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

NCT ID: NCT03845478

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2019-06-01

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

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Control Group (CG)

Education, modifying diet and physical activity

Group Type: ACTIVE_COMPARATOR

Control Group (CG)

Intervention Type: 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.

Intervention Group (IG)

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

Group Type: EXPERIMENTAL

Intervention Group (IG)

Intervention Type: 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.

Interventions

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 Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Córdoba

OTHER

Sponsor Role: lead

Responsible Party

Alberto Hernández de los Reyes

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alberto Hernández-Reyes

Role: PRINCIPAL_INVESTIGATOR

Universidad de Córdoba

References

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.

Reference Type: DERIVED

PMID: 32348263 (View on PubMed)

Other Identifiers

A284R4156

Identifier Type: -

Identifier Source: org_study_id