UndernutritionNCT05517395
The Effectiveness of HBM-based Education Program on Improve Knowledge and Behaviors
A study testing health nutrition education in people with Undernutrition and Stunting, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
The randomized controlled trial design with one intervention arm (nutrition education and complementary feeding) and one control (usual care) arm (1:1 ratio). Randomization of each participant to the groups will be carried out using Random Allocation Software 1.0… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Undernutrition, Stunting, Wasting
- What is being tested?
- health nutrition education
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Sep 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mothers who have children under 2 years of ages with undernutrition categories residences in Lombok Barat or Lombok Tengah District,
- Mothers who are able to speak Bahasa or Sasak languages,
- Mothers who are able to use a telephone.
Who cannot join
- Mothers with impaired cognitive function, and psychiatric diseases,
- Children suffering from severe/chronic diseases, mental retardation, physical disability,
- Children with hospitalization within six months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Health Belief Model Based Education Program on Improve Knowledge and Behaviors Related to Undernutrition Among Mothers With Children Under Two Years in Indonesia
The randomized controlled trial design with one intervention arm (nutrition education and complementary feeding) and one control (usual care) arm (1:1 ratio). Randomization of each participant to the groups will be carried out using Random Allocation Software 1.0 (https://random-allocation-oftware.software.informer.com/1.0/) to intervention or control groups in a 1:1 ratio. The sample size to be recruited is 80 participants.
Read the detailed description
The randomized controlled trial design with one intervention arm (nutrition education and complementary feeding) and one control (usual care) arm (1:1 ratio). will be conducted in the second phase. This trial will be conduct in mothers with children aged under 2 years of age of Nusa Tenggara Barat Province of Indonesia.
Randomization of each participant to the groups will be carried out using Random Allocation Software 1.0 (https://random-allocation-oftware.software.informer.com/1.0/) to intervention or control groups in a 1:1 ratio. The randomization will be performed by a research assistant with no access to participant information and who did not participate in the enrolment process. The permuted block randomization for a block size of four and six will be used in order to maintain an adequate balance in the number of participants allocated to each of the study groups. The person performing the intervention will be blinded to group allocation. Outcome data will be collected by another two blinded research assistants, one for the intervention group and one for the control group. The completed and coded questionnaires will be entered into databases by research assistant who unaware of group allocation.
The eligible participant will include mothers who have children under 2 years of ages with undernutrition categories residences in Lombok Barat or Lombok Tengah District, mothers who are able to speak Bahasa or Sasak languages, mothers who are able to use a telephone. The exclusion criteria will include mothers with impaired cognitive function, and psychiatric diseases, children suffering from severe/chronic diseases, mental retardation, physical disability, and with hospitalization within six months are excluded from participating in this study.
A priori power analysis has been calculated to determine an adequate sample size for the study. Prior data indicates that the application of the health belief model to teach complementary feeding messages in Ethiopia is 56%. Using a level of confidence of .05 and power of 80% the required sample size was 36.85 participants, with the consideration of 10% dropout rate, it was around 40 for one group. In total the investigator will aim for final estimate sample size to be recruited is 80.
- Conditions
- Undernutrition, Stunting, Wasting, Underweight
- Being tested
- health nutrition education, usual care
- Keywords
- Undernutrition, Health belief model, Children
- Medical subject headings
- Malnutrition, Growth Disorders, Cachexia, Thinness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health nutrition educationBehavioural
The participants in intervention group will receive health nutrition education based on a health belief model including nutrition health education (booklet), and telephone call support.
usual careBehavioural
Control group will only receive usual care. Usual care is routine measurement of children including height, length, weight, head circumference, monitoring children's activities, and monitoring the immunization status of children.
