Effectiveness of Food-Based Recommendations for Minangkabau Women of Reproductive Age With Dyslipidemia
Primary Purpose
Dietary Habits, Nutrient Deficiency, Obesity
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Promotion of Food-based recommendations
Nutrition counseling from standard health services care
Sponsored by
About this trial
This is an interventional treatment trial for Dietary Habits focused on measuring Nutrition intervention, Food-Based Recommendations, dietary practices, women of reproductive age, dyslipidemia
Eligibility Criteria
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.
Sites / Locations
- Dinas Kesehatan Kota Padang
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FBR group
non-FBR group
Arm Description
weekly home visit and monthly group meeting for 12 weeks
once nutrition counseling from standard health care services
Outcomes
Primary Outcome Measures
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
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
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
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.
Change in carbohydrate intake
Change from baseline at 12-week intervention for carbohydrate intake ( in gram)
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.
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.
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.
Change in PUFA/SFA (P/S) ratio
Change from baseline at 12-week intervention for P/S
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.
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.
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.
Secondary Outcome Measures
Change in Body weight
Change in Body weight (in Kg) from baseline at 12-week intervention
Change in waist circumference
change of waist circumference (in cm), from baseline at 12-week intervention
Change in total cholesterol level
Change of total cholesterol (in mg/dL) from baseline at 12-week intervention
Change in Low Desnsity Lipoprotein (LDL) cholesterol
Change of LDL (in mg/dL) from baseline at 12-week intervention
Change in serum High Density Lipoprotein (HDL) cholesterol
Change of HDL (mg/dL) from baseline at 12-week intervention
Change in serum triglyceride (TG)
Change of TG (mg/dL) from baseline at 12-week intervention
Full Information
NCT ID
NCT04085874
First Posted
September 4, 2019
Last Updated
September 9, 2019
Sponsor
Politeknik Kesehatan Kemenkes Padang
Collaborators
Indonesia University
1. Study Identification
Unique Protocol Identification Number
NCT04085874
Brief Title
Effectiveness of Food-Based Recommendations for Minangkabau Women of Reproductive Age With Dyslipidemia
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
May 5, 2019 (Actual)
Study Completion Date
June 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Politeknik Kesehatan Kemenkes Padang
Collaborators
Indonesia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dietary Habits, Nutrient Deficiency, Obesity, Dyslipidemias
Keywords
Nutrition intervention, Food-Based Recommendations, dietary practices, women of reproductive age, dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FBR group
Arm Type
Experimental
Arm Description
weekly home visit and monthly group meeting for 12 weeks
Arm Title
non-FBR group
Arm Type
Active Comparator
Arm Description
once nutrition counseling from standard health care services
Intervention Type
Behavioral
Intervention Name(s)
Promotion of Food-based recommendations
Other Intervention Name(s)
Nutrition education
Intervention Description
Prolonged contact through weekly home visits and monthly group meeting for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Nutrition counseling from standard health services care
Other Intervention Name(s)
Standard nutrition care
Intervention Description
once nutrition counselling from health services
Primary Outcome Measure Information:
Title
Change in Dietary practice
Description
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)
Title
Change in energy intake
Description
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)
Title
Change in protein intake
Description
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)
Title
Change in total fat intake
Description
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)
Title
Change in carbohydrate intake
Description
Change from baseline at 12-week intervention for carbohydrate intake ( in gram)
Time Frame
baseline (before intervention and end-line (after 12-weeks interventions)
Title
Change in poly unsaturated fatty acids (PUFA) intake
Description
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)
Title
Change in mono unsaturated fatty acids (MUFA) intakes
Description
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)
Title
Change in saturated fatty acids (SFA) intakes
Description
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)
Title
Change in PUFA/SFA (P/S) ratio
Description
Change from baseline at 12-week intervention for P/S
Time Frame
baseline (before intervention and end-line (after 12-weeks interventions)
Title
Change in dietary fiber intakes
Description
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)
Title
Change in iron (Fe) intake
Description
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)
Title
Change in zinc (Zn) intake
Description
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)
Secondary Outcome Measure Information:
Title
Change in Body weight
Description
Change in Body weight (in Kg) from baseline at 12-week intervention
Time Frame
baseline (before intervention and end-line (after 12-weeks interventions)
Title
Change in waist circumference
Description
change of waist circumference (in cm), from baseline at 12-week intervention
Time Frame
baseline (before intervention and end-line (after 12-weeks interventions)
Title
Change in total cholesterol level
Description
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)
Title
Change in Low Desnsity Lipoprotein (LDL) cholesterol
Description
Change of LDL (in mg/dL) from baseline at 12-week intervention
Time Frame
baseline (before intervention and end-line (after 12-weeks interventions)
Title
Change in serum High Density Lipoprotein (HDL) cholesterol
Description
Change of HDL (mg/dL) from baseline at 12-week intervention
Time Frame
baseline (before intervention and end-line (after 12-weeks interventions)
Title
Change in serum triglyceride (TG)
Description
Change of TG (mg/dL) from baseline at 12-week intervention
Time Frame
baseline (before intervention and end-line (after 12-weeks interventions)
Other Pre-specified Outcome Measures:
Title
Change in Body Mass Index
Description
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)
Title
Change in Castelli's Index
Description
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)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women of reproductive age
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murdani Abdullah
Organizational Affiliation
Indonesia University
Official's Role
Study Chair
Facility Information:
Facility Name
Dinas Kesehatan Kota Padang
City
Padang
State/Province
West Sumatra
ZIP/Postal Code
25171
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34991541
Citation
Gusnedi G, Fahmida U, Witjaksono F, Nurwidya F, Mansyur M, Djuwita R, Dwiriani CM, Abdullah M. Effectiveness of optimized food-based recommendation promotion to improve nutritional status and lipid profiles among Minangkabau women with dyslipidemia: A cluster-randomized trial. BMC Public Health. 2022 Jan 6;22(1):21. doi: 10.1186/s12889-021-12462-5.
Results Reference
derived
Learn more about this trial
Effectiveness of Food-Based Recommendations for Minangkabau Women of Reproductive Age With Dyslipidemia
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