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The Effectiveness of HBM-based Education Program on Improve Knowledge and Behaviors

Primary Purpose

Undernutrition, Stunting, Wasting

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
health nutrition education
usual care
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Undernutrition focused on measuring Undernutrition, Health belief model, Children

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Mothers with impaired cognitive function, and psychiatric diseases,
  • Children suffering from severe/chronic diseases, mental retardation, physical disability,
  • Children with hospitalization within six months.

Sites / Locations

  • Taipei Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

health nutrition education

usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
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.
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.
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
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

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
August 19, 2022
Last Updated
August 25, 2022
Sponsor
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05517395
Brief Title
The Effectiveness of HBM-based Education Program on Improve Knowledge and Behaviors
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 10, 2022 (Anticipated)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Undernutrition, Stunting, Wasting, Underweight
Keywords
Undernutrition, Health belief model, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Masking Description
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 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.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
health nutrition education
Arm Type
Experimental
Arm Description
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.
Arm Title
usual care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
health nutrition education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Knowledge of Undernutrition
Description
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
Time Frame
before intervention
Title
Knowledge of Undernutrition
Description
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
Time Frame
at two weeks after intervention
Title
Complementary Feeding Practice
Description
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.
Time Frame
before intervention
Title
Complementary Feeding Practice
Description
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.
Time Frame
at two weeks after intervention
Title
Self-efficacy
Description
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
Time Frame
before intervention
Title
Self-efficacy
Description
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
Time Frame
at two weeks after intervention
Secondary Outcome Measure Information:
Title
Undernutrition (stunting, wasting, and underweight)
Description
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.
Time Frame
before intervention
Title
Undernutrition (stunting, wasting, and underweight)
Description
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.
Time Frame
at three months after intervention
Title
Undernutrition (stunting, wasting, and underweight)
Description
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.
Time Frame
at six months after intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Mothers with impaired cognitive function, and psychiatric diseases, Children suffering from severe/chronic diseases, mental retardation, physical disability, Children with hospitalization within six months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui-Chuan Huang, Ph.D
Phone
+886227361661
Ext
6349
Email
huichuan@tmu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Raden Ahmad Dedy Mardani, M.N.S
Phone
+886902344306
Email
d432109014@tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Chuan Huang, Ph.D
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University
City
Taipei county
State/Province
Taipei
ZIP/Postal Code
11031
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui-Chuan Huang, Ph.D
Phone
+886227361661
Ext
6349
Email
huichuan@tmu.edu.tw
First Name & Middle Initial & Last Name & Degree
Raden Ahmad Dedy Mardani, M.N.S
Phone
+886902344306
Email
d432109014@tmu.edu.tw
First Name & Middle Initial & Last Name & Degree
Hui-Chuan Huang, Ph.D
First Name & Middle Initial & Last Name & Degree
Raden Ahmad Dedy Mardani, M.N.S

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication

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The Effectiveness of HBM-based Education Program on Improve Knowledge and Behaviors

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