| Study group | Role | What they receive |
|---|---|---|
| health nutrition education | Experimental | The participants in intervention group will receive health nutrition education based on a health belief model including nutrition health education (booklet), and telephone call support. Receives: Behavioral: health nutrition education |
| usual care | Active comparator | Control group will only receive usual care. Usual care is routine measurement of children including height, length, weight, head circumference, monitoring children's activities, and monitoring the immunization status of children. Receives: Behavioral: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of Undernutrition
The Mother's Knowledge of Child Undernutrition questionnaire. This questionnaire is used to assess mother knowledge related to children undernutrition (Mardani et al., 2014), with Cronbach alpha 0.87. This questionnaire consists of 26 items of questions referring to the definition, types, signs and symptoms, diagnosis, management, and prevention of malnutrition in children. Each question has four answer options (A, B, C, D). A correct answer is scored at one point, while a wrong answer is scored at zero. The sum of answers will be calculated to obtain the total knowledge scores for that participant. The item score ranged from 0 to 26. The higher the score, the greater the understanding related to children's undernutrition
Measured: before intervention
Knowledge of Undernutrition
The Mother's Knowledge of Child Undernutrition questionnaire. This questionnaire is used to assess mother knowledge related to children undernutrition (Mardani et al., 2014), with Cronbach alpha 0.87. This questionnaire consists of 26 items of questions referring to the definition, types, signs and symptoms, diagnosis, management, and prevention of malnutrition in children. Each question has four answer options (A, B, C, D). A correct answer is scored at one point, while a wrong answer is scored at zero. The sum of answers will be calculated to obtain the total knowledge scores for that participant. The item score ranged from 0 to 26. The higher the score, the greater the understanding related to children's undernutrition
Measured: at two weeks after intervention
Complementary Feeding Practice
The complementary feeding practice questionnaire. This questionnaire is used to assess mother's knowledge and competence related to complementary feeding (Hajri et al., 2016), with Cronbach alpha 0.92. This questionnaire contains 29 questions referring to the practice of breastfeeding/complementary feeding, feeding practices based on food safety, responsive feeding practices, and practice of adequate feeding. The answers to this questionnaire are based on two kinds of interval scales: (1) score 0 = if the answer is not recommended, 1 = recommended; and (2) an interval scale with scores of 1 = never, 2 = rarely (1-2 times/week), 3 = sometimes (3-4 times/week), 4 = frequently (5-6 times/week), and 5 = always (every day). The high score indicates that mothers have greater understanding refer to complementary feeding in children. The high score indicates that mothers have greater understanding refer to complementary feeding in children.
Measured: before intervention
Complementary Feeding Practice
The complementary feeding practice questionnaire. This questionnaire is used to assess mother's knowledge and competence related to complementary feeding (Hajri et al., 2016), with Cronbach alpha 0.92. This questionnaire contains 29 questions referring to the practice of breastfeeding/complementary feeding, feeding practices based on food safety, responsive feeding practices, and practice of adequate feeding. The answers to this questionnaire are based on two kinds of interval scales: (1) score 0 = if the answer is not recommended, 1 = recommended; and (2) an interval scale with scores of 1 = never, 2 = rarely (1-2 times/week), 3 = sometimes (3-4 times/week), 4 = frequently (5-6 times/week), and 5 = always (every day). The high score indicates that mothers have greater understanding refer to complementary feeding in children. The high score indicates that mothers have greater understanding refer to complementary feeding in children.
Measured: at two weeks after intervention
Self-efficacy
The self-efficacy questionnaire. This questionnaire is used to assess a mother's self-efficacy in feeding children (Hajri et al., 2016), with Cronbach alpha 0.93. This questionnaire includes 28 questions about a healthy diet and food variety; the amount of food; meal cues; meals based on child development; and general efficacy for feeding children. Each question has scale 0-10. The item score ranged from 0 to 280. The higher the number indicates, the more confident. Research assistants will collect the data before and after the intervention
Measured: before intervention
Self-efficacy
The self-efficacy questionnaire. This questionnaire is used to assess a mother's self-efficacy in feeding children (Hajri et al., 2016), with Cronbach alpha 0.93. This questionnaire includes 28 questions about a healthy diet and food variety; the amount of food; meal cues; meals based on child development; and general efficacy for feeding children. Each question has scale 0-10. The item score ranged from 0 to 280. The higher the number indicates, the more confident. Research assistants will collect the data before and after the intervention
Measured: at two weeks after intervention
Secondary outcomes (3)
Undernutrition (stunting, wasting, and underweight)
Secondary outcomes are undernutrition (stunting, wasting, and underweight). They will be measured using WHO Anthro software version 3.2.2 and expressed as Z-scores for each of the anthropometric indices of undernutrition.
Measured: before intervention
Undernutrition (stunting, wasting, and underweight)
Secondary outcomes are undernutrition (stunting, wasting, and underweight). They will be measured using WHO Anthro software version 3.2.2 and expressed as Z-scores for each of the anthropometric indices of undernutrition.
