Trial Outcomes & Findings for Greenlight Plus Study: Approaches to Early Childhood Obesity Prevention (NCT NCT04042467)

Last Updated: 2025-10-16

Results Overview

The primary outcome was child weight for length (kg/m) trajectory over 2 years. Weight and length measurements were obtained during pediatric care visits and abstracted from the medical record.

Recruitment status

COMPLETED

Study phase

Target enrollment

900 participants

Primary outcome timeframe

Baseline to 24 months

Results posted on

2025-10-16

Participant Flow

Participants were recruited from medical clinics at six medical centers: Duke University, University of Miami, New York University Grossman School of Medicine/Bellevue Hospital Center, University of North Carolina at Chapel Hill, Stanford University, and Vanderbilt University Medical Center. Study enrollment occurred between November 2019 and August 2021.

Enrollment numbers and number of participants Started/Completed represent the number of dyads (child and parent).

Participant milestones

Participant milestones
Measure	Greenlight Plus Families will receive the Greenlight intervention plus a health information technology (HIT) intervention aimed at supporting family goal-setting and behavior change. This design allows us to determine if HIT and the asynchronous support it provides between well-child visits can promote additional behavior change and obesity prevention. Greenlight Plus: Families randomized to the Greenlight Plus arm will receive a HIT intervention starting at the newborn clinic visit. During the newborn visit, these families will receive basic instructions on how to access the Greenlight technology platform, which includes the iOTA text-messaging application and a website (usable on desktop or mobile platform). Families will receive text messages and goal-setting over the first 2 years of the child's life. Greenlight: All residents and families seen in the participating clinics will receive the basic Greenlight materials.	Greenlight During each of the recommended well child visits from 0-24 months, pediatric residents, trained in clear health communication skills and shared goal-setting, will use the Greenlight Toolkit of low literacy, age- specific, parent education booklets to promote healthy family behaviors and obesity prevention. Greenlight: All residents and families seen in the participating clinics will receive the basic Greenlight materials.
Overall Study STARTED	449	451
Overall Study COMPLETED	385	392
Overall Study NOT COMPLETED	64	59

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data is for the gestational age of children only. Data missing for 1 Greenlight Plus participant.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline to 24 months

Population: Follow-up outcome measures were not obtained for 3 Greenlight Plus participants and 1 Greenlight participant. NOTE: While the analysis included data from children (n=896) and their parents (n=896), the unit of analysis was the child. Therefore, the number of participants has been reported consistently across the Participant Flow, Baseline Characteristics, and Outcome Measures sections.

The primary outcome was child weight for length (kg/m) trajectory over 2 years. Weight and length measurements were obtained during pediatric care visits and abstracted from the medical record.

Outcome measures

Outcome measures
Measure	Greenlight Plus n=446 Participants Families will receive the Greenlight intervention plus a health information technology (HIT) intervention aimed at supporting family goal-setting and behavior change. This design allows us to determine if HIT and the asynchronous support it provides between well-child visits can promote additional behavior change and obesity prevention. Greenlight Plus: Families randomized to the Greenlight Plus arm will receive a HIT intervention starting at the newborn clinic visit. During the newborn visit, these families will receive basic instructions on how to access the Greenlight technology platform, which includes the iOTA text-messaging application and a website (usable on desktop or mobile platform). Families will receive text messages and goal-setting over the first 2 years of the child's life. Greenlight: All residents and families seen in the participating clinics will receive the basic Greenlight materials.	Greenlight n=450 Participants During each of the recommended well child visits from 0-24 months, pediatric residents, trained in clear health communication skills and shared goal-setting, will use the Greenlight Toolkit of low literacy, age- specific, parent education booklets to promote healthy family behaviors and obesity prevention. Greenlight: All residents and families seen in the participating clinics will receive the basic Greenlight materials.
Child Weight for Length Trajectory 1 Month	8.0 kg/m Standard Deviation 0.9	8.0 kg/m Standard Deviation 0.8
Child Weight for Length Trajectory 2 Months	9.3 kg/m Standard Deviation 1.0	9.4 kg/m Standard Deviation 1.0
Child Weight for Length Trajectory 4 Months	10.8 kg/m Standard Deviation 1.2	11.0 kg/m Standard Deviation 1.2
Child Weight for Length Trajectory 6 Months	11.9 kg/m Standard Deviation 1.2	12.0 kg/m Standard Deviation 1.3
Child Weight for Length Trajectory 9 Months	12.7 kg/m Standard Deviation 1.3	12.9 kg/m Standard Deviation 1.3
Child Weight for Length Trajectory 12 Months	13.1 kg/m Standard Deviation 1.3	13.4 kg/m Standard Deviation 1.5
Child Weight for Length Trajectory 15 Months	13.5 kg/m Standard Deviation 1.4	13.8 kg/m Standard Deviation 1.6
Child Weight for Length Trajectory 18 Months	13.9 kg/m Standard Deviation 1.4	14.2 kg/m Standard Deviation 1.6
Child Weight for Length Trajectory 24 Months	14.8 kg/m Standard Deviation 1.6	15.2 kg/m Standard Deviation 2.0

