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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04085874
• Other study ID #: 18-12-1376
• Status: Completed
• Phase: N/A
• Start date: January 7, 2019
• Est. completion date: June 10, 2019

Study information

• Verified date: September 2019
• Source: Politeknik Kesehatan Kemenkes Padang
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: June 10, 2019
• Est. primary completion date: May 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dietary Habits
• Dyslipidemias
• Nutrient Deficiency
• Obesity

Intervention

Behavioral:
• Promotion of Food-based recommendations
Prolonged contact through weekly home visits and monthly group meeting for 12 weeks
• Nutrition counseling from standard health services care
once nutrition counselling from health services

Locations

Country	Name	City	State
Indonesia	Dinas Kesehatan Kota Padang	Padang	West Sumatra

Sponsors (2)

Lead Sponsor	Collaborator
Politeknik Kesehatan Kemenkes Padang	Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	baseline (before intervention and end-line (after 12-weeks interventions)
Other	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	baseline (before intervention and end-line (after 12-weeks interventions)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)