NCT04796532

Brief Summary

The present protocol aims to evaluate the effect of two different 16-week High-intensity interval training (HIIT) programs on daily physical activity, body composition, cardiorespiratory fitness, eating behaviour, enjoyment and quality of life in overweight women. Methods: Ninety overweight women (25 - 50 years old) with a body mass index ≥ 25 kg/m2 will be randomly assigned to three groups of 30 participants: a remote home-based HIIT intervention group; a traditional HIIT intervention group; and a non-exercise control group. Both intervention groups will undergo a 16-week progressive HIIT program following the Tabata method. Participants will be assessed at baseline, 4th, 8th, and after 16-week for physical activity, body composition, cardiorespiratory fitness, eating behaviour, enjoyment and quality of life. The study will have a 16-week follow-up post intervention. Results: The participant's enrolment will begin in December 2021, and investigators will anticipate the study completion by the mid of 2022. Conclusions: The HIIT programs might have beneficial effects on daily physical activity, body composition, cardiorespiratory fitness and overall quality of life in overweight women. Moreover, it might be a more enjoyable form of exercise, once it is performed faster than other exercise forms. As a beneficial side effect, these healthy behaviours might have a favourable impact on women's eating behaviours. This study results are expected to add health and well-being professionals' evidence-based knowledge to create strategies and design home-based exercise interventions.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

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

February 24, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

February 24, 2021

Last Update Submit

March 12, 2021

Conditions

Keywords

High Intensity TrainingExerciseHome-basedOverweightWomen

Outcome Measures

Primary Outcomes (6)

  • Change from Baseline, between and within groups comparison, in Physical activity.

    Objectively measured daily physical activity will be assessed through accelerometers.

    0,4,8,16,32 weeks

  • Change from Baseline, between and within groups comparison, in Cardiorespiratory fitness.

    To assess VO2max the Chester Step Test will be used.

    0,4,8,16,32 weeks

  • Change from Baseline, between and within groups comparison, in percentage of fat mass.

    It will be assessed % fat mass with a bioimpedance weighing machine electric model Tanita BC601.

    0,4,8,16,32 weeks

  • Change from Baseline, between and within groups comparison, in bone mass.

    It will be assessed bone mass with a bioimpedance weighing machine electric model Tanita BC601. The bone mass will be reported in kilograms.

    0,4,8,16,32 weeks

  • Change from Baseline, between and within groups comparison, in muscle mass.

    It will be assessed muscle mass with a bioimpedance weighing machine electric model Tanita BC601. The muscle mass will be reported in kilograms.

    0,4,8,16,32 weeks

  • Change from Baseline, between and within groups comparison, in body mass index (BMI).

    Weight and height will be measured to the nearest 0.1kg and 0.1cm correspondingly. For BMI, weight in kilograms will be divided by height in squared meters (kg/m2).

    0,4,8,16,32 weeks

Secondary Outcomes (3)

  • Change from Baseline, between and within groups comparison, in Quality of Life

    0,4,8,16,32 weeks

  • Change from Baseline, between and within groups comparison, in Eating Behaviour

    0,4,8,16,32 weeks

  • Change from Baseline, between and within groups comparison, in Enjoyment

    0,4,8,16,32 weeks

Study Arms (3)

Control

NO INTERVENTION

No intervention. The control group will maintain their normal physical and dietary activity.

Homebased HIIT

EXPERIMENTAL

16-week exercise program with HIIT with a frequency of 3 days/week. The Homebased HIIT group participants will attend HIIT workout sessions supervised by a specialised instructor via a videoconference application. This group will have 16 week follow-up.

Other: Home based HIIT

Traditional HIIT

EXPERIMENTAL

16-week exercise program with HIIT with a frequency of 3 days/week. The Traditional-HIIT group participants will attend presential HIIT workout sessions supervised. This group will have 16 week follow-up.

Other: Traditional HIIT

Interventions

Intervention will consist in a 16-week exercise program with HIIT with a frequency of 3 days/week. The Home-HIIT group participants will attend HIIT workout sessions supervised by a specialised instructor via a videoconference application. Every HIIT workout session will have a 10 minutes' warm-up, followed by an 8/12/16/20 minutes of HIIT (stages of physical adaptation every 4 weeks) training and 5 minutes' cool-down. Tabata method will be used with eight sets of 20 seconds of exercise bouts separated by 10 seconds rest, in 2 to 5 blocks. The intervention will have four stages of physical adaptation. This group will have a follow-up period of 16 weeks.

Homebased HIIT

Intervention will consist in a 16-week exercise program with HIIT with a frequency of 3 days/week. The Traditional HIIT group participants will attend a group HIIT workout sessions supervised by a specialised instructor in a sport facility. Every HIIT workout session will have a 10 minutes' warm-up, followed by an 8/12/16/20 minutes of HIIT (stages of physical adaptation every 4 weeks) training and 5 minutes' cool-down. Tabata method will be used with eight sets of 20 seconds of exercise bouts separated by 10 seconds rest, in 2 to 5 blocks. The intervention will have four stages of physical adaptation. This group will have a follow-up period of 16 weeks.

Traditional HIIT

Eligibility Criteria

Age25 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOverweight women between 25 and 50 years old.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • female individuals aged between 25 and 50 years old, at the time of selection;
  • have a BMI equal to or greater than 25kg/m2;
  • have the ZOOM application (San Jose, USA) and a 2x2m2 space at home for the practice of HIIT;
  • who present, in their own form, authorized consent to participate in the referred study. Only one person per household will be allowed to be included.

You may not qualify if:

  • having any health problem and/or condition that limit the implementation of an HIIT program;
  • taking medication that influences the variables to be studied;
  • being involved in any type of exercise intervention/program;
  • being in pre-menopause or menopause period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (29)

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MeSH Terms

Conditions

OverweightObesityMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Jorge Mota, PhD

    Universidade do Porto

    STUDY DIRECTOR
  • Armando Raimundo, PhD

    Universidade de Evora

    STUDY DIRECTOR

Central Study Contacts

Joao Carmo, M.Sc.

CONTACT

Jorge Bravo, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants will be randomized and alllocated in one of the three groups (control or experimental HIIT Homebased or experimental HIIT traditional)
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 3 arm parallel groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Student

Study Record Dates

First Submitted

February 24, 2021

First Posted

March 15, 2021

Study Start

December 1, 2021

Primary Completion

April 1, 2022

Study Completion

September 1, 2022

Last Updated

March 16, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

Yes. We will publish the protocol and study results.

Shared Documents
ICF
Time Frame
Starting 6 months after publication