Effectiveness of Food-Based Recommendations for Minangkabau Women of Reproductive Age With Dyslipidemia

NCT ID: NCT04085874

Last Updated: 2019-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-07
• Study Completion Date: 2019-06-10

Brief Summary

This study aimed to assess effectiveness of promoting the optimized Food-based recommendations (FBRs) for improving dietary practices, nutrient intakes, nutritional status and lipid profile among Minangkabau women of reproductive age with dyslipidemia in a community setting. A cluster randomized community-based trial was conducted in Padang City, West Sumatra, Indonesia. Subjects are Minagabau women of reproductive age (20-44 y) with dyslipidemia. The subjects were assigned either into FBR group (n=48) that involved in 12-weeks prolonged contact of FBRs promotion or into non-FBR group, that received once nutrition counselling from usual standard of nutrition program. Baseline and end-line lipid profiles, nutritional status, dietary practice and nutrient intake data were assessed through biochemical assessment, anthropometri, and interview structured questionaire.

Detailed Description

This study was conducted in two sequential phases. The first stage was a formative phase in the form of observational survey to develop and validate food-based recommendations (FBRs). The second phase was an intervention study to assess the effectiveness of the FBRs in improving dietary practice, the intake of problem nutrient, nutritional status and lipid profile of the subject.

Sample size for intervention per group (n=60/group; 2 groups) was expected to detect mean(±SD) differences in LDL-cholesterol concentration (as an secondary outcome) of 14±20 mg/dL as observed in a previous study in other area, with assumption of 80% power and 25% loss of follow up. Potential subjects were identified prior to dyslipidemia screening before intervention. Field nutritionist and volunteer cadres were requested to identify and list women of reproductive age fulfilling the inclusion criteria living in selected sites. An invitation letter was sent to all identified eligible subjects to visit appointed field laboratory to perform blood measurement. Inform consent was signed by all potential participants before blood measurement.

This study did not compare an intervention group (FBR group) with a true control group, but with a comparison group that received once nutrition counselling from usual nutrition health program (non-FBR group). Drawing on concepts of Plan Behavior Theory, persuasive FBR promotion was designed to influence subjects' attitude, subjective norms, perceive behavior control related to dyslipidemia and dietary management, and intention to change. Participants were prompted to set goals for themselves to improve their dietary practices in order to fulfill their nutrient requirements, improve nutritional status and lipid profile.

Conditions

Dietary Habits; Nutrient Deficiency; Obesity; Dyslipidemias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FBR group

weekly home visit and monthly group meeting for 12 weeks

Group Type: EXPERIMENTAL

Promotion of Food-based recommendations

Intervention Type: BEHAVIORAL

Prolonged contact through weekly home visits and monthly group meeting for 12 weeks

non-FBR group

once nutrition counseling from standard health care services

Group Type: ACTIVE_COMPARATOR

Nutrition counseling from standard health services care

Intervention Type: BEHAVIORAL

once nutrition counselling from health services

Interventions

Promotion of Food-based recommendations

Prolonged contact through weekly home visits and monthly group meeting for 12 weeks

Intervention Type: BEHAVIORAL

Nutrition counseling from standard health services care

once nutrition counselling from health services

Intervention Type: BEHAVIORAL

Other Intervention Names

Nutrition education; Standard nutrition care

Eligibility Criteria

Inclusion Criteria

• women of reproductive age (20-44 years);
• native Minangkabau ethnic (both father and mother from the Minangkabau tribe);
• had abnormal one of isolated blood lipid profiles (cholesterol > 200 mg / dl, LDL-cholesterol >100 mg / dl, HDL < 60 mg/dl, TG > 150 mg/dl);
• signing a written inform consent.

Exclusion Criteria

• in pregnancy;
• having a history or active smoker and alcoholic addict;
• has a history of heart disease, diabetes, asthma, cancer, chronic digestive tract disorders, hemophilia and other chronic diseases;
• routinely taking cholesterol-lowering or blood pressure medications;
• vegetarians;
• use estrogen therapy;
• are participating in other studies.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Indonesia University

OTHER

Sponsor Role: collaborator

Politeknik Kesehatan Kemenkes Padang

OTHER

Sponsor Role: lead

Responsible Party

Gusnedi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Murdani Abdullah

Role: STUDY_CHAIR

Indonesia University

Locations

Dinas Kesehatan Kota Padang

Padang, West Sumatra, Indonesia

Countries

Indonesia

References

Gusnedi G, Fahmida U, Witjaksono F, Nurwidya F, Mansyur M, Djuwita R, Dwiriani CM, Abdullah M. Effectiveness of optimized food-based recommendation promotion to improve nutritional status and lipid profiles among Minangkabau women with dyslipidemia: A cluster-randomized trial. BMC Public Health. 2022 Jan 6;22(1):21. doi: 10.1186/s12889-021-12462-5.

Reference Type: DERIVED

PMID: 34991541 (View on PubMed)

Other Identifiers

18-12-1376

Identifier Type: -

Identifier Source: org_study_id