A cohort of 120 overweight and obese individuals with a body mass index (BMI) between This will be a three-armed, randomised, controlled, parallel design intervention study Fig. 1.<\/strong> Flow of participants\n <\/p>\n The primary outcome measures for this study is weight loss, body composition and waist All participants will be required to attend regular clinical appointments for a duration Table 1.<\/strong> Schedule of assessments\n <\/p>\n At each clinical appointment, weight will be recorded in light clothing without shoes. Based on a three group study with repeated measures, a sample size of 96 achieves Participants A cohort of 120 overweight and obese individuals with a body mass index (BMI) between 25\u00e2\u20ac\u201c40\u00c2\u00a0kg\/m2 and aged between 21 and 65\u00c2\u00a0years will be recruited from the Perth community via flyers posted at community noticeboards, advertisements in local newspapers and advertisements on local community radio stations. Eligible participants will also be required to have […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-13610","post","type-post","status-publish","format-standard","hentry"],"_links":{"self":[{"href":"http:\/\/healthmedicinet.com\/news\/wp-json\/wp\/v2\/posts\/13610","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/healthmedicinet.com\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/healthmedicinet.com\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/healthmedicinet.com\/news\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/healthmedicinet.com\/news\/wp-json\/wp\/v2\/comments?post=13610"}],"version-history":[{"count":0,"href":"http:\/\/healthmedicinet.com\/news\/wp-json\/wp\/v2\/posts\/13610\/revisions"}],"wp:attachment":[{"href":"http:\/\/healthmedicinet.com\/news\/wp-json\/wp\/v2\/media?parent=13610"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/healthmedicinet.com\/news\/wp-json\/wp\/v2\/categories?post=13610"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/healthmedicinet.com\/news\/wp-json\/wp\/v2\/tags?post=13610"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\n 25\u00e2\u20ac\u201c40\u00c2\u00a0kg\/m2<\/sup> and aged between 21 and 65\u00c2\u00a0years will be recruited from the Perth community via flyers
\n posted at community noticeboards, advertisements in local newspapers and advertisements
\n on local community radio stations. Eligible participants will also be required to
\n have access to a computer, laptop, tablet or Smartphone. Exclusion criteria will include
\n smoking, lipid lowering medication, use of steroids and other agents that may influence
\n lipid metabolism, use of warfarin, diabetes mellitus, hypo- or hyperthyroidism, cardiovascular
\n events within the last 6\u00c2\u00a0months, major systemic diseases, gastrointestinal problems,
\n proteinuria, liver disease, renal failure, weight fluctuations over the past 6\u00c2\u00a0months,
\n vegetarianism or participation in any other clinical trials within the last 6\u00c2\u00a0months.
\n All participants will be required to provide written informed consent before the trial
\n commences. All identifiable information from participants will be coded. This study
\n will be conducted according to the ethical guidelines that are specified in the Curtin
\n University Human Research Ethics Committee (HREC) and the National Health and Medical
\n Research Council (NHMRC) guidelines. This trial has been approved by the Curtin University
\n HREC (approval number: HR90\/2014) and has been registered with ANZCTR (registration
\n number: ACTRN12614000536662), on 21 May 2014.\n <\/p>\nStudy design<\/h4>\n
\n undertaken over a 12\u00c2\u00a0week period, with a subsequent 12\u00c2\u00a0week follow-up. Interested
\n participants will be screened according to the inclusion\/exclusion criteria and those
\n eligible will be allocated a number, stratified according to age and gender, and then
\n randomly allocated to one of the three groups of 40 participants, using dedicated
\n computer randomisation software 41], 42] The allocated number will also be used as the participants\u00e2\u20ac\u2122 identification number,
\n to be used on all records and questionnaires. The three groups will consist of: the
\n Control Group who will follow the Australian dietary guidelines 39] and National Physical Activity Guidelines for Adults 16], the Pamphlet Group who will be instructed in the weight management program by written
\n information, and the social media group who will receive exactly the same weight management
\n program via Facebook in the Facebook Group. [Please see Fig.\u00c2\u00a01: Flow of participants.] The initial twelve-week weight management program will be
\n presented to the two intervention groups as a condensed version of the CSIRO TWD 17], which includes information of the weight management program, along with weekly checklists
\n available from the CSIRO TWD 43]. Before the commencement of the trial, participants will attend an information session
\n specific to their group allocation, where the participation requirements, including
\n questionnaires and outcome measurements, will be explained. An additional file explains
\n this in greater detail [please see Additional file 1]. During the Facebook Group information session, participants will be provided with
\n additional information about using Facebook in this context. Facebook Group participants
\n will also be made aware of the role of the primary investigator as administrator and
\n facilitator of the Facebook Group. In addition, participants in this group will be
\n informed that at the completion of the twelve-week intervention period, all facilitation
\n will cease, however the group will still be monitored by the facilitator to ensure
\n that they continue to conduct themselves according the instructions provided. This
\n change in strategy for the twelve-week follow-up period will be used to determine
\n whether the Facebook Group has become self-sustaining. An additional file explains
\n the added information provided for Facebook Group participants in greater detail [please
\n see Additional file 2].<\/p>\nOutcome measures<\/h4>\n
\n circumference. Secondary outcome measures include blood glucose, insulin and lipids,
