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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
Sponsor:
Collaborators:
Medichecks
Watford FC Community Sports and Education Trust
Information provided by (Responsible Party):
Lindsay Bottoms, University of Hertfordshire

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.


Condition or disease Intervention/treatment Phase
Exercise Training Biomarkers Biological: Cardiometabolic biomarkers Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


  2. 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.

  3. 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).



Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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United Kingdom
University of Hertforshire
Hatfield, United Kingdom, AL10 9AB
Sponsors and Collaborators
University of Hertfordshire
Medichecks
Watford FC Community Sports and Education Trust
Investigators
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Principal Investigator: Lindsay Bottoms, PhD University of Hertfordshire
Principal Investigator: Daniel Grant, MBBS Medichecks

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Responsible Party: Lindsay Bottoms, Research Lead for Sport, Health and Exercise, University of Hertfordshire
ClinicalTrials.gov Identifier: NCT03809871     History of Changes
Other Study ID Numbers: LMS
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Anonymised group data will be available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lindsay Bottoms, University of Hertfordshire:
exercise training
weight management
biomarkers