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Trial registered on ANZCTR


Registration number
ACTRN12617000954325p
Ethics application status
Submitted, not yet approved
Date submitted
19/05/2017
Date registered
4/07/2017
Date last updated
4/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of combining weight loss therapy with a Cognitive Behavioural Therapy group program that specifically addresses negative responses to body dissatisfaction in young, obese women.
Scientific title
Effectiveness of combining weight loss therapy with a Cognitive Behavioural Therapy group program that specifically addresses negative responses to body dissatisfaction in young, obese women.
Secondary ID [1] 291988 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
body dissatisfaction 303344 0
Obesity 303345 0
Condition category
Condition code
Mental Health 302773 302773 0 0
Studies of normal psychology, cognitive function and behaviour
Diet and Nutrition 302893 302893 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Obese women will be recruited via advertising targeting the 18-25y demographic, The study will be a two-arm randomised controlled trial where participants will undertake a 3-month weight loss and combined cognitive behavioural therapy (CBT) program conducted by both a psychologist and a dietitian. Participants will receive additional support for a following 3 months and have a final assessment at the 12 month mark. Participants will be assigned to either a standard care or the everyBODY (novel) arm. Body dissatisfaction measures, weight loss and change in body composition will be measured at baseline, 3, 6 and 12 months using scales, measuring tape and bio-electrical impedance. Dietary intake, physical activity, and a range of psychological measures will be assessed via questionnaires at the same time points.
Each arm of the study will have a maximum group of 10-12 women at any one time.
Materials: We have evidence-based protocols and existing resources for the diet, Standard Care and everyBODY CBT, phone coaching and SMS components. These have been harmonised using bridge funding from The University of Sydney. Regular staff meetings will support protocol fidelity. The clinical psychologists will be engaged in implementing both group programs in order to remove clinician effects and CIs Paxton and Rieger will oversee the quality and implementation of group sessions. Participant compliance will be monitored throughout by a) food, physical activity diaries or relevant technology/apps owned/available to participants; b) attendance records.
Mode of delivery:
The first 3 months the women will receive:
2x 60 minute individual appointments with a dietitian (Weeks 1 and 12)- resources provided in these sessions include: specifically developed nutrition resources (on low GI carbohydrates, goal setting, portion control), recipes and meal plans (adapted from the WOW study) printed on paper. All participants in both standard and novel arm will receive the same nutrition resources.
2x 15-30 minute optional drop in appointments with the dietitian (week 6 & 8) (no resources provided, session involve assistance/support with meal plan- questions and adherence)
11 weekly group sessions that each run for 90 minutes (2 with dietitian, week 2-3 and 9 with psychologist, week 4-12). Resources provided include specifically developed nutrition resources on macro-nutrients, fats, alcohol, snacking, healthy cooking methods, healthy takeaway foods and label reading. These resources will be provided to the participants via paper handouts. Both the novel and standard care arms receive the same nutrition information. The psychologist run group sessions are split into the everyBODY novel arm or the Standard care arm:
EveryBODY (novel arm): Is based on the "Set Your Body Free" program. This is a facilitator-supervised CBT group based intervention to address body dissatisfaction, unhealthy responses to weight stigma, psychological functioning and eating patterns. It has been previously evaluated and has a detailed program protocol (La Trobe University Human Ethics Committee Application No. 07-162 and Approval No. 03-18). The EveryBODY program targets the negative impact of body dissatisfaction and the sociocultural pressures to conform to narrow appearance ideals. Each group session contains activities to build levels of body satisfaction, positive body image and self-esteem. Self-monitoring and discussion activities will enable participants to explore their experience with weight stigma and body dissatisfaction and will support the development of skills to challenge negative thoughts and to understand broader body image pressures. Participants learn to reassess their value as individuals independent of body size and also to identify and change body avoidance strategies which include avoidance of physical activity and self-care behaviours.
Standard Care Arm: Participants will receive a CBT weight management lifestyle program founded on current best practice. This program has been evaluated in three trials by CI Rieger (Zwickert K, Rieger E, Caterson I. High and low intensity text-messaging combined with face-to-face treatment promotes weight loss maintenance in obese adults. Obes Res Clin Prac 2016; accepted 30/01/16. Rieger E, Steinbeck KS, Caterson I, et al. The use of motivational enhancement strategies for the maintenance of weight loss among obese individuals: a preliminary investigation. Diabetes Obes Metab 2009;11:637-40. Rieger E, Treasure J…Caterson I. The effectiveness of including support people in a cognitive behavioural weight loss maintenance programme for obese adults: study rationale and design. Clin Obes 2014;4:77-90.). This has a detailed program protocol and comprises of CBT weight management skills that build on concepts of the dietary program. Body dissatisfaction/weight stigma will not be addressed in this program.
For both the standard care and novel arm, paper and powerpoint presentations will be utilised.
3x 15-30 minute telephone coaching/consultations with a dietitian will be conducted at time points week 2, 4 & 10. (no resources provided, session involve assistance/support with meal plan- questions and adherence)

Between 3-6 months participants will receive:
1x 60 minute individual appointment with a dietitian (Weeks 26)-(no resources provided, session involve assistance/support with meal plan- questions and adherence)
1x 15-30 minute telephone coaching/consultations with a dietitian will be conducted at time points week 18. (no resources provided, session involve assistance/support with meal plan- questions and adherence)

Between week 1-26 participants will receive:
2-3 electronic SMS messages will be sent to participants weekly. The electronic messages are designed to dovetail the content of the group sessions. The SMS messages have been informed by evidence from PI Steinbeck’s Loozit trial (Nguyen B, Steinbeck KS, Baur LA. Two-year outcomes of an adjunctive telephone coaching and electronic contact intervention for adolescent weight-loss maintenance: the Loozit), and other studies.

Final assessment:
1x 60 minute assessment at the end of the 12 months (details on measurements taken as seen above)
Location: The group and individual sessions with the participants will take place at Charles Perkins Centre, Camperdown.
Intervention code [1] 298110 0
Behaviour
Intervention code [2] 298209 0
Treatment: Other
Comparator / control treatment
Participants in the standard care (control) arm will receive CBT best practice care that addresses weight loss. This group-based CBT weight management lifestyle
program is founded on current best practice care and has been evaluated in three trials by CI Rieger (1-3) It has a detailed program protocol and comprises an extension of CBT weight management skills. Body dissatisfaction/weight stigma will not be targeted.

In the first 3 months the control arm will receive:
*2x 30-60minute individual face-to-face appointments with a dietitian (Weeks 1, 12)
*2 optional 15-30minute drop in face-to-face appointments with the dietitian (week 6 & 8)
*11 weekly face-to-face group sessions that each run for 90 minutes
*3x 15-30 minute telephone coaching/consultations with a dietitian (week 2, 4 & 10)
*2-3 electronic SMS messages will be sent to participants weekly, starting from week 1 to Week 26. The electronic messages are designed to dovetail the content of the sessions.
*for the 1st 3 months participants will be asked to write food and exercise dairies and be weighed weekly.

Between 4-12 months the study will involve:
*2x 60 minute booster group sessions -(week 18 and 26)
*1x 15-30 minute telephone coaching/consultations with a dietitian (week 18)
*1x 30-60minute individual face-to-face appointments with a dietitian (Weeks 26)

Over the course of the study there will be 4 assessments (beginning of the study at week 12, 26 and 52). These assessments include taking measurements of:
*Weight
*Waist circumference (measured using a tape) and height (only measured once).
*Body composition (fat and lean) by a method called Bio-electrical Impedance.
*Diet intake information via a questionnaire (about 20 mins to complete each time)
*Psychological and behavioural measures via a number of questionnaires (about 45 minutes to complete each time).

References:
1. M Ho, M Gow, J Halim, K Chisholm, LA Baur, M Noakes, K Steinbeck, MR Kohn,
CT Cowell, SP Garnett. Effect of a prescriptive dietary intervention on psychological
dimensions of eating behavior in obese adolescents Int J Behav NutrPhy Act 2013;
10:119.
2. L Graves, SP Garnett, CT Cowell, LA Baur, A Ness, N Sattar, DA Lawlor. Waist to
height ratio and cardiometabolic risk factors in adolescence: findings from a
prospective birth cohort. Paediatric Obesity. DOI: 10.1111/j.2047-6310.2013.00192.x
3. G Joslowski, T Remer, KE Assmann, D Krupp, G Cheng, SP Garnett, et al. Animal
protein intakes during early life and adolescence differ in their relation to the growth
hormone-insulin-like-growth-factor axis in young adulthood. J Nutrition 2013 143: 7
Control group
Active

Outcomes
Primary outcome [1] 302163 0
To assess internalised weight stigma using the Weight Bias Internalization Scale
Timepoint [1] 302163 0
Baseline and at 3, 6 and 12 months after intervention commencement
Secondary outcome [1] 335368 0
To assess change in self-esteem using the Rosenburg Self-esteem scale
Timepoint [1] 335368 0
Baseline and at 3, 6 and 12 months after intervention commencement
Secondary outcome [2] 335369 0
Quality of life assessed using an impact of weight on quality of life questionnaire
Timepoint [2] 335369 0
Baseline and at 3, 6 and 12 months after intervention commencement
Secondary outcome [3] 335370 0
Dietary intake assessed by Food Frequency questionnaire
Timepoint [3] 335370 0
Baseline and at 3, 6 and 12 months after intervention commencement
Secondary outcome [4] 335371 0
Physical activity assessed using a questionnaire developed specifically for this study and by physical activity diary
Timepoint [4] 335371 0
Baseline and at 3, 6 and 12 months after intervention commencement
Secondary outcome [5] 335372 0
Change in Body composition (fat and lean) by Bio-electrical Impedance
Timepoint [5] 335372 0
Baseline and at 3, 6 and 12 months after intervention commencement

Eligibility
Key inclusion criteria
*Between 18-25 years of age
*Female
*A BMI > 30 kg/m2 and < 39.9 kg/m2 (calculated as weight (kg)/height (m)2
*Not pregnant or planning pregnancy within the next 12 months
*Able to attend the scheduled visits at the Charles Perkins Centre, RPA Hospital clinic
*Interested to participate in weight management
*Fluent in English
*Unrestricted access to the Internet and a smartphone
Minimum age
18 Years
Maximum age
25 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
-aged younger than 18 or older than 25
-BMI<29.9
-Obesity grade III or above (BMI >40 kg/m2)
-Secondary obesity
-Intellectual disability
-Significant medical or psychiatric illness
-Pregnancy or planning pregnancy within 6 months
-Taking medications that affect weight acutely
-Limited spoken English
-Current enrollment in a weight loss program
-Male

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)
Allocation is concealed- sealed envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size Calculation: As this is a pilot study, only 60 women will be recruited to form two groups of 30 at the group therapy stage of the intervention.
Analysis plan: Data will be entered and cleaned as collected. Analysis of the baseline, 3, 6 and 12 month data will be performed comparing both primary and secondary outcomes. Analysis will be undertaken by Dr Helen Parker and Dr Helen O’Connor. Support for statistical analysis will be provided by Dr Jenny Peat (The Children’s Hospital Westmead).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/07/2017
Actual
Date of last participant enrolment
Anticipated
3/12/2018
Actual
Date of last data collection
Anticipated
3/12/2019
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8038 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 16072 0
2050 - Camperdown
Recruitment postcode(s) [2] 16074 0
2150 - Parramatta Westfield
Recruitment postcode(s) [3] 16075 0
2000 - Sydney
Recruitment postcode(s) [4] 16076 0
2035 - Maroubra
Recruitment postcode(s) [5] 16077 0
2228 - Miranda
Recruitment postcode(s) [6] 16078 0
2017 - Waterloo

Funding & Sponsors
Funding source category [1] 296500 0
Charities/Societies/Foundations
Name [1] 296500 0
Australian Rotary Health
Country [1] 296500 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 295462 0
None
Name [1] 295462 0
Address [1] 295462 0
Country [1] 295462 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 297725 0
the Ethics Review Committee (RPAH Zone) of the Sydney Local Health District
Ethics committee address [1] 297725 0
Ethics committee country [1] 297725 0
Australia
Date submitted for ethics approval [1] 297725 0
22/05/2017
Approval date [1] 297725 0
Ethics approval number [1] 297725 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74942 0
A/Prof Helen O’Connor
Address 74942 0
Charles Perkins Centre, University of Sydney, Camperdown NSW 2006
Country 74942 0
Australia
Phone 74942 0
+612 9351 9625
Fax 74942 0
Email 74942 0
helen.oconnor@sydney.edu.au
Contact person for public queries
Name 74943 0
Lindsey Thurlby
Address 74943 0
Charles Perkins Centre, University of Sydney, Camperdown NSW 2006
Country 74943 0
Australia
Phone 74943 0
+61 404 112 517
Fax 74943 0
Email 74943 0
lindsey.thurlby@sydney.edu.au
Contact person for scientific queries
Name 74944 0
Helen O’Connor
Address 74944 0
Charles Perkins Centre, University of Sydney, Camperdown NSW 2006
Country 74944 0
Australia
Phone 74944 0
+612 9351 9625
Fax 74944 0
Email 74944 0
helen.oconnor@sydney.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

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