Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000536662
Ethics application status
Approved
Date submitted
15/05/2014
Date registered
21/05/2014
Date last updated
28/09/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Using New Technologies to Promote Weight Management.
Scientific title
The Efficacy of Using Social Media to Deliver a Weight Management Program to Overweight and Obese Individuals to Assist with Sustained Weight Loss.
Secondary ID [1] 284609 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 291911 0
Overweight 291912 0
Condition category
Condition code
Public Health 292258 292258 0 0
Health promotion/education
Diet and Nutrition 292295 292295 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project aims to evaluate the effectiveness of using social media to augment the delivery of, and support for, a weight management program delivered to overweight and obese individuals. One hundred and twenty overweight and obese participants from the Perth community will be enrolled in the study, and randomly divided into three groups: two intervention groups and a control group. The two intervention groups will be instructed to follow the CSIRO Total Wellbeing Diet weight-management program for the twenty four-week intervention period. The primary intervention group will receive the diet via the social networking website Facebook along with a support network on the site. Participants will complete a series of questionnaires of key psychological variables and to attend Curtin University for assessment of body weight and other clinical outcome variables at weeks 0, 6, 12, 18 and 24.
The CSIRO Total Wellbeing Diet is an energy reduced, low fat, high protein diet that promotes 30 minutes of moderate physical activity per day. The research coordinator (who has a BSc (Nutr) will post the program to the Facebook Group's wall at the start of the trial. There will be no personalised feedback, but the research coordinator will post general questions relating to the program regularly (eg. In what way did you get 30 minutes of exercise today?) to facilitate discussion between the Group's members. Participants will be encouraged to check the Facebook Group at their discretion, however every time new content is posted to the Group's wall, all participants in the group will get a notification which, it is hoped, will act as a reminder for them to check in. To monitor adherence, participants will be asked to complete a three day food diary, along with physical activity and other relevant questionnaires, at weeks 0, 6, 12, 18 and 24. The research coordinator will also log in to the Facebook Group daily to check that participants are using the Group.
Intervention code [1] 289382 0
Lifestyle
Comparator / control treatment
The secondary intervention group (or comparator) will receive the intervention (the CSIRO Total Wellbeing Diet weight-management program for the twenty four-week intervention period) in booklet form at baseline. The booklet will contain identical information to that posted for the Facebook Group.

The control group will be instructed to follow the Australian Government National Physical Activity Guidelines for Adults, and the Australian Guide to Healthy Eating, as standard care.
Control group
Active

Outcomes
Primary outcome [1] 292131 0
Weight loss.
Research coordinator will weigh participants using calibrated digital scales during their clinic appointments at weeks 0, 6, 12 and at the 12 week follow-up.
Timepoint [1] 292131 0
Timeline: Baseline, weeks 6, 12, 18 and 24. (No follow-up.)
Secondary outcome [1] 308252 0
Changes to fasting blood glucose levels.
Research coordinator will measure this using a glucometer during their clinic appointments at weeks 0, 6, 12 and at the 12 week follow-up
Timepoint [1] 308252 0
Timeline: Baseline, weeks 6, 12, 18 and 24. (No follow-up.)
Secondary outcome [2] 308254 0
Changes to blood pressure.
Research coordinator will measure resting blood pressure using an automatic sphygmomanometer during their clinic appointments at weeks 0, 6, 12 and at the 12 week follow-up.
Timepoint [2] 308254 0
Timeline: Baseline, weeks 12 and 24 only.
Secondary outcome [3] 308255 0
Changes to waist circumference
Timepoint [3] 308255 0
Timeline: Baseline, weeks 6, 12, 18 and 24. (No follow-up.)
Secondary outcome [4] 308256 0
Hip circumference
Timepoint [4] 308256 0
Timeline: Baseline, weeks 6, 12, 18 and 24. (No follow-up.)
Secondary outcome [5] 308257 0
Changes to physical activity by self-report. Participants will be required to complete the Bouchard's Physical Activity Record in the week prior to each clinic appointment at weeks 0, 6, 12, 18 and 24.
Timepoint [5] 308257 0
Timeline: Baseline, weeks 6, 12, 18 and 24. (No follow-up.)
Secondary outcome [6] 308258 0
Changes to eating behaviour by self-report.
Participants will be required to complete the Three Factor Eating Questionnaire in the week prior to each clinic appointment at weeks 0, 6, 12, and at the 12 week follow-up.
Timepoint [6] 308258 0
Timeline: Baseline, weeks 12 and 24 only.
Secondary outcome [7] 308259 0
Changes to mental well-being (eg. stress, anxiety, depression) by self-report.
Participants will be required to complete the Depression, Anxiety, Stress Scales (questionnaire) in the week prior to each clinic appointment at weeks 0, 6, 12 and at the 12 week follow-up
Timepoint [7] 308259 0
Timeline: Baseline, weeks 12 and 24 only.
Secondary outcome [8] 308260 0
Participants will be required to complete the WHO Quality of Life Questionnaire (QoL) in the week prior to each clinic appointment at weeks 0, 12 and 24.
Timepoint [8] 308260 0
Timeline: Baseline, weeks 12 and 24 only.
Secondary outcome [9] 308261 0
Participants ability to resist detrimental impulses assessed using the Self-Control Scale (Brief) in the week prior to each clinic appointment. Participants will be required to complete the Self-Control Scale (Brief) in the week prior to each clinic appointment at weeks 0, 12 and 24.
Timepoint [9] 308261 0
Timeline: Baseline, weeks 12 and 24 only.
Secondary outcome [10] 308262 0
Changes to self-efficacy by self-report.
Participants will be required to complete the Self-Efficacy Questionnaire in the week prior to each clinic appointment at weeks 0, 6, 12 and at the 12 week follow-up.
Timepoint [10] 308262 0
Timeline: Baseline, weeks 12 and 24 only.
Secondary outcome [11] 308263 0
For the primary intervention group only: Participants will be required to complete the (combined) Facebook Intensity & Network Density Scale (questionnaire) to assess use of Facebook.
Timepoint [11] 308263 0
Timeline: Baseline, weeks 12 and 24 only.
Secondary outcome [12] 317874 0
The Social Media Survey has been added to measure participants opinion of social media, for Facebook Group participants only.
Timepoint [12] 317874 0
Timeline: Baseline, weeks 12 and 24 only.
Secondary outcome [13] 317875 0
A Survey of Weight Management Program has been added, for all participant groups, to assess participants' views on the weight management program provided, for all groups.
Timepoint [13] 317875 0
Timeline: Baseline, weeks 12 and 24 only.
Secondary outcome [14] 317876 0
Participants intentions regarding dietary and physical activity modifications assessed using a Diet and Physical Activity Survey, for all participant groups.
Timepoint [14] 317876 0
Timeline: Baseline, weeks 12 and 24 only.
Secondary outcome [15] 317877 0
A Personality and Individual Difference Questionnaire has been added, a composite secondary outcome, and is a self-reported questionnaire that assesses ingenuity, cognitive ability, insight, health anxiety, initiative, competence and happiness.
Timepoint [15] 317877 0
Timeline: Baseline, weeks 12 and 24 only.
Secondary outcome [16] 317878 0
A Three-Day Food Record will be used to assess dietary consumption, for all participants.
Timepoint [16] 317878 0
Timeline: Baseline, weeks 6, 12, 18 and 24.
Secondary outcome [17] 317879 0
Fasting blood insulin.
Timepoint [17] 317879 0
Timeline: Baseline, weeks 12 and 24 only.
Secondary outcome [18] 317880 0
Fasting blood lipids, including total cholesterol, LDL-C, HDL-C, and triglycerides.
Timepoint [18] 317880 0
Timeline: Baseline, weeks 12 and 24 only.

Eligibility
Key inclusion criteria
Inclusion criteria: overweight and obese individuals with a body mass index (BMI) between 25-40 kg/m2, with access to a computer, laptop, tablet or Smartphone.
Minimum age
21 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Smoking, lipid lowering medication, use of steroids and other agents that may influence lipid metabolism, use of warfarin, diabetes mellitus, hypo- and hyperthyroidism, cardiovascular events within the last 6 months, major systemic diseases, gastrointestinal problems, proteinuria, liver disease, renal failure, weight fluctuations over the past 6 months, vegetarianism and participation in any other clinical trials within the last 6 months.

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)
Randomisation conducted by project coordinator using www.researchrandomizer.org. Allocation is not concealed.
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
30/06/2014
Actual
13/10/2014
Date of last participant enrolment
Anticipated
Actual
11/11/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 289239 0
University
Name [1] 289239 0
Curtin University of Technology
Country [1] 289239 0
Australia
Primary sponsor type
Individual
Name
Monica Jane
Address
c/o A/Prof Sebely Pal
Curtin University
School of Public Health
Building 400
Kent Street
Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 287913 0
Individual
Name [1] 287913 0
A/Prof Sebely Pal
Address [1] 287913 0
Curtin University
School of Public Health
Dept of Epidemiology & Biostatistics
Building 400
Kent Street
Bentley WA 6102
Country [1] 287913 0
Australia
Other collaborator category [1] 278642 0
Individual
Name [1] 278642 0
Prof Jonathan Foster
Address [1] 278642 0
c/o School of Psychology and Speech Pathology
Curtin University
Kent St, Bentley WA 6102
Country [1] 278642 0
Australia
Other collaborator category [2] 278643 0
Individual
Name [2] 278643 0
Prof Martin Hagger
Address [2] 278643 0
c/o School of Psychology and Speech Pathology
Curtin University
Kent St, Bentley WA 6102
Country [2] 278643 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291008 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 291008 0
Curtin University
Office of Research & Development
Building 100
Kent Street
Bentley WA 6102
Ethics committee country [1] 291008 0
Australia
Date submitted for ethics approval [1] 291008 0
19/05/2014
Approval date [1] 291008 0
27/05/2014
Ethics approval number [1] 291008 0
HR09/2014

Summary
Brief summary
The primary purpose of this study is to identify a practical and cost-effective tool to assist overweight and obese people undergoing dietary and lifestyle changes to lose weight and sustain their weight loss.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48442 0
A/Prof Sebely Pal
Address 48442 0
Curtin University
School of Public Health
Dept of Epidemiology & Biostatistics
Building 400
Kent Street
Bentley WA 6102
Country 48442 0
Australia
Phone 48442 0
+618 9266 4755
Fax 48442 0
Email 48442 0
[email protected]
Contact person for public queries
Name 48443 0
Ms Monica Jane
Address 48443 0
c/o A/Prof Sebely Pal
Curtin University
School of Public Health
Building 400
Kent Street
Bentley WA 6102
Country 48443 0
Australia
Phone 48443 0
+61411579339
Fax 48443 0
Email 48443 0
[email protected]
Contact person for scientific queries
Name 48444 0
A/Prof Sebely Pal
Address 48444 0
Curtin University
School of Public Health
Dept of Epidemiology & Biostatistics
Building 400
Kent Street
Bentley WA 6102
Country 48444 0
Australia
Phone 48444 0
+618 9266 4755
Fax 48444 0
Email 48444 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseEffects of a weight management program delivered by social media on weight and metabolic syndrome risk factors in overweight and obese adults: A randomised controlled trial.2017https://dx.doi.org/10.1371/journal.pone.0178326
EmbaseUsing new technologies to promote weight management: a randomised controlled trial study protocol.2015https://dx.doi.org/10.1186/s12889-015-1849-4
N.B. These documents automatically identified may not have been verified by the study sponsor.