Exercise TrainingNCT03809871
Biomarker Feedback on Health and Wellbeing and Exercise Adherence Following a 6 Month Weight Management Course
A study testing Cardiometabolic biomarkers in people with Exercise Training and Biomarkers, run by University of Hertfordshire at 1 site in United Kingdom.
Trial summary
Participants who have signed up to the Watford Football Club Community and Education Trust Weight management programme called Shape Up will be approached to see if they would like to take part in this research study. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Training, Biomarkers
- What is being tested?
- Cardiometabolic biomarkers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jan 2019to 24 Sep 2019
- 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI >28
- No injuries
Who cannot join
- Injury preventing from participating in exercise
- fear of needles
- does not pass a physical activity readiness questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarker Feedback on Health and Wellbeing and Exercise Adherence Following a 6 Month Weight Management Course: A Pilot Study
Participants who have signed up to the Watford Football Club Community and Education Trust Weight management programme called Shape Up will be approached to see if they would like to take part in this research study. Their participation in the Shape Up programme will not be affected if they do not choose to opt in to the research component. Fifty participants will be recruited and randomised in to one of two groups. One group will be the control group and they will undertake the Shape Up programme as normal and will be asked to complete some questionnaires in week 1, week 12 and then at 12 weeks follow up. The intervention group will be asked to complete the same questionnaires and will also have a venous blood sample taken at week 1, 12 and then at 12 weeks follow up. This is for measures of cholesterol, sugar, vitamin D, vitamin B12 and iron. The participants will receive a report from a medical doctor in layman terms on these results a week later and will have access to their data on an online portal set up by Medichecks.
The weight management programme is based on a behaviour change programme where the participants attend a 90-minute session for 12 weeks, and they are then supported for another 12 weeks following the end of the supervision. The participants have weight and BMI measured at week 1, 12 and 12 weeks follow up. Each session consists of an education component followed by an exercise component. Initially, the education part is longer and the exercise is shorter, but as the programme progresses the education part becomes shorter and the exercise longer. The education programme includes topics such as healthy eating, increased physical activity and stress. The exercise programme includes whole body activities such as circuit training as well as other group exercise such as football.
Read more
The questionnaires will include The Treatment Self-Regulation Questionnaire which will identify the motivation behind the participants' health. A general health questionnaire which is a subjective measure of health (Euro qol EQ-5). The Mental Component Summary of the 12- item Short Form (SF12) which measures emotional quality of life. Physical activity will be measured through the short Active Lives Questionnaire. All these questionnaires have been attached as appendices.
All participants will complete an exit telephone interview from the study to determine qualitative feedback on their experience of the study and to explore whether the biomarkers influenced their motivation to change their lifestyle. Some example questions have been attached.
This is just a feasibility study, therefore no hypothesis testing will be undertaken.
- Conditions
- Exercise Training, Biomarkers
- Being tested
- Cardiometabolic biomarkers
- Keywords
- exercise training, weight management, biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiometabolic biomarkersBiological
This is for measures of cholesterol (HDL, LDL and total cholesterol), blood glucose and HbA1c, vitamin D, vitamin B12 and iron levels.
| Study group | Role | What they receive |
|---|---|---|
| Biomarker group | Experimental | These participants will receive information about cardiometabolic biomarkers pre and post weight management course Receives: Biological: Cardiometabolic biomarkers |
| Control group | No intervention | They will receive the same weight management programme as the experimental group, but they will not have biomarker information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behaviour regulation
To determine the behaviour regulation by measuring autonmoic regulation versus controlled regulation through the use of the Treatment Self-Regulation Questionnaire.
An average of the scores on the subscale for autoregulation and also for the controlled regulation questions will be calculated. Scores will be from 1-7 for both sub scales.
Measured: 12 months
Subjective health measure
A standardised measure of health status will be calculated using the Euro qol EQ-5 questionnaire. There are 5 dimensions to the questionnaire (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and each is rated from 1-5. An average of the 5 is calculated as a general health score. A visual analogue scale is also presented for a self related health measure and this is from 0-100. 100 being the best health you can imagine and 0 being the worst health you can imagine.
Measured: 12 months
Physical Activity
Amount of physical activity measured through the short Active Lives questionnaire. The amount of minutes where breathing is increased will be calculated per week.
For each activity that respondents indicate was sufficient to raise their breathing rate, the total number of days is multiplied by the usual minutes spent undertaking the activity to give a measure of total minutes over the 7-day period for that activity.
The respondent's final score is calculated by summing all activities which were sufficient to raise breathing rate, as follows:
(Days of walking * usual minutes of walking IF sufficient to raise breathing rate) + (Days of cycling * usual munities of cycling IF sufficient to raise breathing rate) + (days of sport, fitness or dance * usual minutes of sport, fitness or dance IF sufficient to raise breathing rate).
Measured: 12 months
Secondary outcomes (1)
Cost savings to health care service
Extrapolating the potential cost savings to the health care service of the community programme by analysing the biomarker trend information
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start14 Jan 2019
- Primary completion30 Aug 2019
- Study completion24 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise TrainingStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hertfordshire
- Sponsor type
- University, hospital or other
- Collaborators
- Medichecks, Watford FC Community Sports and Education Trust
- Responsible party
- Principal investigator, Lindsay Bottoms, University of Hertfordshire
- Investigators
- Lindsay Bottoms, PhD, Principal investigator, University of HertfordshireDaniel Grant, MBBS, Principal investigator, Medichecks
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809871
- Sponsor's protocol ID
- LMS
- Status last verified
- Sep 2021
- First submitted
- 15 Jan 2019
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised group data will be available.
