Randomized control trial (RCT)

Citation

(2006), "Randomized control trial (RCT)", Nutrition & Food Science, Vol. 36 No. 5. https://doi.org/10.1108/nfs.2006.01736eab.010

Randomized control trial (RCT)

Randomized control trial (RCT)

The multi-site RCT being conducted into the efficacy of the MEND programme as an obesity treatment programme for children is continuing at the Institute of Child Health, University College London. At the end of May, we will have 6-month data on 92 families and will begin the analysis and write-up of the RCT results. The RCT will continue to run after May, with additional children's data being added to the sample, and with additional follow-up assessments being conducted on all the children at 6 and 12 months. We believe that this RCT will constitute one of the largest sets of data on a community child obesity intervention in the UK.

While we are not permitted to release any comparative data between control and intervention groups from the RCT prior to completion (i.e. not before June/July), I have attached a slide containing some preliminary results from 41 children who have completed the MEND programme intervention. Statistically significant results were achieved in most of the key outcome measures, including BMI reduction and waist circumference reduction (see attached). A notable point to mention is that across all five sites participating in the RCT, over a period of a year, only 3 of the 92 children recruited dropped out. This, combined with an overall mean attendance rate of 92 per cent is both impressive and unusual in such a long programme (ten weeks; twice weekly for two hours). Furthermore, we were pleased to see that these preliminary results show very similar health improvements to the successful results achieved on MEND's initial research pilot, conducted in 2002-2003.

MEND rolls out across PCTs in London, Suffolk, Essex and Northamptonshire

We continue to receive a significant amount of interest in the MEND programme from PCTs, Local Authorities and other local partners looking to implement obesity treatment (or prevention) programmes. (It is important to note that while the RCT is focusing on treatment of obesity, the MEND programme is also suitable for use as a prevention programme, as it is expressly NOT a diet but rather a healthy lifestyle programme teaching children and parents about sustained behavioural change, healthy eating and the benefits of exercise).

MEND is currently running at two sites in Lewisham (London) and in Southwark (London) and Waveney (Suffolk), with new programmes anticipated to start Essex, London and Northamptonshire in May. Many other PCTs are in active discussions with us about implementing MEND in their local areas. (See “Private sector sponsorship” below for details of more programmes running and starting in May.)

PCTs and LA's are pursuing varying strategies in relation to rolling out MEND at the moment. Some are engaging in quite extensive multi-year programmes involving multiple sites and total numbers of families covered in the 60-300 range. Others, (often due to budgetary constraints) are initially implementing MEND on a pilot basis (12-15 families) as a starting point to develop an evidence base, with the idea to then use this evidence base to substantiate funding for a more comprehensive roll-out thereafter.

Based on feedback we have been getting from PCTs running the MEND programme, it is becoming increasingly evident that that the key differentiating attributes of the MEND programme as an obesity solution (as compared to other locally-administered obesity programmes) are:

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  Statistically significant results achieved in key outcome measures such as BMI, Waist circumference and cardiovascular fitness.

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  Recruitment of children and families has been relatively straightforward. Indeed, programmes are often over-subscribed.

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  Very high retention and attendance rates: Average attendance and retention achieved on MEND programmes completed to date is 92 per cent with only three drop-outs.

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  Quality-assurance and standardisation: The MEND teaching manual consists of almost 300 pages, comprising 18 structured sessions, all of which are lesson-planned, contain plenaries and are accompanied by multiple handouts to reinforce key messages. MEND trainers are also required to go through four days of MEND training and satisfy a test of knowledge before being approved to run the programme.

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  External monitoring and evaluation: MEND analyses the measurement data collected on the programme and reports the data back in concise, statistical reports, providing the requisite monitoring and evaluation required to justify (further) results-based funding.

It is interesting to note that PCTs are being very creative how they go about financing MEND in the current climate of budgetary pressure and uncertainty combined with a lack of ring-fenced obesity funds. They often engage in multi-agency collaboration with Local Authorities, local leisure centres and schools, and tap into a combination of different funding sources, including, for example - pump prime funding through LPSA/LAA stretch targets for obesity; using obesity training money to pay for the training element of the MEND costs; combining Choosing Health money and Health Inequalities money to fund MEND (since the incidence of obesity has been shown to be higher in areas of greater social deprivation), tapping into NRF and NDC funding in areas of social deprivation, etc. If you are interested in running a MEND programme in your area, we would be pleased to facilitate a brainstorm on this issue and provide you with examples of innovative practice.

MEND as a practical and cost-effective means to achieve the government's PSA target

“Tackling child obesity - first steps', the joint report by the National Audit Office, the Audit Commission and the Healthcare Commission warns that there is a risk that the Government's target to halt the rise in obesity in under-11s will not be met. The research-based MEND programme has been specifically developed to ensure that it can be rolled out rapidly and cost-effectively in a standardised manner - it is literally a “solution in a box”. It is this investment and its multi-disciplinary nature that allow rapid implementation. Multi-agency working can be fraught with difficulty and frustration, especially if the solution has to be invented by the team before it can be delivered. However, MEND allows you to bypass this due to the clarity of its training materials, including a 300 page manual with 100 handouts per participant. In Waveney, Suffolk, the Public Health Clinician said, “Everyone gave a little bit to deliver the whole Programme, yet it met everybody's individual targets”. The 2 × 2 hours per week Programme was delivered by two PE teachers from Education, one Counsellor from Social Services and a Nutritionist and a Dietitian from the PCT, each contributing about an hour per week - a case-study of multi-agency good practice.

MEND believes strongly that the private sector bears the same responsibility as the public sector in being part of the “solution” to the obesity crisis and to financially supporting community-based programmes like MEND that will allow as many families as possible nationwide to benefit from learning about how to bring about long-term improvements in their nutrition, fitness and health. In this respect, we will continue to work to secure private sector sponsorship for MEND.

MEND receives positive feedback from government departments, agencies and the charitable sector

In recent months, we have had positive and encouraging cross-departmental policy discussions with senior officers leading on obesity at the Department of Health, Department for Education and Skills and the Department for Culture, Media and Sport, who have expressed great interest in MEND and community-based obesity programmes like MEND. Furthermore, positive discussions have been held with senior Healthy Schools representatives, and Sport England has indicated a willingness to match-fund an emerging MEND project being planned for East London.

MEND has received endorsement from The Obesity Awareness and Solutions Trust and has had discussions with several charities regarding the possibility of engaging in (further) joint research into obesity and obesity-related illnesses and is also engaging in the current public consultation on NICE Guidelines regarding child obesity.

Consistently positive feedback received from children and parents who have been on the MEND programme

Please take a look at the attached testimonials for examples of the type of representative feedback that both children and parents/carers consistently give us about their experiences both on (and, more importantly, several months after) the MEND programme. We believe strongly that it is much more powerful to hear directly from the beneficiaries themselves, in what ways they feel they have benefited from MEND, than anything we could say.

New services

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  Obesity management solution. We are increasingly being asked by PCTs about the possibility of being able to offer MEND as a managed solution - i.e. where MEND would employ and provide the staff and run the programme for you, as well as do all the recruiting, assessments (pre and post) the programme and the monitoring and evaluation, thereby negating the need for any internal PCT management time or resources to implement MEND. We are able to offer this to those interested although we would strongly advise that this is not generally the best solution - it is preferable, where finances allow, to train local staff to run a/several MEND programme(s).

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  One-day obesity training for health-care professionals (HCPs). At the request of several PCTs seeking to invest their obesity training funds in the most meaningful manner, we have created a one-day obesity training session for training front-line staff/HCPs on obesity (see attached outline). The training incorporates and explains the current guidelines contained in the Department of Health's Obesity Care Pathway Booklet as well as “Measuring childhood obesity: guidance to primary care trusts”. In addition the training provides knowledge and a selection of practical insights learned from the MEND Pilot Study as well as the current MEND RCT. The cost for this is £50 per person for up to 30.