ANZCTR - Registration

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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]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

body dissatisfaction

Obesity

Condition category

Condition code

Mental Health

Studies of normal psychology, cognitive function and behaviour

Diet and Nutrition

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]

Behaviour

Intervention code [2]

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]

To assess internalised weight stigma using the Weight Bias Internalization Scale

Timepoint [1]