Clinical trial NCT03845478: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight
Obesity
Keywords: Obesity
Physical Activity
Fat mass
Fat free mass
Pedometer
mHealth
Lead sponsor: Universidad de Córdoba
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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

Primary outcomes:
measure: Changes from baseline BMI
timeFrame: At baseline (0 years) and followed for 2 years
measure: Changes from baseline Fatty mass
timeFrame: At baseline (0 years) and followed for 2 years
measure: Changes from baseline Free-fatty mass
timeFrame: At baseline (0 years) and followed for 2 years
measure: Changes from baseline Muscular Mass
timeFrame: At baseline (0 years) and followed for 2 years
measure: Changes from baseline Corporal Water
timeFrame: At baseline (0 years) and followed for 2 years
measure: Adherence to dietary pattern will be also measured through personal interview
timeFrame: At baseline (0 years) and followed for 2 years
measure: Adherence to physical activity patterns will be also measured through IPAQ (International Physical Activity Questionnaire)
timeFrame: At baseline (0 years) and followed for 2 years
measure: Changes from baseline in the number of steps per day
timeFrame: At baseline (0 years) and followed for 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidad de Córdoba
name: Alberto Hernández-Reyes
role: PRINCIPAL_INVESTIGATOR
References:
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.