CompletedNot Applicable

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

Indonesia123 participantsStarted 2019-01-07

Plain-language 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.

Who can participate

Age range

20 Years – 44 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Dietary practice

Timeframe: baseline (before the intervention) and end-line (after 12-weeks intervention)

Change in energy intake

Timeframe: baseline (before intervention and end-line (after 12-weeks interventions)

Change in protein intake

Timeframe: baseline (before intervention and end-line (after 12-weeks interventions)

Change in total fat intake

Timeframe: baseline (before intervention and end-line (after 12-weeks interventions)

Change in carbohydrate intake

Timeframe: baseline (before intervention and end-line (after 12-weeks interventions)

Change in poly unsaturated fatty acids (PUFA) intake

Timeframe: baseline (before intervention and end-line (after 12-weeks interventions)

Change in mono unsaturated fatty acids (MUFA) intakes

Timeframe: baseline (before intervention and end-line (after 12-weeks interventions)

Trial details

NCT IDNCT04085874

SponsorPoliteknik Kesehatan Kemenkes Padang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-05-05

View on ClinicalTrials.gov More Dietary Habits trials

Plain-language summary

Who can participate

Age range

20 Years – 44 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Dietary practice

Timeframe: baseline (before the intervention) and end-line (after 12-weeks intervention)

Change in energy intake

Timeframe: baseline (before intervention and end-line (after 12-weeks interventions)

Change in protein intake

Timeframe: baseline (before intervention and end-line (after 12-weeks interventions)

Change in total fat intake

Timeframe: baseline (before intervention and end-line (after 12-weeks interventions)

Change in carbohydrate intake

Timeframe: baseline (before intervention and end-line (after 12-weeks interventions)

Change in poly unsaturated fatty acids (PUFA) intake

Timeframe: baseline (before intervention and end-line (after 12-weeks interventions)

Change in mono unsaturated fatty acids (MUFA) intakes

Timeframe: baseline (before intervention and end-line (after 12-weeks interventions)