Research project

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Title: Development and evaluation of a family-based programme to increase physical activity among individuals at high risk of diabetes (ISRCTN 61323766)

Project timescale: From 01 October, 1997 to 01 December, 2004
(Added to website on: 11 June, 2003 - Date last updated: 20 April, 2007)

Source of funding:
Medical Research Council, NHS Research and Development , Royal College of General Practitioners, Department of Health/MRC Nutrition Initiative, Diabetes UK .

Aims: The aims are to assess: 1) Whether a theory-based behaviour change programme, aimed at increasing physical activity by the use of self-management skills, can achieve clinically important change in in physical activity among individuals at increased risk of Type 2 diabetes. 2) The potential for the changes in physical activity achieved in midlife to reduce the incidence of obesity and diabetes in later life. 3) How delivery of the programme, at two levels of intensity, affects acceptability, efficacy and costs.

Research designs used:
Action Research
Evaluation
Randomised controlled trial
Study of views/experiences
Systematic review

Methods used to collect data:
Focus groups
Interviews
Validated instruments eg Outcome measures
Questionnaire survey
Observation

Research project description: The project evaluates the effect of a family-based programme to promote physical activity in a high-risk group. Around 350 participants will be recruited via their parent with Type 2 Diabetes on primary care registers or via information in their surgery notes about a family history of diabetes. Sedentary individuals are randomised to either a one-year 'face to face' programme delivered at the participant's home , a one-year 'distance' programme, mainly delivered by telephone and post, or to a comparison arm offering brief advice on the benefits of activity. The programme is based on psychological theory and evidence, and was piloted extensively in collaboration with 15 volunteer families. It is delivered by family health facilitators with extensive training in behaviour change techniques and underlying theories. Participants are equipped with self-management skills to increase their physical activity. Psychological, physiological, anthropometric and biochemical data are collected at baseline, six months and one year, and the impact of increased in physical activity (objective measures at baseline and one year) on obesity and diabetes incidence is modelled using parallel cohort data. The quality assurance of the intervention delivery is evaluated in a separate project. Retention in the intervention programme so far is 94%.

Stages at which the public were involved:
Designing the research instruments
(eg questionnaires, patient information sheets)
Undertaking the research
Prioritising topic areas
Planning the research

Description of public involvement in research stages: The target group was extensively involved in the development and implementation of the behaviour change programme, and in the development of questionnaires. During the development of the programme focus groups were held with people with type 2 diabetes to explore their views about being involved in the recruitment of their own adult offspring to a preventative programme. Focus groups and interview with their adult offspring aimed at identifying their views about a programme to prevent diabetes, a focus on physical activity or diet, the context in which the programme was to be delivered, and strategies to support behaviour change. During the implementation of the programme, 15 volunteer families worked with the facilitators, and helped define the contents and number of interactions, and provided feedback on the acceptability of the recruitment approach and the programme. A series of focus groups was held with the target group to pilot the educational materials for the programme. The target group was also involved in a design of a questionnaire assessing their beliefs towards increasing physical activity. During the trial evaluation of the programme, participants have been involved in the training of new facilitators.

Training and support provided for either members of the public or researchers involved in the project:

Examples of ways the public have made a difference to the research project: People with Type 2 diabetes indicated that their personal involvement in the recruitment of their offspring may not always work, and as a consequence their involvement has been limited to providing contact details and permission to contact their offspring. Their offspring clearly indicated that the programme should adopt a personalised approach, preferably delivered at their homes, with a focus on informal physical activity as opposed to organised activity. These principles were incorporated in the programme, and may be a key reason for the low dropout rates. Active involvement of the target group in the piloting of the programme ensured that the recruitment approach used in the trail, the contents of the programme interactions, and the behaviour change techniques used by the facilitators are acceptable to the target group, which again may have contributed to the low dropout rates. The involvement of the target group in the design of a psychological questionnaire has resulted in a questionnaire assessing beliefs about physical activity that are relevant to this specific target group. The involvement of participants in the training of new facilitators during the trial has been invaluable in providing the facilitators with the opportunity to practice the behaviour change techniques in a real-life setting.

Evaluating the impact of public involvement in the research:

Details of publications or reports resulting from the research: * Hardeman, W., Griffin, S., Johnston, M., Kinmonth, A.L., & Wareham, N.J. (2000). Interventions to prevent weight gain: a systematic review of psychological models and behaviour change methods. International Journal of Obesity and Related Metabolic Disorders, 24, 131-143. * Hardeman, W., Johnston, M., Johnston, D.W., Bonetti, D., Wareham, N.J., & Kinmonth, A.L. (2002). Application of the Theory of Planned Behaviour in Behaviour Change Interventions: A Systematic Review. Psychology and Health, 17(2), 123-158. * Sutton, S., French, D., Hennings, S.J., Mitchell, J., Wareham, N.J., Griffin, S., Hardeman, W., & Kinmonth, A.L. Eliciting salient beliefs in research on the Theory of Planned Behaviour: The effect of question wording. Accepted for publication, Current Psychology. * McLean, N., Griffin, S., Toney, K., & Hardeman, W. Family involvement in weight control, weight maintenance and weight loss interventions: a systematic review of randomised trials. International Journal of Obesity and Related Metabolic Disorders, in press.

Was/is your project user controlled: Not Known

For further information on the project, please contact:
Dr Kate Williams
Trial Co-coordinator
University of Cambridge
General Practice and Primary Care Research Unit
Department of Public Health and Primary Care
Institute of Public Health
Cambridge
CB2 2SR
proactive@medschl.cam.ac.uk
01223 330 324


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