Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-01-05 @ 5:46 PM
Study NCT ID:
NCT04209569
Status:
COMPLETED
Last Update Posted:
2024-01-31
First Post:
2019-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
One Nutrition in Complex Environments (ONCE)
Sponsor:
Tufts University
Organization:
Study Overview
Official Title:
One Nutrition in Complex Environments (ONCE), a Cluster-randomized Trial of Nutrition Education and Access to Simple Supportive Technologies in Improving Agricultural Practices and Water Quality Management
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ONCE
Brief Summary:
This study asks the research question "Does enabling families (particularly mothers and other caregivers) to 'assess and act' on drivers of malnutrition through a targeted SBC+ package succeed in a sustained reduction of risk factors thereby improving child health and nutrition?" This study aims to implement and measure the effects of a multi-level multi-sectoral behavior change information intervention in Agago District of Northern Uganda and determine potential for scale up in a complex environment.
The study design is a three-arm cluster randomized controlled superiority design (cRCT) with a 1:1:1 allocation ratio. The study arms will be: Group 1: NIPP arm; Group 2: NIPP+ arm; and Group 3: Non-intervention control arm. A barrier analysis will be conducted to ensure appropriate targeting and contextualization of the NIPP and NIPP+ approaches prior to implementation. Each intervention arm will receive a 12-week intervention (NIPP or NIPP+) with active monitoring and longitudinal follow ups post intervention at 2, 6, and 12-months post-intervention. The total sample size for the Barrier Analysis will be a maximum of 450 caregivers; for the main intervention, 900 households (300/arm) will be purposely sampled from the randomly selected communities. Respondents for the qualitative portion will be purposely selected.
The study design is a three-arm cluster randomized controlled superiority design (cRCT) with a 1:1:1 allocation ratio. The study arms will be: Group 1: NIPP arm; Group 2: NIPP+ arm; and Group 3: Non-intervention control arm. A barrier analysis will be conducted to ensure appropriate targeting and contextualization of the NIPP and NIPP+ approaches prior to implementation. Each intervention arm will receive a 12-week intervention (NIPP or NIPP+) with active monitoring and longitudinal follow ups post intervention at 2, 6, and 12-months post-intervention. The total sample size for the Barrier Analysis will be a maximum of 450 caregivers; for the main intervention, 900 households (300/arm) will be purposely sampled from the randomly selected communities. Respondents for the qualitative portion will be purposely selected.
Detailed Description:
Objective: This study asks the research question "Does enabling families (particularly mothers and other caregivers) to 'assess and act' on drivers of malnutrition through a targeted SBC+ package succeed in a sustained reduction of risk factors thereby improving child health and nutrition?" This study aims to implement and measure the effects of a multi-level multi-sectoral behavior change information intervention in Agago District of Northern Uganda and determine potential for scale up in a complex environment.
Intervention: Through a collaboration between Tufts University, GOAL International, CIMMYT, and Cornell University, GOAL will implement Nutrition Impact and Positive Practice (NIPP) circles as the standard SBC intervention against which the hypotheses will be tested. GOAL will also implement a NIPP+ approach which will integrate additional interventions for water, sanitation, and hygiene (WASH), and use of improved agriculture inputs. These interventions will be measured by outcome indicators measuring aflatoxin exposure, water contamination, and knowledge transferred to action.
Design: The study design is a three-arm cluster randomized controlled superiority design (cRCT) with a 1:1:1 allocation ratio. The study arms will be: Group 1: NIPP arm; Group 2: NIPP+ arm; and Group 3: Non-intervention control arm. A barrier analysis will be conducted to ensure appropriate targeting and contextualization of the NIPP and NIPP+ approaches prior to implementation. Each intervention arm will receive a 12-week intervention (NIPP or NIPP+) with active monitoring and longitudinal follow ups post intervention at 2, 6, and 12-months post-intervention. The total sample size for the Barrier Analysis will be a maximum of 450 caregivers; for the main intervention, 900 households (300/arm) will be purposely sampled from the randomly selected communities. Respondents for the qualitative portion will be purposely selected.
Analysis: This longitudinal study will collect data from all participants at 3 time points: baseline, endline, and sustainability (12-months post-intervention). The analysis will utilize Intent-to-Treat (ITT) approach using the initial randomization of the treatment arms. Using ITT will allow us to determine the overall impact of having the NIPP vs. NIPP+ vs. control, thus better mimicking real world program implementation and impact. Mixed effects models will be used to determine the role of time-variant and invariant individual (by gender) household, and community characteristics, as well as measures of exposure and integration on key outcome indicators. A difference-in-difference analysis (baseline/endline, baseline/sustainability, endline/sustainability) will also be used to triangulate findings.
Sub-study: a subset of reproductive age women will be purposively selected for enrollment into a validation sub-study that will examine the level of aflatoxin (AFB1-lysine concentration) exposure measured in venous blood compared to capillary blood compared to the innovative SAFE-phone method. This will serve as a validation and calibration sub-study to gauge the accuracy of the SAFE-Phone method compared to venous reference.
Intervention: Through a collaboration between Tufts University, GOAL International, CIMMYT, and Cornell University, GOAL will implement Nutrition Impact and Positive Practice (NIPP) circles as the standard SBC intervention against which the hypotheses will be tested. GOAL will also implement a NIPP+ approach which will integrate additional interventions for water, sanitation, and hygiene (WASH), and use of improved agriculture inputs. These interventions will be measured by outcome indicators measuring aflatoxin exposure, water contamination, and knowledge transferred to action.
Design: The study design is a three-arm cluster randomized controlled superiority design (cRCT) with a 1:1:1 allocation ratio. The study arms will be: Group 1: NIPP arm; Group 2: NIPP+ arm; and Group 3: Non-intervention control arm. A barrier analysis will be conducted to ensure appropriate targeting and contextualization of the NIPP and NIPP+ approaches prior to implementation. Each intervention arm will receive a 12-week intervention (NIPP or NIPP+) with active monitoring and longitudinal follow ups post intervention at 2, 6, and 12-months post-intervention. The total sample size for the Barrier Analysis will be a maximum of 450 caregivers; for the main intervention, 900 households (300/arm) will be purposely sampled from the randomly selected communities. Respondents for the qualitative portion will be purposely selected.
Analysis: This longitudinal study will collect data from all participants at 3 time points: baseline, endline, and sustainability (12-months post-intervention). The analysis will utilize Intent-to-Treat (ITT) approach using the initial randomization of the treatment arms. Using ITT will allow us to determine the overall impact of having the NIPP vs. NIPP+ vs. control, thus better mimicking real world program implementation and impact. Mixed effects models will be used to determine the role of time-variant and invariant individual (by gender) household, and community characteristics, as well as measures of exposure and integration on key outcome indicators. A difference-in-difference analysis (baseline/endline, baseline/sustainability, endline/sustainability) will also be used to triangulate findings.
Sub-study: a subset of reproductive age women will be purposively selected for enrollment into a validation sub-study that will examine the level of aflatoxin (AFB1-lysine concentration) exposure measured in venous blood compared to capillary blood compared to the innovative SAFE-phone method. This will serve as a validation and calibration sub-study to gauge the accuracy of the SAFE-Phone method compared to venous reference.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: