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NCT Number: NCT04085874

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

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.

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Key information

Conditions

Dietary Habits Behavior Behavior, Animal Body Weight Dyslipidemias Feeding Behavior Lipid Metabolism Disorders Metabolic Diseases Nutrient Deficiency Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dinas Kesehatan Kota Padang

Padang, West Sumatra, 25171, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Promotion of Food-based recommendations

Behavioral

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

Other names: Nutrition education

Nutrition counseling from standard health services care

Behavioral

once nutrition counselling from health services

Other names: Standard nutrition care

Primary outcomes

  1. Change in Dietary practice

    Time frame: baseline (before the intervention) and end-line (after 12-weeks intervention)

    Change in food consumption from baseline at 12-week intervention, evaluated based on participant's compliance to the Optimized Food-Based Recommendations. The compliance were measured using one-week Food Frequency Questionnaire (FFQ), stated in servings/week for staple foods. snacks, animal protein (sea fish, eggs, poultry), soy protein (tofu/tempeh), potato, fruits,dark green vegetables (DGLV), total vegetables and fried foods. The recommendations (servings/week) for those food groups/items was 14-21, 7-14, minimum 5, 3-4, 2-3,minimum 7,minimum 5, minimum 7, minimum 5, minimum 14, and maximum 14 respectively. Those who complied with the recommendations was scored 1 for each recommendations, and 0 for those who did not. The total score for the compliance to the FBRs was 0-11. Higher score represents better participant's compliance

  2. Change in energy intake

    Time frame: baseline (before intervention and end-line (after 12-weeks interventions)

    Change from baseline at 12-week intervention for energy intake( in Kcal). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software

  3. Change in protein intake

    Time frame: baseline (before intervention and end-line (after 12-weeks interventions)

    Change from baseline at 12-week intervention for protein intake( in gram). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software

  4. Change in total fat intake

    Time frame: baseline (before intervention and end-line (after 12-weeks interventions)

    Change from baseline at 12-week intervention for total fat intake( in gram). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software.

  5. Change in carbohydrate intake

    Time frame: baseline (before intervention and end-line (after 12-weeks interventions)

    Change from baseline at 12-week intervention for carbohydrate intake ( in gram)

  6. Change in poly unsaturated fatty acids (PUFA) intake

    Time frame: baseline (before intervention and end-line (after 12-weeks interventions)

    Change from baseline at 12-week intervention for PUFA intake ( in gram). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software.

  7. Change in mono unsaturated fatty acids (MUFA) intakes

    Time frame: baseline (before intervention and end-line (after 12-weeks interventions)

    Change from baseline at 12-week intervention for MUFA intake ( in gram). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software.

  8. Change in saturated fatty acids (SFA) intakes

    Time frame: baseline (before intervention and end-line (after 12-weeks interventions)

    Change from baseline at 12-week intervention for SFA intake ( in gram). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software.

  9. Change in PUFA/SFA (P/S) ratio

    Time frame: baseline (before intervention and end-line (after 12-weeks interventions)

    Change from baseline at 12-week intervention for P/S

  10. Change in dietary fiber intakes

    Time frame: baseline (before intervention and end-line (after 12-weeks interventions)

    Change from baseline at 12-week intervention for dietary fiber intake ( in gram). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software.

  11. Change in iron (Fe) intake

    Time frame: baseline (before intervention and end-line (after 12-weeks interventions)

    Change from baseline at 12-week intervention for iron intake ( in mg). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software.

  12. Change in zinc (Zn) intake

    Time frame: baseline (before intervention and end-line (after 12-weeks interventions)

    Change from baseline at 12-week intervention for zinc intake ( in mg). The intake was measured through interview using two replicates 24-hour food recall on non-consecutive days. The foods were converted to energy and nutrients based on Indonesia food composition tables available in nutrisurvey software.

Secondary outcomes

  1. Change in Body weight

    Time frame: baseline (before intervention and end-line (after 12-weeks interventions)

    Change in Body weight (in Kg) from baseline at 12-week intervention

  2. Change in waist circumference

    Time frame: baseline (before intervention and end-line (after 12-weeks interventions)

    change of waist circumference (in cm), from baseline at 12-week intervention

  3. Change in total cholesterol level

    Time frame: baseline (before intervention and end-line (after 12-weeks interventions)

    Change of total cholesterol (in mg/dL) from baseline at 12-week intervention

  4. Change in Low Desnsity Lipoprotein (LDL) cholesterol

    Time frame: baseline (before intervention and end-line (after 12-weeks interventions)

    Change of LDL (in mg/dL) from baseline at 12-week intervention

  5. Change in serum High Density Lipoprotein (HDL) cholesterol

    Time frame: baseline (before intervention and end-line (after 12-weeks interventions)

    Change of HDL (mg/dL) from baseline at 12-week intervention

  6. Change in serum triglyceride (TG)

    Time frame: baseline (before intervention and end-line (after 12-weeks interventions)

    Change of TG (mg/dL) from baseline at 12-week intervention

Other outcomes

  1. Change in Body Mass Index

    Time frame: baseline (before intervention and end-line (after 12-weeks interventions)

    Change in body mass index (kg/m2) from baseline at 12-week intervention, calculated from body weight (in kg) divided by square body height (in meter suquare), endline minus baseline

  2. Change in Castelli's Index

    Time frame: baseline (before intervention and end-line (after 12-weeks interventions)

    Change of Castelli's index from baseline at 12-week intervention, calculated from the total cholesterol level divided by serum HDL

Sponsors and collaborators

Lead sponsor

Politeknik Kesehatan Kemenkes Padang

Other

Collaborators

  • Indonesia University

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 11, 2019
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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