Nutrition Education to Promote Calcium Intake Among 30-65 Year-old Women in Vietnam

Osteoporosis Clinical Trial

Official title:

Nutrition Education Intervention to Promote Dietary Calcium Intake Among Vietnamese Women Aged 30-65 Years in Rural Areas in Hanoi, Vietnam

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04196426
• Other study ID #: IRB2019-22
• Status: Completed
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: August 10, 2019

Study information

• Verified date: December 2019
• Source: Texas Tech University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Osteoporosis is an important public health problem in Vietnam, with one in ten Vietnamese women suffering from it. There is enough evidence demonstrating that low calcium intake is one of the risk factors for osteoporosis among Asian women in general and Vietnamese women in specific. It is reported that the intake of calcium among Vietnamese women is under 400 mg/day, which is less than the daily recommendation of 1,000 mg/day by the Vietnam National Institute of Nutrition, even though calcium-rich foods are largely available in Vietnam. Therefore, the purpose of this study is to promote dietary calcium intake among Vietnamese women aged 30-65 years through implementing a nutrition education intervention.

Description:

Vietnamese women aged 30-65 years without medical problems that could interfere with the calcium consumption, such as kidney stone, kidney and liver diseases. The women will be excluded if they are blinded, deaf, or have general learning disability.

Outcomes of the study are dietary calcium intake, calcium knowledge, and osteoporosis health belief. A quantitative questionnaire is being used to collect these data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: August 10, 2019
• Est. primary completion date: August 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• women aged 30 to 65 years

Exclusion Criteria:

• have medical conditions that can interfere with calcium intake, such as physician-diagnosed kidney stone, kidney and liver diseases, etc.

• blind, deaf, and have general learning disability

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Behavioral:
• Nutrition education intervention about osteoporosis and calcium
The intervention is designed and developed based on the Intervention Mapping Process and the Health Belief Model. Topics of the intervention include: the importance of osteoporosis and risk factors, role of calcium in bone health and controlling the disease, calcium recommendations and sources, role of vitamin D and physical activity in calcium absorption and bone health, and how to identify calcium-rich foods in the locality and prepare meals with local calcium-rich foods. A recipe booklet containing recipes using local calcium-rich foods will be given to the participants after the end of the two nutrition lessons. Interactive activities are incorporated in each lesson to encourage the participation of participants.

Locations

Country	Name	City	State
Vietnam	Preventive Medical Centers	Thach That	Hanoi

Sponsors (3)

Lead Sponsor	Collaborator
Texas Tech University	Hanoi University of Pharmacy, Vietnam National Institute of Nutrition

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dietary calcium intake	The dietary calcium intake (mg/day) will be assessed using a food frequency questionnaire, which consisted of 36 food items contributing to the total calcium intake. The total calcium intake of each participant will be the sum of calcium intake from all food items in the food frequency questionnaire.	5 weeks
Secondary	Nutrition knowledge related to osteoporosis and calcium	The nutrition knowledge related to osteoporosis and calcium will be collected using a questionnaire that participants can answer by pencil. The knowledge included 11 question items. Participants received 1 point if answering correctly and 0 point if answering incorrectly. Total knowledge score ranged from 0 (minimum) to 11 points (maximum).	5 weeks
Secondary	Osteoporosis health beliefs	Osteoporosis health beliefs will be collected using an osteoporosis health belief likert scale. The scale consisted of 6 subscales, including perceived susceptibility, perceived severity, perceived benefits, perceived barriers, health motivation, and self-efficacy. Each sub-scale of the health beliefs scale has 6 statements with 5 answering options, from "strongly disagree" (coded as 1) to "strongly agree" (coded as 5). Possible scores for each sub scale ranged from 6-30, with higher score indicating higher perception.	5 weeks