OsteoporosisNCT04196426
Nutrition Education to Promote Calcium Intake Among 30-65 Year-old Women in Vietnam
A study testing Nutrition education intervention about osteoporosis and calcium in people with Osteoporosis, run by Texas Tech University at 1 site in Vietnam.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Nutrition education intervention about osteoporosis and calcium
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteVietnam
- Study dates
- 10 May 2019to 10 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women aged 30 to 65 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutrition Education Intervention to Promote Dietary Calcium Intake Among Vietnamese Women Aged 30-65 Years in Rural Areas in Hanoi, Vietnam
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.
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- Nutrition education intervention about osteoporosis and calcium
- Keywords
- nutrition education, nutrition intervention, calcium intake, calcium-rich foods
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition education intervention about osteoporosis and calciumBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| nutrition education group | Experimental | 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. Receives: Behavioral: Nutrition education intervention about osteoporosis and calcium |
| delayed nutrition education group | Active comparator | 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. Receives: Behavioral: Nutrition education intervention about osteoporosis and calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
Secondary outcomes (2)
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).
Measured: 5 weeks
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.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start10 May 2019
- Primary completion10 Aug 2019
- Study completion10 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Collaborators
- Hanoi University of Pharmacy, National Institute of Nutrition, Vietnam
- Responsible party
- Principal investigator, Bong, Texas Tech University
- Investigators
- Mary Murimi, PhD, Principal investigator, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196426
- Sponsor's protocol ID
- IRB2019-22
- Status last verified
- Dec 2019
- First submitted
- 10 Dec 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Education Intervention to Promote Dietary Calcium Intake Among Vietnamese Women Aged 30-65 Years in Rural Areas in Hanoi, Vietnam
- ClinicalTrials.gov ID
- NCT04196426
- Acronym / sponsor ID
- IRB2019-22
- Conditions
- Osteoporosis
- Keywords
- nutrition education, nutrition intervention, calcium intake, calcium-rich foods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Collaborators
- Hanoi University of Pharmacy, National Institute of Nutrition, Vietnam
- Study start
- 10 May 2019 (actual)
- Primary completion
- 10 Aug 2019 (actual)
- Study completion
- 10 Aug 2019 (actual)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| nutrition education group | Experimental | Behavioral: Nutrition education intervention about osteoporosis and calciumThe 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. |
| delayed nutrition education group | Active comparator | Behavioral: Nutrition education intervention about osteoporosis and calciumAfter 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women aged 30 to 65 years
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition education intervention about osteoporosis and calciumThe 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. | Behavioural | delayed nutrition education group, nutrition education group |
Primary outcome
Dietary calcium intake
Time frame: 5 weeks
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.
2 secondary outcomes
Nutrition knowledge related to osteoporosis and calcium
Time frame: 5 weeks
Osteoporosis health beliefs
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Murimi, PhD principal investigator
Texas Tech University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition education intervention about osteoporosis and calcium in people with Osteoporosis, run by Texas Tech University at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary calcium intake (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.