Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000844347
Ethics application status
Approved
Date submitted
9/03/2017
Date registered
7/06/2017
Date last updated
7/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of Using Social Media in a Family-based Intervention for Childhood Obesity
Scientific title
Double-blind Randomized Controlled Field Trial Using Social Media in a Family-based Intervention for Overweight and Obese Children, Malaysia
Secondary ID [1] 291409 0
NMRR-14-685-21874
Secondary ID [2] 291410 0
GP-IPS/2013/9398400
Universal Trial Number (UTN)
Trial acronym
REDUCE (REorganise Diet, Unnecessary sCreen time and Exercise)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood obesity 302426 0
Condition category
Condition code
Public Health 301995 301995 0 0
Health promotion/education
Diet and Nutrition 302906 302906 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention programme is targetted for parents of obese and overweight primary school children. It uses REDUCE intervention programme, which is developed based on the social cognitive theory (SCT). REDUCE is an acronym for REorganise Diet, Unnecessary sCreen time and Exercise. The theory explains behaviour as a reciprocal interaction between person, behaviour and environmental factors. Changing the children’s behaviours on dietary intake and physical activity requires improvement in parental knowledge, self-efficacy, healthy practices, parenting skills and environment that is conducive to change which help facilitate and influence the children’s engagement in healthy behaviours. The key components of SCT used include self-monitoring, goal setting, self-efficacy, problem-solving, relapse prevention and stimulus control.

The intervention is provided to the parents in two phases. Phase one is a four-week group training using the REDUCE module. The training involves two face-to-face training and two sessions using Facebook. The face-to-face training is at week one and week four that take place at Universiti Putra Malaysia, half a day training for each session. It is delivered by the researcher who is a family health specialist. However, the intervention was developed to be delivered by paramedical staffs. The module has 8 units which covered on nutrition, physical activity, behavioural modification techniques and parental authoritative feeding style. The exercise tip in Unit 8 is delivered by a sport medicine specialist. For the two sessions using Facebook, the units in the REDUCE module are uploaded weekly and parents can download the units at their own convenience, with no time limit. Parents are encouraged to read, understand, give comments, and post questions on the same day. The researcher designates one-hour session to provide feedback and discussion in response to any queries by the parents on the same day. To ensure confidentiality, this Facebook group was made private, which is a readily built-in feature of Facebook. All sessions are delivered to parents only, except for face-to-face session two where both parents and children are invited.

The training phase is followed by a booster phase. The duration of the booster phase is three months and it comprises of weekly information, delivered via WhatsApp, containing the gist of the content of each unit that is provided during the four-week training, as well as health tips and performance feedback. The information in the booster session are extracted from the REDUCE module and formatted as a poster before sending to the WhatsApp dedicated group. The booster acts as a refresher and to strengthen their knowledge of the targeted behaviours of the REDUCE programme. Parents are encouraged to communicate with the researcher and other parents in the designated WhatsApp group to improve knowledge and skills of the parents in achieving the targeted behaviours.

In total, for the training and booster phase, parents are in contact with the researcher weekly for 16 weeks. Parents’ adherence in Facebook is assessed by the number and percentage of ‘seen’ in the Facebook. Parents’ adherence in WhatsApp is counted when they accessed the messages. To encourage participation in the social media, only members of the intervention group can access the dedicated social media groups (to assure confidentiality and privacy) and discussion are promoted among participants–researcher and participants–participants. Parents are also encouraged to support each other freely in the social media to maintain high motivation.
Intervention code [1] 297447 0
Treatment: Other
Intervention code [2] 297448 0
Lifestyle
Intervention code [3] 297449 0
Behaviour
Comparator / control treatment
The control group is a wait-list control group that will receive the REDUCE intervention after the 6-month follow-up assessments are completed. To encourage participation and prevent drop-outs from the wait-list group, incentives are given to children after the child’s physical measurements are taken and upon the return of the parent-completed questionnaire for each follow-up. These incentives are similar to those received by the intervention group which are mainly stationery materials.
Control group
Active

Outcomes
Primary outcome [1] 301421 0
Change in BMI z-score of the children. BMI z-score is derived from weight, height, gender and age using WHO AnthroPlus software. Height is measured without shoes to the nearest 0.1 cm using a mobile Seca stadiometer, model 213 (Seca, Hamburg, Germany). Weight is measured with light clothing, without shoes, and empty pockets, using a calibrated 2-point body fat analyser, portable scale, Omron Karada Scan, model HBF 212 (Omron, Kyoto, Japan). The measurements are recorded to the nearest 0.1 kg.
Timepoint [1] 301421 0
At baseline, immediately post-training (four weeks), and three and six months post-training.
Secondary outcome [1] 332587 0
Waist circumference percentile. Waist circumference is measured between the edge of the lower chest and iliac crest bone, with light clothing, using an outstretched tape meter (Seca, Hamburg, Germany) without any pressure on the body surface to the nearest 0.1cm. The waist circumference is converted to waist circumference percentile by reading off from the conversion table for the Malaysian children.
Timepoint [1] 332587 0
At baseline, immediately post-training (four weeks), and three and six months post-training.
Secondary outcome [2] 332588 0
Percentage of total body fat is measured with light clothing, without shoes, and empty pockets, using a calibrated 2-point body fat analyser, portable scale, Omron Karada Scan, model HBF 212.
Timepoint [2] 332588 0
At baseline, immediately post-training (four weeks), and three and six months post-training.
Secondary outcome [3] 332589 0
Children’s sugar-sweetened beverages intake is assessed using a parent-administered three-day food diary covering two weekdays and one weekend day.
Timepoint [3] 332589 0
At baseline, immediately post-training (four weeks), and three and six months post-training.
Secondary outcome [4] 332590 0
Children’s vegetable intake is assessed using a parent-administered three-day food diary covering two weekdays and one weekend day.
Timepoint [4] 332590 0
At baseline, immediately post-training (four weeks), and three and six months post-training.
Secondary outcome [5] 332591 0
Children’s fruits intake is assessed using a parent-administered three-day food diary covering two weekdays and one weekend day.
Timepoint [5] 332591 0
At baseline, immediately post-training (four weeks), and three and six months post-training.
Secondary outcome [6] 332592 0
Children’s unhealthy snack intake is assessed using a parent-administered three-day food diary covering two weekdays and one weekend day.
Timepoint [6] 332592 0
At baseline, immediately post-training (four weeks), and three and six months post-training.
Secondary outcome [7] 332593 0
Child eating behaviours are measured using the validated Children’s Eating Behaviour Questionnaire (CEBQ).
Timepoint [7] 332593 0
At baseline, immediately post-training (four weeks), and three and six months post-training.
Secondary outcome [8] 332594 0
Children's physical activity is measured subjectively using a validated parent-administered questionnaire, the children’s physical activity questionnaire (c-PAQ).
Timepoint [8] 332594 0
At baseline, immediately post-training (four weeks), and three and six months post-training.
Secondary outcome [9] 332595 0
Children's screen time is measured subjectively using a validated parent-administered questionnaire, the children’s physical activity questionnaire (c-PAQ).
Timepoint [9] 332595 0
At baseline, immediately post-training (four weeks), and three and six months post-training.
Secondary outcome [10] 332596 0
Parents’ feeding styles are measured using the validated Caregiver’s Feeding Style Questionnaire (CFSQ).
Timepoint [10] 332596 0
At baseline, immediately post-training (four weeks), and three and six months post-training.
Secondary outcome [11] 332597 0
Parents’ self-efficacy is measured using the Parent Efficacy for Child Healthy Weight Behaviour Scale (PECHWB).
Timepoint [11] 332597 0
At baseline, immediately post-training (four weeks), and three and six months post-training.
Secondary outcome [12] 332598 0
Parents' knowledge on nutrition, physical activity, obesity-related risks is measured using a newly developed questionnaire specifically for this study. This is a composite secondary outcome.
Timepoint [12] 332598 0
At baseline, immediately post-training (four weeks), and three and six months post-training.
Secondary outcome [13] 332601 0
Parents' healthy lifestyle practices are measured using a newly developed questionnaire specifically for this study.
Timepoint [13] 332601 0
At baseline, immediately post-training (four weeks), and three and six months post-training.

