NCT05467280

Brief Summary

The general objective is to assess adherence to a HIIT-type exercise program, complemented with nutritional plans and other health-related advice, which will be administered through a mobile application in sedentary girls.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
281

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

August 5, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

February 17, 2023

Status Verified

June 1, 2022

Enrollment Period

6 months

First QC Date

June 29, 2022

Last Update Submit

February 15, 2023

Conditions

Sedentary LifestylePhysical Inactivity

Keywords

Sedentary Behaviors

Outcome Measures

Primary Outcomes (1)

  • Change in daily steps from baseline to 3 and 6 months

    Measured as the daily step count assessed via the Xiaomi Mi Band 5

    T0(Baseline), T1 (3 months) and T2 (6 months)

Secondary Outcomes (20)

  • Adherence (Asistence)

    T2 (6 months)

  • Adherence (Retention)

    T2 (6 months)

  • Adherence (Duration)

    T2 (6 months)

  • Adherence (Intensity)

    T2 (6 months)

  • Change in body weight (kg) from baseline to 3 and 6 months

    T0(Baseline), T1 (3 months) and T2 (6 months)

  • +15 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

They will be given HIIT exercise video sessions twice a week for 6 months, through a mobile application where they will also be given nutritional and health advice, webinars, and challenges.

Other: Online HIIT Intervention

Control

NO INTERVENTION

They will not carry out any type of intervention, they will only be monitored during the 6 months

Interventions

Online HIIT InterventionOTHER

They will be given HIIT exercise video sessions twice a week for 6 months, through a mobile application where they will also be given nutritional and health advice, webinars and challenges.

Intervention

Eligibility Criteria

Age15 Years - 25 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Participants aged between 15 and 24 years.
  • Sedentary participants who do not comply with the WHO physical exercise recommendations and with a low IPAQ, which means that they do not perform at least:
  • or more days of vigorous activity for at least 20 minutes a day.
  • or more days of moderate-intensity activity.
  • Walk at least 30 minutes a day every day.
  • or more days of combined moderate or vigorous intensity activities or walking achieved a minimum of 600 METs(min/week).

You may not qualify if:

  • Participants with diabetes.
  • Participants with possible heart problems or other type of contraindication that does not allow physical exercise (for this, the PAR-Q survey will be passed)
  • Participants who are not willing to wear the watch during the 6 months that the intervention lasts.
  • Participants who have contracted severe COVID-19 in the last 3 months. If the patients suffer from COVID-19 during the study, then they will stop exercising, but the measurements will be taken at the end of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat de Valencia

Valencia, 46020, Spain

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2022

First Posted

July 20, 2022

Study Start

August 5, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

February 17, 2023

Record last verified: 2022-06

Locations

ES(1)