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

NCT04196426 | Completed DMC

• 1 other identifier: IRB2019-22
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

nutrition education; nutrition intervention; calcium intake; calcium-rich foods

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Nutrition knowledge related to osteoporosis and calcium

  5 weeks

• Osteoporosis health beliefs

  5 weeks

Study Arms (2)

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.

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.

Behavioral: Nutrition education intervention about osteoporosis and calcium

Interventions

Nutrition education intervention about osteoporosis and calcium 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; nutrition education group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women aged 30 to 65 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Tech University: lead
• Hanoi University of Pharmacy: collaborator
• Vietnam National Institute of Nutrition: collaborator

Study Sites (1)

Preventive Medical Centers

Thach That, Hanoi, Vietnam

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Calcium

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Study Officials

• Mary Murimi, PhD

  Texas Tech University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: 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.

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 12, 2019
• Study Start: May 10, 2019
• Primary Completion: August 10, 2019
• Study Completion: August 10, 2019
• Last Updated: December 13, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)