Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001243505
Ethics application status
Approved
Date submitted
16/10/2015
Date registered
12/11/2015
Date last updated
12/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of Nutrition Education for Overweight/Obese Mother with Stunted Children (NEO-MOM) in reducing double burden of malnutrition
Scientific title
The effectiveness of Nutrition Education for Overweight/Obese Mother with Stunted Children (NEO-MOM) in reducing double burden of malnutrition
Secondary ID [1] 287685 0
Nil known
Universal Trial Number (UTN)
U1111-1175-5834
Trial acronym
NEO-MOM Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Maternal Overweight 296519 0
Maternal Obesity 296520 0
Child Stunting 296521 0
Double Burden of Malnutrition 296522 0
Condition category
Condition code
Diet and Nutrition 296777 296777 0 0
Obesity
Diet and Nutrition 296778 296778 0 0
Other diet and nutrition disorders
Public Health 296779 296779 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
NEO-MOM project is a randomized controlled trial research with 3 months behavior intervention towards households with stunted children and overweight/obese mother (SCOWT). The intervention in NEO-MOM project will consist of combination of 6 sessions Nutrition Education and 6 sessions of motivational interviewing through home visit. The sessions will be conducted in biweekly basis or every two weeks or twice a months. The 6 nutrition intervention sessions will be administered alternatively with home visit (motivational interviewing session) throughout the intervention period. In total, the intervention will span 3 months. The approximate duration of each nutrition education session is 100 minutes consist of 50 minutes class session followed by 50 minutes hands-on experience. The motivational interviewing session approximately lasted for 1 hour. The nutrition education class will be administered by 3 co-researchers in Indonesia. They are faculty members of Department of Nutrition, Universitas Airlangga with expertise in nutrition and behavioral change intervention. All of them hold master degree in public health or community nutrition. The hands-on experience session will be delivered by 2 trained research assistants that holds bachelor degree in public health nutrition. The motivational interviewing session (through home visit) will be delivered by trained community health worker that live in participants living area. The sessions are administered to mothers only. The general content of the 6 sessions’ nutrition educations are: session 1) 50 minutes nutrition education class on the introduction on the double burden of malnutrition, especially consequences and management of overweight/obesity and child stunting. The session followed by 20 minutes dance session and 30 minutes hands-on experience on making goal setting to improve physical activity (as in daily steps), fruit and vegetable intake for mother and serving animal protein for their children; 2) 50 minutes nutrition education class on healthy grocery shopping followed by 20 minutes dance session and 30 minutes mocked grocery shopping. 3) 50 minutes nutrition education class on Indonesian balance diet and Indonesian version of MyPlate followed by 20 minutes dance session and 30 minutes menu making for under five year old children with emphasize of including animal protein (chicken liver, catfish or egg). 4) 30 minutes nutrition education class on healthy cooking method followed by 20 minutes dance session and 60 minutes cooking demonstration; 5) 50 minutes nutrition education class on Child feeding practice with emphasize of responsive feeding followed by 20 minutes dance session and 30 minutes role play and jingle/song making related to combating child stunting. 6) 50 minutes FGD on how to overcome barriers towards child feeding practice followed by 20 minutes dance session and 30 minutes creation of pledge and strategies to tackle stunted child and overweight/obese mother (SCOWT) from mothers own perspective. The motivational interviewing delivered through home visit (6 times throughout the study administered in alternate week from nutrition education class and hands-on activity session) will focus on providing verbal motivation for mothers to achieve their biweekly goal setting (consist of: improving daily steps, fruit and vegetables intake, and serving child with animal protein), and help them with strategies to overcome barriers. To monitor adherence to the intervention we will make a log of nutrition education sessions including attendance list filled by our research assistants, form of biweekly goal settings filled by mothers at the end of class and hands-on activity sessions. Through collaboration with local grocery store, we will monitor maternal grocery purchase from the recorded grocery voucher that we gave to the mothers each time they attend our class and hands-on session. In addition, to monitor adherence towards physical activity improvement we will monitor maternal daily steps using pedometer during home visit and record it into the log for each participants.
Intervention code [1] 293078 0
Behaviour
Comparator / control treatment
Control group will be an active control where they receive regular care for malnourished children by Indonesian government through sub-district health center ("puskesmas"). In addition both control and intervention group will receive 6 sets of educational materials in the form of booklets that describe strategies to improve the health of stunted children as well as overweight mothers align with the construct of social cognitive theory (SCT)
Control group
Active

