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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Change in energy intake
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in energy intake
时间窗: 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
Change in protein intake
时间窗: 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
Change in saturated fatty acids (SFA) intakes
时间窗: 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.
Change in dietary fiber intakes
时间窗: 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.
Change in carbohydrate intake
时间窗: baseline (before intervention and end-line (after 12-weeks interventions)
Change from baseline at 12-week intervention for carbohydrate intake ( in gram)
Change in poly unsaturated fatty acids (PUFA) intake
时间窗: 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.
Change in zinc (Zn) intake
时间窗: 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.
Change in mono unsaturated fatty acids (MUFA) intakes
时间窗: 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.
Change in iron (Fe) intake
时间窗: 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.
Change in Dietary practice
时间窗: 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
Change in PUFA/SFA (P/S) ratio
时间窗: baseline (before intervention and end-line (after 12-weeks interventions)
Change from baseline at 12-week intervention for P/S
Change in total fat intake
时间窗: 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.
次要结局
- Change in waist circumference(baseline (before intervention and end-line (after 12-weeks interventions))
- Change in total cholesterol level(baseline (before intervention and end-line (after 12-weeks interventions))
- Change in Low Desnsity Lipoprotein (LDL) cholesterol(baseline (before intervention and end-line (after 12-weeks interventions))
- Change in Body weight(baseline (before intervention and end-line (after 12-weeks interventions))
- Change in serum High Density Lipoprotein (HDL) cholesterol(baseline (before intervention and end-line (after 12-weeks interventions))
- Change in serum triglyceride (TG)(baseline (before intervention and end-line (after 12-weeks interventions))
研究者
Gusnedi
Associate Professor
Politeknik Kesehatan Kemenkes Padang