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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]

Nil

Universal Trial Number (UTN)

Nil

Trial acronym

HeLP-her Rural

Linked study record

Health condition

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

Obesity

Condition category

Condition code

Diet and Nutrition

Obesity

Public Health

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]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

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]

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]

Baseline, 12 months and 24 months

Secondary outcome [1]

Secondary outcomes:
a) anthropometry using standard protocols - meaaurments taken by qualified health professionals

Timepoint [1]

Baseline, 12 months and 24 months

Secondary outcome [2]

b) dietary energy and macronutrients, assessed using a validated Cancer Council Food Frequency Questionnaire

Timepoint [2]

At baseline and 12 and 24 months

Secondary outcome [3]

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]

These measures will be taken at baseline, 12, 24 months

Secondary outcome [4]

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]

Baseline, 12 and 24 months.

Eligibility

Key inclusion criteria

Women of reproductive age

Minimum age

18 Years

Maximum age

55 Years

Sex

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

1/09/2012

Actual

14/09/2012

Date of last participant enrolment

Anticipated

Actual

19/04/2013

Date of last data collection

Anticipated

Actual

Sample size

Target

650

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Hospital

Name [1]

Southern Health

Address [1]

Monash Medical Centre
246 Clayton Road
Clayton VIC 3168

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

Deakin University

Address [2]

Deakin University
221 Burwood Highway Burwood VIC 3125

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health Human Research Ethics Committee

Ethics committee address [1]

246 Clayton Road 
Clayton 
Victoria 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/02/2012

Approval date [1]

28/03/2012

Ethics approval number [1]

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

Dr Dr Catherine Lombard

Address

Monash Centre for Health Research and Implementation (MCHRI). 43-51 Kankook Grove Clayton, 3168 VIC

Country

Australia

Phone

+61 3 95947582

Fax

catherine.lombard@monash.edu.au

Contact person for public queries

Name

Catherine Lombard

Address

Women’s Health Research Program, 43-51 Kanooka Grove, Clayton
VIC 3168

Country

Australia

Phone

+ 61 (03)9594 7532

Fax

Catherine.Lombard@monash.edu

Contact person for scientific queries

Name

Catherine Lombard

Address

Monash Centre for Health Research and Implementation, 43-51 Kanooka Grove Clayton, 3168, VIC

Country

Australia

Phone

+ 61 (03)9594 7532

Fax

Catherine.Lombard@monash.edu

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

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effectiveness and implementation of an obesity prevention intervention: the HeLP-her Rural cluster randomised controlled trial.	2014	https://dx.doi.org/10.1186/1471-2458-14-608
Embase	Acceptability of delivery modes for lifestyle advice in a large scale randomised controlled obesity prevention trial.	2015	https://dx.doi.org/10.1186/s12889-015-1995-8
Embase	Engaging rural women in healthy lifestyle programs: Insights from a randomized controlled trial.	2015	https://dx.doi.org/10.1186/s13063-015-0860-5
Embase	Initiating and continuing behaviour change within a weight gain prevention trial a qualitative investigation.	2015	https://dx.doi.org/10.1371/journal.pone.0119773
Embase	Evaluation of a large healthy lifestyle program: informing program implementation and scale-up in the prevention of obesity.	2016
Embase	Optimizing Implementation of Obesity Prevention Programs: A Qualitative Investigation Within a Large-Scale Randomized Controlled Trial.	2016	https://dx.doi.org/10.1111/jrh.12133
Embase	Effect of a low-intensity, self-management lifestyle intervention on knee pain in community-based young to middle-aged rural women: A cluster randomised controlled trial.	2018	https://dx.doi.org/10.1186/s13075-018-1572-5

N.B. These documents automatically identified may not have been verified by the study sponsor.

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