Trial Outcomes & Findings for Family-Based Nutrition Intervention for Latino Children (NCT NCT00224887)
NCT ID: NCT00224887
Last Updated: 2021-05-04
Results Overview
child's Body Mass Index
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
307 participants
Primary outcome timeframe
12 months
Results posted on
2021-05-04
Participant Flow
Participant milestones
| Measure |
in Home Nutrition Counseling
In-home family-based behavioral counseling using in-person and video interventions delivered by community health advisors
In home nutrition counseling: In home family-based behavioral counseling
|
Standard Nutrition Education Curriculum
standard nutrition education curriculum consisting of video and lesson plans based on USDA Food Guide pyramid
standard nutrition education curriculum: video and lesson plans based on USDA Food Guide Pyramid
|
|---|---|---|
|
Overall Study
STARTED
|
154
|
153
|
|
Overall Study
COMPLETED
|
148
|
147
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
in Home Nutrition Counseling
In-home family-based behavioral counseling using in-person and video interventions delivered by community health advisors
In home nutrition counseling: In home family-based behavioral counseling
|
Standard Nutrition Education Curriculum
standard nutrition education curriculum consisting of video and lesson plans based on USDA Food Guide pyramid
standard nutrition education curriculum: video and lesson plans based on USDA Food Guide Pyramid
|
|---|---|---|
|
Overall Study
Pregnancy
|
6
|
6
|
Baseline Characteristics
Family-Based Nutrition Intervention for Latino Children
Baseline characteristics by cohort
| Measure |
in Home Nutrition Counseling
n=154 Participants
In-home family-based behavioral counseling using in-person and video interventions delivered by community health advisors
In home nutrition counseling: In home family-based behavioral counseling
|
Standard Nutrition Education Curriculum
n=153 Participants
standard nutrition education curriculum consisting of video and lesson plans based on USDA Food Guide pyramid
standard nutrition education curriculum: video and lesson plans based on USDA Food Guide Pyramid
|
Total
n=307 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.7 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
7.8 years
STANDARD_DEVIATION 1.1 • n=7 Participants
|
7.7 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
221 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthschild's Body Mass Index
Outcome measures
| Measure |
in Home Nutrition Counseling
n=154 Participants
In-home family-based behavioral counseling using in-person and video interventions delivered by community health advisors
In home nutrition counseling: In home family-based behavioral counseling
|
Standard Nutrition Education Curriculum
n=153 Participants
standard nutrition education curriculum consisting of video and lesson plans based on USDA Food Guide pyramid
standard nutrition education curriculum: video and lesson plans based on USDA Food Guide Pyramid
|
|---|---|---|
|
Mean Change in Body Mass Index (BMI)
|
0.52 kg/m^2
Standard Deviation 1.56
|
0.66 kg/m^2
Standard Deviation 1.43
|
Adverse Events
in Home Nutrition Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Nutrition Education Curriculum
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