- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04085874
Effectiveness of Food-Based Recommendations for Minangkabau Women of Reproductive Age With Dyslipidemia
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 Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
West Sumatra
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Padang, West Sumatra, Indonesia, 25171
- Dinas Kesehatan Kota Padang
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: FBR group
weekly home visit and monthly group meeting for 12 weeks
|
Prolonged contact through weekly home visits and monthly group meeting for 12 weeks
Other Names:
|
ACTIVE_COMPARATOR: non-FBR group
once nutrition counseling from standard health care services
|
once nutrition counselling from health services
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline (before the intervention) and end-line (after 12-weeks intervention)
|
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
|
baseline (before intervention and end-line (after 12-weeks interventions)
|
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
|
baseline (before intervention and end-line (after 12-weeks interventions)
|
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.
|
baseline (before intervention and end-line (after 12-weeks interventions)
|
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)
|
baseline (before intervention and end-line (after 12-weeks interventions)
|
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.
|
baseline (before intervention and end-line (after 12-weeks interventions)
|
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.
|
baseline (before intervention and end-line (after 12-weeks interventions)
|
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.
|
baseline (before intervention and end-line (after 12-weeks interventions)
|
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
|
baseline (before intervention and end-line (after 12-weeks interventions)
|
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.
|
baseline (before intervention and end-line (after 12-weeks interventions)
|
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.
|
baseline (before intervention and end-line (after 12-weeks interventions)
|
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.
|
baseline (before intervention and end-line (after 12-weeks interventions)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline (before intervention and end-line (after 12-weeks interventions)
|
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
|
baseline (before intervention and end-line (after 12-weeks interventions)
|
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
|
baseline (before intervention and end-line (after 12-weeks interventions)
|
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
|
baseline (before intervention and end-line (after 12-weeks interventions)
|
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
|
baseline (before intervention and end-line (after 12-weeks interventions)
|
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
|
baseline (before intervention and end-line (after 12-weeks interventions)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline (before intervention and end-line (after 12-weeks interventions)
|
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
|
baseline (before intervention and end-line (after 12-weeks interventions)
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Murdani Abdullah, Indonesia University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-12-1376
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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