\n blood pressure, arterial stiffness and hip circumference, as indicators of changes
\n to cardiometabolic disease risk factors. Dietary and physical activity compliance,
\n eating behaviour, quality of life, mental well-being (stress, anxiety, and depression),
\n self-control, self-efficacy, Facebook activity, and program evaluation will also be
\n evaluated as further secondary outcome measures. These clinical and self-reported
\n measurements have been chosen to test the participants\u00e2\u20ac\u2122 adherence to the weight management
\n program, and to compare the outcomes of the two different weight loss program delivery
\n methods.\n <\/p>\nAssessments<\/h4>\n
\n of approximately 15\u00c2\u00a0min, as follows: at baseline, at weeks 6 and 12, and then again
\n for a follow-up appointment at week 24. Prior to each appointment, participants will
\n complete a Three-Day Food Record and selection of questionnaires to monitor compliance
\n and address some of the secondary outcome measures. The Bouchard Three-Day Physical
\n Activity Record 44] will be used to measure of total physical activity. The Three-Factor Eating Questionnaire
\n (TFEQ) 45] will provide a measure of dietary restraint, disinhibition and hunger, and will also
\n be used here to assess changes in satiety. The Self-Efficacy Scale 46] will be used to assess changes to participants\u00e2\u20ac\u2122 self-efficacy. The WHO Quality of
\n Life Questionnaire 47] will be used to determine changes in participants\u00e2\u20ac\u2122 quality of life. The short version
\n of the Depression Anxiety Stress Scale (DASS 21) 48] will be used to measure changes in general psychological wellbeing. The Self-Control
\n (Brief) Scale 49] will be used to provide an understanding of participants\u00e2\u20ac\u2122 impulse control as it relates
\n to eating behaviour. The Diet and Physical Activity Survey, constructed using the
\n Theory of Planned Behaviour 50], will be used to determine participants\u00e2\u20ac\u2122 intentions with regard to the dietary and
\n physical activity guidelines being used in the trial. The Survey of Weight Management
\n Program has some general questions regarding the ease of use of the dietary and physical
\n activity guidelines being utilized; there will be an extra section for Facebook Group
\n participants to assess the preferred device for accessing the weight management information
\n provided on Facebook. For Facebook Group participants only, the Social Media Survey
\n will be used to assess participants\u00e2\u20ac\u2122 attitudes to social media. The final questionnaire
\n will also be administered to Facebook Group participants only; the Facebook Intensity
\n and Network Density Scales contains a combination of questions used in previous social
\n media research 51], 52]. It will be adapted for this study to assess the degree to which participants make
\n use of Facebook, as well as the strength and frequency of the social interactions
\n within the Facebook Group. In addition, the Facebook Group page will be printed at
\n the end of each week to corroborate self-reported Facebook usage data and monitor
\n participants\u00e2\u20ac\u2122 online behaviour. Participants will be given questionnaires (including
\n the Food Record and Physical Activity Record) at each clinic appointment, according
\n to their group allocation. [For further information regarding the assessments please
\n see Table\u00c2\u00a01: Schedule of Assessments.] Participants will be instructed to use their participant
\n identification number only when completing all documents relating to this trial 42].<\/p>\n
\n (UM-018 Digital Scales; Tanita Corporation, Tokyo, Japan). Body composition will be
\n measured by bioelectrical impedance analysis (BIA) in light clothing without shoes
\n using the digital scales just mentioned. Height will be measured without shoes to
\n the nearest 0.1\u00c2\u00a0cm using a wall-mounted stadiometer (26SM 200\u00c2\u00a0cm SECA, Hamburg, Germany).
\n Height and weight measurements will be used to calculate participants\u00e2\u20ac\u2122 BMI. Waist
\n circumference will be measured in the standing position at the narrowest area between
\n the lateral lower rib and the iliac crest; hip circumference will be measured at the
\n widest area across the buttocks. Briefly, fasting blood glucose will be taken using
\n the Accu-Chek\u00c2\u00ae Performa glucometer and lancing device (Roche, Australia). Blood pressure
\n will be assessed with an automated, calibrated sphygmomanometer (Dinamap, Compact
\n T, Critikon, Germany). Pulse contour analysis (PCA) will be used to assess arterial
\n stiffness using the Pulse Trace PCA 2 (CareFusion, NSW, Australia). In addition, at
\n weeks 0 and 12 participants will be required to attend a local pathology collection
\n centre (PathWest Laboratory Medicine, Western Australia) for blood tests to measure
\n lipids (triglycerides (TG), total cholesterol (TC), low density lipoprotein (LDL)
\n and high density lipoprotein (HDL)) and insulin. [For further information regarding
\n the assessments please see Table\u00c2\u00a01: Schedule of Assessments.]\n <\/p>\nStatistical analysis<\/h4>\n
\n 80\u00c2\u00a0% statistical power to detect a medium to large effect size (Cohen\u00e2\u20ac\u2122s d<\/em>?=?0.4); that is, a difference of 6\u00c2\u00a0kg between the two intervention groups, with alpha
\n set at 0.05. To allow for an attrition rate of 20\u00c2\u00a0%, a total of 120 participants will
\n be recruited; i.e. 40 participants per group. Stratified randomisation will be used
\n to ensure that each group is matched in age and gender. The results will be analysed
\n using a mixed repeated measures analysis of variance (ANOVA) design. Data will be
\n expressed as mean (\u00c2\u00b1SEM) and assessed for normality to ensure that the assumptions
\n of the analysis are met. If significant between groups effects are present, post hoc
\n analysis will be conducted using the Least Significant Difference (LSD) method. Statistical
\n significance will be considered at p??0.05. All statistical analyses will be performed
\n using SPSS 21.0 for Windows (SPSS Inc., Chicago, IL), and conducted using the participant
\n identification number only 42].\n <\/p>\n","protected":false},"excerpt":{"rendered":"