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The Effect of Physical Activity Intervention Flexibility on the Time Course of Changes in Body Composition and Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02020239
Recruitment Status : Unknown
Verified October 2016 by Dr Andrew Blannin, University of Birmingham.
Recruitment status was:  Active, not recruiting
First Posted : December 24, 2013
Last Update Posted : October 28, 2016
Sponsor:
Collaborator:
Cereal Partners Worldwide
Information provided by (Responsible Party):
Dr Andrew Blannin, University of Birmingham

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Sedentary Overweight Other: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Physical Activity Intervention Flexibility on the Time Course of Changes in Body Composition and Metabolism
Study Start Date : December 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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.
Other: Exercise
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.
Other: Exercise
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.



Primary Outcome Measures :
  1. Change in body composition (fat and fat-free mass in kg) [ Time Frame: 4 weeks, 12 weeks and 24 weeks ]

Secondary Outcome Measures :
  1. Perceived body shape [ Time Frame: 4 weeks, 12 weeks and 24 weeks ]
  2. Maximal aerobic capacity [ Time Frame: 4 weeks, 12 weeks, 24 weeks ]
  3. Fat oxidation rates [ Time Frame: 4 weeks, 12 weeks and 24 weeks ]
  4. Body tone [ Time Frame: 4 weeks, 12 weeks, 24 weeks ]

Other Outcome Measures:
  1. Blood-borne markers of metabolic health [ Time Frame: 4 weeks, 12 weeks, 24 weeks ]
  2. Psychological measures relating to perceived body image [ Time Frame: 4 weeks, 12 weeks, 24 weeks ]
  3. Psychological measures of attitudes towards exercise and physical activity [ Time Frame: 4 weeks, 12 weeks, 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020239


Locations
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United Kingdom
University of Birmingham, School of Sport, Exercise and Rehabilitation Sciences
Birmingham, United Kingdom, B15 2TT
Sponsors and Collaborators
University of Birmingham
Cereal Partners Worldwide
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Andrew Blannin, Dr (PhD), Lecturer, University of Birmingham
ClinicalTrials.gov Identifier: NCT02020239    
Other Study ID Numbers: Bham_CPW_PhysActIntervention
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Keywords provided by Dr Andrew Blannin, University of Birmingham:
physical activity
females
body composition
Additional relevant MeSH terms:
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Overweight
Body Weight