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

October 27, 2016 updated by: Dr Andrew Blannin, University of Birmingham

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

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Birmingham, United Kingdom, B15 2TT
        • University of Birmingham, School of Sport, Exercise and Rehabilitation Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
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.

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
4 weeks, 12 weeks and 24 weeks

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
Maximal aerobic capacity
Time Frame: 4 weeks, 12 weeks, 24 weeks
4 weeks, 12 weeks, 24 weeks
Fat oxidation rates
Time Frame: 4 weeks, 12 weeks and 24 weeks
4 weeks, 12 weeks and 24 weeks
Body tone
Time Frame: 4 weeks, 12 weeks, 24 weeks
4 weeks, 12 weeks, 24 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Blood-borne markers of metabolic health
Time Frame: 4 weeks, 12 weeks, 24 weeks
4 weeks, 12 weeks, 24 weeks
Psychological measures relating to perceived body image
Time Frame: 4 weeks, 12 weeks, 24 weeks
4 weeks, 12 weeks, 24 weeks
Psychological measures of attitudes towards exercise and physical activity
Time Frame: 4 weeks, 12 weeks, 24 weeks
4 weeks, 12 weeks, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 12, 2013

First Submitted That Met QC Criteria

December 18, 2013

First Posted (Estimate)

December 24, 2013

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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