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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

Tracking Information
First Submitted Date  ICMJE January 15, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date February 6, 2019
Actual Study Start Date  ICMJE January 14, 2019
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • 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.
  • Subjective health measure [ Time Frame: 12 months ]
    General health will be measured using the Euro qol EQ-5 questionnaire
  • Physical Activity [ Time Frame: 12 months ]
    Amount of physical activity measured through the short Active Lifestyle questionnaire
Change History Complete list of historical versions of study NCT03809871 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biomarker Feedback on Health and Wellbeing and Exercise Adherence Following a 6 Month Weight Management Course
Official Title  ICMJE Biomarker Feedback on Health and Wellbeing and Exercise Adherence Following a 6 Month Weight Management Course: A Pilot Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Exercise Training
  • Biomarkers
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Biomarker group
    These participants will receive information about cardiometabolic biomarkers pre and post weight management course
    Intervention: Biological: Cardiometabolic biomarkers
  • No Intervention: Control group
    They will receive the same weight management programme as the experimental group, but they will not have biomarker information.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: January 17, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03809871
Other Study ID Numbers  ICMJE LMS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Anonymised group data will be available.
Responsible Party Lindsay Bottoms, University of Hertfordshire
Study Sponsor  ICMJE University of Hertfordshire
Collaborators  ICMJE
  • Medichecks
  • Watford FC Community Sports and Education Trust
Investigators  ICMJE
Principal Investigator: Lindsay Bottoms, PhD University of Hertfordshire
Principal Investigator: Daniel Grant, MBBS Medichecks
PRS Account University of Hertfordshire
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP