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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04085874
Recruitment Status : Completed
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
Indonesia University
Information provided by (Responsible Party):
Gusnedi, Politeknik Kesehatan Kemenkes Padang

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.

Condition or disease Intervention/treatment Phase
Dietary Habits Nutrient Deficiency Obesity Dyslipidemias Behavioral: Promotion of Food-based recommendations Behavioral: Nutrition counseling from standard health services care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 7, 2019
Actual Primary Completion Date : May 5, 2019
Actual Study Completion Date : June 10, 2019

Arm Intervention/treatment
Experimental: FBR group
weekly home visit and monthly group meeting for 12 weeks
Behavioral: Promotion of Food-based recommendations
Prolonged contact through weekly home visits and monthly group meeting for 12 weeks
Other Name: Nutrition education

Active Comparator: non-FBR group
once nutrition counseling from standard health care services
Behavioral: Nutrition counseling from standard health services care
once nutrition counselling from health services
Other Name: Standard nutrition care




Primary Outcome Measures :
  1. Change in Dietary practice [ Time Frame: 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

  2. Change in energy intake [ Time Frame: 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

  3. Change in protein intake [ Time Frame: 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

  4. Change in total fat intake [ Time Frame: 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.

  5. Change in carbohydrate intake [ Time Frame: baseline (before intervention and end-line (after 12-weeks interventions) ]
    Change from baseline at 12-week intervention for carbohydrate intake ( in gram)

  6. Change in poly unsaturated fatty acids (PUFA) intake [ Time Frame: 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.

  7. Change in mono unsaturated fatty acids (MUFA) intakes [ Time Frame: 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.

  8. Change in saturated fatty acids (SFA) intakes [ Time Frame: 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.

  9. Change in PUFA/SFA (P/S) ratio [ Time Frame: baseline (before intervention and end-line (after 12-weeks interventions) ]
    Change from baseline at 12-week intervention for P/S

  10. Change in dietary fiber intakes [ Time Frame: 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.

  11. Change in iron (Fe) intake [ Time Frame: 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.

  12. Change in zinc (Zn) intake [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in Body weight [ Time Frame: baseline (before intervention and end-line (after 12-weeks interventions) ]
    Change in Body weight (in Kg) from baseline at 12-week intervention

  2. Change in waist circumference [ Time Frame: baseline (before intervention and end-line (after 12-weeks interventions) ]
    change of waist circumference (in cm), from baseline at 12-week intervention

  3. Change in total cholesterol level [ Time Frame: baseline (before intervention and end-line (after 12-weeks interventions) ]
    Change of total cholesterol (in mg/dL) from baseline at 12-week intervention

  4. Change in Low Desnsity Lipoprotein (LDL) cholesterol [ Time Frame: baseline (before intervention and end-line (after 12-weeks interventions) ]
    Change of LDL (in mg/dL) from baseline at 12-week intervention

  5. Change in serum High Density Lipoprotein (HDL) cholesterol [ Time Frame: baseline (before intervention and end-line (after 12-weeks interventions) ]
    Change of HDL (mg/dL) from baseline at 12-week intervention

  6. Change in serum triglyceride (TG) [ Time Frame: baseline (before intervention and end-line (after 12-weeks interventions) ]
    Change of TG (mg/dL) from baseline at 12-week intervention


Other Outcome Measures:
  1. Change in Body Mass Index [ Time Frame: baseline (before intervention and end-line (after 12-weeks interventions) ]
    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

  2. Change in Castelli's Index [ Time Frame: baseline (before intervention and end-line (after 12-weeks interventions) ]
    Change of Castelli's index from baseline at 12-week intervention, calculated from the total cholesterol level divided by serum HDL



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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women of reproductive age
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085874


Locations
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Indonesia
Dinas Kesehatan Kota Padang
Padang, West Sumatra, Indonesia, 25171
Sponsors and Collaborators
Politeknik Kesehatan Kemenkes Padang
Indonesia University
Investigators
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Study Chair: Murdani Abdullah Indonesia University

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Responsible Party: Gusnedi, Associate Professor, Politeknik Kesehatan Kemenkes Padang
ClinicalTrials.gov Identifier: NCT04085874    
Other Study ID Numbers: 18-12-1376
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gusnedi, Politeknik Kesehatan Kemenkes Padang:
Nutrition intervention
Food-Based Recommendations
dietary practices
women of reproductive age
dyslipidemia
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases