Biomarker Feedback on Health and Wellbeing and Exercise Adherence Following a 6 Month Weight Management Course
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|ClinicalTrials.gov Identifier: NCT03809871|
Recruitment Status : Enrolling by invitation
First Posted : January 18, 2019
Last Update Posted : February 6, 2019
Participants who have signed up to the Watford Football Club Community and Education Trust Weight management programme called Shape Up will be approached to see if they would like to take part in this research study. Their participation in the Shape Up programme will not be affected if they do not choose to opt in to the research component. Fifty participants will be recruited and randomised in to one of two groups. One group will be the control group and they will undertake the Shape Up programme as normal and will be asked to complete some questionnaires in week 1, week 12 and then at 12 weeks follow up. The intervention group will be asked to complete the same questionnaires and will also have a venous blood sample taken at week 1, 12 and then at 12 weeks follow up. This is for measures of cholesterol, sugar, vitamin D, vitamin B12 and iron. The participants will receive a report from a medical doctor in layman terms on these results a week later and will have access to their data on an online portal set up by Medichecks.
The weight management programme is based on a behaviour change programme where the participants attend a 90-minute session for 12 weeks, and they are then supported for another 12 weeks following the end of the supervision. The participants have weight and BMI measured at week 1, 12 and 12 weeks follow up. Each session consists of an education component followed by an exercise component. Initially, the education part is longer and the exercise is shorter, but as the programme progresses the education part becomes shorter and the exercise longer. The education programme includes topics such as healthy eating, increased physical activity and stress. The exercise programme includes whole body activities such as circuit training as well as other group exercise such as football.
The questionnaires will include The Treatment Self-Regulation Questionnaire which will identify the motivation behind the participants' health. A general health questionnaire which is a subjective measure of health (Euro qol EQ-5). The Mental Component Summary of the 12- item Short Form (SF12) which measures emotional quality of life. Physical activity will be measured through the short Active Lives Questionnaire. All these questionnaires have been attached as appendices.
All participants will complete an exit telephone interview from the study to determine qualitative feedback on their experience of the study and to explore whether the biomarkers influenced their motivation to change their lifestyle. Some example questions have been attached.
This is just a feasibility study, therefore no hypothesis testing will be undertaken.
|Condition or disease||Intervention/treatment||Phase|
|Exercise Training Biomarkers||Biological: Cardiometabolic biomarkers||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Biomarker Feedback on Health and Wellbeing and Exercise Adherence Following a 6 Month Weight Management Course: A Pilot Study|
|Actual Study Start Date :||January 14, 2019|
|Estimated Primary Completion Date :||August 1, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Biomarker group
These participants will receive information about cardiometabolic biomarkers pre and post weight management course
Biological: Cardiometabolic biomarkers
This is for measures of cholesterol (HDL, LDL and total cholesterol), blood glucose and HbA1c, vitamin D, vitamin B12 and iron levels.
No Intervention: Control group
They will receive the same weight management programme as the experimental group, but they will not have biomarker information.
- Behaviour regulation [ Time Frame: 12 months ]
To determine the behaviour regulation by measuring autonmoic regulation versus controlled regulation through the use of the Treatment Self-Regulation Questionnaire.
An average of the scores on the subscale for autoregulation and also for the controlled regulation questions will be calculated. Scores will be from 1-7 for both sub scales.
- Subjective health measure [ Time Frame: 12 months ]A standardised measure of health status will be calculated using the Euro qol EQ-5 questionnaire. There are 5 dimensions to the questionnaire (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and each is rated from 1-5. An average of the 5 is calculated as a general health score. A visual analogue scale is also presented for a self related health measure and this is from 0-100. 100 being the best health you can imagine and 0 being the worst health you can imagine.
- Physical Activity [ Time Frame: 12 months ]
Amount of physical activity measured through the short Active Lives questionnaire. The amount of minutes where breathing is increased will be calculated per week.
For each activity that respondents indicate was sufficient to raise their breathing rate, the total number of days is multiplied by the usual minutes spent undertaking the activity to give a measure of total minutes over the 7-day period for that activity.
The respondent's final score is calculated by summing all activities which were sufficient to raise breathing rate, as follows:
(Days of walking * usual minutes of walking IF sufficient to raise breathing rate) + (Days of cycling * usual munities of cycling IF sufficient to raise breathing rate) + (days of sport, fitness or dance * usual minutes of sport, fitness or dance IF sufficient to raise breathing rate).
- Cost savings to health care service [ Time Frame: 12 months ]Extrapolating the potential cost savings to the health care service of the community programme by analysing the biomarker trend information
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): NCT03809871
|University of Hertforshire|
|Hatfield, United Kingdom, AL10 9AB|
|Principal Investigator:||Lindsay Bottoms, PhD||University of Hertfordshire|
|Principal Investigator:||Daniel Grant, MBBS||Medichecks|