SedentaryNCT02020239
The Effect of Physical Activity Intervention Flexibility on the Time Course of Changes in Body Composition and Metabolism
A study testing Exercise in people with Sedentary and Overweight, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
The investigators goal is to optimise physical activity interventions to help previously inactive women improve their body shape and composition. Many people seeking to lose weight or improve body composition initiate an exercise programme. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sedentary, Overweight
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2013to Dec 2017
- 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 25 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Aged 25-50 years old
- Inactive (less than 150 minutes of moderate-intensity aerobic physical activity per week)
- BMI 25-35 kg/m2
- Good general health, as assessed by the School of Sport, Exercise and Rehabilitation Sciences' General Health Questionnaire
- Willing to strictly comply with all study procedures and restrictions
- Willing to participate, as demonstrated by voluntary written informed consent
Who cannot join
- Positive result from the urine sample pregnancy test
- Currently breast feeding
- Currently participating in another clinical trial deemed to potentially interfere with this study
- Current or recent (within the last 30 days) smoker
- Currently taking prescription or non-prescription medication that may interfere with metabolism (including beta-blockers, insulin, bronchodilators, anti-inflammatory agents, thyroxine and medication/supplements that in the opinion of the investigators may affect metabolism).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Birmingham, School of Sport, Exercise and Rehabilitation Sciences
Birmingham, B15 2TT
About this study
The investigators goal is to optimise physical activity interventions to help previously inactive women improve their body shape and composition. Many people seeking to lose weight or improve body composition initiate an exercise programme. The most common recommendation of an exercise intervention for someone attempting to manage their weight, has been to 'prescribe' the recommended 150 minutes of exercise per week (World Health Organisation), often using one mode of exercise. An alternative approach might be to offer a portfolio of activities, from which the exerciser can pick and choose, to facilitate greater amounts of physical activity. The problem with this is how do you account for the different intensities of walking, washing the car, playing badminton, cycling, jogging, etc? In this study, the investigators will try to overcome this barrier by allocating a number of "physical activity points" to each activity. Using this physical activity points system, participants will be provided with a points target that they can meet using any combination of activities.
The investigators research aim is therefore to compare this points-based system against the traditional 5x30minute prescription (and sedentary control) for their ability to help previously inactive women to drop a dress size, increase fat burning, positively change their body composition and tone their tummy.
- Conditions
- Sedentary, Overweight
- Being tested
- Exercise
- Keywords
- physical activity, females, body composition
- Medical subject headings
- Sedentary Behavior, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Prescribed exercise | Experimental | Participants will be asked to choose one activity and stick to it for the duration of the intervention. Participants will be able to choose between brisk walking/slow jogging or cycling. The intervention will require the completion of 30 minutes of chosen activity on 5 days of the week, which will be recorded in a physical activity diary. Receives: Other: Exercise |
| Points-based physical activity | Experimental | Participants will be asked to achieve a pre-set, individualised points target for physical activity each week. Points are acquired through the completion of a minimum 10 minutes of activity, choosing from the extensive list of activities provided; for example, 10 minutes of jogging achieves 4.5 points, whereas 10 minutes of washing a car achieves 1.5 points. The target will be 35-40 points per week, which equates to approximately 6 points per day. Any combination of activity, duration and frequency can be selected. Receives: Other: Exercise |
| Waiting list control | No intervention | Participants will be asked to maintain their normal activities and diet. They will be added to a waiting list to receive either exercise intervention after completing the 24-week trial period, so that they do not miss out on the opportunity to receive the exercise intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body composition (fat and fat-free mass in kg)
Measured: 4 weeks, 12 weeks and 24 weeks
Secondary outcomes (4)
Perceived body shape
Measured: 4 weeks, 12 weeks and 24 weeks
Maximal aerobic capacity
Measured: 4 weeks, 12 weeks, 24 weeks
Fat oxidation rates
Measured: 4 weeks, 12 weeks and 24 weeks
Body tone
Measured: 4 weeks, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
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 SedentaryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Cereal Partners Worldwide
- Responsible party
- Principal investigator, Dr Andrew Blannin, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020239
- Sponsor's protocol ID
- Bham_CPW_PhysActIntervention
- Status last verified
- Oct 2016
- First submitted
- 12 Dec 2013
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Holliday A, Burgin A, Fernandez EV, Fenton SAM, Thielecke F, Blannin AK. Points-based physical activity: a novel approach to facilitate changes in body composition in inactive women with overweight and obesity. BMC Public Health. 2018 Feb 17;18(1):261. doi: 10.1186/s12889-018-5125-2.
PubMed 29454318
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physical Activity Intervention Flexibility on the Time Course of Changes in Body Composition and Metabolism
- ClinicalTrials.gov ID
- NCT02020239
- Acronym / sponsor ID
- Bham_CPW_PhysActIntervention
- Conditions
- Sedentary, Overweight
- Keywords
- physical activity, females, body composition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Cereal Partners Worldwide
- Study start
- Dec 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 24 Dec 2013 (estimated)
- 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.
The investigators goal is to optimise physical activity interventions to help previously inactive women improve their body shape and composition. Many people seeking to lose weight or improve body composition initiate an exercise programme. The most common recommendation of an exercise intervention for someone attempting to manage their weight, has been to 'prescribe' the recommended 150 minutes of exercise per week (World Health Organisation), often using one mode of exercise. An alternative approach might be to offer a portfolio of activities, from which the exerciser can pick and choose, to facilitate greater amounts of physical activity. The problem with this is how do you account for the different intensities of walking, washing the car, playing badminton, cycling, jogging, etc? In this study, the investigators will try to overcome this barrier by allocating a number of "physical activity points" to each activity. Using this physical activity points system, participants will be provided with a points target that they can meet using any combination of activities.
The investigators research aim is therefore to compare this points-based system against the traditional 5x30minute prescription (and sedentary control) for their ability to help previously inactive women to drop a dress size, increase fat burning, positively change their body composition and tone their tummy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prescribed exercise | Experimental | Other: ExerciseParticipants will be asked to choose one activity and stick to it for the duration of the intervention. Participants will be able to choose between brisk walking/slow jogging or cycling. The intervention will require the completion of 30 minutes of chosen activity on 5 days of the week, which will be recorded in a physical activity diary. |
| Points-based physical activity | Experimental | Other: ExerciseParticipants will be asked to achieve a pre-set, individualised points target for physical activity each week. Points are acquired through the completion of a minimum 10 minutes of activity, choosing from the extensive list of activities provided; for example, 10 minutes of jogging achieves 4.5 points, whereas 10 minutes of washing a car achieves 1.5 points. The target will be 35-40 points per week, which equates to approximately 6 points per day. Any combination of activity, duration and frequency can be selected. |
| Waiting list control | No intervention | –Participants will be asked to maintain their normal activities and diet. They will be added to a waiting list to receive either exercise intervention after completing the 24-week trial period, so that they do not miss out on the opportunity to receive the exercise intervention. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female
- Aged 25-50 years old
- Inactive (less than 150 minutes of moderate-intensity aerobic physical activity per week)
- BMI 25-35 kg/m2
- Good general health, as assessed by the School of Sport, Exercise and Rehabilitation Sciences' General Health Questionnaire
Key exclusion criteria (5 listed)
- Positive result from the urine sample pregnancy test
- Currently breast feeding
- Currently participating in another clinical trial deemed to potentially interfere with this study
- Current or recent (within the last 30 days) smoker
- Currently taking prescription or non-prescription medication that may interfere with metabolism (including beta-blockers, insulin, bronchodilators, anti-inflammatory agents, thyroxine and medication/supplements that in the opinion of the investigators may affect metabolism).
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 |
|---|---|---|
| Exercise | Other | Points-based physical activity, Prescribed exercise |
Primary outcome
Change in body composition (fat and fat-free mass in kg)
Time frame: 4 weeks, 12 weeks and 24 weeks
4 secondary outcomes
Perceived body shape
Time frame: 4 weeks, 12 weeks and 24 weeks
Maximal aerobic capacity
Time frame: 4 weeks, 12 weeks, 24 weeks
Fat oxidation rates
Time frame: 4 weeks, 12 weeks and 24 weeks
Body tone
Time frame: 4 weeks, 12 weeks, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Derived from this study: PubMed 29454318Holliday A, Burgin A, Fernandez EV, Fenton SAM, Thielecke F, Blannin AK. Points-based physical activity: a novel approach to facilitate changes in body composition in inactive women with overweight and obesity. BMC Public Health. 2018 Feb 17;18(1):261. doi: 10.1186/s12889-018-5125-2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Sedentary and Overweight, run by University of Birmingham 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 7 inclusion and 5 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 28 Oct 2016. 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?
Results are not available in the source record.
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?
Change in body composition (fat and fat-free mass in kg) (time frame: 4 weeks, 12 weeks and 24 weeks). 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 NCT02020239, 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 28 Oct 2016; AzTrials last refreshed its copy on 1 Nov 2026.