Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000280909
Ethics application status
Approved
Date submitted
15/03/2011
Date registered
17/03/2011
Date last updated
13/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study of the efficacy of text messages in preventing BMI gain in young children
Scientific title
A randomized control trial of a text message-based intervention on body mass index change in overweight children aged 3 to 6 years
Secondary ID [1] 259774 0
nil
Universal Trial Number (UTN)
U1111-1119-9375
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
overweight 261358 0
Condition category
Condition code
Diet and Nutrition 259517 259517 0 0
Obesity
Public Health 259528 259528 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. a leaflet containing general information on obesity and health impacts, tips on healthy eating and healthy life style for the preschool children given at the baseline
2. short text messages containing reminders about healthy eating and healthy life style sending to parents everyday during the first month and repeat important nutritional tips every-two-day for one month.
Intervention code [1] 264209 0
Prevention
Intervention code [2] 264222 0
Lifestyle
Intervention code [3] 264223 0
Behaviour
Comparator / control treatment
a leaflet containing general information on obesity and health impacts, tips on healthy eating and healthy life style for the preschool children given at the baseline
Control group
Active

Outcomes
Primary outcome [1] 262319 0
BMI gain assessed by the difference of BMI [weight (kg) divided by height (metre) squared] measured before (March) and after the 2 months school break (May
Timepoint [1] 262319 0
two months (school vacation) after the randomisation
Secondary outcome [1] 273536 0
Child rearing during the school vacation using a questionnaire
Timepoint [1] 273536 0
two months (school vacation) after the randomisation

Eligibility
Key inclusion criteria
- overweight defined as BMI-z-score > +1 of the WHO BMI reference for age and gender
- attending the kindergartens in Hat Yai and Songkhla municipality
- child has at least one parent or caregiver with a mobile phone
Minimum age
3 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
severely handicapped child

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)
randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment outside Australia
Country [1] 3300 0
Thailand
State/province [1] 3300 0

Funding & Sponsors
Funding source category [1] 264652 0
University
Name [1] 264652 0
Faculty of Medicine, Prince of Songkla University
Country [1] 264652 0
Thailand
Primary sponsor type
Individual
Name
Ladda Mo-suwan, MD
Address
15 Karnjanavanich road, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110
Country
Thailand
Secondary sponsor category [1] 263791 0
Individual
Name [1] 263791 0
Maneerat Puwanant, MD
Address [1] 263791 0
15 Karnjanavanich road, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110
Country [1] 263791 0
Thailand
Secondary sponsor category [2] 263792 0
Individual
Name [2] 263792 0
Pasuree Sangsupawanich, MD
Address [2] 263792 0
15 Karnjanavanich road, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110
Country [2] 263792 0
Thailand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266648 0
Ethics Committee for Research in Human Subjects
Ethics committee address [1] 266648 0
15 Karnjanavanich road, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110
Ethics committee country [1] 266648 0
Thailand
Date submitted for ethics approval [1] 266648 0
Approval date [1] 266648 0
30/01/2011
Ethics approval number [1] 266648 0
EC 53-085-01-4-3

Summary
Brief summary
The study aims to investigate the efficacy of short text messages in preventing weight gain in the overweight preschool children during two months of school vacation.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 32338 0
Address 32338 0
Country 32338 0
Phone 32338 0
Fax 32338 0
Email 32338 0
Contact person for public queries
Name 15585 0
Dr Ladda Mo-suwan
Address 15585 0
15 Karnjanavanich road, Department of Pediatrics, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110
Country 15585 0
Thailand
Phone 15585 0
66-74-451273
Fax 15585 0
Email 15585 0
[email protected]
Contact person for scientific queries
Name 6513 0
Dr Ladda Mo-suwan
Address 6513 0
15 Karnjanavanich road, Department of Pediatrics, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110
Country 6513 0
Thailand
Phone 6513 0
66-74-451273
Fax 6513 0
Email 6513 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
No additional documents have been identified.