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Trial registered on ANZCTR


Registration number
ACTRN12612000115831
Ethics application status
Approved
Date submitted
23/01/2012
Date registered
24/01/2012
Date last updated
10/12/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Preventing weight gain in young to mid-age women living in rural communities: a cluster randomised controlled trial (RCT)
Scientific title
In women living in rural communities does a low intensity self-management intervention prevent weight gain over one year, compared to a control group receiving health information alone?
Secondary ID [1] 279774 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
HeLP-her Rural
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 285656 0
Condition category
Condition code
Diet and Nutrition 285832 285832 0 0
Obesity
Public Health 285842 285842 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. The intervention participants will attend a group session at a central location such as the local primary school at a specified time in each participating town. This session will take approximately 2 hours.
2. Women will have the project explained individually and baseline measures assessed
3. Following baseline assessment a health professional will deliver a group session according to the program manual on achieving a healthy lifestyle. Participants will receive a program specific manual and advised on how to access program website, and asked to weigh themselves regularly.
4. During week 2-6 participants will work through the three sessions in the manual. The intervention content includes five clear healthy eating messages based on population healthy eating guidelines and simple physical activity messages to be moderately active that are delivered in a non-prescriptive format. Intervention content is underpinned by key components of the behavioural theory including skills of goal setting, action planning and self-monitoring all of which are important factors in long-term behavioural change. Each session will take participants approximately 20 minutes to complete.
5. At 16 weeks they will receive a telephone coaching session to review progress, provide encouragement and assistance and to ensure skill sessions are completed. This session will take approximately 20 minutes.

On going support: Continued support is important to establish new behaviours.
1. The intervention group will receive monthly mobile phone text messages (SMS) throughout the intervention until week fifty-two. The content of these text messages will be simple strategies to improve physical activity such as "remember exercise 30 minutes a day" or healthy eating messages such as "a lower fat diet with lots fruit and veg is best for health and weight". The messages will also encourage self monitoring such as "Weigh yourself and make an action plan each week".
Intervention code [1] 284097 0
Prevention
Intervention code [2] 284103 0
Lifestyle
Intervention code [3] 284104 0
Behaviour
Comparator / control treatment
1. The control participants will attend a single group session at a central location such as a primary school at a specified time in each participating town.
2. Women will have the project explained and baseline anthropometric measures assessed privately.
3. Following baseline assessment a health professional will deliver session to the group. The session content will be based on readily available Australian Population Dietary and Physical Activity Guidelines, and participants will receive the accompanying guideline brochures.
4. No specific or individual advice will be provided.
5. After the completion of the research program control participants will be given access to the program resources, website and materials (after 24 months).
Control group
Active

Outcomes
Primary outcome [1] 286342 0
Primary outcome is the difference in weight gain between groups: all participants will be weighed to the nearest 0.1 kg in light clothing, without shoes, and with an empty bladder on a single electronic scale calibrated prior to each time point.
Timepoint [1] 286342 0
Baseline, 12 months and 24 months
Secondary outcome [1] 295639 0
Secondary outcomes:
a) anthropometry using standard protocols - meaaurments taken by qualified health professionals
Timepoint [1] 295639 0
Baseline, 12 months and 24 months
Secondary outcome [2] 295646 0
b) dietary energy and macronutrients, assessed using a validated Cancer Council Food Frequency Questionnaire
Timepoint [2] 295646 0
At baseline and 12 and 24 months
Secondary outcome [3] 295647 0
c) Physical activity, measured using a validated international physical activity questionnaire (IPAQ) which measures usual weekly physical activity, plus a sealed Yamax digiwalker pedometer worn for 7 days
Timepoint [3] 295647 0
These measures will be taken at baseline, 12, 24 months
Secondary outcome [4] 295648 0
d) Self-management strategies which will be assessed using the self-management questionnaire which includes 12 items on cognitive and behavioural strategies related to physical activity and diet
Timepoint [4] 295648 0
Baseline, 12 and 24 months.

Eligibility
Key inclusion criteria
Women of reproductive age
Minimum age
18 Years
Maximum age
55 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1)Serious physical or psychological condition
2)Type 1 Diabetes Mellitus
3)Pregnancy or become pregnant during the study
4)Breast feeding
5)Taking weight control medications
6)Had obesity surgery
7)Malignancy

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
In both the intervention and control communities, women will be invited to participate in a healthy lifestyle research program. Women will be invited to participate using local media, and flyers attached to newsletters via local schools, kindergartens, maternal and child health centres and social clubs.
1. Letter to the Manager of Community Services at local government areas relevant to this project advising on the overall aims and methods of the project.
2. Letters sent to school principal/ kindergarten directors and local women’s organisations advising of the project and inviting support.
3. Follow up phone call made with school principal, kindergarten directors to answer any questions they may have regarding the project.
4. If the school principal and kindergarten directors and any other relevant body agrees to support the recruiting and delivery of the project, we will arrange for flyers to be attached to newsletters to mothers. These flyers will invite women to participate in the program. There will be no costs incurred by the supporting organisations.
5. If agreed by the organisation leaders, research staff will be available to give a presentation to women e.g via assembly or can be available at ‘pick up time’ to provide project information to interested women.
6. Women interested will be invited to complete a replied paid notice, to email or phone their interest and proceed through eligibility screening.

