Biomarker Feedback on Health and Wellbeing and Exercise Adherence Following a 6 Month Weight Management Course
Condition: Exercise Training; Biomarkers
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): Cardiometabolic biomarkers
Intervention type(s): Biological
Intervention description(s): This is for measures of cholesterol (HDL, LDL and total cholesterol), blood glucose and HbA1c, vitamin D, vitamin B12 and iron levels.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: exercise training; weight management; biomarkers