Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000459325
Ethics application status
Approved
Date submitted
21/03/2017
Date registered
30/03/2017
Date last updated
25/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does telephone and text behavioural support improve adherence to a community based obesity management program? A randomised cross-over trial
Scientific title
Does telephone and text behavioural support improve adherence to a community based obesity management program? A randomised cross-over trial
Secondary ID [1] 291493 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 302559 0
Condition category
Condition code
Diet and Nutrition 302091 302091 0 0
Obesity
Public Health 302131 302131 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This 8-month randomised cross-over trial is designed to determine if the addition of telephone and text message support to a community based obesity management program improves lifestyle intervention adherence and clinical outcomes when compared to standard care. The additional support will be grounded in behaviour change theory, with a range of behavioural treatment strategies targeted, including: goal setting, self-monitoring, motivational interviewing, problem solving, relapse prevention, stimulus control, cognitive restructuring and self-reinforcement. This study will be conducted within the ACT Health Obesity Management Service (OMS). Participants will be randomly assigned to receive four months of telephone and text message support (tech-support) in addition to standard OMS care, or standard OMS care alone. After four months, the participants will cross over to the alternative sequence for four additional months. One group will therefore receive the tech-support intervention first, followed by the standard care condition (TS-SC), while the other group will receive the standard care condition first, followed by the tech-support intervention (SC-TS). Telephone calls will be provided monthly throughout the four-month intervention period (maximum of four calls). A range of behavioural treatment strategies will be targeted within these calls, and participants will be guided to set two-three S.M.A.R.T goals to work toward over the following month. Potential strategies to achieve these goals will be discussed, including problem solving and self-monitoring. The information gathered within these telephone calls will be used to tailor and individualise the subsequent month of text messages. Three text messages will be sent each week, aimed to remind or prompt participants to strive toward their goals, as well as foster a sense of support and accountability. Wording of text messages will be tailored to individuals based on their chosen goals, identified barriers and strategies to overcome them, preparatory behaviours to achieve their goals and self-monitoring strategies. The primary investigator (Accredited Practicing Dietitian and Accredited Exercise Physiologist) will conduct all telephone calls at a time mutually convenient to both parties. Telephone calls will be roughly 15-20 minutes in duration. Text messages will be manually written every month following the participant’s telephone call and sent on an automated timer using a software program. A research assistant may be employed to assist with the intervention, pending the speed of rolling recruitment. If this does occur, fidelity checklists will be prepared for telephone calls, text messages and face-to-face assessment appointments. Checklists for each session will specify (a) prescribed/ scripted session content and (b) proscribed session content. All research assistants will be thoroughly orientated to the requirements.
Intervention code [1] 297561 0
Behaviour
Intervention code [2] 297562 0
Lifestyle
Comparator / control treatment
This is a cross-over trial - all participants will receive the intervention as well as standard OMS care. The OMS is a referral-based service that aims to support adults with Class III obesity (BMI >40kg/m2) to improve their health and wellbeing. The OMS is run by a multidisciplinary team, including medical officers, registered nurses, dietitians and a psychologist and exercise physiologist. The holistic weight management program includes group and individualised support, including a 4-session education group, allied health consultations, medical follow-up and a 12-week exercise program where appropriate.
Control group
Active

Outcomes
Primary outcome [1] 301533 0
Dietary adherence - measured using changes in dietary habits via the Fat and Fibre Behaviour Questionnaire. This questionnaire assesses eating habits over the previous month. Eleven items relate to consumption of high fat or fibre foods, and the remaining nine items ask about behaviours related to cooking, eating or choice of foods.
Timepoint [1] 301533 0
Baseline, 4 month, 8 months
Primary outcome [2] 301563 0
Physical activity adherence - measured by change in total minutes of physical activity per week and/or change in total steps per week using accelerometers worn for seven consecutive days, accompanied by a seven-day physical activity diary.
Timepoint [2] 301563 0
Baseline, 4 month, 8 months
Secondary outcome [1] 332946 0
Weight - measured without shoes using a digital scale accurate to 0.1kg.
Timepoint [1] 332946 0
Baseline, 4 month, 8 months
Secondary outcome [2] 333040 0
Eating self-efficacy - measured using the Weight Efficacy Lifestyle Questionnaire – Short Form (WEL-SF), an eight item self-report measure used to assess changes in weight management self-efficacy, with high scores reflecting self-confidence for controlling eating behaviour in particular situations.
Timepoint [2] 333040 0
Baseline, 4 month, 8 months
Secondary outcome [3] 333144 0
Exercise self-efficacy - measured using the Physical Activity Assessment Inventory (PAAI). The PAAI is a 13-item scale that asks respondents to rate how confident they are that they can perform their usual physical activity in a variety of circumstances. Scores range from 0 – 1300, with higher scores indicating greater self-efficacy for physical activity.
Timepoint [3] 333144 0
Baseline, 4 month, 8 months
Secondary outcome [4] 333235 0
BMI - measured using height and weight
Timepoint [4] 333235 0
Baseline, 4 month, 8 months
Secondary outcome [5] 333236 0
Waist circumference - measured in the horizontal plane midway between the lowest rib and the iliac crest.
Timepoint [5] 333236 0
Baseline, 4 month, 8 months
Secondary outcome [6] 352269 0
Treatment self-regulation, measured using the treatment self-regulation for diet and exercise questionnaires.
Timepoint [6] 352269 0
Baseline, 4 months, 8 months

Eligibility
Key inclusion criteria
Inclusion criteria include: (a) BMI >40kg/m2; (b) >18 years of age; (c) access to a mobile phone, computer and internet connection; (d) sufficient technological literacy and English skills; (e) willing and able to receive three weekly texts and one monthly phone call over a period of six months; and (f) willing and able to attend follow-up assessments over the next 12 months. Participants will be both male and female.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include: (a) presence of contraindications for low-moderate physical activity; (b) pregnancy; and (c) psychiatric or medial condition that would preclude full participation in the treatment.

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)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation with stratification for age (>/<50 years) and gender.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed-model analysis will be used to assess the effects of time (baseline, 4 month, 8 month) and group (control and intervention) on the dependent variables of dietary adherence, physical activity adherence, program attendance/attrition, weight loss, self-efficacy and motivational readiness. The data will be analysed using intention-to-treat principles.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/06/2017
Actual
21/07/2017
Date of last participant enrolment
Anticipated
15/12/2017
Actual
17/11/2017
Date of last data collection
Anticipated
14/12/2018
Actual
27/07/2018
Sample size
Target
50
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment postcode(s) [1] 15617 0
2617 - Belconnen

Funding & Sponsors
Funding source category [1] 295973 0
University
Name [1] 295973 0
University of Canberra Reserach Institute for Sport and Exericse
Country [1] 295973 0
Australia
Primary sponsor type
University
Name
University of Canberra Reserach Institute for Sport and Exercise
Address
University of Canberra Reserach Institute for Sport and Exercise, Building 29, University Drive South, University of Canberra, Bruce, ACT 2617
Country
Australia
Secondary sponsor category [1] 294866 0
Government body
Name [1] 294866 0
ACT Health
Address [1] 294866 0
Obesity Management Service, Belconnen Community Health Centre, 56 Lathlain street, Belconnen, ACT 2617
Country [1] 294866 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297243 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 297243 0
Ethics committee country [1] 297243 0
Australia
Date submitted for ethics approval [1] 297243 0
03/04/2017
Approval date [1] 297243 0
11/07/2017
Ethics approval number [1] 297243 0

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

Contacts
Principal investigator
Name 73438 0
Miss Emily Burgess
Address 73438 0
University of Canberra Research Institute for Sport and Exercise, Building 29, University Drive South, University of Canberra. Bruce, ACT 2617
Country 73438 0
Australia
Phone 73438 0
+61 402554987
Fax 73438 0
Email 73438 0
[email protected]
Contact person for public queries
Name 73439 0
Emily Burgess
Address 73439 0
University of Canberra Research Institute for Sport and Exercise, Building 29, University Drive South, University of Canberra. Bruce, ACT 2617
Country 73439 0
Australia
Phone 73439 0
+61 402554987
Fax 73439 0
Email 73439 0
[email protected]
Contact person for scientific queries
Name 73440 0
Emily Burgess
Address 73440 0
University of Canberra Research Institute for Sport and Exercise, Building 29, University Drive South, University of Canberra. Bruce, ACT 2617
Country 73440 0
Australia
Phone 73440 0
+61 402554987
Fax 73440 0
Email 73440 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo The addition of telephone and text message support... [More Details]
Study results articleYes Published: 11 September 2019 Lewis E, Huang H-C, ... [More Details]

Documents added automatically
No additional documents have been identified.