Trial Outcomes & Findings for Buen Provecho!: A Virtual Family-Based Intervention to Promote Health (NCT NCT05419557)
NCT ID: NCT05419557
Last Updated: 2024-10-08
Results Overview
Days per week child ate vegetables with dinner meal, post intervention Measured with a food frequency questionnaire, question: "Think about all the foods your child ate at your dinner/supper meal and snacks in the past week. On how many days did your child eat vegetables for the dinner meal?" Answer options: 1, Never \| 2, 1-3 days \| 3, 1-2 days \| 4, 3-4 days \| 5, 5-6 days \| 6, Every day (Higher score indicates increased vegetable consumption)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
3 months post-study intervention
Results posted on
2024-10-08
Participant Flow
Recruitment Occurred between 08/18/2022 and 10/10/2022
None. All participants enrolled were assigned to a group.
Participant milestones
| Measure |
Intervention
12 week virtual family-based health eating program
Virtual Family-Based Healthy Plate Club: IHPC provides produce boxes, nutrition and meal-preparation, education, and supportive counseling to address barriers related to obtaining produce and food. The intervention provides participants with a bi-weekly produce box for 12 weeks and helps families identify sustainable ways to obtain vegetables once the produce boxes end. The CHW will support families by coaching them on how to prepare these unfamiliar vegetables, give tips on finding sales at grocery stores, as well as by navigation to food assistance sites including food pantries. Parents will learn strategies to increase vegetable consumption by addressing perceived barriers - such as the child doesn't like vegetables. Curriculum will also include topics such as how to increase physical activity and reduce screen time.
|
Comparison
Standard in-office counseling about diet
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
20
|
|
Overall Study
COMPLETED
|
11
|
16
|
|
Overall Study
NOT COMPLETED
|
11
|
4
|
Reasons for withdrawal
| Measure |
Intervention
12 week virtual family-based health eating program
Virtual Family-Based Healthy Plate Club: IHPC provides produce boxes, nutrition and meal-preparation, education, and supportive counseling to address barriers related to obtaining produce and food. The intervention provides participants with a bi-weekly produce box for 12 weeks and helps families identify sustainable ways to obtain vegetables once the produce boxes end. The CHW will support families by coaching them on how to prepare these unfamiliar vegetables, give tips on finding sales at grocery stores, as well as by navigation to food assistance sites including food pantries. Parents will learn strategies to increase vegetable consumption by addressing perceived barriers - such as the child doesn't like vegetables. Curriculum will also include topics such as how to increase physical activity and reduce screen time.
|
Comparison
Standard in-office counseling about diet
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
4
|
Baseline Characteristics
12 Withdrew from the study, 3 lost to Follow-Up
Baseline characteristics by cohort
| Measure |
Intervention
n=22 Participants
12 week virtual family-based health eating program
Virtual Family-Based Healthy Plate Club: IHPC provides produce boxes, nutrition and meal-preparation, education, and supportive counseling to address barriers related to obtaining produce and food. The intervention provides participants with a bi-weekly produce box for 12 weeks and helps families identify sustainable ways to obtain vegetables once the produce boxes end. The CHW will support families by coaching them on how to prepare these unfamiliar vegetables, give tips on finding sales at grocery stores, as well as by navigation to food assistance sites including food pantries. Parents will learn strategies to increase vegetable consumption by addressing perceived barriers - such as the child doesn't like vegetables. Curriculum will also include topics such as how to increase physical activity and reduce screen time.
|
Comparison
n=20 Participants
Standard in-office counseling about diet, physical activity and screen time
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=22 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=22 Participants
|
20 Participants
n=20 Participants
|
42 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=22 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=22 Participants
|
20 Participants
n=20 Participants
|
42 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=22 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=11 Participants • 12 Withdrew from the study, 3 lost to Follow-Up
|
14 Participants
n=16 Participants • 12 Withdrew from the study, 3 lost to Follow-Up
|
24 Participants
n=27 Participants • 12 Withdrew from the study, 3 lost to Follow-Up
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=11 Participants • 12 Withdrew from the study, 3 lost to Follow-Up
|
2 Participants
n=16 Participants • 12 Withdrew from the study, 3 lost to Follow-Up
|
3 Participants
n=27 Participants • 12 Withdrew from the study, 3 lost to Follow-Up
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants • 12 Withdrew from the study, 3 lost to Follow-Up
|
0 Participants
n=16 Participants • 12 Withdrew from the study, 3 lost to Follow-Up
|
0 Participants
n=27 Participants • 12 Withdrew from the study, 3 lost to Follow-Up
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants • 12 Withdrew, 3 Lost to Follow-Up
|
0 Participants
n=16 Participants • 12 Withdrew, 3 Lost to Follow-Up
|
0 Participants
n=27 Participants • 12 Withdrew, 3 Lost to Follow-Up
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants • 12 Withdrew, 3 Lost to Follow-Up
|
0 Participants
n=16 Participants • 12 Withdrew, 3 Lost to Follow-Up
|
0 Participants
n=27 Participants • 12 Withdrew, 3 Lost to Follow-Up
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants • 12 Withdrew, 3 Lost to Follow-Up
|
0 Participants
n=16 Participants • 12 Withdrew, 3 Lost to Follow-Up
|
0 Participants
n=27 Participants • 12 Withdrew, 3 Lost to Follow-Up
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=11 Participants • 12 Withdrew, 3 Lost to Follow-Up
|
0 Participants
n=16 Participants • 12 Withdrew, 3 Lost to Follow-Up
|
0 Participants
n=27 Participants • 12 Withdrew, 3 Lost to Follow-Up
|
|
Race (NIH/OMB)
White
|
11 Participants
n=11 Participants • 12 Withdrew, 3 Lost to Follow-Up
|
15 Participants
n=16 Participants • 12 Withdrew, 3 Lost to Follow-Up
|
26 Participants
n=27 Participants • 12 Withdrew, 3 Lost to Follow-Up
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants • 12 Withdrew, 3 Lost to Follow-Up
|
1 Participants
n=16 Participants • 12 Withdrew, 3 Lost to Follow-Up
|
1 Participants
n=27 Participants • 12 Withdrew, 3 Lost to Follow-Up
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants • 12 Withdrew, 3 Lost to Follow-Up
|
0 Participants
n=16 Participants • 12 Withdrew, 3 Lost to Follow-Up
|
0 Participants
n=27 Participants • 12 Withdrew, 3 Lost to Follow-Up
|
|
Region of Enrollment
United States
|
22 Participants
n=22 Participants
|
20 Participants
n=20 Participants
|
42 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 3 months post-study interventionDays per week child ate vegetables with dinner meal, post intervention Measured with a food frequency questionnaire, question: "Think about all the foods your child ate at your dinner/supper meal and snacks in the past week. On how many days did your child eat vegetables for the dinner meal?" Answer options: 1, Never \| 2, 1-3 days \| 3, 1-2 days \| 4, 3-4 days \| 5, 5-6 days \| 6, Every day (Higher score indicates increased vegetable consumption)
Outcome measures
| Measure |
Intervention
n=11 Participants
12 week virtual family-based health eating program
Virtual Family-Based Healthy Plate Club: IHPC provides produce boxes, nutrition and meal-preparation, education, and supportive counseling to address barriers related to obtaining produce and food. The intervention provides participants with a bi-weekly produce box for 12 weeks and helps families identify sustainable ways to obtain vegetables once the produce boxes end. The CHW will support families by coaching them on how to prepare these unfamiliar vegetables, give tips on finding sales at grocery stores, as well as by navigation to food assistance sites including food pantries. Parents will learn strategies to increase vegetable consumption by addressing perceived barriers - such as the child doesn't like vegetables. Curriculum will also include topics such as how to increase physical activity and reduce screen time.
|
Comparison
n=16 Participants
Standard in-office counseling about diet, physical activity and screen time
|
|---|---|---|
|
Count of Participants Who Consumed Vegetables With Their Dinner Meal More Than 5 Days Per Week
|
9 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 3 months post-study interventionGuardians who reported being Confident or Very Confident that they could increase the number of vegetables the child eats each week As measured by guardian self-efficacy and confidence questions related to modifiable lifestyle behaviors on a likert scale Question: How confident do you feel that you can increase the number of vegetables your child eats each week? Likert Scale: 1, Not confident = It is impossible for me to do this \| 2, Somewhat confident = Maybe I can do this \| 3, Confident = I think I can do this \| 4, Very confident = I can absolutely do this (Higher score indicates better outcome than lower score on Likert scale)
Outcome measures
| Measure |
Intervention
n=11 Participants
12 week virtual family-based health eating program
Virtual Family-Based Healthy Plate Club: IHPC provides produce boxes, nutrition and meal-preparation, education, and supportive counseling to address barriers related to obtaining produce and food. The intervention provides participants with a bi-weekly produce box for 12 weeks and helps families identify sustainable ways to obtain vegetables once the produce boxes end. The CHW will support families by coaching them on how to prepare these unfamiliar vegetables, give tips on finding sales at grocery stores, as well as by navigation to food assistance sites including food pantries. Parents will learn strategies to increase vegetable consumption by addressing perceived barriers - such as the child doesn't like vegetables. Curriculum will also include topics such as how to increase physical activity and reduce screen time.
|
Comparison
n=16 Participants
Standard in-office counseling about diet, physical activity and screen time
|
|---|---|---|
|
Count of Guardians Who Reported Being Confident or Very Confident That They Could Increase the Number of Vegetables the Child Eats Each Week
|
7 Participants
|
5 Participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Comparison
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