Clinical trial NCT04085874: Effectiveness of Food-Based Recommendations for Minangkabau Women of Reproductive Age With Dyslipidemia
Official title: Effectiveness of Optimized Food-Based Recommendations to Improve Dietary Practice, Intake of Problem Nutrient, Nutritional Status and Lipid Profile Among Minangkabau Women of Reproductive Age With Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Habits
Nutrient Deficiency
Obesity
Dyslipidemias
Keywords: Nutrition intervention
Food-Based Recommendations
dietary practices
women of reproductive age
dyslipidemia
Lead sponsor: Politeknik Kesehatan Kemenkes Padang
Sponsor class: OTHER
Collaborators: name: Indonesia University
First posted: 2019-09-11
Enrollment: 123
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Dietary practice
timeFrame: baseline (before the intervention) and end-line (after 12-weeks intervention)
measure: Change in energy intake
timeFrame: baseline (before intervention and end-line (after 12-weeks interventions)
measure: Change in protein intake
timeFrame: baseline (before intervention and end-line (after 12-weeks interventions)
measure: Change in total fat intake
timeFrame: baseline (before intervention and end-line (after 12-weeks interventions)
measure: Change in carbohydrate intake
timeFrame: baseline (before intervention and end-line (after 12-weeks interventions)
measure: Change in poly unsaturated fatty acids (PUFA) intake
timeFrame: baseline (before intervention and end-line (after 12-weeks interventions)
measure: Change in mono unsaturated fatty acids (MUFA) intakes
timeFrame: baseline (before intervention and end-line (after 12-weeks interventions)
measure: Change in saturated fatty acids (SFA) intakes
timeFrame: baseline (before intervention and end-line (after 12-weeks interventions)
measure: Change in PUFA/SFA (P/S) ratio
timeFrame: baseline (before intervention and end-line (after 12-weeks interventions)
measure: Change in dietary fiber intakes
timeFrame: baseline (before intervention and end-line (after 12-weeks interventions)
measure: Change in iron (Fe) intake
timeFrame: baseline (before intervention and end-line (after 12-weeks interventions)
measure: Change in zinc (Zn) intake
timeFrame: baseline (before intervention and end-line (after 12-weeks interventions)
Secondary outcomes:
measure: Change in Body weight
timeFrame: baseline (before intervention and end-line (after 12-weeks interventions)
measure: Change in waist circumference
timeFrame: baseline (before intervention and end-line (after 12-weeks interventions)
measure: Change in total cholesterol level
timeFrame: baseline (before intervention and end-line (after 12-weeks interventions)
measure: Change in Low Desnsity Lipoprotein (LDL) cholesterol
timeFrame: baseline (before intervention and end-line (after 12-weeks interventions)
measure: Change in serum High Density Lipoprotein (HDL) cholesterol
timeFrame: baseline (before intervention and end-line (after 12-weeks interventions)
measure: Change in serum triglyceride (TG)
timeFrame: baseline (before intervention and end-line (after 12-weeks interventions)
Other outcomes:
measure: Change in Body Mass Index
timeFrame: baseline (before intervention and end-line (after 12-weeks interventions)
measure: Change in Castelli's Index
timeFrame: baseline (before intervention and end-line (after 12-weeks interventions)
Locations:
city: Padang
country: Indonesia
facility: Dinas Kesehatan Kota Padang
state: West Sumatra
Study officials:
affiliation: Indonesia University
name: Murdani Abdullah
role: STUDY_CHAIR
References:
citation: 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.