Trial of efficacy of a family-based programme to increase physical activity among individuals at high risk of diabetes

ISRCTN	ISRCTN61323766
DOI	https://doi.org/10.1186/ISRCTN61323766
Secondary identifying numbers	G0000753

Submission date: 10/01/2001
Registration date: 10/01/2001
Last edited: 15/09/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Simon Griffin
Scientific

MRC Epidemiology Unit
Institute of Metabolic Science, Box 285
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Phone	+44 (0)1223 330315
Email	Simon.Griffin@mrc-epid.cam.ac.uk

Study information

Study design	Randomised controlled trial and long-term follow-up
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Trial of efficacy of a family-based programme to increase physical activity among individuals at high risk of diabetes
Study acronym	ProActive
Study objectives	1. Behaviour change: to estimate the extent to which an innovative approach to increasing physical activity can achieve clinically important changes in a high risk group 2. Disease impact: to model the potential for this behaviour change to reduce the incidence of obesity and diabetes in later life 3. Dose finding: to estimate the effect of delivery of the intervention at two levels of intensity on acceptability, efficacy and costs Please note that as of 18/03/2009 this record was updated; all updates can be found under the relevant field with the above updated date. Please also note that at this time, details of the follow-up study 'ProActive: follow-up study' were added to this record. All details of this follow-up study can be found in the relevant section under the sub-heading 'ProActive: follow-up study'. The ProActive: follow-up study has the following trial dates: Overall trial start date: 01/04/2009 Overall trial end date: 01/10/2011 ProActive: follow-up study - We aim to follow-up ProActive trial participants and to quantify changes in objectively measured physical activity and its clinical and psychological correlates over time. Specific objectives include: 1. Assessment of changes in physical activity and its consequences: 1.1. To determine the efficacy of the ProActive intervention programme on objectively measured physical activity and its clinical and psychological correlates five years post-randomisation 1.2. To examine to what extent observed increases in objectively measured physical activity at one year in the ProActive cohort were sustained 1.3. To conduct a cohort analysis to examine whether feasible changes in objectively measured physical activity are associated with clinically important changes in metabolic risk factors 2. Assessment of the determinants of physical activity and self-rated health: 2.1. To characterise individuals who maintained, increased and decreased their levels of physical activity by quantifying the association between determinants and change in physical activity over time. We will examine individual and environmental determinants of physical activity: 2.1.1. Individual determinants: biological, behavioural, demographic, psychological 2.1.2. Environmental determinants: both objective and perceived environmental data 2.2. To examine which psychological variables (e.g. intention, perceived behavioural control, satisfaction) predict long-term change in physical activity in the whole cohort and whether predictors differ across the three trial arms 2.3. To similarly identify predictors and outcomes of self-rated health in a cohort of healthy adults in order to better understand the mechanisms by which self-rated health is created and how it influences outcomes 3. Adding meaning to the trial and cohort study findings: 3.1. To elicit participants' perceptions of self-rated health and explore the reasons for the effect of the intervention on self-rated health 3.2. To analyse individuals' reflections on participating in the ProActive study, their understandings of the specific intervention they received, and their personal reports of the impact these aspects had on them 3.3. To elicit and analyse personal accounts of activity change, and explore the extent to which this is interpreted as a result of the original intervention, of some other aspect of trial involvement, or because of other influences related to their social or physical environment 3.4. To understand better the barriers and facilitators of long term changes in physical activity, and their relationship with self-rated health and perceptions of disease risk through exploring participants' own perceptions and meanings
Ethics approval(s)	1. Eastern MREC, 31/10/2002, ref: 02/5/53 2. ProActive: follow-up study - Cambridgeshire 2 REC, 23/01/2009, ref: 09/H0308/3
Health condition(s) or problem(s) studied	Diabetes
Intervention	Three levels of facilitating physical activity: 1. Face to face of a programme to support motivation, action 2. Telephone delivery and maintenance 3. Comparison group (brief advice by leaflet) Interventions 1 and 2 are delivered by a facilitator trained in evidence-based methods from psychology. Added 18/03/2009: The intervention lasted 12 months; 5 months of intensive intervention followed by 7 months of follow-up. Co-sponsor as of March 2009 (along with University of Cambridge - see sponsor section below): MRC Epidemiology Unit (UK) Institute of Metabolic Science, Box 285 Addenbrooke's Hospital Hills Road Cambridge CB2 0QQ United Kingdom Website: http://www.mrc-epid.cam.ac.uk/ Initial sponsor at time of registration until March 2009: CamStrad (Cambridgeshire Support Team - Research & Development) (UK)
