Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001022358
Ethics application status
Approved
Date submitted
21/05/2017
Date registered
14/07/2017
Date last updated
15/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Singapore Physical Activity and Nutrition Study: A community-based physical and nutrition intervention for women aged 50 years and above in recreational settings
Scientific title
A randomised controlled trial of a community-based physical activity and nutrition lifestyle intervention to examine the health risk parameters of older women aged 50 years and above in Singapore.
Secondary ID [1] 292003 0
Not applicable
Universal Trial Number (UTN)
Trial acronym
SPANS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus
 303385 0
Cardiovascular disease
 303386 0
Overweight/obesity 303387 0
Condition category
Condition code
Diet and Nutrition 302800 302800 0 0
Obesity
Public Health 302801 302801 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This 6-month community-based cluster randomised controlled trial (RCT) will involve the implementation and evaluation of a physical activity (PA) and nutrition program for community dwelling Singaporean women, who currently attend recreational centres (RCs are public government facilities open to the general community to promote social leisure activities) in their local neighbourhood. The intervention will include dietary education and counselling sessions, physical activity classes, and telephone contact by nutritionists and fitness instructors. Social Cognitive Theory with Motivational Interviewing (MI) will inform the development of strategies to support health behaviour change.

This 6-month community based intervention program will be conducted at the RCs and will comprise: a) nutrition education and dietary counselling sessions; b) group PA sessions; c) educational resources; d) follow-up phone contact and e) healthy text messages. Fitness instructors and nutritionists will undergo comprehensive training and provided with structured lesson plans. Those delivering the program (nutritionists and fitness instructors) will attend training session on MI techniques and implementation of the program content.

a. Group nutrition education (3 X 1 hour session), 1 session every 2 months and paired dietary counselling sessions (3 X 30-50 minutes session), 1 session every 2 months
These sessions will be implemented by qualified nutritionists trained in MI strategies, and incorporate a ‘buddy’ system whereby peers can pair up, share information, and support one another throughout the intervention. Program ambassadors will be responsible for recording participants’ attendance, contact details, and any feedback provided.

b. Group PA sessions
A variety of weekly PA session (12 X 1 hour session), 2 sessions per month over a period of 6 months such as resistance, strength training, and balancing exercises etc. led by program ambassadors trained in MI will help motivate participants to increase their PA levels. Participants will be encouraged to try and walk 30 minutes per day and reminded to monitor their progress and physical activity goals. These reminders will be emphasized during their monthly PA sessions, nutrition education sessions, paired dietary counselling, follow-up calls and healthy text messages.

c. Educational resources
-Calendar: Participants will receive easy, healthy recipes in a ‘health calendar’ to support healthy cooking practices. The calendar will also contain health tips acting as reminders to stay active and eat healthy.
-Booklets: Take home resources will provide information on PA and diet. The program ambassadors will introduce the 6-month intervention and distribute the resources at the 1st session prior to commencement of the intervention.
A) An ‘Active for Life’ booklet will be provided prior to the first PA session. The nutritionists will explain the content, referring participants to information on the benefits of PA; guidelines for frequency, intensity, time and type of PA; safety issues; and ask them to read and use the booklet as a guide before they embark on a series of PA sessions i.e. walking, strength training and balance sessions.
B) Five health booklets will be explained by the nutritionists during the group nutrition education sessions and distributed:
1) ‘Recipes for healthy aging’: Nutrition guide booklet (during session 1): my healthy plate model, dietary guidelines for older adults and servings sizes for various food groups.
2) ‘Recipes for healthy aging’: Recipe booklet (during session 1), tasty and nutritious recipes as well as healthy eating tips.
3) ‘Lowering BP’ booklet (during session 4): healthy BP range; problems of high BP levels; dietary sources of sodium; ways to control BP levels; and learn ways to manage BP levels.
4) ‘Keeping Cholesterol in Check’ booklet (during session 5): various dietary sources of fat and cholesterol; preferred ways to reduce dietary cholesterol; and education on recipe modification for better heart health.
5) ‘Tips to Better Health- Keeping my blood sugar level healthy’ booklet (during session 6): What is pre – diabetes and diabetes; why worry about it; and how do I keep a healthy lifestyle.

d. Telephone contact
The nutritionist and program ambassadors will conduct monthly follow-up calls with participants (6 sessions of 15 minutes per month), once every month that aim to support the adoption of healthy PA and dietary intake and to monitor progress towards health goals.

e. Healthy text messages
One different healthy physical activity and nutrition messages will be sent to all intervention participants every month for a period of 6 months by the nutritionists and fitness instructors to remind them to practice healthy lifestyle habits.
Intervention code [1] 298132 0
Lifestyle
Intervention code [2] 298133 0
Prevention
Comparator / control treatment
The control clusters will only undergo pre and post data collection and will not receive the intervention. However, they will receive a falls prevention booklet and an incentive of health products to demonstrate our appreciation for their time.
Control group
Active

Outcomes
Primary outcome [1] 302180 0
Lipid profile: cholesterol and triglycerides.