Screening process will be done via online or phone interview.

Allocation of treatment will occur via randomization.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each town will be randomised to receive either the intervention or control, this randomization process will be computer generated. A statistician independent of the study team will implement the randomisation and administer allocation to ensure concealment. Participants will be allocated to intervention or control according to town of residence. Participants will be blinded to group allocation but will be aware they are participating in a healthy lifestyle intervention. Team members involved in data management will be blind to group allocation and will not participate in intervention delivery.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284558 0
Government body
Name [1] 284558 0
National Health and Medical Research Council
Address [1] 284558 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 284558 0
Australia
Primary sponsor type
University
Name
School Public Health and Preventive Medicine, Monash University
Address
Monash Centre for Health Research and Implementation (MCHRI), School of Public Health and Preventive Medicine,
Monash University.
43-51 Kanooka Grove Clayton 3168 VIC
Country
Australia
Secondary sponsor category [1] 283480 0
None
Name [1] 283480 0
Address [1] 283480 0
Country [1] 283480 0
Other collaborator category [1] 260470 0
Hospital
Name [1] 260470 0
Southern Health
Address [1] 260470 0
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country [1] 260470 0
Australia
Other collaborator category [2] 260471 0
University
Name [2] 260471 0
Deakin University
Address [2] 260471 0
Deakin University
221 Burwood Highway Burwood VIC 3125
Country [2] 260471 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286538 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 286538 0
246 Clayton Road
Clayton
Victoria 3168
Ethics committee country [1] 286538 0
Australia
Date submitted for ethics approval [1] 286538 0
01/02/2012
Approval date [1] 286538 0
28/03/2012
Ethics approval number [1] 286538 0
12034B

Summary
Brief summary
A major focus on weight gain prevention is urgently needed in all population groups including adults who are still within the healthy weight range as well as in those already overweight. Women are an important target group with greater prevalence of obesity, in particular abdominal obesity. Weight gain prevention has the potential to underpin and reduce the need for, intensive and costly obesity treatment programs. information alone. Women in rural communities are living with greater disadvantage, limited access to health services, and according to the longitudinal data from Women’s Health Australia, are gaining weight faster than urban dwelling women. The positive effect of the HeLP-her intervention requires confirmation in larger studies, over longer time periods, in diverse populations and settings. The proposed trial presents an opportunity to evaluate the effectiveness of HeLP-her in young, rural women with benefits to physical, metabolic and reproductive health. If, as appears likely, we can prevent weight gain with a simple intervention which proves to be cost effective and can be delivered easily to most women in Australia, we can make a significant contribution toward preventing the predicted upward shift in population weight and the consequences of obesity related illness.

The Healthy Lifestyle Program (HeLP-her) is voluntary and participants were able to withdraw at any stage within the program. Written consent was provided by all participants and data collected was stored in a de-identified manner to ensure participant confidentiality.
Trial website
www.healthylifestyleprogram.org.au
Trial related presentations / publications
Publications
Lombard CB, Harrison CL, Kozica SL, Zoungas S, Keating C, Teede HJ. Effectiveness and implementation of an obesity prevention intervention: the HeLP-her Rural cluster randomised controlled trial. BMC public health. 2014;14(1):608.
Public notes

Contacts
Principal investigator
Name 33665 0
Dr Dr Catherine Lombard
Address 33665 0
Monash Centre for Health Research and Implementation (MCHRI). 43-51 Kankook Grove Clayton, 3168 VIC
Country 33665 0
Australia
Phone 33665 0
+61 3 95947582
Fax 33665 0
Email 33665 0
catherine.lombard@monash.edu.au
Contact person for public queries
Name 16912 0
Dr Catherine Lombard
Address 16912 0
Women’s Health Research Program, 43-51 Kanooka Grove, Clayton
VIC 3168
Country 16912 0
Australia
Phone 16912 0
+ 61 (03)9594 7532
Fax 16912 0
Email 16912 0
Catherine.Lombard@monash.edu
Contact person for scientific queries
Name 7840 0
Dr Catherine Lombard
Address 7840 0
Monash Centre for Health Research and Implementation, 43-51 Kanooka Grove Clayton, 3168, VIC
Country 7840 0
Australia
Phone 7840 0
+ 61 (03)9594 7532
Fax 7840 0
Email 7840 0
Catherine.Lombard@monash.edu

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary