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Water Exercise and Health (WATHEALTH) (WATHEALTH)

Primary Purpose

Overweight, Hunger

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Food intake
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Energy expenditure, Food intake, Women, aquacycling

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women aged between 20 and 40 years
  • BMI under 25kg.m2 for normal weight women and between 25 and 29,9 kg.m2 for overweight women
  • Daily breakfast
  • Subject which approved informed consent
  • Subject with French medical affiliation

Exclusion Criteria:

  • Specific medical treatment
  • Aquaphobia
  • Subject under specific diet regimen or weight loss program
  • Subject with cardio-vascular disease
  • Surgical intervention less than 3 months
  • Subject refusing informed and written consent
  • Subject without French medical affiliation
  • subject refusing inscription to the national voluntary list
  • subject being in an exclusion period
  • subject smoking or drinking alcohol frequently
  • subject with intense physical activity

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

normal weight women

overweight women

Arm Description

20 women with a body mass index ranging between 18,5 and 24,9 kg.m2

20 women with a body mass index ranging between 25 and 29,9 kg.m2

Outcomes

Primary Outcome Measures

Food intake during buffet meal 30 minutes after the end of experimental session
total energy intake at the post session lunch will be calculated by measuring food intake
Food intake during buffet meal 30 minutes after the end of experimental session
total energy intake at the post session lunch will be calculated by measuring food intake
Food intake during buffet meal 30 minutes after the end of experimental session
total energy intake at the post session lunch will be calculated by measuring food intake
Food intake during buffet meal 30 minutes after the end of experimental session
total energy intake at the post session lunch will be calculated by measuring food intake

Secondary Outcome Measures

Appetite, hunger and satiety
using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
Appetite, hunger and satiety
using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
Appetite, hunger and satiety
using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
Appetite, hunger and satiety
using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
Energy expenditure
with a gas analyser energy expenditure will be measured in kcal
Energy expenditure
with a gas analyser energy expenditure will be measured in kcal
Energy expenditure
with a gas analyser energy expenditure will be measured in kcal
Energy expenditure
with a gas analyser energy expenditure will be measured in kcal
Perceived exertion
using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
Perceived exertion
using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
Perceived exertion
using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
Perceived exertion
using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)

Full Information

First Posted
June 3, 2019
Last Updated
September 20, 2019
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
SSR Obésité Nutrition UGECAM, Aquafit Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03978975
Brief Title
Water Exercise and Health (WATHEALTH)
Acronym
WATHEALTH
Official Title
Effect of Water Temperature on Energy Response During Aquatic Cycling in Women: Impact of Weight Status
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 19, 2019 (Actual)
Primary Completion Date
December 19, 2020 (Anticipated)
Study Completion Date
January 19, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
SSR Obésité Nutrition UGECAM, Aquafit Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Aquatic cycling is becoming more popular as it appears to be more suitable for men and women even with poor physical activity level. Commercial tagline highlight beneficial effect of this activity on weight management. However there are poor information concerning the energy response induced by this activity. The aim of this project is to investigate effect of water temperature on energetic response (energy expenditure and food intake) of cycling exercise in water in normal weight and overweight premenopausal women.
Detailed Description
After inclusion visit, all subject will be submitted to DXA to obtain body composition data. Then subjects will be submitted to four experimental session in a semi-randomized order. For all those session, subjects will take a standardized breakfast (570kcal) three hours before experimental session. Control session (CON): subject will stand sited without any activity during 40 min. Subjects will be submitted to three aquatic cycling exercise session: session 27°C :aquatic cycling at 27°C without water jet during 40 min session 27°C+ water jets : aquatic cycling at 27 °C with water jets during 40 min session 18°C : aquatic cycling at 187°C without water jet during 40 min Every exercise session will be set at 70% of theorical maximal heart rate During each session, oxygen consumption and carbon dioxide production will be analysed with gas analysis system. Appetite and hunger sensation will be measured with a specific scale at different time point of each day of experimental session. Thirty minutes after the end of each experimental session subjects will have a buffet meal for lunch time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Hunger
Keywords
Energy expenditure, Food intake, Women, aquacycling