The concentration of triglyceride, total cholesterol, HDL-C, LDL-C measured by fasting blood samples.
Timepoint [1] 302180 0
After the completion of the 6 months intervention (post screening)
Primary outcome [2] 302181 0
Blood glucose

The concentration of blood glucose measured by fasting blood samples.
Timepoint [2] 302181 0
After completion of the 6 months intervention (post screening)
Primary outcome [3] 302182 0
Self-reported levels of physical activity behaviour (incidental, programmed and sedentary)

This will be obtained through the administration of a Global Physical Activity Questionnaire (GPAQ), a validated and reliable instrument.
Timepoint [3] 302182 0
After completion of 6 months intervention (post screening)
Secondary outcome [1] 335109 0
Body Mass Index (BMI)
Weight will be measured (wearing light clothing without shoes) using a calibrated electronic scale and recorded to the nearest 0.01 kg while height will be measured with a portable stadiometer to the nearest 0.1 cm (barefooted).
Timepoint [1] 335109 0
After completion of 6 months intervention (post screening)
Secondary outcome [2] 335110 0
Objective measured levels of PA (incidental, programmed and sedentary) using ActiGraph GXT3 accelerometers.

The data from the accelerometers (ActiGraph GXT3) will be downloaded using the ActiLife 6 software.
Timepoint [2] 335110 0
After completion of 6 months intervention (post screening)
Secondary outcome [3] 335111 0
Self reported dietary behaviors on wholegrains, fat, oils, salt, sugar, fruits and vegetables consumption using STEPS dietary behavior questionnaire developed by World Health Organisation (WHO).
.
Timepoint [3] 335111 0
After completion of 6 months (post screening)
Secondary outcome [4] 335810 0
Waist Hip Ratio (WHR)

WC will be measured by a non-stretch tape, standing up at the level midway between the lowest rib margin and the iliac crest and recorded to the nearest 0.1 cm.
Hip circumference will be measured at the largest level of the symphysis pubis and gluteus maximus. WHR will be calculated as waist circumference divided by hip circumference.
Timepoint [4] 335810 0
After completion of 6 month intervention (post screening)
Secondary outcome [5] 335811 0
Body fat percentage.

Body fat percentage will be measured by an Endo Body Fat Composition Analyzer E-DBS908 (without shoes and socks).

Timepoint [5] 335811 0
After completion of 6 month intervention (post screening)
Secondary outcome [6] 335812 0
Waist circumference (WC)

WC will be measured by a non-stretch tape, standing up at the level midway between the lowest rib margin and the iliac crest and recorded to the nearest 0.1 cm.
Timepoint [6] 335812 0
After 6 month intervention (post screening)
Secondary outcome [7] 335813 0
Self-reported health related quality of life will be assessed using Short Form 8 questionnaire
Timepoint [7] 335813 0
After 6 month intervention (post health screening)

Eligibility
Key inclusion criteria
Participants will be required to be: a) aged 50 years and above; b) achieve less than 150 minutes of moderate intensity physical activity (PA) per week; c) not have any medical condition that prohibit involvement in PA program; and d) not participating in any nutrition and PA research.

Minimum age
50 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The following exclusion criteria will apply;
1. After the pre-screening results, program ambassadors and nutritionists need to be aware to exclude participants with significantly elevated lipids and blood glucose levels. These relates to high TC (6.2 mmol/L), high LDL cholesterol (4.1- 4.8 mmol/L), low HDL (less than 1 mmol/L), high TG (2..3-4.4 mmol/L) and fasting plasma glucose greater than or equal to 7.0mmol/L or greater than 126mg/dL). They are to refer such cases to their medical practitioner for immediate action.
2. Participants who has taken part in any physical activity and nutrition program within the past year, or/and
3. is an individual who is residing in the same household as another participant that has already been recruited for the study (to avoid contamination).

