NCT05858151

Brief Summary

Global Alliance for Improved Nutrition (GAIN)'s "Transforming Food Systems to Improve Diet Quality and Resilience for the Most Vulnerable" program seeks to improve consumption of healthy foods by improving supply, increasing demand, and improving the enabling environment for different targeted foods in 4 countries by operating at multiple levels - individuals, households, markets, producers, and policies. RTI and local partners propose to conduct impact and process evaluations of GAIN's program tailored to the theory of change and the target foods for Mozambique. The evaluation in Mozambique will include a mix of quantitative and qualitative methods and will be guided by the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) implementation research framework.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,216

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
May 2023Nov 2027

First Submitted

Initial submission to the registry

April 19, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

4.4 years

First QC Date

April 19, 2023

Last Update Submit

April 20, 2026

Conditions

Keywords

dietanimal source foodsmarket interventionsocial and behavior change communication interventionmenwomenMozambique

Outcome Measures

Primary Outcomes (1)

  • ASF frequency of consumption

    Change in the mean frequency of fish, chicken, and egg consumption during the last 7 days by men and women in BoP households

    Baseline (May 2023), endline (May 2026 (3 years))

Secondary Outcomes (1)

  • Percent of household members with increased knowledge of target ASFs

    Baseline (May 2023), endline (May 2026 (3 years))

Study Arms (2)

Intervention

ACTIVE COMPARATOR
Behavioral: Food system and demand generation

Control/No Intervention

NO INTERVENTION

Interventions

The Global Alliance for Improved Nutrition (GAIN) will implement the Transforming Food Systems to Improve Diet Quality and Resilience for the Most Vulnerable program, which will use a market-based approach to improving diets through food systems. The set of interventions proposed is based on characteristics and challenges of the food environments of bottom of pyramid consumers in Mozambique. GAIN will focus on elements of the food environment related to accessibility, affordability, and desirability of animal source foods (ASFs) in Mozambique.

Intervention

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Reside in the enumeration areas;
  • Be a man ≥ 18 years or a woman 18-49 years;
  • The household earns \<$3.20 per person per day;
  • Be able to speak one of the main local languages and/or Portuguese;
  • Provide informed consent to participate in the study.

You may not qualify if:

  • Have a mental or psychological illness that prevents them from understanding the study;
  • Have any physical illness that prevents them from being safely and constructively involved in the investigation;
  • Be under the age of 18 years at the time of the study.
  • Market Actor Surveys
  • Be a retailer of fish, chicken or eggs in one of the markets in the districts selected for the evaluation;
  • Be over 18 years old;
  • Be able to speak one of the main local languages and/or Portuguese;
  • Provide informed consent to participate in the study.
  • Have a mental or psychological illness that prevents them from understanding the study;
  • Have any physical illness that prevents them from being safely and constructively involved in the investigation;
  • Be under the age of 18 years at the time of the study.
  • In-depth interviews with market actors:
  • Be a food transporter, trader, large-scale retailer, government official or other stakeholder involved in market-related activities in the fish, chicken or egg value chains in the intervention districts selected for the evaluation;
  • Be over 18 years old;
  • Be able to speak one of the main local languages and/or Portuguese;
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Numbers Whizzy

Maputo, Mozambique

Location

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Multiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Study Officials

  • Sofia Costa

    Universidade Lúrio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Data will be collected through household surveys, market actor surveys and observations, in-depth interviews (IDIs), and focus group discussions (FGDs). The protocol team has selected a subset of the intervention districts for the evaluation and identify an equal number of districts outside the program coverage area with similar characteristics to serve as the control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Public Health Analyst

Study Record Dates

First Submitted

April 19, 2023

First Posted

May 15, 2023

Study Start

May 15, 2023

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Dataset will be shared through Nesstar

Locations