- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02020239
The Effect of Physical Activity Intervention Flexibility on the Time Course of Changes in Body Composition and Metabolism
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 Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Birmingham, United Kingdom, B15 2TT
- University of Birmingham, School of Sport, Exercise and Rehabilitation Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prescribed exercise
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.
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Experimental: Points-based physical activity
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.
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No Intervention: Waiting list control
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in body composition (fat and fat-free mass in kg)
Time Frame: 4 weeks, 12 weeks and 24 weeks
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4 weeks, 12 weeks and 24 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Perceived body shape
Time Frame: 4 weeks, 12 weeks and 24 weeks
|
4 weeks, 12 weeks and 24 weeks
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Maximal aerobic capacity
Time Frame: 4 weeks, 12 weeks, 24 weeks
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4 weeks, 12 weeks, 24 weeks
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Fat oxidation rates
Time Frame: 4 weeks, 12 weeks and 24 weeks
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4 weeks, 12 weeks and 24 weeks
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Body tone
Time Frame: 4 weeks, 12 weeks, 24 weeks
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4 weeks, 12 weeks, 24 weeks
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood-borne markers of metabolic health
Time Frame: 4 weeks, 12 weeks, 24 weeks
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4 weeks, 12 weeks, 24 weeks
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Psychological measures relating to perceived body image
Time Frame: 4 weeks, 12 weeks, 24 weeks
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4 weeks, 12 weeks, 24 weeks
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Psychological measures of attitudes towards exercise and physical activity
Time Frame: 4 weeks, 12 weeks, 24 weeks
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4 weeks, 12 weeks, 24 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bham_CPW_PhysActIntervention
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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