Trial Outcomes & Findings for Evaluating a Family-based Nutrition and Garden Intervention in Rural Guatemala (NCT NCT03689504)
NCT ID: NCT03689504
Last Updated: 2021-11-09
Results Overview
Calculated from the World Health Organization Infant and Young Child Feeding Indicators 24 hour diet recall tool
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
140 participants
Primary outcome timeframe
Baseline, 6 months
Results posted on
2021-11-09
Participant Flow
Participant milestones
| Measure |
Standard of Care
The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.
Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)
Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
|
Home Garden Intervention
This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)
Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)
Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
70
|
|
Overall Study
COMPLETED
|
65
|
70
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
data missing
Baseline characteristics by cohort
| Measure |
Standard of Care
n=70 Participants
The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.
Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)
Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
|
Home Garden Intervention
n=70 Participants
This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)
Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)
Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
376 days
n=70 Participants
|
343 days
n=70 Participants
|
353 days
n=140 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=70 Participants
|
29 Participants
n=70 Participants
|
61 Participants
n=140 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=70 Participants
|
41 Participants
n=70 Participants
|
79 Participants
n=140 Participants
|
|
Race/Ethnicity, Customized
Maya ethnicity/language preference
|
65 Participants
n=69 Participants • data missing
|
68 Participants
n=70 Participants • data missing
|
133 Participants
n=139 Participants • data missing
|
|
Region of Enrollment
Guatemala
|
70 participants
n=70 Participants
|
70 participants
n=70 Participants
|
140 participants
n=140 Participants
|
|
Length for age Z score
|
-3.05 Z score
n=70 Participants
|
-3.20 Z score
n=70 Participants
|
-3.15 Z score
n=140 Participants
|
|
Weight for age Z score
|
-1.55 Z score
n=70 Participants
|
-1.58 Z score
n=70 Participants
|
-1.56 Z score
n=140 Participants
|
|
Weight for length Z score
|
0.18 Z score
n=70 Participants
|
0.32 Z score
n=70 Participants
|
0.3 Z score
n=140 Participants
|
|
Minimum acceptable diet
|
34 Participants
n=70 Participants
|
48 Participants
n=70 Participants
|
82 Participants
n=140 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsCalculated from the World Health Organization Infant and Young Child Feeding Indicators 24 hour diet recall tool
Outcome measures
| Measure |
Standard of Care
n=70 Participants
The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.
Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)
Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
|
Home Garden Intervention
n=64 Participants
This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)
Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)
Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
|
|---|---|---|
|
Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Child
|
0.6 food groups
Standard Deviation 1.84
|
1.29 food groups
Standard Deviation 1.59
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsCalculated from the World Health Organization Infant and Young Child Feeding Indicators 24 hour diet recall tool
Outcome measures
| Measure |
Standard of Care
n=70 Participants
The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.
Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)
Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
|
Home Garden Intervention
n=70 Participants
This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)
Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)
Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
|
|---|---|---|
|
Change From Baseline in Mean Number of Solid Meals Consumed Per Day at 6 Months - Child
|
0.81 solid meals
Standard Deviation 1.61
|
1.11 solid meals
Standard Deviation 1.45
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsStandardized food insecurity score, using the Food and Agriculture Organization's Global Food Insecurity Experience Scale (possible score range 0-8), higher scores indicate more food insecurity
Outcome measures
| Measure |
Standard of Care
n=70 Participants
The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.
Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)
Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
|
Home Garden Intervention
n=64 Participants
This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)
Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)
Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
|
|---|---|---|
|
Change From Baseline in Raw Household Food Insecurity Score at 6 Months
|
-0.55 score on a scale
Standard Deviation 1.86
|
-0.84 score on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsCalculated from the Food and Agriculture Organization's Minimum Dietary Diversity for Women dietary recall
Outcome measures
| Measure |
Standard of Care
n=70 Participants
The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.
Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)
Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
|
Home Garden Intervention
n=64 Participants
This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)
Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)
Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
|
|---|---|---|
|
Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Female Head of Household
|
-0.01 food groups
Standard Deviation 1.88
|
0.42 food groups
Standard Deviation 1.75
|
SECONDARY outcome
Timeframe: 0 months (baseline), 6 monthsThese are differences from 0 to 6 months (baseline to 6 months of intervention) z-scores calculated against the World Health Organization pediatric growth reference population (https://www.who.int/tools/child-growth-standards/standards)
Outcome measures
| Measure |
Standard of Care
n=70 Participants
The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.
Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)
Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
|
Home Garden Intervention
n=64 Participants
This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)
Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)
Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
|
|---|---|---|
|
Change in Height/Length for Age Z Score From Baseline to 6 Months
|
-0.21 change in Z score
Standard Deviation 0.49
|
-0.07 change in Z score
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: 0 months (Baseline), 6 monthsThese are differences from 0 to 6 months (baseline to 6 months of intervention) z-scores calculated against the World Health Organization pediatric growth reference population (https://www.who.int/tools/child-growth-standards/standards)
Outcome measures
| Measure |
Standard of Care
n=70 Participants
The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.
Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)
Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
|
Home Garden Intervention
n=64 Participants
This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)
Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)
Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
|
|---|---|---|
|
Change in Weight for Age Z Score From Baseline to 6 Months
|
-0.22 Change in Z score
Standard Deviation 0.39
|
-0.12 Change in Z score
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsThese are differences from 0 to 6 months (baseline to 6 months of intervention) z-scores calculated against the World Health Organization pediatric growth reference population (https://www.who.int/tools/child-growth-standards/standards)
Outcome measures
| Measure |
Standard of Care
n=70 Participants
The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.
Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)
Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
|
Home Garden Intervention
n=64 Participants
This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)
Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)
Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
|
|---|---|---|
|
Change in Weight for Height/Length Z Score From Baseline to 6 Months
|
-0.38 Change in Z score
Standard Deviation 0.64
|
-0.24 Change in Z score
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsRaw count of total crop species cultivated in the home
Outcome measures
| Measure |
Standard of Care
n=70 Participants
The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.
Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)
Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
|
Home Garden Intervention
n=64 Participants
This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)
Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)
Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
|
|---|---|---|
|
Mean Change in Household Crop Species From Baseline to 6 Months Diversity Score
|
-1.1 crop species
Standard Deviation 4.15
|
4.62 crop species
Standard Deviation 4.66
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Home Garden Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place