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)
Program recruitment flyers will be placed on the RCs bulletin boards and promoted by the RC management. RC managers will provide the program ambassadors with the contact numbers of the interested participants. Potential participants will then be telephoned to explain the purpose of the study and to determine their eligibility based on the selection criteria. After the initial telephone screening, eligible participants will be invited to participate in the study, informed of their rights and confidentiality, and a baseline data collection date will be set at a central RC location. The baseline self-report data will be collected face-to-face by a program ambassador.
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Firstly, using simple randomisation through coin-tossing procedures,the five major districts in Singapore, was divided into the intervention clusters (districts: 2-North West, 3-Central, and 5-South East) and the control clusters (districts: 1–South West, 4-North East).

After that, randomisation of the RCs from all these 5 districts will be performed using computerised sequence generation to determine the 60 recreational centres (30 intervention RCs versus 30 control RCs) located in Singapore. A minimum of a 4 km radius between all selected RCs to avoid risk of contamination.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative analysis:
After data collection, subgroups of interest such as blood profiles, self-reported behaviours, and anthropometric measures will be examined and compared via the Statistical Package for the Social Science (SPSS) version 23 or STATA version 14. Descriptive and summary statistics will be used to quantify participants’ characteristics and outcome variables. Non-parametric statistics will be applied whenever non-normality of the outcomes are detected. Multi-variable mixed regression analyses will be used to confirm the effects of the proposed health intervention, taking into account the repeated measures (at two time points) and the clustering of the observations.

Qualitative Analysis:
All qualitative data will be transcribed within two weeks of interviewing. At least 10% of all transcribed data will be randomly selected and reviewed for each transcription. Transcribed data will be coded and common themes or categories created. Data will be collated, presented thematically and supported by direct quotes from participants. Data management of full transcripts and other text will be facilitated by the NVIVO software package. Participants will not be identified in any transcription. The consolidated criteria for reporting qualitative research (COREQ) will be utilised during the exit interviews.

The power calculations are based on a logistic mixed regression model with the prevalence of moderate intensity PA participation as the outcome variable. To account for an 80% data completion based on 2 time points (pre and post intervention), a total of n=600 adult women will be initially recruited at baseline. For the mixed regression analyses when adjusting for the clustering RCs, a final sample size of n=480 participants [240 participants per group] will allow for a 80% statistical power to detect a medium effect size of 10% improvement in moderate PA prevalence by the intervention group relative to the control group at a significance level of 5%. It also takes a 20% attrition rate and non-respondents into consideration within the duration of the study but without covariate adjustment.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/10/2016
Date of last participant enrolment
Anticipated
15/11/2018
Actual
1/10/2017
Date of last data collection
Anticipated
16/05/2019
Actual
31/03/2018
Sample size
Target
600
Accrual to date
Final
580
Recruitment outside Australia
Country [1] 8914 0
Singapore
State/province [1] 8914 0
Singapore

Funding & Sponsors
Funding source category [1] 296524 0
University
Name [1] 296524 0
Curtin University of Technology
Country [1] 296524 0
Australia
Primary sponsor type
University
Name
Curtin University of Technology
Address
Curtin University, Kent St Bentley WA, 6102
Country
Australia
Secondary sponsor category [1] 295482 0
None
Name [1] 295482 0
Address [1] 295482 0
Country [1] 295482 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297741 0
Curtin University Human Research Ethics Committee.
Ethics committee address [1] 297741 0
Ethics committee country [1] 297741 0
Australia
Date submitted for ethics approval [1] 297741 0
02/09/2016
Approval date [1] 297741 0
11/10/2016
Ethics approval number [1] 297741 0
HRE2016-0366

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

Contacts
Principal investigator
Name 74994 0
A/Prof Jonine Jancey
Address 74994 0
Curtin University
Kent St
Bentley WA 6102
Country 74994 0
Australia
Phone 74994 0
+618 9266 3807
Fax 74994 0
Email 74994 0
[email protected]
Contact person for public queries
Name 74995 0
Elaine Wong Yee Sing
Address 74995 0
Red Element Health International Pty Ltd
1 Sophia Road,
#07-23, Peace Centre.
Singapore 228149.


,
Country 74995 0
Singapore
Phone 74995 0
+65 81387834
Fax 74995 0
Email 74995 0
[email protected]
Contact person for scientific queries
Name 74996 0
Andy Lee
Address 74996 0
Curtin University
Kent St
Bentley WA 6102
Country 74996 0
Australia
Phone 74996 0
+618 9266 4180
Fax 74996 0
Email 74996 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePhysical activity and nutrition intervention for Singaporean women aged 50 years and above: Study protocol for a randomised controlled trial.2018https://dx.doi.org/10.1186/s13063-018-2562-2
N.B. These documents automatically identified may not have been verified by the study sponsor.