None listed
Conditions
Brief summary
This is a 12 month single blinded parallel randomised controlled trial with 3 arms: control (usual care), intervention (multidisciplinary lifestyle support). A 3rd arm comprises intervention + a food supplement . Participants will be randomised into a control or one of the intervention groups testing the effect of a novel versus conventional form of individualised health care targeting diet, exercise and health behaviour. An additional 12 month long term follow-up will be offered to all participants. Consenting participants will attend quarterly visits with a dietitian
Interventions
This is a 12 month single blinded parallel randomised controlled trial with 3 arms: control (usual care), intervention (multidisciplinary lifestyle support) and intervention (multidisciplinary lifestyle support) + a food supplement. Participants will be randomised into a control or one of the intervention groups testing the effect of a novel versus conventional form of individualised health care targeting diet, exercise and health behaviour. Both control and intervention arms will attend the cli
This is a 12 month single blinded parallel randomised controlled trial with 3 arms: control (usual care), intervention (multidisciplinary lifestyle support) and intervention (multidisciplinary lifestyle support) + a food supplement. Participants will be randomised into a control or one of the intervention groups testing the effect of a novel versus conventional form of individualised health care targeting diet, exercise and health behaviour. Both control and intervention arms will attend the clinic at baseline, 1,2,3,6,9,12 mo for a face to face session with a health practitioner (nurse/control or dietitian supported by an Exercise Physiologist (EP)/intervention) for 40-60 mins. Participants will be encouraged to set diet and physical activity goals based on either information sheets devised for the control or intervention strategy. A client centred approach will be used, with cognitive behavioural enhancement strategies in the intervention group. A phone call will be made between visits by the nurse/control or a health coach (supervised by psychologists)/intervention. Adherence will be monitored by repeat 4 day food records and pedometers. A subset will be given accelerometers. The food supplement is 30g snack packs of walnuts /day for 12 months. At the end of 12 months all participants will be offered to participate in a further 12 months of follow-up. All consented participants will attend for quarterly visits with a dietitian at 15, 18, 21 and 24 months.
Sponsors
Illawarra Health and Medical Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
25 Years to 54 Years
Healthy volunteers
No
Inclusion criteria
men and women from the Illawarra community (adults aged 25-54 years, permanent resident, community dwelling), at higher risk of lifestyle related disease (defined by BMI range 25-40kg/m2
Exclusion criteria
Unable to communicate in English; severe medical conditions impairing ability to participate in study; other medical conditions thought to limit survival to 1 year; immunodeficiency; reported illegal drug use or regular alcohol intake associated with alcoholism (>50g/day); difficulties or major impediments to participating in the components of the study
Outcome results
None listed