Measured: at three months after intervention
Undernutrition (stunting, wasting, and underweight)
Secondary outcomes are undernutrition (stunting, wasting, and underweight). They will be measured using WHO Anthro software version 3.2.2 and expressed as Z-scores for each of the anthropometric indices of undernutrition.
Measured: at six months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start10 Sep 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UndernutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomized controlled trial design with one intervention arm (nutrition education and complementary feeding) and one control (usual care) arm (1:1 ratio).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang, Hui-Chuan, Taipei Medical University
- Investigators
- Hui-Chuan Huang, Ph.D, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517395
- Sponsor's protocol ID
- N202208020
- Status last verified
- Jun 2024
- First submitted
- 19 Aug 2022
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Health Belief Model Based Education Program on Improve Knowledge and Behaviors Related to Undernutrition Among Mothers With Children Under Two Years in Indonesia
- ClinicalTrials.gov ID
- NCT05517395
- Acronym / sponsor ID
- N202208020
- Conditions
- Undernutrition, Stunting, Wasting, Underweight
- Keywords
- Undernutrition, Health belief model, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The randomized controlled trial design with one intervention arm (nutrition education and complementary feeding) and one control (usual care) arm (1:1 ratio). Randomization of each participant to the groups will be carried out using Random Allocation Software 1.0 (https://random-allocation-oftware.software.informer.com/1.0/) to intervention or control groups in a 1:1 ratio. The sample size to be recruited is 80 participants.
Detailed description
The randomized controlled trial design with one intervention arm (nutrition education and complementary feeding) and one control (usual care) arm (1:1 ratio). will be conducted in the second phase. This trial will be conduct in mothers with children aged under 2 years of age of Nusa Tenggara Barat Province of Indonesia.
Randomization of each participant to the groups will be carried out using Random Allocation Software 1.0 (https://random-allocation-oftware.software.informer.com/1.0/) to intervention or control groups in a 1:1 ratio. The randomization will be performed by a research assistant with no access to participant information and who did not participate in the enrolment process. The permuted block randomization for a block size of four and six will be used in order to maintain an adequate balance in the number of participants allocated to each of the study groups. The person performing the intervention will be blinded to group allocation. Outcome data will be collected by another two blinded research assistants, one for the intervention group and one for the control group. The completed and coded questionnaires will be entered into databases by research assistant who unaware of group allocation.
The eligible participant will include mothers who have children under 2 years of ages with undernutrition categories residences in Lombok Barat or Lombok Tengah District, mothers who are able to speak Bahasa or Sasak languages, mothers who are able to use a telephone. The exclusion criteria will include mothers with impaired cognitive function, and psychiatric diseases, children suffering from severe/chronic diseases, mental retardation, physical disability, and with hospitalization within six months are excluded from participating in this study.
A priori power analysis has been calculated to determine an adequate sample size for the study. Prior data indicates that the application of the health belief model to teach complementary feeding messages in Ethiopia is 56%. Using a level of confidence of .05 and power of 80% the required sample size was 36.85 participants, with the consideration of 10% dropout rate, it was around 40 for one group. In total the investigator will aim for final estimate sample size to be recruited is 80.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The randomized controlled trial design with one intervention arm (nutrition education and complementary feeding) and one control (usual care) arm (1:1 ratio).
| Arm | Type | Receives |
|---|---|---|
| health nutrition education | Experimental | Behavioral: health nutrition educationThe participants in intervention group will receive health nutrition education based on a health belief model including nutrition health education (booklet), and telephone call support. |
| usual care | Active comparator | Behavioral: usual careControl group will only receive usual care. Usual care is routine measurement of children including height, length, weight, head circumference, monitoring children's activities, and monitoring the immunization status of children. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Mothers who have children under 2 years of ages with undernutrition categories residences in Lombok Barat or Lombok Tengah District,
- Mothers who are able to speak Bahasa or Sasak languages,
- Mothers who are able to use a telephone.
