search
Back to results

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

Primary Purpose

Sedentary, Overweight

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sedentary focused on measuring physical activity, females, body composition

Eligibility Criteria

25 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • University of Birmingham, School of Sport, Exercise and Rehabilitation Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Prescribed exercise

Points-based physical activity

Waiting list control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in body composition (fat and fat-free mass in kg)

Secondary Outcome Measures

Perceived body shape
Maximal aerobic capacity
Fat oxidation rates
Body tone

Full Information

First Posted
December 12, 2013
Last Updated
October 27, 2016
Sponsor
University of Birmingham
Collaborators
Cereal Partners Worldwide
search

1. Study Identification

Unique Protocol Identification Number
NCT02020239
Brief Title
The Effect of Physical Activity Intervention Flexibility on the Time Course of Changes in Body Composition and Metabolism
Official Title
The Effect of Physical Activity Intervention Flexibility on the Time Course of Changes in Body Composition and Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Birmingham
Collaborators
Cereal Partners Worldwide

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary, Overweight
Keywords
physical activity, females, body composition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prescribed exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Points-based physical activity
Arm Type
Experimental
Arm Description
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.
Arm Title
Waiting list control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Primary Outcome Measure Information:
Title
Change in body composition (fat and fat-free mass in kg)
Time Frame
4 weeks, 12 weeks and 24 weeks
Secondary Outcome Measure Information:
Title
Perceived body shape
Time Frame
4 weeks, 12 weeks and 24 weeks
Title
Maximal aerobic capacity
Time Frame
4 weeks, 12 weeks, 24 weeks
Title
Fat oxidation rates
Time Frame
4 weeks, 12 weeks and 24 weeks
Title
Body tone
Time Frame
4 weeks, 12 weeks, 24 weeks
Other Pre-specified Outcome Measures:
Title
Blood-borne markers of metabolic health
Time Frame
4 weeks, 12 weeks, 24 weeks
Title
Psychological measures relating to perceived body image
Time Frame
4 weeks, 12 weeks, 24 weeks
Title
Psychological measures of attitudes towards exercise and physical activity
Time Frame
4 weeks, 12 weeks, 24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Facility Information:
Facility Name
University of Birmingham, School of Sport, Exercise and Rehabilitation Sciences
City
Birmingham
ZIP/Postal Code
B15 2TT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29454318
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs