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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Dietary Habits, Nutrient Deficiency, Obesity, Dyslipidemias

Intervention / Treatment
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* Behavioral: Promotion of Food-based recommendations
* Behavioral: Nutrition counseling from standard health services care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FBR group<br>weekly home visit and monthly group meeting for 12 weeks | Behavioral: Promotion of Food-based recommendations<br>* Prolonged contact through weekly home visits and monthly group meeting for 12 weeks<br>* Other names: Nutrition education;|
| Active Comparator: non-FBR group<br>once nutrition counseling from standard health care services | Behavioral: Nutrition counseling from standard health services care<br>* once nutrition counselling from health services<br>* Other names: Standard nutrition care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Dietary practice | 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 | baseline (before the intervention) and end-line (after 12-weeks intervention) | 
| Change in energy intake | 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 | baseline (before intervention and end-line (after 12-weeks interventions) | 
| Change in protein intake | 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 | baseline (before intervention and end-line (after 12-weeks interventions) | 
| Change in total fat intake | 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. | baseline (before intervention and end-line (after 12-weeks interventions) | 
| Change in carbohydrate intake | Change from baseline at 12-week intervention for carbohydrate intake ( in gram) | baseline (before intervention and end-line (after 12-weeks interventions) | 
| Change in poly unsaturated fatty acids (PUFA) intake | 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. | baseline (before intervention and end-line (after 12-weeks interventions) | 
| Change in mono unsaturated fatty acids (MUFA) intakes | 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. | baseline (before intervention and end-line (after 12-weeks interventions) | 
| Change in saturated fatty acids (SFA) intakes | 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. | baseline (before intervention and end-line (after 12-weeks interventions) | 
| Change in PUFA/SFA (P/S) ratio | Change from baseline at 12-week intervention for P/S | baseline (before intervention and end-line (after 12-weeks interventions) | 
| Change in dietary fiber intakes | 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. | baseline (before intervention and end-line (after 12-weeks interventions) | 
| Change in iron (Fe) intake | 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. | baseline (before intervention and end-line (after 12-weeks interventions) | 
| Change in zinc (Zn) intake | 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. | baseline (before intervention and end-line (after 12-weeks interventions) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body weight | Change in Body weight (in Kg) from baseline at 12-week intervention | baseline (before intervention and end-line (after 12-weeks interventions) | 
| Change in waist circumference | change of waist circumference (in cm), from baseline at 12-week intervention | baseline (before intervention and end-line (after 12-weeks interventions) | 
| Change in total cholesterol level | Change of total cholesterol (in mg/dL) from baseline at 12-week intervention | baseline (before intervention and end-line (after 12-weeks interventions) | 
| Change in Low Desnsity Lipoprotein (LDL) cholesterol | Change of LDL (in mg/dL) from baseline at 12-week intervention | baseline (before intervention and end-line (after 12-weeks interventions) | 
| Change in serum High Density Lipoprotein (HDL) cholesterol | Change of HDL (mg/dL) from baseline at 12-week intervention | baseline (before intervention and end-line (after 12-weeks interventions) | 
| Change in serum triglyceride (TG) | Change of TG (mg/dL) from baseline at 12-week intervention | baseline (before intervention and end-line (after 12-weeks interventions) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition intervention, Food-Based Recommendations, dietary practices, women of reproductive age, dyslipidemia