An interventional study of Promotion of Food-based recommendations and Nutrition counseling from standard health services care in Dietary Habits, Nutrient Deficiency and Obesity, sponsored by Politeknik Kesehatan Kemenkes Padang. Completed at 1 site in Indonesia. Open to female participants aged 20 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-11.
Sponsored by Politeknik Kesehatan Kemenkes Padang · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 123 is above the median of 99 across 842 interventional studies indexed under Dyslipidemias.
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Exclusion Criteria:
weekly home visit and monthly group meeting for 12 weeks
Behavioral: Promotion of Food-based recommendations
once nutrition counseling from standard health care services
Behavioral: Nutrition counseling from standard health services care
Prolonged contact through weekly home visits and monthly group meeting for 12 weeks
Also known as: Nutrition education
once nutrition counselling from health services
Also known as: Standard nutrition care
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline (before intervention and end-line (after 12-weeks interventions)
Change in Body weight
Change in Body weight (in Kg) from baseline at 12-week intervention
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline (before intervention and end-line (after 12-weeks interventions)
Change in Body Mass Index
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
Time frame: baseline (before intervention and end-line (after 12-weeks interventions)
Change in Castelli's Index
Change of Castelli's index from baseline at 12-week intervention, calculated from the total cholesterol level divided by serum HDL
Time frame: baseline (before intervention and end-line (after 12-weeks interventions)
Plan to share: No
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Politeknik Kesehatan Kemenkes Padang