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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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000422224
Acronym
HEALS
Enrollment
64
Registered
2018-03-23
Start date
2018-03-28
Completion date
2018-07-02
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary objective of this RCT is to compare the short-term (8-weeks) effects of a protocol developed by a commercial organisation which combines commercially pre-prepared meals and structured exercise programme with a programme which include standard dietary guidelines with a structured exercise programme on body composition changes (body weight and fat mass). The secondary objective is to examine biological factors (fitness and blood profile) and psychosocial well-being and facilitators and barriers to completing the intervention programme and its acceptability.

Interventions

In this study participants will be randomized to either a meals and exercise condition or nutritional information and exercise condition. The intervention will run for 8 weeks with assessments of body composition (DEXA), cardio-respiratory fitness (VO2max), hematological functioning (total cholesterol, HDL-C, LDL-C, Triglycerides, C-reactive protein and Adiponectin), blood pressure and psychosocial health (DASS21 & SF12) pre- and post-intervention. The intervention group will be provided with pr

In this study participants will be randomized to either a meals and exercise condition or nutritional information and exercise condition. The intervention will run for 8 weeks with assessments of body composition (DEXA), cardio-respiratory fitness (VO2max), hematological functioning (total cholesterol, HDL-C, LDL-C, Triglycerides, C-reactive protein and Adiponectin), blood pressure and psychosocial health (DASS21 & SF12) pre- and post-intervention. The intervention group will be provided with prepared meals for the duration of the intervention whereas the control group will be provided with standard information on healthy eating (according to NHMRC guidelines). Both will be provided with an exercise program by personal trainers consisting of resistance and aerobic exercise. This will include 3 gym sessions per week which include exercises at 75% of max HR and weight training between 60 and 85 of 1 RM (exercises include but are not limited to squats, bench press, leg curls, shoulder pull; the aim is to train all muscle groups within the body).. The sessions will be approximately 45 minutes in duration and include a short warm-up and warm-down with stretching exercises. The participants will also be advised to engage in walking on 2 additional days for 30 minutes on each day. In the first 2 weeks gym exercises are with a personal trainer whereas in the remaining 6 weeks there is 1 session with the personal trainer. All participants will receive a manual with exercises for the 8 weeks (weekly program). There are 3 gym sessions whereas the other activities can be done from home/work place. In terms of the meals, participants in the experimental arm will be provided with 3 meals per day as well as snacks. The food provided to the experimental group varies according to the exercise program it accompanies. For example, it will include post-exercise snacks on days when there is structured exercise but not on other days. On average the participants will receive about 2000 calories per day of a high fat low carb diet (fat up to 65%, protein 30% and carbs 5%). Examples include: Roast chicken breast with carrots and greens, beef cheeks with broccoli and cauliflower rice;; Snacks include protein bars, almond and chia.; breakfast Granola. The participants will be required to keep a log book as well as send a weekly audio or video blog to the research team. The blog is based on predetermined questions.. The following questions will be asked: 1. How did you get on with this week’s exercise program? What have you found easy? What were your challenges? How did you get on with this week’s nutritional program? What have you found easy? What were your challenges? How are you going to meet these challenges next week? Please comment on any physical or psychological changes that you’ve observed within yourself and record anything else you want to share with the HEALS Team. On a scale from 1 to 10, how confident are you in your ability to achieve your goal for next week?

Sponsors

Queensland University of Technology
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026