NCT02020239

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 24, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

4 years

First QC Date

December 12, 2013

Last Update Submit

October 27, 2016

Conditions

Keywords

physical activityfemalesbody composition

Outcome Measures

Primary Outcomes (1)

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

    4 weeks, 12 weeks and 24 weeks

Secondary Outcomes (4)

  • Perceived body shape

    4 weeks, 12 weeks and 24 weeks

  • Maximal aerobic capacity

    4 weeks, 12 weeks, 24 weeks

  • Fat oxidation rates

    4 weeks, 12 weeks and 24 weeks

  • Body tone

    4 weeks, 12 weeks, 24 weeks

Other Outcomes (3)

  • Blood-borne markers of metabolic health

    4 weeks, 12 weeks, 24 weeks

  • Psychological measures relating to perceived body image

    4 weeks, 12 weeks, 24 weeks

  • Psychological measures of attitudes towards exercise and physical activity

    4 weeks, 12 weeks, 24 weeks

Study Arms (3)

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.

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.

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.

Interventions

Points-based physical activityPrescribed exercise

Eligibility Criteria

Age25 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Birmingham, B15 2TT, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sedentary BehaviorOverweightMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr (PhD), Lecturer

Study Record Dates

First Submitted

December 12, 2013

First Posted

December 24, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations