Developing effective weight loss strategies for shift workers.

Not Applicable

Recruiting

• Conditions: Obesity; Metabolic Syndrome; Diet and Nutrition - Obesity; Metabolic and Endocrine - Metabolic disorders

• Registration Number: ACTRN12619001035112
• Lead Sponsor: A/Professor Maxine Bonham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-19
• Last Update Posted: 27 December 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 423

Inclusion Criteria

For Caucasian, BMI greater than or equal to 28 kg/m2
For Asians, BMI greater than or equal to 26 kg/m2
Weight loss in the past 3 months with weight change of no more than 5kg

Exclusion Criteria

• Within healthy weight range
• Individuals that do not work night shift i.e., day shift only workers are excluded
• Have a genetic condition that impacts weight, appetite and/or metabolic measures (e.g., Prada Willi)
• Diagnosed with a medical condition (e.g., Inflammatory bowel disease, Diabetes, Polycystic Ovarian Syndrome, CVD)
• Pregnancy / breastfeeding
• Dietary allergies / intolerance preventing consumption of provided study-meals
• Prescription medication and over-the-counter-medication that affect metabolic outcomes/measures
• Require drug-therapy (e.g., Insulin, Levothyroxine, anti-depressants, statins) that impacts weight, appetite and or metabolic measures. Assess on a case-by-case basis.
• Failure to satisfy the investigator regarding suitability to participate for any other reason
• Had previous weight loss surgery
• Unwilling or unable to provide informed consent
• Pregnant, planning a pregnancy or breastfeeding, and not prepared to do a pregnancy test
• Not able to complete a 6-month weight loss intervention and a 12-month maintenance follow-up
• Dietary allergies or dietary restrictions that prevent consumption of provided study foods
• Taking extended leave from work in the next 6 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body weight in kg will be assessed using scales<br>[0, 3, 6, 12 and 18 months (0 and 6 months primary time points for hypothesis testing)<br> <br>];HOMA-IR<br>Fasting glucose (clinical chemistry analyser) and fasting insulin (ELIZA)<br>[0, 6 months]