A parallel, single-blinded, multi-centre randomized controlled trial conducted at the South Australian Health and Medical Research Institute (SAHMRI) and the Mary Mackillop Institute for Health Research (MMIHR; Australian Catholic University), by researchers from the University of Adelaide, Australian Catholic University and La Trobe University.
In a parallel groups design, a total of 268 individuals will be recruited across both sites. After a 2-week baseline period, and a baseline metabolic visit, participants will be randomized into one of two groups (TRE, time-restricted eating; CP, current practice guidelines). All participants will receive five (5) telehealth consultations at baseline, week 2, 4, 8 and 12, the content of which will be based around their randomized condition. They will undergo metabolic testing on two (2) further occasions (4 months, 12 months) over a 12-month period to assess the changes in primary and secondary outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
247
Time restricted eating for a self-selected 9 hour window per day
Best practice guidelines to improve diet quality
South Australian Health and Medical Research Institute
Adelaide, South Australia, Australia
Mary Mackillop Institute for Health Research
Melbourne, Victoria, Australia
HbA1c
Glycated haemoglobin concentration
Time frame: baseline, 4 months
HbA1c
Glycated haemoglobin concentration
Time frame: 12 months
Fasting blood glucose
fasting blood glucose concentrations
Time frame: baseline, 4 months, 12 months
Fasting insulin
fasting insulin concentrations
Time frame: baseline, 4 months, 12 months
HOMA-IR
HOMA-IR
Time frame: baseline, 4 months, 12 months
Nocturnal glucose
AUC of glucose assessed by CGM from midnight to 0400
Time frame: baseline, 4 months
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