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

Study Overview
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Brief Summary
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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
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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

Official Title
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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.

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Behavioral: Control Group (CG)
* Behavioral: Intervention Group (IG)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group (CG)<br>Education, modifying diet and physical activity | Behavioral: Control Group (CG)<br>* 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.<br>|
| Experimental: Intervention Group (IG)<br>Education and modifying diet and physical activity with prescription and goal setting | Behavioral: Intervention Group (IG)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Physical Activity, Fat mass, Fat free mass, Pedometer, mHealth