ISRCTN ISRCTN31641049
DOI https://doi.org/10.1186/ISRCTN31641049
Secondary identifying numbers N/A
Submission date
20/11/2018
Registration date
04/01/2019
Last edited
27/02/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Physical activity or exercise, by increasing the energy expended during the day, would appear to be an efficient tool to prevent and possibly treat obesity. However, the impact of exercise on body weight and composition is often much less than anticipated. Lean individuals who are regular exercisers usually maintain a stable body weight, but this study aimed to determine whether this was also the case for obese individuals.

Who can participate?
Women who are overweight or obese.

What does the study involve?
Participants had to train for 3-months at a low or high intensity and expend 1500 kcal per week.

What are the possible benefits and risks of participating?
Participating in the study allowed participants to access a gym for free and get more active.

Where is the study run from?
University of Ottawa

When is the study starting and how long is it expected to run for?
September 2010 to December 2012

Who is funding the study?
University of Ottawa

Who is the main contact?
Éric Doucet
edoucet@uottawa.ca

Study website

Contact information

Dr Éric Doucet
Scientific

Behavioural and Metabolic Research Unit (BMRU), School of Human Kinetics, Faculty of Health Sciences, University of Ottawa, Ottawa, Ontario, Canada.
Ottawa
K1N 6N5
Canada

Phone 613-562-5800 poste/ext. 7364
Email eric.doucet@uottawa.ca

Study information

Study designInterventional single-centre repeated measures randomised parallel trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleComparing high and low intensity supervised exercise interventions on energy compensation in overweight or obese women : a randomised parallel trial
Study objectivesWomen training at high intensity will have higher energy compensation across the intervention due to greater energy intake. Non-structured physical activity will decrease more in women training at high intensity vs lower intensity.
Ethics approval(s)University of Ottawa Ethics Committee, 24/01/2011, H10-10-03
Health condition(s) or problem(s) studiedOverweight and obesity in women
InterventionWe conducted a 3-month exercise training program at a low or high intensity. Participants had to train 5 times per week and had to achieve 300 kcal per exercise session for a total of 1500 kcal/week. Participants were tested (during 7-day) 1 month before the exercise intervention; a 14-day phase at the onset of the exercise intervention (wk 1, wk 2); and a 7-day phase at the end of the 3-month exercise intervention (wk 12).
Intervention typeBehavioural
Primary outcome measureThe following were assessed during 3 data collection phases - a 7 day baseline phase (1 month prior to the exercise intervention), a 14 day phase at the beginning of the intervention, and a 7 day phase at the end of the intervention (after 3 months):
1. Energy intake, assessed using lunch boxes and a food journal (according to McNeil et al., 2012)
2. Energy expenditure, assessed using doubly labelled water (according to Schoeller and van Santen, 1982).
3. Body composition, assessed using dual X-ray absorptiometry
Secondary outcome measuresThe following were assessed during 3 data collection phases - a 7 day baseline phase (1 month prior to the exercise intervention), a 14 day phase at the beginning of the intervention, and a 7 day phase at the end of the intervention (after 3 months):
1. Appetite, assessed using a visual analogue scale (VAS)
2. Eating behaviour traits, assessed using the Three-Factor Eating Questionnaire (TFEQ)
3. Food rewards, assessed using the Leeds Food Preference Questionnaire (LFPQ)
4. Time spent performing activities, assessed using an accelerometer
Overall study start date01/09/2010
Completion date11/12/2012

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexFemale
Target number of participants21 participants (11 in the low intensity group and 10 in the high intensity group)
Total final enrolment21
Key inclusion criteria1. Aged 20-45 years
2. Female
3. Stable weight for the last 2 months
4. Body mass index (BMI) >30 kg/m²
5. Sedentary (no more than 2 hours of structured physical activity per week)
6. Menstrual periods every month
Key exclusion criteria1. Pregnancy
2. Smokers
3. Drug users
4. Consuming more than 2 units of alcohol per day
5. Claustrophobic
6. Use of nutritional supplements
7. Not using oral contraceptives or hormones
8. Diabetic (type 1 or type 2)
9. Thyroid disorders
10. Renal disease
11. Liver disease
12. Cancer
13. Inflammatory disease
14. Asthma
15. Respiratory problems
16. Cardiovascular disease
17. Peripheral vascular disease
18. Stroke
19. Orthopaedic limitations
20. Using any of the following:
20.1. Systemic corticosteroids (e.g. prednisone)
20.2. Anti-obesity agents (e.g. Xenical®, Meridia®)
20.3. Natural supplemented for weight loss or weight control (e.g. Megace)
20.4. Antipsychotics
20.5. Mood stabilisers or antidepressants that have a significant impact on weight (e.g. Zyprexa®, Remeron®)
20.6. Diuretics (e.g. Lasix®, furosemide)
21. Treatment with thyroid hormones (stable dose for at least 3 months before the start of the study)
22. Use of thiazide diuretics (hydrochlotozide) for less than 3 months
Date of first enrolment25/01/2011
Date of final enrolment11/09/2012

Locations

Countries of recruitment

  • Canada

Study participating centre

University of Ottawa
Behavioural and Metabolic Research Unit (BMRU), School of Human Kinetics, Faculty of Health Sciences, University of Ottawa, Ottawa, Ontario, Canada.
Ottawa
K1N 6N5
Canada

Sponsor information

University of Ottawa
University/education

School of Human Kinetics
Ottawa
K1N 6N5
Canada

Website uottawa.ca
ROR logo "ROR" https://ror.org/03c4mmv16

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date26/11/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe full study is currently under review at Frontiers in Physiology.
IPD sharing planThe datasets generated and/or analysed during the current study are available on request from Marie-Ève Riou (mriou039@uottawa.com). All the data is already collected and is in binders in a locked room. The consent forms for each individual are kept in a separate binder in another locked room. Participant anonymity in the data is fully respected and names are not included.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results 05/12/2018 04/01/2019 No No
Results article 22/08/2019 27/02/2023 Yes No

Additional files

ISRCTN31641049_BasicResults_5Dec18.pdf
Uploaded 04/01/2019

Editorial Notes

27/02/2023: Publication reference and total final enrolment added.
11/01/2019: Internal review.