Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000272594
Ethics application status
Approved
Date submitted
10/03/2015
Date registered
23/03/2015
Date last updated
1/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating a weight loss program for young women delivered using technology: Be Positive Be Healthe
Scientific title
Effect of a targeted eHealth intervention for young overweight/obese women on weight-related outcomes
Secondary ID [1] 286335 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and obesity 294451 0
Condition category
Condition code
Diet and Nutrition 294753 294753 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Be Positive Be Healthe is a 6-month intervention. The goal of Be Positive Be Healthe is to facilitate a 5 to 10% reduction from baseline weight. Participants will set an individualised energy intake and energy expenditure goal to facilitate a weight loss of approximately 0.5kg/week. They will be encouraged to meet this goal by making changes to the eating and physical activity behaviours that cause weight gain and increase CVD risk. To assist young women to implement the desired changes to behaviour, the behavioural strategies for weight management, which will be targeted throughout the intervention, and be highlighted as a weekly topic. Participants will be asked to engage with the eHealth tools to facilitate behaviour change and meet their weight loss goal. The eHealth tools include a study website (information and resources available at all times); online quizzes with individualised email feedback (Week 1, 3, 8, 12 and 20) and goal setting (Week 1); a smartphone application for self-monitoring (recommended to use 4 days per week), email newsletters and text messages for education (1 newsletter/week and 2 text messages/week Week 1-12 and 1 newsletter/fortnight and 1 text message/week Week 13-26), and social media (Facebook and Instagram) for social support (available at all times).
Intervention code [1] 291387 0
Behaviour
Intervention code [2] 291388 0
Lifestyle
Intervention code [3] 291389 0
Treatment: Other
Comparator / control treatment
Waiting list control group (will receive access to Be Positive Be Healthe after 6-months)
Control group
Active

Outcomes
Primary outcome [1] 294513 0
Weight will be objectively measured on a digital scale (Inbody 720).
Timepoint [1] 294513 0
Weight change from baseline to post-intervention (6-months).
Secondary outcome [1] 313530 0
Body mass index: Height will be measured using a stadiometer (Inbody BSM 370), and BMI will be calculated from measured height and weight using the standard equation
Timepoint [1] 313530 0
Change from baseline to post-intervention (6-months)
Secondary outcome [2] 313531 0
Dietary intake (energy, macro/micronutrient and food group intake, diet quality) will be assessed using a validated Food Frequency Questionnaire (Australian Eating Survey).
Timepoint [2] 313531 0
Change from baseline to 3-months and 6-months
Secondary outcome [3] 313534 0
Intervention participants usage of the eHealth intervention (e.g. website visits, use of smartphone application) will be objectively tracked by the program.
Timepoint [3] 313534 0
Throughout intervention (from baseline to 6-months)
Secondary outcome [4] 313618 0
Waist and hip circumference will be measured to 0.1 cm using a non-extensible steel tape, with waist measured at the narrowest point between the lower costal border and the umbilicus and hip measured at the level of the greatest circumference of the gluteals. Waist-to-hip ratio will be calculated
Timepoint [4] 313618 0
Change from baseline to 6-months
Secondary outcome [5] 313619 0
Systolic and diastolic blood pressure will be measured using an automatic sphygmomanometer (Inbody BPBIO320)
Timepoint [5] 313619 0
Change from baseline to 6-months
Secondary outcome [6] 313620 0
Total cholesterol, HDL-Cholesterol, LDL-Cholesterol and Triglycerides will be measured via a finger prick blood sample which will be analysed using the Cardiochek.
Timepoint [6] 313620 0
Change from baseline to 6-months
Secondary outcome [7] 313621 0
Alcohol intake will be assessed using short questions from the NSW Health Survey.
Timepoint [7] 313621 0
Change from baseline to 3- and 6-months
Secondary outcome [8] 313622 0
Physical activity (step counts) will be objectively measured using pedometers (Yamax DigiWalker SW700).
Timepoint [8] 313622 0
Change from baseline to 6-months
Secondary outcome [9] 313623 0
Physical activity and sedentary behaviour will be self-reported using the Godin Leisure Time Exercise Questionnaire and the Sitting Questionnaire.
Timepoint [9] 313623 0
Change from baseline to 3- and 6-months
Secondary outcome [10] 313624 0
Self-esteem: Body-esteem will be self-reported using the validated Body Esteem Scale for Adolescents and Adults.
Timepoint [10] 313624 0
Change from baseline to 3- and 6-months
Secondary outcome [11] 313625 0
Quality of life will be assessed via the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short form and the Satisfaction with Life Scale
Timepoint [11] 313625 0
Change from baseline to 3- and 6-months
Secondary outcome [12] 313626 0
Program acceptability will be evaluated using a process evaluation questionnaire (intervention group only) that was designed by the researchers for the study.
Timepoint [12] 313626 0
3 and 6-months

Eligibility
Key inclusion criteria
Female
Age 18 to 35 years
BMI 25 to 34.9kg/m2
Access to a computer with email and Internet facilities
Own an iPhone with Internet access
A Facebook and Instagram account they are willing to use for the study
Able to attend the University campus for assessments
Minimum age
18 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently pregnant or breastfeeding or planning to become pregnant
Currently or planning to participate in another weight loss program
Recent weight loss (last 3-months) of 5% or more of initial weight
Taking medications that have caused weight gain
Suffers from a metabolic disorder, eating disorder or any other medical condition where weight loss may compromise health
Non-English speaking

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/03/2015
Actual
31/03/2015
Date of last participant enrolment
Anticipated
Actual
16/04/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
114
Accrual to date
Final
57
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290910 0
Charities/Societies/Foundations
Name [1] 290910 0
National Heart Foundation of Australia Postdoctoral Research Fellowship
Country [1] 290910 0
Australia
Funding source category [2] 290911 0
University
Name [2] 290911 0
University of Newcastle
Country [2] 290911 0
Australia
Primary sponsor type
Individual
Name
Dr Melinda Hutchesson
Address
University Of Newcastle, School of Health Sciences, Hunter Building (HA12), University Drive, Callaghan, NSW 2308
Country
Australia
Secondary sponsor category [1] 289591 0
University
Name [1] 289591 0
University of Newcastle
Address [1] 289591 0
University Drive, Callaghan, NSW, Australia 2308
Country [1] 289591 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292511 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 292511 0
Ethics committee country [1] 292511 0
Australia
Date submitted for ethics approval [1] 292511 0
Approval date [1] 292511 0
03/06/2014
Ethics approval number [1] 292511 0
H-2014-0138

Summary
Brief summary
The aim of the research is to compare the efficacy of a 6-month weight loss intervention for young (18 to 35 years) overweight and obese (Body Mass Index 25 to 34.9kg/m2) women delivered using eHealth technologies to a waiting list control group.

Participants will be randomly allocated to the intervention (Be Positive Be Healthe) or waiting list control group. After 6-months the waiting list control group will receive access to Be Positive Be Healthe program tools.

Participants in both groups will be asked to have a series of measures taken (e.g. weight, height) and complete online questionnaires at the start of the program (baseline), mid-program (3-months) and post program (6-months). The researchers will also track intervention participants use of the eHealth tools.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55658 0
Dr Melinda Hutchesson
Address 55658 0
School of Health Sciences, Hunter Building (HA12), University Drive, The University of Newcastle, Callaghan, NSW 2308
Country 55658 0
Australia
Phone 55658 0
+61 2 49215405
Fax 55658 0
Email 55658 0
melinda.hutchesson@newcastle.edu.au
Contact person for public queries
Name 55659 0
Dr Melinda Hutchesson
Address 55659 0
School of Health Sciences, Hunter Building (HA12), University Drive, The University of Newcastle, Callaghan, NSW 2308
Country 55659 0
Australia
Phone 55659 0
+61 2 49215405
Fax 55659 0
Email 55659 0
melinda.hutchesson@newcastle.edu.au
Contact person for scientific queries
Name 55660 0
Dr Melinda Hutchesson
Address 55660 0
School of Health Sciences, Hunter Building (HA12), University Drive, The University of Newcastle, Callaghan, NSW 2308
Country 55660 0
Australia
Phone 55660 0
+61 2 49215405
Fax 55660 0
Email 55660 0
melinda.hutchesson@newcastle.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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