Outcomes
Primary outcome [1] 296384 0
Prevalence of child stunting as measured by height for age z-score (HAZ) using the 2005 WHO reference
Timepoint [1] 296384 0
Baseline, and at 3, 6 and 12 months after intervention commencement
Primary outcome [2] 296385 0
Prevalence of maternal overweight and obesity as measured by Body Mass Index (BMI) of the mother
Timepoint [2] 296385 0
Baseline, and at 3, 6, and 12 months after intervention commencement
Primary outcome [3] 296386 0
Prevalence of Stunted Child and Overweight/Obese Mother (SCOWT) as measure by child's HAZ and maternal BMI
Timepoint [3] 296386 0
Baseline, and at 3, 6 and 12 months after intervention commencement
Secondary outcome [1] 318307 0
Maternal self-efficacy for eating fruit and vegetables as measured using 28 items questionnaire with Likert scale answer. It was designed specifically for this study.
Timepoint [1] 318307 0
Baseline and at 3, 6 and 12 months after intervention commencement
Secondary outcome [2] 318308 0
Maternal self-efficacy for feeding their child with animal protein as measured using 25 items questionnaire with Likert scale answer. It was designed specifically for this study.
Timepoint [2] 318308 0
Baseline, and at 3, 6, and 12 months after intervention commencement
Secondary outcome [3] 318309 0
Maternal physical activity as estimated from daily steps count measured using YanMax Digiwalker Pedometer SW200 (Tokyo, Japan).
Timepoint [3] 318309 0
Baseline, and at 3, 6 and 12 months after intervention commencement. At each time point the pedometer is worn for 3 days
Secondary outcome [4] 318310 0
Maternal outcome expectation as assessed using 30 items questionnaire with Likert scale answer. It was designed specifically for this study.
Timepoint [4] 318310 0
Baseline, and at 3, 6 and 12 months after intervention commencement
Secondary outcome [5] 318311 0
Maternal dietary intake as assessed using repeated 24 hours dietary food recall
Timepoint [5] 318311 0
Baseline, and at 3, 6 and 12 months after intervention commencement
Secondary outcome [6] 318312 0
Maternal Dietary Diversity as assessed using 16 food groups of Household Dietary Diversity SCore (HDDS) categorization from FAO
Timepoint [6] 318312 0
Baseline, and at 3, 6 and 12 months after intervention commencement
Secondary outcome [7] 318313 0
Maternal Nutrition Literacy as assessed 28 items questionnaire. It was designed specifically for this study.
Timepoint [7] 318313 0
Baseline, and at 3, 6 and 12 months after intervention commencement

Eligibility
Key inclusion criteria
The inclusion criteria are: fluent in conventional Bahasa Indonesia, permanent resident and planning to stay in Surabaya City for at least 6 months, having stunted under five years old child, and being overweight/obese. In addition, the child has to be registered in the community health post (posyandu) and receiving complementary feeding program form Indonesian government. The minimum age of the child is 2 years or 24 months at the time of enrollment.
Minimum age
2 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria are: either the mother or the child have physical disability, mother participate in a weight loss program or deliberately fasting due to spiritual deed and if child is diagnosed with serious medical problems.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software (excel 2013)
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
To analyze the difference in the outcome from control and intervention group, the test of ANOVA was used. This statistical analysis was adjusted for possible confounding such as maternal characteristics, SES and household characteristics. All data analysis performed in IBM SPSS Statistics 22. The power calculation of our main outcome variables is based on the previous RCT in Bangladesh with similar 3 months length and twice a month intensive nutrition education intervention along with complementary feeding on child’s height gain (Roy et al. 2005). Even though our study did not directly provide complementary feeding, it is one of our inclusion criteria that participant in our study must receive complementary feeding program from the government of Indonesia. The effect size of provision of complementary food and intensive nutrition education on height gain (cm) in Bangladesh was 0.80 (95%CI=0.007-1.53). We select this fairly large effect size of 0.8 expressed as mean difference in child’s height, which translates to an ability to detect a difference between two groups of 0.80 cm child’s height at 3 months follow-up. Our study has a 90% power to detect changes that may be modest at the individual level, but would have an important impact if occurring at the population level. Minimum total sample size of 66 is needed to detect these differences in our primary hypothesis, with two tailed alpha of 0.05. Assuming dropout rate of 3%, the total sample size of 68 will be required (34 in intervention group and 34 in control group/usual care).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
26/10/2015
Date of last participant enrolment
Anticipated
16/11/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment outside Australia
Country [1] 7249 0
Indonesia
State/province [1] 7249 0
East Java

