Development and Stage 2 RCT with Internal Pilot of a Weight Loss Maintenance Intervention for Obese Adults after Clinically Significant Weight Loss

  • Sniehotta, Falko (Primary Chief Investigator (PCI))
  • Batterham, Alan (Chief Investigator (CI))
  • McColl, Elaine (Chief Investigator (CI))
  • White, Martin (Chief Investigator (CI))
  • Adamson, Ashley (Chief Investigator (CI))
  • Brown, Heather (Chief Investigator (CI))
  • Wright, Peter (Chief Investigator (CI))
  • Olivier, Patrick (Chief Investigator (CI))
  • Steen, Ian (Chief Investigator (CI))
  • Araujo-Soares, Vera (Chief Investigator (CI))
  • Vale, Luke (Chief Investigator (CI))

Project: Research

Project Description

Medical Research Council - Award value: £620,991 (UK pounds)
Obesity is a major problem worldwide, with 1 out of 4 adults being obese in the UK. Obesity is strongly related to chronic illnesses, sickness absence from work and reduced life expectancy. Weight problems costs the UK economy £16 billion a year. The NHS and the public invest considerably in weight loss treatments, but most people who are successful in losing weight quickly regain the weight they lost. Helping people not to regain weight after successful weight loss is vital in tackling the obesity epidemic.

In stage 1, we will develop a weight loss maintenance intervention for adults who were previously obese but who have lost at least 5% of their body weight in the previous 6 months. The intervention will be based on evidence from a comprehensive review of the research literature and will use techniques and theory of behaviour change which have been used in previously effective interventions. After an initial face-to-face meeting for advice and to set personal goals, participants will receive pedometers and body weighing scales which communicate data wirelessly to a central server. They will be asked to weigh themselves every day and will be prompted by text message reminder if they forgot to do so for more than one day. Weighing and weight data will be received immediately by a central server and this will trigger the delivery of automated intervention content which has been individually tailored based on the recorded weight The intervention will provide 'light touch' daily support in periods of successful weight loss maintenance, and will become more intensive of periods of weight regain.

The details of the intervention content, hardware and software will be developed in the first year using in consultation with potential users and building on the complementary expertise of our research team and the evidence from our systematic review. In addition, we will conduct a series of small pilot studies so that we can learn how to make the intervention as acceptable,possible and easy to use as possible.
In stage 2 we will recruit 288 initially obese adults after weight loss and then and randomly place them to receive either the new intervention (test) or not (a control) for six months. We will follow the participants for 12 months to test if weight regain differs between both the two groups. We will measure body weight, and other aspects related to body composition, physical activity and psychological aspects before people are allocated to each group and again 12 months later. Use of services and participant costs will be measured over the 12 month follow-up period.

To ensure that the procedures for identification/recruitment, allocation and measurement are possible and acceptable to participants we have specified a set of criteria and additional assessments based on the first three months of recruitment and first 60 participants which check if the procedures are appropriate to recruit and retain 288 trial participants within a two year period. If these pre-set targets are not met, we will consult the funder and our independent Trial Steering Committee and seek advice to either discontinue the trial or change the procedures. If the pre-set targets are met, we will continue the study and the pilot data will form part of the final trial data set. The inclusion of an internal pilot study like this provides better value for money than conducting a standalone pilot study over a relevant period for WLM and will also allow us to obtain evidence for effectiveness much more rapidly than the traditional approach of a standalone pilot would.

In addition to the standard procedures for analysing the outcomes of a randomised trial, part of the trial will be an economic evaluation which will explore the value for money of the intervention. We will also explore the relationships between socio-economic status and other participant characteristics with weight loss maintenance.
StatusFinished
Effective start/end date1/09/1231/05/16