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

NCT ID: NCT04196426

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-10

Study Completion Date

2019-08-10

Brief Summary

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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

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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.

Conditions

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Osteoporosis

Keywords

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nutrition education nutrition intervention calcium intake calcium-rich foods

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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nutrition education group

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.

Group Type EXPERIMENTAL

Nutrition education intervention about osteoporosis and calcium

Intervention Type BEHAVIORAL

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.

delayed nutrition education group

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.

Group Type ACTIVE_COMPARATOR

Nutrition education intervention about osteoporosis and calcium

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hanoi University of Pharmacy

UNKNOWN

Sponsor Role collaborator

Vietnam National Institute of Nutrition

UNKNOWN

Sponsor Role collaborator

Texas Tech University

OTHER

Sponsor Role lead

Responsible Party

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Bong

PhD Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary Murimi, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University

Locations

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Preventive Medical Centers

Thach That, Hanoi, Vietnam

Site Status

Countries

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Vietnam

Other Identifiers

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IRB2019-22

Identifier Type: -

Identifier Source: org_study_id