Publications
Grant D, Smith J, Bottoms L. Assessing the role of biomarker feedback in a 12-week community weight management programme among overweight men: A pilot study. PLoS One. 2024 Mar 28;19(3):e0299636. doi: 10.1371/journal.pone.0299636. eCollection 2024.
PubMed 38547224
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Feedback on Health and Wellbeing and Exercise Adherence Following a 6 Month Weight Management Course: A Pilot Study
- ClinicalTrials.gov ID
- NCT03809871
- Acronym / sponsor ID
- LMS
- Conditions
- Exercise Training, Biomarkers
- Keywords
- exercise training, weight management, biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of HertfordshireUniversity, hospital or other
- Collaborators
- Medichecks, Watford FC Community Sports and Education Trust
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 18 Jan 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.
Participants who have signed up to the Watford Football Club Community and Education Trust Weight management programme called Shape Up will be approached to see if they would like to take part in this research study. Their participation in the Shape Up programme will not be affected if they do not choose to opt in to the research component. Fifty participants will be recruited and randomised in to one of two groups. One group will be the control group and they will undertake the Shape Up programme as normal and will be asked to complete some questionnaires in week 1, week 12 and then at 12 weeks follow up. The intervention group will be asked to complete the same questionnaires and will also have a venous blood sample taken at week 1, 12 and then at 12 weeks follow up. This is for measures of cholesterol, sugar, vitamin D, vitamin B12 and iron. The participants will receive a report from a medical doctor in layman terms on these results a week later and will have access to their data on an online portal set up by Medichecks.
The weight management programme is based on a behaviour change programme where the participants attend a 90-minute session for 12 weeks, and they are then supported for another 12 weeks following the end of the supervision. The participants have weight and BMI measured at week 1, 12 and 12 weeks follow up. Each session consists of an education component followed by an exercise component. Initially, the education part is longer and the exercise is shorter, but as the programme progresses the education part becomes shorter and the exercise longer. The education programme includes topics such as healthy eating, increased physical activity and stress. The exercise programme includes whole body activities such as circuit training as well as other group exercise such as football.
The questionnaires will include The Treatment Self-Regulation Questionnaire which will identify the motivation behind the participants' health. A general health questionnaire which is a subjective measure of health (Euro qol EQ-5). The Mental Component Summary of the 12- item Short Form (SF12) which measures emotional quality of life. Physical activity will be measured through the short Active Lives Questionnaire. All these questionnaires have been attached as appendices.
All participants will complete an exit telephone interview from the study to determine qualitative feedback on their experience of the study and to explore whether the biomarkers influenced their motivation to change their lifestyle. Some example questions have been attached.
This is just a feasibility study, therefore no hypothesis testing will be undertaken.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biomarker group | Experimental | Biological: Cardiometabolic biomarkersThese participants will receive information about cardiometabolic biomarkers pre and post weight management course |
| Control group | No intervention | –They will receive the same weight management programme as the experimental group, but they will not have biomarker information. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI >28
- No injuries
Key exclusion criteria (3 listed)
- Injury preventing from participating in exercise
- fear of needles
- does not pass a physical activity readiness questionnaire
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 |
|---|---|---|
| Cardiometabolic biomarkersThis is for measures of cholesterol (HDL, LDL and total cholesterol), blood glucose and HbA1c, vitamin D, vitamin B12 and iron levels. | Biological | Biomarker group |
Primary outcome
Behaviour regulation
Time frame: 12 months
To determine the behaviour regulation by measuring autonmoic regulation versus controlled regulation through the use of the Treatment Self-Regulation Questionnaire. An average of the scores on the subscale for autoregulation and also for the controlled regulation questions will be calculated. Scores will be from 1-7 for both sub scales.
Subjective health measure
Time frame: 12 months
A standardised measure of health status will be calculated using the Euro qol EQ-5 questionnaire. There are 5 dimensions to the questionnaire (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and each is rated from 1-5. An average of the 5 is calculated as a general health score. A visual analogue scale is also presented for a self related health measure and this is from 0-100. 100 being the best health you can imagine and 0 being the worst health you can imagine.
Physical Activity
Time frame: 12 months
Amount of physical activity measured through the short Active Lives questionnaire. The amount of minutes where breathing is increased will be calculated per week. For each activity that respondents indicate was sufficient to raise their breathing rate, the total number of days is multiplied by the usual minutes spent undertaking the activity to give a measure of total minutes over the 7-day period for that activity. The respondent's final score is calculated by summing all activities which were sufficient to raise breathing rate, as follows: (Days of walking * usual minutes of walking IF sufficient to raise breathing rate) + (Days of cycling * usual munities of cycling IF sufficient to raise breathing rate) + (days of sport, fitness or dance * usual minutes of sport, fitness or dance IF sufficient to raise breathing rate).
1 secondary outcome
Cost savings to health care service
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Derived from this study: PubMed 38547224Grant D, Smith J, Bottoms L. Assessing the role of biomarker feedback in a 12-week community weight management programme among overweight men: A pilot study. PLoS One. 2024 Mar 28;19(3):e0299636. doi: 10.1371/journal.pone.0299636. eCollection 2024.
- Individual participant dataSharing planned: No. Anonymised group data will be available.
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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.
Lindsay Bottoms, PhD principal investigator
University of Hertfordshire
Daniel Grant, MBBS principal investigator
Medichecks
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiometabolic biomarkers in people with Exercise Training and Biomarkers, run by University of Hertfordshire at 1 site in United Kingdom.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 6 Oct 2021. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behaviour regulation (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03809871, which also lists 1 linked publication.
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 6 Oct 2021.