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

NCT04085874 | Completed

• 1 other identifier: 18-12-1376
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Dietary Habits; Nutrient Deficiency; Obesity; Dyslipidemias

Keywords

Nutrition intervention; Food-Based Recommendations; dietary practices; women of reproductive age; dyslipidemia

Outcome Measures

Primary Outcomes (12)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (6)

• Change in Body weight

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

• Change in waist circumference

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

• Change in total cholesterol level

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

• Change in Low Desnsity Lipoprotein (LDL) cholesterol

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

• Change in serum High Density Lipoprotein (HDL) cholesterol

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

Other Outcomes (2)

• Change in Body Mass Index

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

• Change in Castelli's Index

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

Study Arms (2)

FBR group

EXPERIMENTAL

weekly home visit and monthly group meeting for 12 weeks

Behavioral: Promotion of Food-based recommendations

non-FBR group

ACTIVE COMPARATOR

once nutrition counseling from standard health care services

Behavioral: Nutrition counseling from standard health services care

Interventions

Promotion of Food-based recommendations BEHAVIORAL

Prolonged contact through weekly home visits and monthly group meeting for 12 weeks

Also known as: Nutrition education

FBR group

Nutrition counseling from standard health services care BEHAVIORAL

once nutrition counselling from health services

Also known as: Standard nutrition care

non-FBR group

Eligibility Criteria

• Age: 20 Years - 44 Years
• Gender Eligibility Details: Women of reproductive age
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Politeknik Kesehatan Kemenkes Padang: lead
• Indonesia University: collaborator

Study Sites (1)

Dinas Kesehatan Kota Padang

Padang, West Sumatra, 25171, Indonesia

Location

Related Publications (1)

• 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.

  PMID: 34991541 DERIVED

MeSH Terms

Conditions

Feeding Behavior; Obesity; Dyslipidemias

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Murdani Abdullah

  Indonesia University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 11, 2019
• Study Start: January 7, 2019
• Primary Completion: May 5, 2019
• Study Completion: June 10, 2019
• Last Updated: September 11, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)