OverweightWATHEALTHNCT03978975
Water Exercise and Health (WATHEALTH)
A study testing Food intake in people with Overweight and Hunger, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Hunger
- What is being tested?
- Food intake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2019to 19 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, drci@chu-clermontferrand.fr
Martine Duclos
About this study
Official title: Effect of Water Temperature on Energy Response During Aquatic Cycling in Women: Impact of Weight Status
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.
Read the 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.
- Conditions
- Overweight, Hunger
- Being tested
- Food intake
- Keywords
- Energy expenditure, Food intake, Women, aquacycling
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food intakeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| normal weight women | Active comparator | 20 women with a body mass index ranging between 18,5 and 24,9 kg.m2 Receives: Behavioral: Food intake |
| overweight women | Experimental | 20 women with a body mass index ranging between 25 and 29,9 kg.m2 Receives: Behavioral: Food intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 7
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
Measured: Day 14
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
Measured: Day 21
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
Measured: Day 28
Secondary outcomes (12)
Appetite, hunger and satiety
using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
Measured: Day 7
Appetite, hunger and satiety
using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
Measured: Day 14
Appetite, hunger and satiety
using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
Measured: Day 21
Appetite, hunger and satiety
using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
Measured: Day 28
Energy expenditure
with a gas analyser energy expenditure will be measured in kcal
Measured: Day 7
Energy expenditure
with a gas analyser energy expenditure will be measured in kcal
Measured: Day 14
Energy expenditure
with a gas analyser energy expenditure will be measured in kcal
Measured: Day 21
Energy expenditure
with a gas analyser energy expenditure will be measured in kcal
Measured: Day 28
Perceived exertion
using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
Measured: Day 7
Perceived exertion
using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
Measured: Day 14
Perceived exertion
using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
Measured: Day 21
Perceived exertion
using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start19 Sep 2019
- Primary completion19 Dec 2020 (estimated)
- Study completion19 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- participants may receive different interventions sequentially during the protocol
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- SSR Obésité Nutrition UGECAM, Aquafit Technology
- Responsible party
- Sponsor
- Investigators
- Martine Duclos, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978975
- Sponsor's protocol ID
- RBHP 2018 DUCLOS 4 (Wathealth)
- Other IDs
- 2019-A00353-54
- Acronym
- WATHEALTH
- Status last verified
- Sep 2019
- First submitted
- 3 Jun 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Water Temperature on Energy Response During Aquatic Cycling in Women: Impact of Weight Status
- ClinicalTrials.gov ID
- NCT03978975
- Acronym / sponsor ID
- WATHEALTH / RBHP 2018 DUCLOS 4 (Wathealth)
- Conditions
- Overweight, Hunger
- Keywords
- Energy expenditure, Food intake, Women, aquacycling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- SSR Obésité Nutrition UGECAM, Aquafit Technology
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 19 Dec 2020 (estimated)
- Study completion
- 19 Jan 2022 (estimated)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- participants may receive different interventions sequentially during the protocol
| Arm | Type | Receives |
|---|---|---|
| normal weight women | Active comparator | Behavioral: Food intake20 women with a body mass index ranging between 18,5 and 24,9 kg.m2 |
| overweight women | Experimental | Behavioral: Food intake20 women with a body mass index ranging between 25 and 29,9 kg.m2 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- Specific medical treatment
- Aquaphobia
- Subject under specific diet regimen or weight loss program
- Subject with cardio-vascular disease
- Surgical intervention less than 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food intakeFor 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. | Behavioural | normal weight women, overweight women |
Primary outcome
Food intake during buffet meal 30 minutes after the end of experimental session
Time frame: Day 7
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
Time frame: Day 14
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
Time frame: Day 21
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
Time frame: Day 28
total energy intake at the post session lunch will be calculated by measuring food intake
12 secondary outcomes
Appetite, hunger and satiety
Time frame: Day 7
Appetite, hunger and satiety
Time frame: Day 14
Appetite, hunger and satiety
Time frame: Day 21
Appetite, hunger and satiety
Time frame: Day 28
Energy expenditure
Time frame: Day 7
Energy expenditure
Time frame: Day 14
Energy expenditure
Time frame: Day 21
Energy expenditure
Time frame: Day 28
Perceived exertion
Time frame: Day 7
Perceived exertion
Time frame: Day 14
Perceived exertion
Time frame: Day 21
Perceived exertion
Time frame: Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine Duclos principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food intake in people with Overweight and Hunger, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LISE LACLAUTRE (+33473754963, drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food intake during buffet meal 30 minutes after the end of experimental session (time frame: Day 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.