Trial Outcomes & Findings for A Home-based Intervention to Improve the Diet Quality of Preschoolers (NCT NCT03923491)

NCT ID: NCT03923491

Last Updated: 2023-12-18

Results Overview

HEI-2015 scores will be calculated from twenty four hour recall data (two of them which are combined and scored per 1000 kcal or as a % of intake per NCI scoring guidelines). HEI was designed to measure diet quality in terms of how well diets conform to the 2015 Dietary Guidelines for Americans. The total HEI score represents the sum of 12 components scores (minimum component can be 0 and maximum component score shown in parentheses for each), including total fruit (5), whole fruit (5), total vegetables (5), green and beans (includes dark green vegetables and cooked, dried beans and peas because intakes of these types of vegetables are furthest from the amounts recommended in the USDA Food Patterns) (5), whole grain (10), dairy (10), total protein food (5), seafood and plant proteins (5), fatty acids (10), refined grains (10), sodium (10) added sugar (10), saturated fat (10). Higher scores reflect better outcomes.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

63 participants

Primary outcome timeframe

Healthy Eating Index Scores at study completion (6 months)

Results posted on

2023-12-18

Participant Flow

Participants were recruited through a variety of active and passive strategies. For active recruitment, Special Supplemental Nutrition Program for Women, Infants and Children (WIC) nutritionists collected contact information of interested participants, which was then passed to research staff for follow-up. Study staff members also recruited caregivers in WIC waiting rooms or child welfare organizations.

Participant milestones

Participant milestones
Measure
Healthy Feeding, Healthy Eating
The experimental arm will receive three home visits over the first three months of the intervention.Visits will be conducted by a community health worker (CHW) trained in Motivational Interviewing. The home visits will include video-feedback on a meal; in-home cooking demonstrations; tailored text-messages, and mailed materials. During the last three months of the intervention, CHW will conduct monthly phone calls, together with mailed materials and text messages. The intervention will be tailored for families based on the child's appetitive traits and eating behaviors. Healthy Feeding, Healthy Eating: Home Based Motivational Interviewing to Improve Diet Quality of Preschoolers
Reading and Readiness
The Reading and Readiness group will receive information on school readiness promotion. Materials will be adapted and delivered by the community health worker (CHW) with a similar dose and schedule as the intervention group (three home visits and three phone calls). During the home visits, the CHW will show a video that models early childhood caregiver-child activities and demonstrates simple methods to interact with their children. They will also send a video of themselves reading with a child, receive text-messages based on these materials as well as the print materials during the last three months of the intervention. Reading Readiness: Active Control that uses Motivational Interviewing to improve Reading Readiness of Preschool Children
Overall Study
STARTED
33
30
Overall Study
COMPLETED
24
16
Overall Study
NOT COMPLETED
9
14

Reasons for withdrawal

Reasons for withdrawal
Measure
Healthy Feeding, Healthy Eating
The experimental arm will receive three home visits over the first three months of the intervention.Visits will be conducted by a community health worker (CHW) trained in Motivational Interviewing. The home visits will include video-feedback on a meal; in-home cooking demonstrations; tailored text-messages, and mailed materials. During the last three months of the intervention, CHW will conduct monthly phone calls, together with mailed materials and text messages. The intervention will be tailored for families based on the child's appetitive traits and eating behaviors. Healthy Feeding, Healthy Eating: Home Based Motivational Interviewing to Improve Diet Quality of Preschoolers
Reading and Readiness
The Reading and Readiness group will receive information on school readiness promotion. Materials will be adapted and delivered by the community health worker (CHW) with a similar dose and schedule as the intervention group (three home visits and three phone calls). During the home visits, the CHW will show a video that models early childhood caregiver-child activities and demonstrates simple methods to interact with their children. They will also send a video of themselves reading with a child, receive text-messages based on these materials as well as the print materials during the last three months of the intervention. Reading Readiness: Active Control that uses Motivational Interviewing to improve Reading Readiness of Preschool Children
Overall Study
Lost to Follow-up
5
8
Overall Study
Withdrawal by Subject
4
6

Baseline Characteristics

A Home-based Intervention to Improve the Diet Quality of Preschoolers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Healthy Feeding, Healthy Eating
n=33 Participants
The experimental arm will receive three home over the first three months of the intervention.Visits will be conducted by a community health worker (CHW) trained in Motivational Interviewing. The home visits will include video-feedback on a meal; in-home cooking demonstrations; tailored text-messages, and mailed materials. During the last three months of the intervention, CHW will conduct monthly phone calls, together with mailed materials and text messages. The intervention will be tailored for families based on the child's appetitive traits and eating behaviors. Healthy Feeding, Healthy Eating: Home Based Motivational Interviewing to Improve Diet Quality of Preschoolers
Reading and Readiness
n=30 Participants
The Reading and Readiness group will receive information on school readiness promotion. Materials will be adapted and delivered by the community health worker (CHW) with a similar dose and schedule as the intervention group (three home visits and three phone calls). During the home visits, the CHW will show a video that models early childhood caregiver-child activities and demonstrates simple methods to interact with their children. They will also send a video of themselves reading with a child, receive text-messages based on these materials as well as the print materials during the last three months of the intervention. Reading Readiness: Active Control that uses Motivational Interviewing to improve Reading Readiness of Preschool Children
Total
n=63 Participants
Total of all reporting groups
Age, Continuous
34.67 years
STANDARD_DEVIATION 6.94 • n=99 Participants
34.27 years
STANDARD_DEVIATION 8.36 • n=107 Participants
34.48 years
STANDARD_DEVIATION 7.59 • n=206 Participants
Sex: Female, Male
Female
30 Participants
n=99 Participants
28 Participants
n=107 Participants
58 Participants
n=206 Participants
Sex: Female, Male
Male
3 Participants
n=99 Participants
2 Participants
n=107 Participants
5 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
29 Participants
n=99 Participants
26 Participants
n=107 Participants
55 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants
n=99 Participants
4 Participants
n=107 Participants
8 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race/Ethnicity, Customized
White
12 Participants
n=99 Participants
12 Participants
n=107 Participants
24 Participants
n=206 Participants
Race/Ethnicity, Customized
Multiracial
6 Participants
n=99 Participants
5 Participants
n=107 Participants
11 Participants
n=206 Participants
Race/Ethnicity, Customized
Unknown
9 Participants
n=99 Participants
6 Participants
n=107 Participants
15 Participants
n=206 Participants
Race/Ethnicity, Customized
Other
6 Participants
n=99 Participants
7 Participants
n=107 Participants
13 Participants
n=206 Participants
Region of Enrollment
United States
33 participants
n=99 Participants
30 participants
n=107 Participants
63 participants
n=206 Participants
Gender of target child
Female
18 Participants
n=99 Participants
10 Participants
n=107 Participants
28 Participants
n=206 Participants
Gender of target child
Male
15 Participants
n=99 Participants
20 Participants
n=107 Participants
35 Participants
n=206 Participants
Caregiver's relationship to child
Mother
30 Participants
n=99 Participants
27 Participants
n=107 Participants
57 Participants
n=206 Participants
Caregiver's relationship to child
Father or other
3 Participants
n=99 Participants
3 Participants
n=107 Participants
6 Participants
n=206 Participants
Country of birth
United States
11 Participants
n=99 Participants
13 Participants
n=107 Participants
24 Participants
n=206 Participants
Country of birth
Other
22 Participants
n=99 Participants
17 Participants
n=107 Participants
39 Participants
n=206 Participants
Language used at home
English
9 Participants
n=99 Participants
12 Participants
n=107 Participants
21 Participants
n=206 Participants
Language used at home
Spanish
23 Participants
n=99 Participants
18 Participants
n=107 Participants
41 Participants
n=206 Participants
Language used at home
Missing
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Annual Household Income
< $25,000
14 Participants
n=99 Participants
20 Participants
n=107 Participants
34 Participants
n=206 Participants
Annual Household Income
$25,000-74,999
14 Participants
n=99 Participants
6 Participants
n=107 Participants
20 Participants
n=206 Participants
Annual Household Income
>75,000
2 Participants
n=99 Participants
1 Participants
n=107 Participants
3 Participants
n=206 Participants
Annual Household Income
Unknown
3 Participants
n=99 Participants
3 Participants
n=107 Participants
6 Participants
n=206 Participants
Highest level of education
Less than 8th grade
4 Participants
n=99 Participants
5 Participants
n=107 Participants
9 Participants
n=206 Participants
Highest level of education
High School
11 Participants
n=99 Participants
12 Participants
n=107 Participants
23 Participants
n=206 Participants
Highest level of education
College
18 Participants
n=99 Participants
13 Participants
n=107 Participants
31 Participants
n=206 Participants
Employment status
Employment full time
10 Participants
n=99 Participants
5 Participants
n=107 Participants
15 Participants
n=206 Participants
Employment status
Employment part time
6 Participants
n=99 Participants
7 Participants
n=107 Participants
13 Participants
n=206 Participants
Employment status
Other, includes employed seasonally, unemployed/looking for work, student, homemaker and disable. )
17 Participants
n=99 Participants
18 Participants
n=107 Participants
35 Participants
n=206 Participants
Marital status
Married
15 Participants
n=99 Participants
13 Participants
n=107 Participants
28 Participants
n=206 Participants
Marital status
Not married includes never married, separated, divorced, widowed.
15 Participants
n=99 Participants
10 Participants
n=107 Participants
25 Participants
n=206 Participants
Marital status
Missing
3 Participants
n=99 Participants
7 Participants
n=107 Participants
10 Participants
n=206 Participants
Currently living with a spouse/partner
Yes
23 Participants
n=99 Participants
20 Participants
n=107 Participants
43 Participants
n=206 Participants
Currently living with a spouse/partner
No
8 Participants
n=99 Participants
9 Participants
n=107 Participants
17 Participants
n=206 Participants
Currently living with a spouse/partner
Missing
2 Participants
n=99 Participants
1 Participants
n=107 Participants
3 Participants
n=206 Participants
Number of other adults living in home
None
2 Participants
n=99 Participants
3 Participants
n=107 Participants
5 Participants
n=206 Participants
Number of other adults living in home
One
9 Participants
n=99 Participants
6 Participants
n=107 Participants
15 Participants
n=206 Participants
Number of other adults living in home
Two or more
21 Participants
n=99 Participants
21 Participants
n=107 Participants
42 Participants
n=206 Participants
Number of other adults living in home
Missing
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Number of children (<18 y) living at home
One
8 Participants
n=99 Participants
11 Participants
n=107 Participants
19 Participants
n=206 Participants
Number of children (<18 y) living at home
Two or more
25 Participants
n=99 Participants
19 Participants
n=107 Participants
44 Participants
n=206 Participants
Currently pregnant
Yes
2 Participants
n=99 Participants
5 Participants
n=107 Participants
7 Participants
n=206 Participants
Currently pregnant
No
27 Participants
n=99 Participants
22 Participants
n=107 Participants
49 Participants
n=206 Participants
Currently pregnant
Missing
4 Participants
n=99 Participants
3 Participants
n=107 Participants
7 Participants
n=206 Participants
Food Assistance
Yes
27 Participants
n=99 Participants
24 Participants
n=107 Participants
51 Participants
n=206 Participants
Food Assistance
No
6 Participants
n=99 Participants
5 Participants
n=107 Participants
11 Participants
n=206 Participants
Food Assistance
Missing
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Food insecurity
Yes, Includes any level of food insecurity
11 Participants
n=99 Participants
17 Participants
n=107 Participants
28 Participants
n=206 Participants
Food insecurity
No
22 Participants
n=99 Participants
13 Participants
n=107 Participants
35 Participants
n=206 Participants
Target child attends childcare
Yes
11 Participants
n=99 Participants
9 Participants
n=107 Participants
20 Participants
n=206 Participants
Target child attends childcare
No
22 Participants
n=99 Participants
21 Participants
n=107 Participants
43 Participants
n=206 Participants

PRIMARY outcome

Timeframe: Healthy Eating Index Scores at study completion (6 months)

HEI-2015 scores will be calculated from twenty four hour recall data (two of them which are combined and scored per 1000 kcal or as a % of intake per NCI scoring guidelines). HEI was designed to measure diet quality in terms of how well diets conform to the 2015 Dietary Guidelines for Americans. The total HEI score represents the sum of 12 components scores (minimum component can be 0 and maximum component score shown in parentheses for each), including total fruit (5), whole fruit (5), total vegetables (5), green and beans (includes dark green vegetables and cooked, dried beans and peas because intakes of these types of vegetables are furthest from the amounts recommended in the USDA Food Patterns) (5), whole grain (10), dairy (10), total protein food (5), seafood and plant proteins (5), fatty acids (10), refined grains (10), sodium (10) added sugar (10), saturated fat (10). Higher scores reflect better outcomes.

Outcome measures

Outcome measures
Measure
Healthy Feeding, Healthy Eating
n=24 Participants
The experimental arm will receive three home over the first three months of the intervention.Visits will be conducted by a community health worker (CHW) trained in Motivational Interviewing. The home visits will include video-feedback on a meal; in-home cooking demonstrations; tailored text-messages, and mailed materials. During the last three months of the intervention, CHW will conduct monthly phone calls, together with mailed materials and text messages. The intervention will be tailored for families based on the child's appetitive traits and eating behaviors. Healthy Feeding, Healthy Eating: Home Based Motivational Interviewing to Improve Diet Quality of Preschoolers
Reading and Readiness
n=16 Participants
The Reading and Readiness group will receive information on school readiness promotion. Materials will be adapted and delivered by the community health worker (CHW) with a similar dose and schedule as the intervention group (three home visits and three phone calls). During the home visits, the CHW will show a video that models early childhood caregiver-child activities and demonstrates simple methods to interact with their children. They will also send a video of themselves reading with a child, receive text-messages based on these materials as well as the print materials during the last three months of the intervention. Reading Readiness: Active Control that uses Motivational Interviewing to improve Reading Readiness of Preschool Children
HEI-2015 Total and Component Scores
HEI-2015 total
61.6 score on a scale
Standard Deviation 10.8
65.7 score on a scale
Standard Deviation 12.9
HEI-2015 Total and Component Scores
HEI-2015 Total Vegetable
2.1 score on a scale
Standard Deviation 1.5
2.3 score on a scale
Standard Deviation 1.5
HEI-2015 Total and Component Scores
HEI-2015 Greens & Beans
2.5 score on a scale
Standard Deviation 2.4
2.7 score on a scale
Standard Deviation 2.3
HEI-2015 Total and Component Scores
HEI-2015 Total Fruit
3.9 score on a scale
Standard Deviation 1.6
3.8 score on a scale
Standard Deviation 1.8
HEI-2015 Total and Component Scores
HEI-2015 Whole Fruit
4.1 score on a scale
Standard Deviation 1.7
2.8 score on a scale
Standard Deviation 2.4
HEI-2015 Total and Component Scores
HEI-2015 Whole Grain
4.6 score on a scale
Standard Deviation 3.4
4.0 score on a scale
Standard Deviation 3.9
HEI-2015 Total and Component Scores
HEI-2015 Total Dairy
8.3 score on a scale
Standard Deviation 2.7
8.7 score on a scale
Standard Deviation 2.0
HEI-2015 Total and Component Scores
HEI-2015 Total Protein
4.5 score on a scale
Standard Deviation 1.8
4.0 score on a scale
Standard Deviation 1.6
HEI-2015 Total and Component Scores
HEI-2015 Seafood Plant Protein
2.3 score on a scale
Standard Deviation 2.4
3.1 score on a scale
Standard Deviation 2.2
HEI-2015 Total and Component Scores
HEI-2015 Fatty Acid
3.5 score on a scale
Standard Deviation 3.1
5.2 score on a scale
Standard Deviation 3.1
HEI-2015 Total and Component Scores
HEI-2015 Sodium
4.8 score on a scale
Standard Deviation 3.2
7.0 score on a scale
Standard Deviation 2.7
HEI-2015 Total and Component Scores
HEI-2015 Refined Grain
6.6 score on a scale
Standard Deviation 2.9
7.0 score on a scale
Standard Deviation 2.9
HEI-2015 Total and Component Scores
HEI-2015 Added Sugar
7.4 score on a scale
Standard Deviation 2.7
7.5 score on a scale
Standard Deviation 3.2
HEI-2015 Total and Component Scores
HEI-2015 Saturated Fats
7.0 score on a scale
Standard Deviation 3.1
7.6 score on a scale
Standard Deviation 3.0

SECONDARY outcome

Timeframe: Food Parenting Practices at study completion (6 months)

The intervention effects on 14 subscales of the Food Parenting Inventory were used as secondary outcome measures: Encourage try new foods (P), Encourage exploration of new foods (P), Urge child to eat new foods (P), Repeated Presentation of New foods (P), Family meals (P), Regular timing of meals and snacks (P), Inconsistent mealtimes (N), Indifferent feeding (N), Child involvement in food preparation (P), Pressure to Eat (N), Restriction (N), Food as a reward (N), Responsiveness to child's fullness cues (P), Monitoring (P). We also use one subscale of the Comprehensive Feeding Practices Questionnaire: Healthy Eating Guidance (P). All scales are rated on a 5-point Likert scale ranging from 1 (min) to 5 (max). Higher subscale scores indicate greater use of that child feeding practice. We have noted which practice has more positive/desirable practices with a (P) and more negative/not desired sub-scales have an (N) with higher scores.

Outcome measures

Outcome measures
Measure
Healthy Feeding, Healthy Eating
n=24 Participants
The experimental arm will receive three home over the first three months of the intervention.Visits will be conducted by a community health worker (CHW) trained in Motivational Interviewing. The home visits will include video-feedback on a meal; in-home cooking demonstrations; tailored text-messages, and mailed materials. During the last three months of the intervention, CHW will conduct monthly phone calls, together with mailed materials and text messages. The intervention will be tailored for families based on the child's appetitive traits and eating behaviors. Healthy Feeding, Healthy Eating: Home Based Motivational Interviewing to Improve Diet Quality of Preschoolers
Reading and Readiness
n=16 Participants
The Reading and Readiness group will receive information on school readiness promotion. Materials will be adapted and delivered by the community health worker (CHW) with a similar dose and schedule as the intervention group (three home visits and three phone calls). During the home visits, the CHW will show a video that models early childhood caregiver-child activities and demonstrates simple methods to interact with their children. They will also send a video of themselves reading with a child, receive text-messages based on these materials as well as the print materials during the last three months of the intervention. Reading Readiness: Active Control that uses Motivational Interviewing to improve Reading Readiness of Preschool Children
Food Parenting Practices
Encourage try new foods (P)
4.1 units on a scale
Standard Deviation 0.5
4.1 units on a scale
Standard Deviation 0.6
Food Parenting Practices
Encourage exploration of new foods (P)
3.9 units on a scale
Standard Deviation 0.9
3.9 units on a scale
Standard Deviation 1.2
Food Parenting Practices
Urge child to eat new foods (P)
4.2 units on a scale
Standard Deviation 0.7
4.1 units on a scale
Standard Deviation 0.8
Food Parenting Practices
Repeated Presentation of New foods (P)
4.0 units on a scale
Standard Deviation 0.9
4.0 units on a scale
Standard Deviation 0.9
Food Parenting Practices
Family meals (P)
4.4 units on a scale
Standard Deviation 0.5
3.6 units on a scale
Standard Deviation 0.8
Food Parenting Practices
Regular timing of meals and snacks (P)
4.3 units on a scale
Standard Deviation 0.6
2.2 units on a scale
Standard Deviation 1.0
Food Parenting Practices
Inconsistent mealtimes (N)
2.1 units on a scale
Standard Deviation 0.9
2.2 units on a scale
Standard Deviation 1.0
Food Parenting Practices
Indifferent feeding (N)
2.5 units on a scale
Standard Deviation 1.2
2.7 units on a scale
Standard Deviation 1.1
Food Parenting Practices
Child involvement in food preparation (P)
3.0 units on a scale
Standard Deviation 0.8
2.8 units on a scale
Standard Deviation 1.2
Food Parenting Practices
Pressure to Eat (N)
3.3 units on a scale
Standard Deviation 1.1
3.4 units on a scale
Standard Deviation 1.1
Food Parenting Practices
Restriction (N)
4.0 units on a scale
Standard Deviation 1.2
4.1 units on a scale
Standard Deviation 1.1
Food Parenting Practices
Food as a reward (N)
3.0 units on a scale
Standard Deviation 1.0
3.5 units on a scale
Standard Deviation 0.9
Food Parenting Practices
Responsiveness to child's fullness cues (P)
4.2 units on a scale
Standard Deviation 0.8
3.6 units on a scale
Standard Deviation 1.2
Food Parenting Practices
Monitoring (P)
3.8 units on a scale
Standard Deviation 1.0
3.8 units on a scale
Standard Deviation 1.2
Food Parenting Practices
Healthy Eating Guidance (P
4.6 units on a scale
Standard Deviation 0.4
4.4 units on a scale
Standard Deviation 0.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Changes in Home Food Inventory Scores between baseline and study completion at 6 months

Home Food Inventory Change Scores. Home food inventory (HFI) will be used to assess a wide range of commonly available foods in the home environment. A total healthy food availability score will be created from the following items (fruit- frozen, canned, fresh or dried, vegetables-frozen, fresh or canned, milk, water, whole grains, legumes) with a higher score representing more availability of healthy foods. Scores can range from 0-11. An unhealthy food score will also be created from the following items (Chips, Cakes/Cookies, Candy, Pastries, Juice, Soda, Sports drinks, Sweetened Beverages)- scores can range from 0-8 with higher scores representing availability of unhealthy foods.

Outcome measures

Outcome data not reported

Adverse Events

Healthy Feeding, Healthy Eating

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Reading and Readiness

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

Dr. Alison Tovar

Brown University School of Public Health

Phone: 401-863-7327

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place