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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN61323766
Enrollment
365
Registered
2001-01-10
Start date
2001-04-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Nutritional, Metabolic, Endocrine Diabetes

Interventions

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) Interv
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) Institut

Sponsors

University of Cambridge (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 6, 2026