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
participants may receive different interventions sequentially during the protocol
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
normal weight women
Arm Type
Active Comparator
Arm Description
20 women with a body mass index ranging between 18,5 and 24,9 kg.m2
Arm Title
overweight women
Arm Type
Experimental
Arm Description
20 women with a body mass index ranging between 25 and 29,9 kg.m2
Intervention Type
Behavioral
Intervention Name(s)
Food intake
Intervention Description
For all those session, subjects will take a standardized breakfast (570kcal) three hours before experimental session. Control session (CON): subject will stand sited without any activity during 40 min. Subjects will be submitted to three aquatic cycling exercise session: session 27°C :aquatic cycling at 27°C without water jet during 40 min session 27°C+ water jets : aquatic cycling at 27 °C with water jets during 40 min session 18°C : aquatic cycling at 187°C without water jet during 40 min Every exercise session will be set at 70% of theorical maximal heart rate During each session, oxygen consumption and carbon dioxide production will be analysed with gas analysis system. Appetite and hunger sensation will be measured with a specific scale at different time point of each day of experimental session. Thirty minutes after the end of each experimental session subjects will have a buffet meal for lunch time.
Primary Outcome Measure Information:
Title
Food intake during buffet meal 30 minutes after the end of experimental session
Description
total energy intake at the post session lunch will be calculated by measuring food intake
Time Frame
Day 7
Title
Food intake during buffet meal 30 minutes after the end of experimental session
Description
total energy intake at the post session lunch will be calculated by measuring food intake
Time Frame
Day 14
Title
Food intake during buffet meal 30 minutes after the end of experimental session
Description
total energy intake at the post session lunch will be calculated by measuring food intake
Time Frame
Day 21
Title
Food intake during buffet meal 30 minutes after the end of experimental session
Description
total energy intake at the post session lunch will be calculated by measuring food intake
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Appetite, hunger and satiety
Description
using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
Time Frame
Day 7
Title
Appetite, hunger and satiety
Description
using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
Time Frame
Day 14
Title
Appetite, hunger and satiety
Description
using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
Time Frame
Day 21
Title
Appetite, hunger and satiety
Description
using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
Time Frame
Day 28
Title
Energy expenditure
Description
with a gas analyser energy expenditure will be measured in kcal
Time Frame
Day 7
Title
Energy expenditure
Description
with a gas analyser energy expenditure will be measured in kcal
Time Frame
Day 14
Title
Energy expenditure
Description
with a gas analyser energy expenditure will be measured in kcal
Time Frame
Day 21
Title
Energy expenditure
Description
with a gas analyser energy expenditure will be measured in kcal
Time Frame
Day 28
Title
Perceived exertion
Description
using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
Time Frame
Day 7
Title
Perceived exertion
Description
using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
Time Frame
Day 14
Title
Perceived exertion
Description
using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
Time Frame
Day 21
Title
Perceived exertion
Description
using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
Time Frame
Day 28

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women aged between 20 and 40 years BMI under 25kg.m2 for normal weight women and between 25 and 29,9 kg.m2 for overweight women Daily breakfast Subject which approved informed consent Subject with French medical affiliation Exclusion Criteria: Specific medical treatment Aquaphobia Subject under specific diet regimen or weight loss program Subject with cardio-vascular disease Surgical intervention less than 3 months Subject refusing informed and written consent Subject without French medical affiliation subject refusing inscription to the national voluntary list subject being in an exclusion period subject smoking or drinking alcohol frequently subject with intense physical activity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LISE LACLAUTRE
Phone
+33473754963
Email
drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine Duclos
Organizational Affiliation
CHU de Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
Email
drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Martine Duclos

12. IPD Sharing Statement

Learn more about this trial

Water Exercise and Health (WATHEALTH)

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