Effect of the Prescription of 10,000 Steps Per Day Using a Pedometer APP in the Body Composition of Overweight Adults

Obesity Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03845478
• Other study ID #: A284R4156
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: June 1, 2019

Study information

• Verified date: February 2019
• Source: Universidad de Córdoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 1, 2019
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Control Group (CG)
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 Group (IG)
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Córdoba

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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