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

NCT05517395 | Completed

• 1 other identifier: N202208020
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Undernutrition; Stunting; Wasting; Underweight

Keywords

Undernutrition; Health belief model; Children

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Undernutrition (stunting, wasting, and underweight)

  before intervention

• Undernutrition (stunting, wasting, and underweight)

  at three months after intervention

• Undernutrition (stunting, wasting, and underweight)

  at six months after intervention

Study Arms (2)

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.

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.

Behavioral: usual care

Interventions

health nutrition education BEHAVIORAL

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.

health nutrition education

usual care BEHAVIORAL

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.

usual care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

Taipei County, Taipei, 11031, Taiwan

Location

MeSH Terms

Conditions

Malnutrition; Growth Disorders; Cachexia; Thinness

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms

Study Officials

• Hui-Chuan Huang, Ph.D

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Model Details: The randomized controlled trial design with one intervention arm (nutrition education and complementary feeding) and one control (usual care) arm (1:1 ratio).

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 26, 2022
• Study Start: September 10, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TW (1)