a Pedometer APP in the Body Composition of Overweight Adults
Primary Purpose
Overweight, Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Control Group (CG)
Intervention Group (IG)
Sponsored by
About this trial
This is an interventional other trial for Overweight focused on measuring Obesity, Physical Activity, Fat mass, Fat free mass, Pedometer, mHealth
Eligibility Criteria
Inclusion Criteria:
- Having a IMC >25,
- Being sedentary and
- Have not been submitted to a restrictive diet in the 6 months preceding this study.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group (CG)
Intervention Group (IG)
Arm Description
Education, modifying diet and physical activity
Education and modifying diet and physical activity with prescription and goal setting
Outcomes
Primary Outcome Measures
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
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03845478
First Posted
February 15, 2019
Last Updated
February 18, 2019
Sponsor
Universidad de Córdoba
1. Study Identification
Unique Protocol Identification Number
NCT03845478
Brief Title
Effect of the Prescription of 10,000 Steps Per Day Using a Pedometer APP in the Body Composition of Overweight Adults
Official Title
Effect of the Prescription of 10,000 Steps a Day Using a Pedometer Via Mobile APP, Through a Goal Setting System, in the Body Composition of Overweight Adults: a 6-Month Randomized Weight Loss and mHealth Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 15, 2018 (Actual)
Study Completion Date
June 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Córdoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The promotion of the increase in (FA) should be a priority in the treatment of weight loss in overweight or obese subjects. Walking is a solution to overcome physical inactivity, due to its low impact in which the person can control the intensity, duration and effort in order to reduce the risk of injury.
Monitoring the AF through the number of steps / day offers the possibility of standardizing the evaluation and monitoring. Although the goal of 10,000 steps a day may not be appropriate at various levels of age and physical condition, it is considered a reasonable and motivating goal for healthy adults and previous studies have demonstrated its effectiveness in weight loss programs.
The objective of this study is to compare the effect of the implementation of a monitoring system, goal to achieve, on physical activity in overweight and obese adults. Both groups, control and intervention, have a prescription of 10,000 steps a day to reach, but only the intervention group will have a control system, messages of encouragement and follow-up.
Participants (n=120) will be recruited through outpatient from private clinics in Cádiz, Andalucía, Spain, as well as through community presentations. Overweight or obese and sedentary adult will be randomly assigned into two groups.
For 6 months, all of the adults shall follow the same diet with an identical distribution of macronutrients. There will be a weekly check up of weight, fat, body water and muscle mass for all of them. The status of the number of steps in Accupedo is also checked every week
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Obesity, Physical Activity, Fat mass, Fat free mass, Pedometer, mHealth
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group (CG)
Arm Type
Active Comparator
Arm Description
Education, modifying diet and physical activity
Arm Title
Intervention Group (IG)
Arm Type
Experimental
Arm Description
Education and modifying diet and physical activity with prescription and goal setting
Intervention Type
Behavioral
Intervention Name(s)
Control Group (CG)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intervention Group (IG)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes from baseline BMI
Description
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
Time Frame
At baseline (0 years) and followed for 2 years
Title
Changes from baseline Fatty mass
Description
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.
Time Frame
At baseline (0 years) and followed for 2 years
Title
Changes from baseline Free-fatty mass
Description
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.
Time Frame
At baseline (0 years) and followed for 2 years
Title
Changes from baseline Muscular Mass
Description
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.
Time Frame
At baseline (0 years) and followed for 2 years
Title
Changes from baseline Corporal Water
Description
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.
Time Frame
At baseline (0 years) and followed for 2 years
Title
Adherence to dietary pattern will be also measured through personal interview
Description
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.
Time Frame
At baseline (0 years) and followed for 2 years
Title
Adherence to physical activity patterns will be also measured through IPAQ (International Physical Activity Questionnaire)
Description
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.
Time Frame
At baseline (0 years) and followed for 2 years
Title
Changes from baseline in the number of steps per day
Description
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.
Time Frame
At baseline (0 years) and followed for 2 years
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Having a IMC >25,
Being sedentary and
Have not been submitted to a restrictive diet in the 6 months preceding this study.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Hernández-Reyes
Organizational Affiliation
Universidad de Córdoba
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32348263
Citation
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.
Results Reference
derived
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Effect of the Prescription of 10,000 Steps Per Day Using a Pedometer APP in the Body Composition of Overweight Adults
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