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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Nutrition education intervention about osteoporosis and calcium
Sponsored by
Texas Tech University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring nutrition education, nutrition intervention, calcium intake, calcium-rich foods

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Preventive Medical Centers

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

nutrition education group

delayed nutrition education group

Arm Description

The nutrition education group receive the intervention first, which include 2 nutrition lessons about osteoporosis and calcium and calcium rich foods. The 2 lessons are delivered in one week for 2 hours each lesson. After this week, participants in the intervention group receive handouts about osteoporosis and calcium once a week for a period of 4 weeks.

After the intervention group finish their intervention (5 weeks period), post data collection will be administered in both nutrition education and delayed nutrition education group. After this post data collection, the delayed nutrition education group receive the same intervention.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
December 10, 2019
Last Updated
December 11, 2019
Sponsor
Texas Tech University
Collaborators
Hanoi University of Pharmacy, Vietnam National Institute of Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT04196426
Brief Title
Nutrition Education to Promote Calcium Intake Among 30-65 Year-old Women in Vietnam
Official Title
Nutrition Education Intervention to Promote Dietary Calcium Intake Among Vietnamese Women Aged 30-65 Years in Rural Areas in Hanoi, Vietnam
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
August 10, 2019 (Actual)
Study Completion Date
August 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Tech University
Collaborators
Hanoi University of Pharmacy, Vietnam National Institute of Nutrition

4. Oversight

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

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
nutrition education, nutrition intervention, calcium intake, calcium-rich foods

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Three communities receive the nutrition intervention while three other communities do not. After 1 month, the first 3 communities do not receive the intervention while the later 3 communities receive the same nutrition intervention. Baseline, post intervention data are collected.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nutrition education group
Arm Type
Experimental
Arm Description
The nutrition education group receive the intervention first, which include 2 nutrition lessons about osteoporosis and calcium and calcium rich foods. The 2 lessons are delivered in one week for 2 hours each lesson. After this week, participants in the intervention group receive handouts about osteoporosis and calcium once a week for a period of 4 weeks.
Arm Title
delayed nutrition education group
Arm Type
Active Comparator
Arm Description
After the intervention group finish their intervention (5 weeks period), post data collection will be administered in both nutrition education and delayed nutrition education group. After this post data collection, the delayed nutrition education group receive the same intervention.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition education intervention about osteoporosis and calcium
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dietary calcium intake
Description
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.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Nutrition knowledge related to osteoporosis and calcium
Description
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).
Time Frame
5 weeks
Title
Osteoporosis health beliefs
Description
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.
Time Frame
5 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Murimi, PhD
Organizational Affiliation
Texas Tech University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Preventive Medical Centers
City
Thach That
State/Province
Hanoi
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared to other researchers. Any report that is generated will be based on aggregated data and will never identify individual responses.

Learn more about this trial

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

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