Stunting Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | December 30, 2022 |
Est. primary completion date | December 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Medical University | Taipei county | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taipei Medical University |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | before intervention | |
Primary | 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 | at two weeks after intervention | |
Primary | 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. | before intervention | |
Primary | 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. | at two weeks after intervention | |
Primary | 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 | before intervention | |
Primary | 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 | at two weeks after intervention | |
Secondary | 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. | before intervention | |
Secondary | 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. | at three months after intervention | |
Secondary | 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. | at six months after intervention |
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