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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04085874
Other study ID # 18-12-1376
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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