- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07640594
Randomized Evaluation of Voucher Interventions for Value and Effectiveness (REVIVE) in Philippines (REVIVE)
This study aims to evaluate whether revised food voucher programs, combined with nutrition education sessions, can improve food security, dietary quality, nutrition knowledge, and nutritional outcomes among low-income households in the Philippines. Researchers will compare different monthly voucher amounts-Philippine Peso (PhP) 3,000, PhP 5,000, and PhP 8,000-with a no-voucher control group to determine which approach is most effective.
The main questions the study aims to answer are:
- Do food vouchers improve household food security, reduce hunger, and improve dietary quality and nutrient intake?
- Do larger voucher amounts lead to greater improvements in nutrition and health outcomes?
- Does enhanced nutrition education improve nutrition knowledge and healthy eating practices?
Participants will:
- Receive either a monthly food voucher or no voucher, depending on study group assignment
- Attend nutrition education and Social and Behavior Change Communication (SBCC) sessions if assigned to a voucher group
- Complete household interviews on food consumption, household expenditures, food security, and nutrition knowledge
- Participate in dietary assessments and anthropometric measurements for women and children under 5 years of age
Studienübersicht
Status
Detaillierte Beschreibung
The REVIVE study is a cluster-randomized controlled trial designed to evaluate the effectiveness of revised food voucher interventions combined with nutrition-focused Social and Behavior Change Communication (SBCC) among low-income households in the Philippines. The study will compare three monthly voucher amounts (PhP 3,000, PhP 5,000, and PhP 8,000) with a control group receiving no voucher to assess whether larger voucher values lead to greater improvements in food security, dietary quality, and nutrition-related outcomes.
The intervention includes structured food vouchers with revised allocations emphasizing protein-rich foods, fruits, and vegetables, together with nutrition education sessions delivered by trained local government staff. The study will be implemented across selected urban and rural areas in the Philippines.
Researchers will collect household- and individual-level data through surveys, dietary assessments, and anthropometric measurements to examine the effects of the intervention on household food consumption, nutrition knowledge, food insecurity, dietary quality, and nutritional status among women of reproductive age and children under five years of age. The study will also assess potential spillover effects within participating communities.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Phuong H Nguyen, PhD
- Telefonnummer: 02028625600
- E-Mail: P.H.Nguyen@cgiar.org
Studieren Sie die Kontaktsicherung
- Name: Neha Kumar, PhD
- E-Mail: N.Kumar@cgiar.org
Studienorte
-
-
District of Columbia
-
Washington D.C., District of Columbia, Vereinigte Staaten, 20006
- Rekrutierung
- International Food Policy Research Institute
-
Kontakt:
- Phuong Nguyen
- Telefonnummer: 2028264088
- E-Mail: p.h.nguyen@cgiar.org
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Households enrolled in the REVIVE study sample drawn from Listahanan 3-eligible low-income households
- Residency within selected study clusters in the study municipalities
- Household consent to participate in the study and all survey components
- Availability of a primary respondent (meal planner or primary food preparer) willing to participate in household interviews
- For individual dietary assessment components: presence of at least one woman of reproductive age (15-49 years) and/or at least one child under five years of age, where applicable
Exclusion Criteria:
- Households unwilling or unable to provide informed consent
- Households not residing within the designated study clusters at the time of baseline data collection
- Inability to complete core survey modules due to communication barriers or other conditions preventing reliable data collection
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: Control: No Voucher
Households in this arm do not receive food vouchers during the study period
|
|
|
Experimental: Monthly Food Voucher - PhP 3,000
Households receive a monthly food voucher valued at PhP 3,000, structured with a 10% allocation for carbohydrates and oils, 45% for protein-rich foods, and 45% for fruits and vegetables.
Vouchers can be redeemed continuously and are accompanied by six structured nutrition-focused social and behavior change communication (SBCC) sessions delivered by trained local government staff.
|
Households receive a monthly food voucher valued at PhP 3,000 with a structured allocation of 10% for carbohydrates and oils, 45% for protein-rich foods, and 45% for fruits and vegetables.
Vouchers are redeemable continuously throughout the month.
The intervention is combined with six structured social and behavior change communication (SBCC) sessions focused on nutrition knowledge, healthy dietary practices, maternal and child nutrition, and WASH behaviors, delivered by trained local government staff.
|
|
Experimental: Monthly Food Voucher - PhP 5,000
Households receive a monthly food voucher valued at PhP 5,000, with the same food group allocation (10% carbohydrates and oils, 45% protein, 45% fruits and vegetables) and continuous redemption design.
Voucher receipt is combined with six SBCC sessions aimed at improving nutrition knowledge and dietary practices.
|
Households receive a monthly food voucher valued at PhP 5,000 with the same allocation structure (10% carbohydrates and oils, 45% protein, 45% fruits and vegetables) and continuous redemption design.
The voucher is paired with six SBCC sessions covering nutrition education and behavior change topics related to diet quality and household nutrition.
|
|
Experimental: Monthly Food Voucher - PhP 8,000
Households receive a monthly food voucher valued at PhP 8,000, structured with 10% allocation for carbohydrates and oils, 45% for protein, and 45% for fruits and vegetables, and redeemed continuously.
The intervention is paired with six nutrition-focused SBCC sessions delivered by trained local government personnel to improve dietary behaviors and nutrition knowledge.
|
Households receive a monthly food voucher valued at PhP 8,000 with the same structured food group allocation and continuous redemption system.
The intervention includes six SBCC sessions aimed at improving nutrition knowledge and dietary practices for maternal and child health.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Nutrition Knowledge
Zeitfenster: Baseline and End of intervention (approximately 24 months)
|
Composite measure of nutrition knowledge assessed using a structured questionnaire administered to the primary household meal planner.
The instrument includes items on food groups, dietary diversity, micronutrient-rich foods, maternal and child feeding practices, and understanding of voucher allocation rules.
A total score will be constructed by summing correct responses and standardizing across respondents.
Subdomain scores (e.g., dietary diversity knowledge, micronutrient knowledge, child feeding knowledge) will also be analyzed.
|
Baseline and End of intervention (approximately 24 months)
|
|
Individual Nutrient Adequacy
Zeitfenster: End of intervention (approximately 24 months)
|
Summary measure of dietary nutrient adequacy among women of reproductive age and children under five years, derived from 24-hour dietary recall data.
Probability of adequacy will be estimated for energy, macronutrients, and selected micronutrients (vitamin A, B-complex vitamins, vitamin C, calcium, iron, and zinc).
The mean probability of adequacy will be calculated by averaging across 11 micronutrients.
|
End of intervention (approximately 24 months)
|
|
Minimum Dietary Diversity for Women (MDD-W)
Zeitfenster: End of intervention (approximately 24 months)
|
Minimum Dietary Diversity for Women (MDD-W), defined as the proportion of women of reproductive age who consume foods from at least 5 of 10 food groups during the previous 24 hours, based on a 24-hour dietary recall.
|
End of intervention (approximately 24 months)
|
|
Global Dietary Quality Score (GDQS)
Zeitfenster: End of intervention (approximately 24 months)
|
Global Dietary Quality Score (GDQS), a food-based metric derived from 24-hour dietary recall data that assesses overall dietary quality by accounting for consumption of both healthy and unhealthy food groups.
GDQS ranges from 0 to 49, with higher scores indicating better dietary quality and lower risk of nutrient inadequacy and diet-related non-communicable diseases.
|
End of intervention (approximately 24 months)
|
|
Hunger and Food Insecurity Experience Scale
Zeitfenster: Baseline and End of intervention (approximately 24 months)
|
Household food insecurity and hunger will be assessed using the Food Insecurity Experience Scale (FIES), an experience-based measure consisting of eight questions about access to adequate food during the previous 4 weeks. The scale captures a range of food insecurity experiences, including worry about obtaining food, reduced dietary quality, reduced food quantity, skipping meals, and going without food. The raw FIES score ranges from 0 to 8, with higher scores indicating greater severity of food insecurity and hunger. Responses will be used to calculate both continuous FIES scores and categorical classifications of food insecurity severity. |
Baseline and End of intervention (approximately 24 months)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Household Food Consumption Score (FCS)
Zeitfenster: Baseline and endline (approximately 24 months after baseline survey)
|
The Food Consumption Score (FCS) is a composite measure of household dietary diversity, food frequency, and relative nutritional importance of foods consumed. The FCS is calculated using a 7-day recall of household food consumption across standardized food groups. Consumption frequencies are weighted according to the nutritional value of each food group and summed to generate the total score. The FCS ranges from 0 to 112, with higher scores indicating better household food consumption, greater dietary diversity, and improved food access. Lower scores indicate poorer food consumption patterns and greater vulnerability to food insecurity. |
Baseline and endline (approximately 24 months after baseline survey)
|
|
Height-for-Age Z-score (HAZ) in Children Under Five Years of Age
Zeitfenster: End of intervention (approximately 24 months)
|
Height-for-age z-score (HAZ) among children under five years of age, calculated using the World Health Organization (WHO) Child Growth Standards.
HAZ is a standardized measure of linear growth relative to age and sex.
HAZ values typically range from approximately -6 to +6, with higher values indicating better growth status.
Children with HAZ < -2 standard deviations are classified as stunted.
|
End of intervention (approximately 24 months)
|
|
Weight-for-Age Z-score (WAZ) in Children Under Five Years of Age
Zeitfenster: End of intervention (approximately 24 months)
|
Weight-for-age z-score (WAZ) among children under five years of age, calculated using the World Health Organization (WHO) Child Growth Standards.
WAZ is a standardized measure of body weight relative to age and sex.
WAZ values typically range from approximately -6 to +6, with higher values indicating better nutritional status.
Children with WAZ < -2 standard deviations are classified as underweight.
|
End of intervention (approximately 24 months)
|
|
Weight-for-Height Z-score (WHZ) in Children Under Five Years of Age
Zeitfenster: End of intervention (approximately 24 months)
|
Weight-for-height z-score (WHZ) among children under five years of age, calculated using the World Health Organization (WHO) Child Growth Standards.
WHZ is a standardized measure of body weight relative to height.
WHZ values typically range from approximately -5 to +5, with higher values indicating better nutritional status.
Children with WHZ < -2 standard deviations are classified as wasted.
|
End of intervention (approximately 24 months)
|
|
Body Mass Index (BMI) Among Women of Reproductive Age
Zeitfenster: End of intervention (approximately 24 months)
|
Body mass index (BMI) among women of reproductive age, calculated as weight in kilograms divided by height in meters squared (kg/m²).
BMI is a continuous measure of nutritional status.
Higher BMI values indicate greater body mass relative to height.
Nutritional status categories (underweight, normal weight, overweight, and obesity) will be classified according to World Health Organization (WHO) standard cut-offs and Asian-specific cut-offs
|
End of intervention (approximately 24 months)
|
|
Household Food and Non-food Expenditure
Zeitfenster: Baseline and End of intervention (approximately 24 months)
|
Total household food expenditure over a 4-week recall period, including food purchased, produced, received as transfers, and redeemed through food vouchers.
Monthly-equivalent household expenditures on non-food categories including health, education, housing, utilities, transport, communication, clothing, durable goods, debt repayment, and other miscellaneous expenditures
|
Baseline and End of intervention (approximately 24 months)
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NDH-26-0412
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
IPD-Sharing-Zeitrahmen
IPD-Sharing-Zugriffskriterien
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Ernährungsunsicherheit
-
Jazz PharmaceuticalsAbgeschlossenFood-EffektVereinigtes Königreich
-
Emalex Biosciences Inc.Abgeschlossen
-
Hutchison Medipharma LimitedAbgeschlossenFood-Effekt | GesundheitsthemenChina
-
Ranok Therapeutics (Hangzhou) Co., Ltd.Noch keine Rekrutierung
-
Verastem, Inc.Abgeschlossen
-
Yale-NUS CollegeUnbekanntFood-Fotografie | Non-Food Photography | No Phone UseSingapur
-
Yale-NUS CollegeUnbekanntFood-Fotografie | Non-Food Photography | No Phone UseSingapur
-
Pennington Biomedical Research CenterAbgeschlossenNahrungsaufnahme | Energieaufnahme | Ernährungsbewertung | Food-FotografieVereinigte Staaten
-
United Arab Emirates UniversityAbgeschlossenErnährungsverhalten | Functional Food | ErnährungserziehungVereinigte Arabische Emirate
-
Donesta BioscienceAbgeschlossen