Clinical trial NCT03809871: Biomarker Feedback on Health and Wellbeing and Exercise Adherence Following a 6 Month Weight Management Course
Official title: Biomarker Feedback on Health and Wellbeing and Exercise Adherence Following a 6 Month Weight Management Course: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Training
Biomarkers
Keywords: exercise training
weight management
biomarkers
Lead sponsor: University of Hertfordshire
Sponsor class: OTHER
Collaborators: name: Medichecks
name: Watford FC Community Sports and Education Trust
First posted: 2019-01-18
Enrollment: 43
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

* BMI \>28
* No injuries

Exclusion Criteria:

* Injury preventing from participating in exercise
* fear of needles
* does not pass a physical activity readiness questionnaire

Primary outcomes:
measure: Behaviour regulation
timeFrame: 12 months
measure: Subjective health measure
timeFrame: 12 months
measure: Physical Activity
timeFrame: 12 months
Secondary outcomes:
measure: Cost savings to health care service
timeFrame: 12 months
Other outcomes:
Locations:
city: Hatfield
country: United Kingdom
facility: University of Hertforshire
Study officials:
affiliation: University of Hertfordshire
name: Lindsay Bottoms, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medichecks
name: Daniel Grant, MBBS
role: PRINCIPAL_INVESTIGATOR
References: