Trial Outcomes & Findings for Intervening in Food Insecurity to Reduce and Mitigate (InFoRM) Childhood Obesity (NCT NCT05586269)
NCT ID: NCT05586269
Last Updated: 2025-05-22
Results Overview
Proportion of eligible participants who were recruited and enrolled in the intervention, prior to randomization.
COMPLETED
NA
59 participants
2 months to baseline
2025-05-22
Participant Flow
Recruitment was conducted at a primary care clinic between February and March 2023. The first participant was enrolled on February 13, 2023, and the last participant was enrolled on March 9, 2023.
Dyad (caregiver + child) eligibility was based child criteria and caregiver language (see Study Design). The child and their primary caregiver were enrolled in the study. There were 30 children and 29 caregivers enrolled in the study. One caregiver had two children enrolled in the study.
Participant milestones
| Measure |
Meal Kits, Then Newsletter + Food Pantry Referral: Caregivers
Dyads (caregiver + child) receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.
|
Meal Kits, Then Newsletter + Food Pantry Referral: Children
Dyads (caregiver + child) receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.
|
Newsletter + Food Pantry Referral, Then Meal Kits: Caregivers
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kits: Children
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
|---|---|---|---|---|
|
First Intervention (6 Weeks)
STARTED
|
14
|
15
|
15
|
15
|
|
First Intervention (6 Weeks)
Received Intervention
|
13
|
14
|
15
|
15
|
|
First Intervention (6 Weeks)
COMPLETED
|
10
|
11
|
12
|
12
|
|
First Intervention (6 Weeks)
NOT COMPLETED
|
4
|
4
|
3
|
3
|
|
Second Intervention (6 Weeks)
STARTED
|
10
|
11
|
12
|
12
|
|
Second Intervention (6 Weeks)
COMPLETED
|
10
|
11
|
11
|
11
|
|
Second Intervention (6 Weeks)
NOT COMPLETED
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Meal Kits, Then Newsletter + Food Pantry Referral: Caregivers
Dyads (caregiver + child) receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.
|
Meal Kits, Then Newsletter + Food Pantry Referral: Children
Dyads (caregiver + child) receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.
|
Newsletter + Food Pantry Referral, Then Meal Kits: Caregivers
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kits: Children
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
|---|---|---|---|---|
|
First Intervention (6 Weeks)
Lost to Follow-up
|
4
|
4
|
3
|
3
|
|
Second Intervention (6 Weeks)
Lost to Follow-up
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Caregivers and children were analyzed separately.
Baseline characteristics by cohort
| Measure |
Meal Kits, Then Newsletter + Food Pantry Referral
n=29 Participants
Dyads (caregiver + child) receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.
|
Newsletter + Food Pantry Referral, Then Meal Kits
n=30 Participants
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Child age
|
10 years
n=15 Participants • Caregivers and children were analyzed separately.
|
9 years
n=15 Participants • Caregivers and children were analyzed separately.
|
9 years
n=30 Participants • Caregivers and children were analyzed separately.
|
|
Age, Continuous
Caregiver age
|
42 years
n=14 Participants • Caregivers and children were analyzed separately.
|
39 years
n=15 Participants • Caregivers and children were analyzed separately.
|
42 years
n=29 Participants • Caregivers and children were analyzed separately.
|
|
Sex: Female, Male
Child sex · Female
|
5 Participants
n=15 Participants • Caregivers and children were analyzed separately. In the "Meal Kits, Then Newsletter + Food Pantry Referral" arm, one caregiver was missing information.
|
8 Participants
n=15 Participants • Caregivers and children were analyzed separately. In the "Meal Kits, Then Newsletter + Food Pantry Referral" arm, one caregiver was missing information.
|
13 Participants
n=30 Participants • Caregivers and children were analyzed separately. In the "Meal Kits, Then Newsletter + Food Pantry Referral" arm, one caregiver was missing information.
|
|
Sex: Female, Male
Child sex · Male
|
10 Participants
n=15 Participants • Caregivers and children were analyzed separately. In the "Meal Kits, Then Newsletter + Food Pantry Referral" arm, one caregiver was missing information.
|
7 Participants
n=15 Participants • Caregivers and children were analyzed separately. In the "Meal Kits, Then Newsletter + Food Pantry Referral" arm, one caregiver was missing information.
|
17 Participants
n=30 Participants • Caregivers and children were analyzed separately. In the "Meal Kits, Then Newsletter + Food Pantry Referral" arm, one caregiver was missing information.
|
|
Sex: Female, Male
Caregiver sex · Female
|
12 Participants
n=13 Participants • Caregivers and children were analyzed separately. In the "Meal Kits, Then Newsletter + Food Pantry Referral" arm, one caregiver was missing information.
|
13 Participants
n=15 Participants • Caregivers and children were analyzed separately. In the "Meal Kits, Then Newsletter + Food Pantry Referral" arm, one caregiver was missing information.
|
25 Participants
n=28 Participants • Caregivers and children were analyzed separately. In the "Meal Kits, Then Newsletter + Food Pantry Referral" arm, one caregiver was missing information.
|
|
Sex: Female, Male
Caregiver sex · Male
|
1 Participants
n=13 Participants • Caregivers and children were analyzed separately. In the "Meal Kits, Then Newsletter + Food Pantry Referral" arm, one caregiver was missing information.
|
2 Participants
n=15 Participants • Caregivers and children were analyzed separately. In the "Meal Kits, Then Newsletter + Food Pantry Referral" arm, one caregiver was missing information.
|
3 Participants
n=28 Participants • Caregivers and children were analyzed separately. In the "Meal Kits, Then Newsletter + Food Pantry Referral" arm, one caregiver was missing information.
|
|
Ethnicity (NIH/OMB)
Child ethnicity · Hispanic or Latino
|
11 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
15 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
26 Participants
n=30 Participants • Caregivers and children were analyzed separately.
|
|
Ethnicity (NIH/OMB)
Child ethnicity · Not Hispanic or Latino
|
3 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
0 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
3 Participants
n=30 Participants • Caregivers and children were analyzed separately.
|
|
Ethnicity (NIH/OMB)
Child ethnicity · Unknown or Not Reported
|
1 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
0 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
1 Participants
n=30 Participants • Caregivers and children were analyzed separately.
|
|
Ethnicity (NIH/OMB)
Caregiver ethnicity · Hispanic or Latino
|
9 Participants
n=14 Participants • Caregivers and children were analyzed separately.
|
15 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
24 Participants
n=29 Participants • Caregivers and children were analyzed separately.
|
|
Ethnicity (NIH/OMB)
Caregiver ethnicity · Not Hispanic or Latino
|
4 Participants
n=14 Participants • Caregivers and children were analyzed separately.
|
0 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
4 Participants
n=29 Participants • Caregivers and children were analyzed separately.
|
|
Ethnicity (NIH/OMB)
Caregiver ethnicity · Unknown or Not Reported
|
1 Participants
n=14 Participants • Caregivers and children were analyzed separately.
|
0 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
1 Participants
n=29 Participants • Caregivers and children were analyzed separately.
|
|
Race (NIH/OMB)
Child race · American Indian or Alaska Native
|
1 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
1 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
2 Participants
n=30 Participants • Caregivers and children were analyzed separately.
|
|
Race (NIH/OMB)
Child race · Asian
|
0 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
0 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
0 Participants
n=30 Participants • Caregivers and children were analyzed separately.
|
|
Race (NIH/OMB)
Child race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
1 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
1 Participants
n=30 Participants • Caregivers and children were analyzed separately.
|
|
Race (NIH/OMB)
Child race · Black or African American
|
7 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
6 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
13 Participants
n=30 Participants • Caregivers and children were analyzed separately.
|
|
Race (NIH/OMB)
Child race · White
|
3 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
4 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
7 Participants
n=30 Participants • Caregivers and children were analyzed separately.
|
|
Race (NIH/OMB)
Child race · More than one race
|
1 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
0 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
1 Participants
n=30 Participants • Caregivers and children were analyzed separately.
|
|
Race (NIH/OMB)
Child race · Unknown or Not Reported
|
3 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
3 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
6 Participants
n=30 Participants • Caregivers and children were analyzed separately.
|
|
Race (NIH/OMB)
Caregiver race · American Indian or Alaska Native
|
1 Participants
n=14 Participants • Caregivers and children were analyzed separately.
|
1 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
2 Participants
n=29 Participants • Caregivers and children were analyzed separately.
|
|
Race (NIH/OMB)
Caregiver race · Asian
|
0 Participants
n=14 Participants • Caregivers and children were analyzed separately.
|
0 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
0 Participants
n=29 Participants • Caregivers and children were analyzed separately.
|
|
Race (NIH/OMB)
Caregiver race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants • Caregivers and children were analyzed separately.
|
1 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
1 Participants
n=29 Participants • Caregivers and children were analyzed separately.
|
|
Race (NIH/OMB)
Caregiver race · Black or African American
|
6 Participants
n=14 Participants • Caregivers and children were analyzed separately.
|
5 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
11 Participants
n=29 Participants • Caregivers and children were analyzed separately.
|
|
Race (NIH/OMB)
Caregiver race · White
|
3 Participants
n=14 Participants • Caregivers and children were analyzed separately.
|
3 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
6 Participants
n=29 Participants • Caregivers and children were analyzed separately.
|
|
Race (NIH/OMB)
Caregiver race · More than one race
|
1 Participants
n=14 Participants • Caregivers and children were analyzed separately.
|
0 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
1 Participants
n=29 Participants • Caregivers and children were analyzed separately.
|
|
Race (NIH/OMB)
Caregiver race · Unknown or Not Reported
|
3 Participants
n=14 Participants • Caregivers and children were analyzed separately.
|
5 Participants
n=15 Participants • Caregivers and children were analyzed separately.
|
8 Participants
n=29 Participants • Caregivers and children were analyzed separately.
|
|
Number of people living in the household
Number of adults 18 years and older
|
2 persons
n=13 Participants • Only caregivers reported number of people living in the household. In the "Meal Kits, Then Newsletter + Food Pantry Referral" arm, one caregiver was missing information.
|
2 persons
n=15 Participants • Only caregivers reported number of people living in the household. In the "Meal Kits, Then Newsletter + Food Pantry Referral" arm, one caregiver was missing information.
|
2 persons
n=28 Participants • Only caregivers reported number of people living in the household. In the "Meal Kits, Then Newsletter + Food Pantry Referral" arm, one caregiver was missing information.
|
|
Number of people living in the household
Number of children younger than 18 years
|
2 persons
n=13 Participants • Only caregivers reported number of people living in the household. In the "Meal Kits, Then Newsletter + Food Pantry Referral" arm, one caregiver was missing information.
|
2 persons
n=15 Participants • Only caregivers reported number of people living in the household. In the "Meal Kits, Then Newsletter + Food Pantry Referral" arm, one caregiver was missing information.
|
2 persons
n=28 Participants • Only caregivers reported number of people living in the household. In the "Meal Kits, Then Newsletter + Food Pantry Referral" arm, one caregiver was missing information.
|
|
Caregiver marital status
Married
|
3 Participants
n=14 Participants • Only caregivers reported marital status.
|
3 Participants
n=15 Participants • Only caregivers reported marital status.
|
6 Participants
n=29 Participants • Only caregivers reported marital status.
|
|
Caregiver marital status
Never married
|
5 Participants
n=14 Participants • Only caregivers reported marital status.
|
2 Participants
n=15 Participants • Only caregivers reported marital status.
|
7 Participants
n=29 Participants • Only caregivers reported marital status.
|
|
Caregiver marital status
Divorced
|
1 Participants
n=14 Participants • Only caregivers reported marital status.
|
3 Participants
n=15 Participants • Only caregivers reported marital status.
|
4 Participants
n=29 Participants • Only caregivers reported marital status.
|
|
Caregiver marital status
Separated
|
3 Participants
n=14 Participants • Only caregivers reported marital status.
|
4 Participants
n=15 Participants • Only caregivers reported marital status.
|
7 Participants
n=29 Participants • Only caregivers reported marital status.
|
|
Caregiver marital status
Widowed
|
1 Participants
n=14 Participants • Only caregivers reported marital status.
|
0 Participants
n=15 Participants • Only caregivers reported marital status.
|
1 Participants
n=29 Participants • Only caregivers reported marital status.
|
|
Caregiver marital status
Prefer not to answer
|
0 Participants
n=14 Participants • Only caregivers reported marital status.
|
3 Participants
n=15 Participants • Only caregivers reported marital status.
|
3 Participants
n=29 Participants • Only caregivers reported marital status.
|
|
Caregiver marital status
Missing
|
1 Participants
n=14 Participants • Only caregivers reported marital status.
|
0 Participants
n=15 Participants • Only caregivers reported marital status.
|
1 Participants
n=29 Participants • Only caregivers reported marital status.
|
|
Total annual household income
Less than $20,000
|
7 Participants
n=14 Participants • Only caregivers reported household income.
|
10 Participants
n=15 Participants • Only caregivers reported household income.
|
17 Participants
n=29 Participants • Only caregivers reported household income.
|
|
Total annual household income
Between $20,000 and $70,000
|
2 Participants
n=14 Participants • Only caregivers reported household income.
|
3 Participants
n=15 Participants • Only caregivers reported household income.
|
5 Participants
n=29 Participants • Only caregivers reported household income.
|
|
Total annual household income
More than $70,000
|
2 Participants
n=14 Participants • Only caregivers reported household income.
|
0 Participants
n=15 Participants • Only caregivers reported household income.
|
2 Participants
n=29 Participants • Only caregivers reported household income.
|
|
Total annual household income
Don't know
|
2 Participants
n=14 Participants • Only caregivers reported household income.
|
1 Participants
n=15 Participants • Only caregivers reported household income.
|
3 Participants
n=29 Participants • Only caregivers reported household income.
|
|
Total annual household income
Prefer not to answer
|
0 Participants
n=14 Participants • Only caregivers reported household income.
|
1 Participants
n=15 Participants • Only caregivers reported household income.
|
1 Participants
n=29 Participants • Only caregivers reported household income.
|
|
Total annual household income
Missing
|
1 Participants
n=14 Participants • Only caregivers reported household income.
|
0 Participants
n=15 Participants • Only caregivers reported household income.
|
1 Participants
n=29 Participants • Only caregivers reported household income.
|
|
Highest grade or degree completed
8th grade or less
|
2 Participants
n=14 Participants • Only caregivers reported their highest grade or degree completed.
|
2 Participants
n=15 Participants • Only caregivers reported their highest grade or degree completed.
|
4 Participants
n=29 Participants • Only caregivers reported their highest grade or degree completed.
|
|
Highest grade or degree completed
Some high school
|
2 Participants
n=14 Participants • Only caregivers reported their highest grade or degree completed.
|
6 Participants
n=15 Participants • Only caregivers reported their highest grade or degree completed.
|
8 Participants
n=29 Participants • Only caregivers reported their highest grade or degree completed.
|
|
Highest grade or degree completed
High school graduate
|
3 Participants
n=14 Participants • Only caregivers reported their highest grade or degree completed.
|
4 Participants
n=15 Participants • Only caregivers reported their highest grade or degree completed.
|
7 Participants
n=29 Participants • Only caregivers reported their highest grade or degree completed.
|
|
Highest grade or degree completed
Some college or technical school
|
2 Participants
n=14 Participants • Only caregivers reported their highest grade or degree completed.
|
1 Participants
n=15 Participants • Only caregivers reported their highest grade or degree completed.
|
3 Participants
n=29 Participants • Only caregivers reported their highest grade or degree completed.
|
|
Highest grade or degree completed
College graduate
|
3 Participants
n=14 Participants • Only caregivers reported their highest grade or degree completed.
|
2 Participants
n=15 Participants • Only caregivers reported their highest grade or degree completed.
|
5 Participants
n=29 Participants • Only caregivers reported their highest grade or degree completed.
|
|
Highest grade or degree completed
Postgraduate training or degree
|
1 Participants
n=14 Participants • Only caregivers reported their highest grade or degree completed.
|
0 Participants
n=15 Participants • Only caregivers reported their highest grade or degree completed.
|
1 Participants
n=29 Participants • Only caregivers reported their highest grade or degree completed.
|
|
Highest grade or degree completed
Don't know or prefer not to answer
|
0 Participants
n=14 Participants • Only caregivers reported their highest grade or degree completed.
|
0 Participants
n=15 Participants • Only caregivers reported their highest grade or degree completed.
|
0 Participants
n=29 Participants • Only caregivers reported their highest grade or degree completed.
|
|
Highest grade or degree completed
Missing
|
1 Participants
n=14 Participants • Only caregivers reported their highest grade or degree completed.
|
0 Participants
n=15 Participants • Only caregivers reported their highest grade or degree completed.
|
1 Participants
n=29 Participants • Only caregivers reported their highest grade or degree completed.
|
|
Caregiver relationship to child
Mother
|
12 Participants
n=14 Participants • Only caregivers reported their relationship to their child.
|
13 Participants
n=15 Participants • Only caregivers reported their relationship to their child.
|
25 Participants
n=29 Participants • Only caregivers reported their relationship to their child.
|
|
Caregiver relationship to child
Father
|
1 Participants
n=14 Participants • Only caregivers reported their relationship to their child.
|
2 Participants
n=15 Participants • Only caregivers reported their relationship to their child.
|
3 Participants
n=29 Participants • Only caregivers reported their relationship to their child.
|
|
Caregiver relationship to child
Missing
|
1 Participants
n=14 Participants • Only caregivers reported their relationship to their child.
|
0 Participants
n=15 Participants • Only caregivers reported their relationship to their child.
|
1 Participants
n=29 Participants • Only caregivers reported their relationship to their child.
|
PRIMARY outcome
Timeframe: 2 months to baselinePopulation: All participants who met eligibility criteria after being screened.
Proportion of eligible participants who were recruited and enrolled in the intervention, prior to randomization.
Outcome measures
| Measure |
Both Arms
n=69 Participants
The total sample is included as the proportion of eligible participants, including children and caregivers, who were recruited and enrolled in the intervention was assessed prior to randomization to one of two arms.
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver
Caregivers receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children
Children receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
|---|---|---|---|---|
|
Study Feasibility: Recruitment
Enrolled
|
59 Participants
|
—
|
—
|
—
|
|
Study Feasibility: Recruitment
Declined to enroll
|
10 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At baselinePopulation: All participants (caregivers and children) who consented to participate in the study. Randomization occurred by caregiver after completing the consent. There were 30 children and 29 caregivers enrolled in the study. One caregiver had two children enrolled in the study.
Number of participants enrolled per month, then subject to randomization.
Outcome measures
| Measure |
Both Arms
n=29 Participants
The total sample is included as the proportion of eligible participants, including children and caregivers, who were recruited and enrolled in the intervention was assessed prior to randomization to one of two arms.
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery
n=30 Participants
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver
Caregivers receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children
Children receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
|---|---|---|---|---|
|
Study Feasibility: Randomization
Number of participants enrolled (February)
|
20 Participants
|
20 Participants
|
—
|
—
|
|
Study Feasibility: Randomization
Number of participants enrolled (March)
|
9 Participants
|
10 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At the baseline first study visit (baseline), at the second study visit (week 6-8), and at the third study visit (week 14-16).Population: All participants enrolled in the study.
Number of participants retained at each study visit
Outcome measures
| Measure |
Both Arms
n=14 Participants
The total sample is included as the proportion of eligible participants, including children and caregivers, who were recruited and enrolled in the intervention was assessed prior to randomization to one of two arms.
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery
n=15 Participants
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver
n=15 Participants
Caregivers receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children
n=15 Participants
Children receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
|---|---|---|---|---|
|
Study Feasibility: Retention
First study visit · Participants remaining in study visit
|
13 Participants
|
14 Participants
|
15 Participants
|
15 Participants
|
|
Study Feasibility: Retention
First study visit · Participants lost to follow up in study visit
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Study Feasibility: Retention
Second study visit · Participants remaining in study visit
|
10 Participants
|
11 Participants
|
12 Participants
|
12 Participants
|
|
Study Feasibility: Retention
Second study visit · Participants lost to follow up in study visit
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Study Feasibility: Retention
Third study visit · Participants remaining in study visit
|
10 Participants
|
11 Participants
|
11 Participants
|
11 Participants
|
|
Study Feasibility: Retention
Third study visit · Participants lost to follow up in study visit
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Third study visit (week 14-16)Population: All participants with assessment data at the third study visit.
Number of participants who reported receipt of all six weeks of meal kit delivery
Outcome measures
| Measure |
Both Arms
n=21 Participants
The total sample is included as the proportion of eligible participants, including children and caregivers, who were recruited and enrolled in the intervention was assessed prior to randomization to one of two arms.
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery
n=22 Participants
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver
Caregivers receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children
Children receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
|---|---|---|---|---|
|
Study Feasibility: Protocol
|
19 Participants
|
22 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Third study visit (week 14-16)Population: All caregivers with assessment data at the third study visit.
Total number of recipes prepared by caregivers
Outcome measures
| Measure |
Both Arms
n=10 Participants
The total sample is included as the proportion of eligible participants, including children and caregivers, who were recruited and enrolled in the intervention was assessed prior to randomization to one of two arms.
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery
n=11 Participants
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver
Caregivers receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children
Children receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
|---|---|---|---|---|
|
Study Feasibility: Adherence - Caregivers
Caregivers who prepared 7-12 recipes
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Study Feasibility: Adherence - Caregivers
Caregivers who prepared 3-6 recipes
|
4 Participants
|
4 Participants
|
—
|
—
|
|
Study Feasibility: Adherence - Caregivers
Caregivers who prepared 1-2 recipes
|
2 Participants
|
5 Participants
|
—
|
—
|
|
Study Feasibility: Adherence - Caregivers
Caregivers who did not prepare any recipe
|
1 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Third study visit (week 14-16)Population: All caregivers with assessment data at the third study visit.
Number of children who tasted/ate food from the meal kit
Outcome measures
| Measure |
Both Arms
n=11 Participants
The total sample is included as the proportion of eligible participants, including children and caregivers, who were recruited and enrolled in the intervention was assessed prior to randomization to one of two arms.
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery
n=11 Participants
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver
Caregivers receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children
Children receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
|---|---|---|---|---|
|
Study Feasibility: Adherence - Children
|
10 Participants
|
11 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At the baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)Population: The first study visit included a baseline demographic survey, 2 child assessments, and 1 caregiver assessment. The second study visit included 2 child assessments and 1 parent assessment. The third study visit included 2 child assessments, 1 parent assessment, and 1 satisfaction questionnaire. The "Meal Kit Delivery, Then Newsletter + Food Pantry Referral" arm included 14 caregivers and 15 children (one pair of siblings), thus the discrepancy between total planned assessments in each arm.
Proportion of planned assessments completed at each study visit
Outcome measures
| Measure |
Both Arms
n=162 Survey/Assessments
The total sample is included as the proportion of eligible participants, including children and caregivers, who were recruited and enrolled in the intervention was assessed prior to randomization to one of two arms.
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery
n=165 Survey/Assessments
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver
Caregivers receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children
Children receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
|---|---|---|---|---|
|
Study Feasibility: Assessments
Planned assessments completed after visit 1
|
56 Survey/Assessments
|
60 Survey/Assessments
|
—
|
—
|
|
Study Feasibility: Assessments
Planned assessments completed after visit 2
|
32 Survey/Assessments
|
35 Survey/Assessments
|
—
|
—
|
|
Study Feasibility: Assessments
Planned assessments completed after visit 3
|
38 Survey/Assessments
|
43 Survey/Assessments
|
—
|
—
|
SECONDARY outcome
Timeframe: At the baseline first study visit (baseline)Population: Caregivers who reported household-level food security at baseline study visit 1 (baseline).
Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into: Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security
Outcome measures
| Measure |
Both Arms
n=13 Participants
The total sample is included as the proportion of eligible participants, including children and caregivers, who were recruited and enrolled in the intervention was assessed prior to randomization to one of two arms.
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery
n=15 Participants
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver
Caregivers receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children
Children receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
|---|---|---|---|---|
|
Number of Participants With Household Food Insecurity at the First Study Visit
High food security
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Household Food Insecurity at the First Study Visit
Marginal food security
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Household Food Insecurity at the First Study Visit
Low food security
|
8 Participants
|
11 Participants
|
—
|
—
|
|
Number of Participants With Household Food Insecurity at the First Study Visit
Very low food security
|
4 Participants
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At second study visit (week 6-8)Population: Caregivers who reported household-level food security at study visit 2 (week 6-8).
Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into: Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security
Outcome measures
| Measure |
Both Arms
n=10 Participants
The total sample is included as the proportion of eligible participants, including children and caregivers, who were recruited and enrolled in the intervention was assessed prior to randomization to one of two arms.
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery
n=12 Participants
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver
Caregivers receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children
Children receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
|---|---|---|---|---|
|
Number of Participants With Household Food Insecurity at Second Study Visit
High
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Household Food Insecurity at Second Study Visit
Marginal food security
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Household Food Insecurity at Second Study Visit
Low food security
|
5 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants With Household Food Insecurity at Second Study Visit
Very low food security
|
3 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At third study visit (week 14-16)Population: Caregivers who reported household-level food security at third study visit (week 14-16).
Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into: Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security
Outcome measures
| Measure |
Both Arms
n=9 Participants
The total sample is included as the proportion of eligible participants, including children and caregivers, who were recruited and enrolled in the intervention was assessed prior to randomization to one of two arms.
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery
n=11 Participants
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver
Caregivers receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children
Children receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
|---|---|---|---|---|
|
Number of Participants With Household Food Insecurity at Third Study Visit
High food security
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Household Food Insecurity at Third Study Visit
Marginal food security
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Household Food Insecurity at Third Study Visit
Low food security
|
5 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants With Household Food Insecurity at Third Study Visit
Very low food security
|
2 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline, at second study visit (week 6-8), and at third study visit (week 14-16)Population: Children with BMI data at three study visits.
Weight and height were combined to report BMI in kg/m\^2 based on Centers for Disease Control growth curves.
Outcome measures
| Measure |
Both Arms
n=9 Participants
The total sample is included as the proportion of eligible participants, including children and caregivers, who were recruited and enrolled in the intervention was assessed prior to randomization to one of two arms.
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery
n=10 Participants
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver
Caregivers receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children
Children receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
|---|---|---|---|---|
|
Change in BMI For Children With BMI Assessments At All Visits
Change from Visit 2 and Visit 3
|
-0.10 kg/m^2
Standard Deviation 0.62
|
-0.01 kg/m^2
Standard Deviation 0.70
|
—
|
—
|
|
Change in BMI For Children With BMI Assessments At All Visits
BMI at Baseline
|
26.29 kg/m^2
Standard Deviation 3.07
|
24.82 kg/m^2
Standard Deviation 2.85
|
—
|
—
|
|
Change in BMI For Children With BMI Assessments At All Visits
BMI at Visit 2
|
26.64 kg/m^2
Standard Deviation 2.78
|
24.67 kg/m^2
Standard Deviation 2.68
|
—
|
—
|
|
Change in BMI For Children With BMI Assessments At All Visits
BMI at Visit 3
|
26.54 kg/m^2
Standard Deviation 2.81
|
24.66 kg/m^2
Standard Deviation 2.81
|
—
|
—
|
|
Change in BMI For Children With BMI Assessments At All Visits
Change from Baseline at Visit 2
|
0.36 kg/m^2
Standard Deviation 1.52
|
-0.15 kg/m^2
Standard Deviation 0.59
|
—
|
—
|
|
Change in BMI For Children With BMI Assessments At All Visits
Change from Baseline at Visit 3
|
0.26 kg/m^2
Standard Deviation 1.77
|
-0.16 kg/m^2
Standard Deviation 0.50
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline, at second study visit (week 6-8), and at third study visit (week 14-16)Population: Children with BMI data at all three study visits.
BMI percentage of the 95th percentile (BMIp95) was calculated using CDC extended BMI-for-age growth charts for children with BMI assessments at all study visits
Outcome measures
| Measure |
Both Arms
n=9 Participants
The total sample is included as the proportion of eligible participants, including children and caregivers, who were recruited and enrolled in the intervention was assessed prior to randomization to one of two arms.
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery
n=10 Participants
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver
Caregivers receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children
Children receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
|---|---|---|---|---|
|
Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits
BMIp95 at Baseline
|
117.5 percentage of the 95th percentile
Standard Deviation 12
|
113.3 percentage of the 95th percentile
Standard Deviation 11
|
—
|
—
|
|
Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits
BMIp95 at Visit 2
|
118.5 percentage of the 95th percentile
Standard Deviation 12
|
111.8 percentage of the 95th percentile
Standard Deviation 12
|
—
|
—
|
|
Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits
BMIp95 at Visit 3
|
117.3 percentage of the 95th percentile
Standard Deviation 12
|
111.0 percentage of the 95th percentile
Standard Deviation 12
|
—
|
—
|
|
Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits
Change from Baseline at Visit 2
|
1.0 percentage of the 95th percentile
Standard Deviation 7
|
-1.5 percentage of the 95th percentile
Standard Deviation 2
|
—
|
—
|
|
Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits
Change from Baseline at Visit 3
|
-0.2 percentage of the 95th percentile
Standard Deviation 8
|
-2.3 percentage of the 95th percentile
Standard Deviation 2
|
—
|
—
|
|
Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits
Change from Visit 2 to Visit 3
|
-1.1 percentage of the 95th percentile
Standard Deviation 3
|
-0.8 percentage of the 95th percentile
Standard Deviation 3
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)Population: Children with dietary data at study visits.
The PrimeScreen survey was used to assess the total prime diet quality score (PDQS) for the child (parent-reported). The survey enables calculation of a food group's daily intake frequency. Scores range from 5 (minimum) to 65 (maximum) across thirteen food groups. A higher score indicates more healthy diet quality.
Outcome measures
| Measure |
Both Arms
n=14 Participants
The total sample is included as the proportion of eligible participants, including children and caregivers, who were recruited and enrolled in the intervention was assessed prior to randomization to one of two arms.
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery
n=15 Participants
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver
Caregivers receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children
Children receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
|---|---|---|---|---|
|
Total Prime Diet Quality Score at Each Study Visit: Children
Child Prime Diet Quality Score (PDQS) at Baseline
|
39 units on a scale
Standard Deviation 6
|
39 units on a scale
Standard Deviation 4
|
—
|
—
|
|
Total Prime Diet Quality Score at Each Study Visit: Children
Child Prime Diet Quality Score (PDQS) at Visit 2
|
44 units on a scale
Standard Deviation 7
|
41 units on a scale
Standard Deviation 4
|
—
|
—
|
|
Total Prime Diet Quality Score at Each Study Visit: Children
Child Prime Diet Quality Score (PDQS) at Visit 3
|
44 units on a scale
Standard Deviation 7
|
43 units on a scale
Standard Deviation 4
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)Population: Parents with dietary data at study visits.
The PrimeScreen survey was used to assess the total prime diet quality score (PDQS) for the caregiver (self-reported). The survey enables calculation of a food group's daily intake frequency. Scores range from 5 (minimum) to 65 (maximum) across thirteen food groups. A higher score indicates more healthy diet quality.
Outcome measures
| Measure |
Both Arms
n=13 Participants
The total sample is included as the proportion of eligible participants, including children and caregivers, who were recruited and enrolled in the intervention was assessed prior to randomization to one of two arms.
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery
n=15 Participants
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver
Caregivers receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children
Children receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
|---|---|---|---|---|
|
Total Prime Diet Quality Score at Each Study Visit: Caregiver
Caregiver Prime Diet Quality Score (PDQS) at Baseline
|
44 score on a scale
Standard Deviation 6
|
42 score on a scale
Standard Deviation 6
|
—
|
—
|
|
Total Prime Diet Quality Score at Each Study Visit: Caregiver
Caregiver Prime Diet Quality Score (PDQS) at Visit 2
|
48 score on a scale
Standard Deviation 6
|
46 score on a scale
Standard Deviation 5
|
—
|
—
|
|
Total Prime Diet Quality Score at Each Study Visit: Caregiver
Caregiver Prime Diet Quality Score (PDQS) at Visit 3
|
48 score on a scale
Standard Deviation 5
|
47 score on a scale
Standard Deviation 5
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline first study visit (baseline)Population: Children with parent-reported data on mealtime behavior.
Caregivers rated Likert scale items from 1 (never) to 5 (everyday): "How often does your child eat dinner together with family members?"
Outcome measures
| Measure |
Both Arms
n=14 Participants
The total sample is included as the proportion of eligible participants, including children and caregivers, who were recruited and enrolled in the intervention was assessed prior to randomization to one of two arms.
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery
n=15 Participants
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver
Caregivers receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children
Children receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
|---|---|---|---|---|
|
Caregiver Reported Mealtime Behavior at First Study Visit
Never/Less than once per week
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Caregiver Reported Mealtime Behavior at First Study Visit
Once per week
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Caregiver Reported Mealtime Behavior at First Study Visit
2-4 times per week
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Caregiver Reported Mealtime Behavior at First Study Visit
5-6 times per week
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Caregiver Reported Mealtime Behavior at First Study Visit
Everyday
|
5 Participants
|
10 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At second study visit (week 6-8)Population: Children with parent-reported mealtime behavior data.
Caregivers rated Likert scale items from 1 (never) to 5 (everyday): "How often does your child eat dinner together with family members?"
Outcome measures
| Measure |
Both Arms
n=11 Participants
The total sample is included as the proportion of eligible participants, including children and caregivers, who were recruited and enrolled in the intervention was assessed prior to randomization to one of two arms.
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery
n=12 Participants
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver
Caregivers receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children
Children receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
|---|---|---|---|---|
|
Caregiver Reported Mealtime Behavior at Second Study Visit
Never/Less than once per week
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Caregiver Reported Mealtime Behavior at Second Study Visit
Once per week
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Caregiver Reported Mealtime Behavior at Second Study Visit
2-4 times per week
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Caregiver Reported Mealtime Behavior at Second Study Visit
5-6 times per week
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Caregiver Reported Mealtime Behavior at Second Study Visit
Everyday
|
4 Participants
|
6 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At third study visit (week 14-16)Population: Children with parent-reported mealtime behavior data.
Caregivers rated Likert scale items from 1 (never) to 5 (everyday): "How often does your child eat dinner together with family members?"
Outcome measures
| Measure |
Both Arms
n=10 Participants
The total sample is included as the proportion of eligible participants, including children and caregivers, who were recruited and enrolled in the intervention was assessed prior to randomization to one of two arms.
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery
n=11 Participants
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver
Caregivers receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children
Children receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
|---|---|---|---|---|
|
Caregiver Reported Mealtime Behavior at Third Study Visit
Never/Less than once per week
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Caregiver Reported Mealtime Behavior at Third Study Visit
Once per week
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Caregiver Reported Mealtime Behavior at Third Study Visit
2-4 times per week
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Caregiver Reported Mealtime Behavior at Third Study Visit
5-6 times per week
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Caregiver Reported Mealtime Behavior at Third Study Visit
Everyday
|
3 Participants
|
4 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline first study visit (baseline)Population: Caregivers with perceived stress data.
The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress: 0-13: low stress 14-26: moderate stress 27-40: high perceived stress
Outcome measures
| Measure |
Both Arms
n=13 Participants
The total sample is included as the proportion of eligible participants, including children and caregivers, who were recruited and enrolled in the intervention was assessed prior to randomization to one of two arms.
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery
n=14 Participants
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver
Caregivers receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children
Children receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
|---|---|---|---|---|
|
Caregiver Perceived Stress at First Study Visit
High perceived stress
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Caregiver Perceived Stress at First Study Visit
Moderate perceived stress
|
7 Participants
|
7 Participants
|
—
|
—
|
|
Caregiver Perceived Stress at First Study Visit
Low perceived stress
|
5 Participants
|
7 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At second study visit (week 6-8)Population: Caregivers with perceived stress data.
The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress: 0-13: low stress 14-26: moderate stress 27-40: high perceived stress
Outcome measures
| Measure |
Both Arms
n=9 Participants
The total sample is included as the proportion of eligible participants, including children and caregivers, who were recruited and enrolled in the intervention was assessed prior to randomization to one of two arms.
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery
n=12 Participants
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver
Caregivers receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children
Children receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
|---|---|---|---|---|
|
Caregiver Perceived Stress at Second Study Visit
High perceived stress
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Caregiver Perceived Stress at Second Study Visit
Moderate perceived stress
|
5 Participants
|
5 Participants
|
—
|
—
|
|
Caregiver Perceived Stress at Second Study Visit
Low perceived stress
|
4 Participants
|
7 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At third study visit (week 14-16)Population: Caregivers with perceived stress data.
The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress: 0-13: low stress 14-26: moderate stress 27-40: high perceived stress
Outcome measures
| Measure |
Both Arms
n=8 Participants
The total sample is included as the proportion of eligible participants, including children and caregivers, who were recruited and enrolled in the intervention was assessed prior to randomization to one of two arms.
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery
n=11 Participants
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver
Caregivers receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children
Children receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).
|
|---|---|---|---|---|
|
Caregiver Perceived Stress at Third Study Visit
High perceived stress
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Caregiver Perceived Stress at Third Study Visit
Moderate perceived stress
|
3 Participants
|
5 Participants
|
—
|
—
|
|
Caregiver Perceived Stress at Third Study Visit
Low perceived stress
|
4 Participants
|
6 Participants
|
—
|
—
|
Adverse Events
Meal Kit Delivery: Caregivers
Meal Kit Delivery: Children
Newsletter + Food Pantry Referral: Caregivers
Newsletter + Food Pantry Referral: Children
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