Evaluating a meal replacement program for accelerated weight loss and greater program retention.

Not Applicable

Completed

• Conditions: Overweight and obesity; Weight loss; Diet and Nutrition - Obesity

• Registration Number: ACTRN12616000110482
• Lead Sponsor: CSIRO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-02
• Study Completion: 2016-09-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

1.Adults with a BMI greater than or equal to 27kg/m2;
2.Aged 25-60 years;
3.Willing to attend CSIRO SAHMRI clinic in Adelaide on 10 occasions;
4.Willing to participate in the study including collection of blood samples on 2 occasions, and completing questionnaires,
5.Willing to follow a weight loss dietary protocol for 16 weeks plus weight maintenance dietary protocol a further 8 weeks;
6. Non-smoker;
7. Has been weight stable (i.e. less than 3 kg weight loss) for the past 2 months.

Exclusion Criteria

1. Any known pre-existing, diagnosed medical condition (assessed by self report in the screening medical questionnaire) that may prevent them from participating in the study, including but not limited to:
a. Kidney disease or renal impairment;
b. Gall bladder disorders or stones;
2.Regular use of prescribed weight loss medications; or medications that contain Mono-amine oxidase inhibitors, Lithium, Anticoagulants e.g. Warfarin.
3.Regular use of any other medications prescribed by a medical practitioner that are deemed unsuitable for this trial – as determined by the appointed study physician during screening process;
4.A food allergy/intolerance to, or not willing to consume, the foods prescribed in the protocol;
5.A score of greater than or equal to 2 on the SCOFF screening questionnaire for eating disorders*;
6.A person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol;
7.Women who are attempting to become pregnant, pregnant, lactating, (postmenopausal women should not change HRT regimen during the study);
8.Participation in another study within 30 days of commencement of the present study.

a.Liver disease (e.g. cirrhosis);
b.Angina, chest pain (undiagnosed) or severe shortness of breath;
c.Diagnosed cardiovascular disease;
d.Cardiac arrhythmia, heart disease, heart attack, coronary bypass surgery;
e.Stroke;
f.Dementia;
g.Thyroid disease;
h.Gout;
i.Gastrointestinal disease (including celiac or malabsorption diseases Crohns disease);
j.History of bariatric surgery;
k.Epilepsy;
l.Neurological or psychiatric conditions;
m.Severe depression;
n.Cancer (unless benign or non-progressive skin cancer);
o.Type 1 or type 2 diabetes.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Participant retention in the weight loss program/study, assessed as the final recorded clinic attendance.[week 0 & 16];weight loss assessed using calibrated digital scales[week 0 & 16]