Intervention type	Other
Primary outcome measure	An objective measure of physical activity (PAL), daytime energy expenditure and its ration to basal metabolic rate. Psychological and physiological correlates of this behaviour and costs to the NHS will also be measured. ProActive: follow-up study - Physical activity measured as the daytime physical activity ratio (dayPAR). This is the ratio of daytime energy expenditure to resting energy expenditure measured using heart rate monitoring with individual calibration for the heart rate-energy expenditure relationship. The method has been extensively validated: 1. Oxygen uptake (ml O2/kg/body weight) will be measured by indirect calorimetry during a submaximal graded treadmill exercise test 2. Maximal cardiorespiratory fitness (VO2max) will be estimated using predicted maximal heart rate (i.e. 220 minus age) 3. Activity energy expenditure (AEE) will be individually calculated from heart rate monitoring as the amount of energy expended above that during a standardised reference activity (i.e. treadmill walking at 3.2 km.h-1) 4. Time (% of monitored time per day) spent above 1.75 resting heart rate will be individually calculated as an indicator of moderate intensity PA Physical activity will also be measured by the EPAQ2 questionnaire covering work, recreation and domestic activity over the previous month and year.
Secondary outcome measures	Added 18/03/2009: Measured at baseline and at 1 year: 1. Maximal cardiorespiratory fitness (VO2max) 2. Self-reported physical activity 3. Weight 4. Height 5. Body fat percentage 6. Blood pressure 7. Glycosylated haemoglobin 8. Fasting plasma glucose, lipids and insulin 9. 36-item short form health survey (SF-36) (wellbeing) 10. Worry about diabetes and perceived risk of diabetes 11. Psychological outcomes including beliefs about increasing physical activity (e.g. attitude, subjective norm, intention, perceived behavioural control), based on the Theory of Planned Behaviour All self-reported questionnaires (except the SF-36) were also collected at 6 months. At 6 months and 1 year participants were asked about the acceptability of the programme and it's delivery. ProActive: follow-up study - 1. Physiological correlates of activity: 1.1. Weight measured on standard scales calibrated at three monthly intervals 1.2. Body fat percentage measured by bio-electrical impedance (Bodystat, Isle of Man, UK) 1.3. Systolic/diastolic blood pressure, measured using an automatic sphygmomanometer (Accutorr, UK) 2. An electrocardiogram (ECG) will be performed 3. Biochemical correlates, including fasting plasma glucose, insulin, glycosylated haemoglobin, and lipids measured in one laboratory with established quality assurance systems 4. Psychological outcomes, including beliefs about increasing physical activity over the coming 12 months (e.g. attitude, subjective norm, intention, perceived behavioural control), based on the Theory of Planned Behaviour 5. Self-report measures of well-being and quality of life, including subjective health and energy (SF-36) A follow-up qualitative component - a two-stage interview procedure - will also be performed at follow-up
Overall study start date	01/04/2001
Completion date	31/03/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	365 (ProActive: follow-up study - 353)
Key inclusion criteria	Offspring of patients with Type 2 diabetes reporting a sedentary lifestyle. ProActive: follow-up study - Existing participants we are able to contact who are willing and able to attend for follow-up measures.
Key exclusion criteria	1. Age greater than 30 years, less than 50 years 2. Known diabetes 3. Physical or psychiatric illness limiting programme involvement ProActive: follow-up study - Participants who are unable to be contacted, or unable or unwilling to attend for follow-up measures.
Date of first enrolment	01/04/2001
Date of final enrolment	31/03/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Addenbrooke's Hospital

Cambridge
CB2 0QQ
United Kingdom

Sponsor information

University of Cambridge (UK)
University/education

Research Services Division
16 Mill Lane
Cambridge
CB2 1SB
England
United Kingdom

Website	http://www.rsd.cam.ac.uk/
"ROR"	https://ror.org/013meh722

Funders

Funder type

Research council

Medical Research Council (MRC) (UK) (ref: G0000753)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

National Institute for Health Research (NIHR) (UK) - School for Primary Care Research

No information available

Medical Research Council (MRC) Epidemiology Unit (UK) Programme funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	18/10/2004	Yes	No
Results article	results	05/01/2008	Yes	No
Results article	results	17/03/2009	Yes	No
Results article	results	30/04/2010	Yes	No
Results article	results	01/07/2011	Yes	No
Results article	results	01/02/2014	Yes	No
Results article	results	01/01/2015	Yes	No