Funding & Sponsors
Funding source category [1] 292235 0
Self funded/Unfunded
Name [1] 292235 0
Trias Mahmudiono
Country [1] 292235 0
Indonesia
Funding source category [2] 292236 0
Self funded/Unfunded
Name [2] 292236 0
Richard Rosenkranz
Country [2] 292236 0
United States of America
Primary sponsor type
Individual
Name
Trias Mahmudiono
Address
Department of Nutrition,
Faculty of Public Health, Universitas Airlangga
Jl. Mulyorejo Kampus C Surabaya - INDONESIA 60115
Country
Indonesia
Secondary sponsor category [1] 290914 0
University
Name [1] 290914 0
Fakultas Kesehatan Masyarakat, Universitas Airlangga
Address [1] 290914 0
Jl. Mulyorejo Kampus C Surabaya - INDONESIA 60115
Country [1] 290914 0
Indonesia
Other collaborator category [1] 278662 0
Individual
Name [1] 278662 0
Dini Ririn Andrias
Address [1] 278662 0
Department of Nutrition, Faculty of Public Health, Universitas Airlangga
Jl. Mulyorejo Kampus C Surabaya - INDONESIA 60115
Country [1] 278662 0
Indonesia
Other collaborator category [2] 278663 0
Individual
Name [2] 278663 0
Triska Susila Nindya
Address [2] 278663 0
Department of Nutrition, Faculty of Public Health, Universitas Airlangga
Jl. Mulyorejo Kampus C Surabaya - INDONESIA 60115
Country [2] 278663 0
Indonesia
Other collaborator category [3] 278664 0
Individual
Name [3] 278664 0
Hario Megatsari
Address [3] 278664 0
Department of Health Education and Behavior, Faculty of Public Health, Universitas Airlangga
Jl. Mulyorejo Kampus C Surabaya - INDONESIA 60115
Country [3] 278664 0
Indonesia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293702 0
Rick Scheidt, Chair; Committee on Research Involving Human Subjects
Ethics committee address [1] 293702 0
Ethics committee country [1] 293702 0
United States of America
Date submitted for ethics approval [1] 293702 0
18/09/2015
Approval date [1] 293702 0
08/10/2015
Ethics approval number [1] 293702 0
7894

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

Contacts
Principal investigator
Name 61018 0
Mr Trias Mahmudiono
Address 61018 0
Department of Nutrition,
Faculty of Public Health, Universitas Airlangga
Jl. Mulyorejo Kampus C Surabaya - INDONESIA 60115
Country 61018 0
Indonesia
Phone 61018 0
+62 31 5964808
Fax 61018 0
+62 31 5964809
Email 61018 0
[email protected]
Contact person for public queries
Name 61019 0
Trias Mahmudiono
Address 61019 0
Department of Nutrition,
Faculty of Public Health, Universitas Airlangga
Jl. Mulyorejo Kampus C Surabaya - INDONESIA 60115
Country 61019 0
Indonesia
Phone 61019 0
+62 31 5964808
Fax 61019 0
+62 31 5964809
Email 61019 0
[email protected]
Contact person for scientific queries
Name 61020 0
Trias Mahmudiono
Address 61020 0
Department of Nutrition,
Faculty of Public Health, Universitas Airlangga
Jl. Mulyorejo Kampus C Surabaya - INDONESIA 60115
Country 61020 0
Indonesia
Phone 61020 0
+62 31 5964808
Fax 61020 0
+62 31 5964809
Email 61020 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
EmbaseThe effectiveness of nutrition education for overweight/obese mothers with stunted children (NEO-MOM) in reducing the double burden of malnutrition in Indonesia: study protocol for a randomized controlled trial.2016https://dx.doi.org/10.1186/s12889-016-3155-1
N.B. These documents automatically identified may not have been verified by the study sponsor.