Key exclusion criteria (3 listed)
- Mothers with impaired cognitive function, and psychiatric diseases,
- Children suffering from severe/chronic diseases, mental retardation, physical disability,
- Children with hospitalization within six months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| health nutrition educationThe participants in intervention group will receive health nutrition education based on a health belief model including nutrition health education (booklet), and telephone call support. | Behavioural | health nutrition education |
| usual careControl group will only receive usual care. Usual care is routine measurement of children including height, length, weight, head circumference, monitoring children's activities, and monitoring the immunization status of children. | Behavioural | usual care |
Primary outcome
Knowledge of Undernutrition
Time frame: before intervention
The Mother's Knowledge of Child Undernutrition questionnaire. This questionnaire is used to assess mother knowledge related to children undernutrition (Mardani et al., 2014), with Cronbach alpha 0.87. This questionnaire consists of 26 items of questions referring to the definition, types, signs and symptoms, diagnosis, management, and prevention of malnutrition in children. Each question has four answer options (A, B, C, D). A correct answer is scored at one point, while a wrong answer is scored at zero. The sum of answers will be calculated to obtain the total knowledge scores for that participant. The item score ranged from 0 to 26. The higher the score, the greater the understanding related to children's undernutrition
Knowledge of Undernutrition
Time frame: at two weeks after intervention
The Mother's Knowledge of Child Undernutrition questionnaire. This questionnaire is used to assess mother knowledge related to children undernutrition (Mardani et al., 2014), with Cronbach alpha 0.87. This questionnaire consists of 26 items of questions referring to the definition, types, signs and symptoms, diagnosis, management, and prevention of malnutrition in children. Each question has four answer options (A, B, C, D). A correct answer is scored at one point, while a wrong answer is scored at zero. The sum of answers will be calculated to obtain the total knowledge scores for that participant. The item score ranged from 0 to 26. The higher the score, the greater the understanding related to children's undernutrition
Complementary Feeding Practice
Time frame: before intervention
The complementary feeding practice questionnaire. This questionnaire is used to assess mother's knowledge and competence related to complementary feeding (Hajri et al., 2016), with Cronbach alpha 0.92. This questionnaire contains 29 questions referring to the practice of breastfeeding/complementary feeding, feeding practices based on food safety, responsive feeding practices, and practice of adequate feeding. The answers to this questionnaire are based on two kinds of interval scales: (1) score 0 = if the answer is not recommended, 1 = recommended; and (2) an interval scale with scores of 1 = never, 2 = rarely (1-2 times/week), 3 = sometimes (3-4 times/week), 4 = frequently (5-6 times/week), and 5 = always (every day). The high score indicates that mothers have greater understanding refer to complementary feeding in children. The high score indicates that mothers have greater understanding refer to complementary feeding in children.
Complementary Feeding Practice
Time frame: at two weeks after intervention
The complementary feeding practice questionnaire. This questionnaire is used to assess mother's knowledge and competence related to complementary feeding (Hajri et al., 2016), with Cronbach alpha 0.92. This questionnaire contains 29 questions referring to the practice of breastfeeding/complementary feeding, feeding practices based on food safety, responsive feeding practices, and practice of adequate feeding. The answers to this questionnaire are based on two kinds of interval scales: (1) score 0 = if the answer is not recommended, 1 = recommended; and (2) an interval scale with scores of 1 = never, 2 = rarely (1-2 times/week), 3 = sometimes (3-4 times/week), 4 = frequently (5-6 times/week), and 5 = always (every day). The high score indicates that mothers have greater understanding refer to complementary feeding in children. The high score indicates that mothers have greater understanding refer to complementary feeding in children.
Self-efficacy
Time frame: before intervention
The self-efficacy questionnaire. This questionnaire is used to assess a mother's self-efficacy in feeding children (Hajri et al., 2016), with Cronbach alpha 0.93. This questionnaire includes 28 questions about a healthy diet and food variety; the amount of food; meal cues; meals based on child development; and general efficacy for feeding children. Each question has scale 0-10. The item score ranged from 0 to 280. The higher the number indicates, the more confident. Research assistants will collect the data before and after the intervention
Self-efficacy
Time frame: at two weeks after intervention
The self-efficacy questionnaire. This questionnaire is used to assess a mother's self-efficacy in feeding children (Hajri et al., 2016), with Cronbach alpha 0.93. This questionnaire includes 28 questions about a healthy diet and food variety; the amount of food; meal cues; meals based on child development; and general efficacy for feeding children. Each question has scale 0-10. The item score ranged from 0 to 280. The higher the number indicates, the more confident. Research assistants will collect the data before and after the intervention
3 secondary outcomes
Undernutrition (stunting, wasting, and underweight)
Time frame: before intervention
Undernutrition (stunting, wasting, and underweight)
Time frame: at three months after intervention
Undernutrition (stunting, wasting, and underweight)
Time frame: at six months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui-Chuan Huang, Ph.D principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing health nutrition education in people with Undernutrition and Stunting, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of Undernutrition (time frame: before intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.