Eligibility
Key inclusion criteria
i) Malay parents of overweight and obese children with BMI z-scores of +1SD or more.
ii) Parents that are computer literate, have easy access to the internet and are willing to use social media as a medium of interaction.

iii) Children are 7 to 10 years of age during recruitment.
Minimum age
7 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
i) Parents reported their child as having co-morbidities, chronic disease, physical disabilities, learning disabilities, or that they were on any medication.

ii) Parents currently participating in other clinical trials.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
To ensure concealment of allocation, a “third-party” assignment is used where the list of parents codes (without the parents’ name) is sent to a research assistant (RA) to produce a computer generated randomisation list that allocated participants into intervention or wait-list groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation procedure with 1:1 allocation is performed using a computer generated randomisation, a software from the web page of Research Randomiser (Urbaniak and Plous, 2007).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculation is based on detecting BMI z-score differences between intervention and wait-list groups using the standard formula for trials using individual randomisation. A difference of 0.24 in BMI z-scores with a standard deviation of 0.48 is expected to be relevant, based on a previous study. Thus, n = 49 per group, at 95% level of significance and 80% power. The dropout rate is assumed at about 15% after randomisation; a minimum sample size of 56 parents per group is required to detect this difference with a two-sample t-test.

Data analyses are performed using SPSS version 22.0. Tests of normality are conducted on all data with interval and ratio scale using skewness, kurtosis, and graphs. For descriptive analysis, mean and standard deviation are used to describe continuous data and percentages are used for categorical data.

For inferential statistics, student’s t-test and chi-square test/ Fisher’s exact test are used for continuous and categorical data, respectively. Generalised Linear Mixed Model (GLMM) analysis is used to evaluate the effectiveness of the intervention, adjusted for baseline covariates on both continuous and categorical outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/02/2015
Date of last participant enrolment
Anticipated
Actual
10/02/2015
Date of last data collection
Anticipated
Actual
30/09/2015
Sample size
Target
112
Accrual to date
Final
134
Recruitment outside Australia
Country [1] 8727 0
Malaysia
State/province [1] 8727 0
Selangor

Funding & Sponsors
Funding source category [1] 295881 0
University
Name [1] 295881 0
Universiti Putra Malaysia
Country [1] 295881 0
Malaysia
Primary sponsor type
University
Name
Universiti Putra Malaysia
Address
43400 UPM Serdang,
Selangor,
Country
Malaysia
Secondary sponsor category [1] 294746 0
None
Name [1] 294746 0
Address [1] 294746 0
Country [1] 294746 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297160 0
Medical Research Ethics Committee for Human Research, Universiti Putra Malaysia
Ethics committee address [1] 297160 0
Ethics committee country [1] 297160 0
Malaysia
Date submitted for ethics approval [1] 297160 0
15/01/2014
Approval date [1] 297160 0
07/03/2014
Ethics approval number [1] 297160 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1568 1568 0 0
/AnzctrAttachments/372531-kelulusan JKEUPM.pdf (Ethics approval)
Attachments [2] 1569 1569 0 0
/AnzctrAttachments/372531-manuscript-IJPHCS-Drnorliza ahmad-revise.pdf (Publication)

Contacts
Principal investigator
Name 73182 0
Dr Norliza Ahmad
Address 73182 0
Department of Community Health,
Faculty of Medicine and Health Sciences,
Universiti Putra Malaysia,
43400 UPM Serdang,
Selangor
Country 73182 0
Malaysia
Phone 73182 0
Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor
Fax 73182 0
+603-89450151
Email 73182 0
[email protected]
Contact person for public queries
Name 73183 0
Norliza Ahmad
Address 73183 0
Department of Community Health,
Faculty of Medicine and Health Sciences,
Universiti Putra Malaysia,
43400 UPM Serdang,
Selangor
Country 73183 0
Malaysia
Phone 73183 0
+603-89472582
Fax 73183 0
+603-89450151
Email 73183 0
[email protected]
Contact person for scientific queries
Name 73184 0
Norliza Ahmad
Address 73184 0
Department of Community Health,
Faculty of Medicine and Health Sciences,
Universiti Putra Malaysia,
43400 UPM Serdang,
Selangor
Country 73184 0
Malaysia
Phone 73184 0
+603-89472582
Fax 73184 0
+603-89450151
Email 73184 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
EmbaseFamily-based intervention using face-to-face sessions and social media to improve Malay primary school children's adiposity: A randomized controlled field trial of the Malaysian REDUCE programme.2018https://dx.doi.org/10.1186/s12937-018-0379-1
N.B. These documents automatically identified may not have been verified by the study sponsor.