Effect of an 8-week free pre-prepared meals and prescribed exercise on weight loss in obese and overweight individuals: The Healthy Eating And Living Study (HEALS) randomized controlled trial

Not Applicable

Completed

• Conditions: Obesity; Physical inactivity; Diet and Nutrition - Obesity; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12618000422224
• Lead Sponsor: Queensland University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-23
• Study Completion: 2018-09-17
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Body mass index (BMI) in the range of 27-35 Kg m-2.
-Aged between 18 and 50 years at enrolment.
-No history of diabetes or eating disorders.
-Not planning or currently pregnant or breastfeeding.
-Not diagnosed with any food allergy.
-No history of bariatric surgery.
-Willing to allow blood collection (No medical issues arising from blood collection or severe phobia of needles).
-Capable of performing a cardiopulmonary fitness test.
-Willingness to participate in a 10 week study.

Exclusion Criteria

-Inability to participate in exercise because of comorbidity or disability (e.g., severe arthritic condition).
-A history or presence of a comorbid disease for which diet modifications and increased exercise participation may be contraindicated.
-Regular cigarette smoker, has quit smoking in the last 6 months, or are regularly exposed to environmental tobacco smoke.
-History of and severe hypertension (systolic 160-179 mmHg systolic; diastolic 100-109 mmHg).
-If participants have had any recent significant injury that will impede their ability to perform exercise during the study or any other contraindications that will impede their ability/safety during exercise.
-Will not have participated in a diet and/or exercise study in the last 6 months.
-History of significant psychiatric disorder or other condition that, in the judgement of the investigators would interfere with participation.
-If they presented with a diagnosis of any uncontrollable metabolic or cardiovascular disorder (including heart disease), arrhythmias, thyroid disease or hypogonadism, hepatorenal, autoimmune or neurological disease, currently taking dietary supplements for thyroid, hyperlipidemia, hypoglycaemia, or weight loss supplements (e.g., ephedra, thermogenic compounds) within 3 months before the start of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body fat. This will assessed using DEXA at the pre- and post-test (following the 8 week intervention)[1 week post completion of the 8 week intervention ];Body weight (using DEXA and Scale).[1 week post completion of the 8 week intervention ]