SECONDARY outcome

Timeframe: Baseline to 24 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 24 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at 24 months

Outcome defined by CDC or WHO standards

Outcome measures

Outcome data not reported

Adverse Events

Greenlight Plus

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Greenlight

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Greenlight Plus n=898 participants at risk Families will receive the Greenlight intervention plus a health information technology (HIT) intervention aimed at supporting family goal-setting and behavior change. This design allows us to determine if HIT and the asynchronous support it provides between well-child visits can promote additional behavior change and obesity prevention. Greenlight Plus: Families randomized to the Greenlight Plus arm will receive a HIT intervention starting at the newborn clinic visit. During the newborn visit, these families will receive basic instructions on how to access the Greenlight technology platform, which includes the iOTA text-messaging application and a website (usable on desktop or mobile platform). Families will receive text messages and goal-setting over the first 2 years of the child's life. Greenlight: All residents and families seen in the participating clinics will receive the basic Greenlight materials.	Greenlight n=902 participants at risk During each of the recommended well child visits from 0-24 months, pediatric residents, trained in clear health communication skills and shared goal-setting, will use the Greenlight Toolkit of low literacy, age- specific, parent education booklets to promote healthy family behaviors and obesity prevention. Greenlight: All residents and families seen in the participating clinics will receive the basic Greenlight materials.
General disorders	0.11% 1/898 • Adverse event data were collected across the study's 2-year duration for each participant. AE: Any unfavorable and unintended sign, symptom, laboratory abnormality, or disease associated with study participation. SAE: Is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in death or persistent or significant disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a participant. A study-related event follows a temporal sequence from participation and cannot be reasonably explained by other factors.	0.00% 0/902 • Adverse event data were collected across the study's 2-year duration for each participant. AE: Any unfavorable and unintended sign, symptom, laboratory abnormality, or disease associated with study participation. SAE: Is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in death or persistent or significant disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a participant. A study-related event follows a temporal sequence from participation and cannot be reasonably explained by other factors.

Additional Information

Filoteia Popescu

Vanderbilt University Medical Center

Phone: 615-875-9083

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Greenlight Plus n=898 Participants Families will receive the Greenlight intervention plus a health information technology (HIT) intervention aimed at supporting family goal-setting and behavior change. This design allows us to determine if HIT and the asynchronous support it provides between well-child visits can promote additional behavior change and obesity prevention. Greenlight Plus: Families randomized to the Greenlight Plus arm will receive a HIT intervention starting at the newborn clinic visit. During the newborn visit, these families will receive basic instructions on how to access the Greenlight technology platform, which includes the iOTA text-messaging application and a website (usable on desktop or mobile platform). Families will receive text messages and goal-setting over the first 2 years of the child's life. Greenlight: All residents and families seen in the participating clinics will receive the basic Greenlight materials.	Greenlight n=902 Participants During each of the recommended well child visits from 0-24 months, pediatric residents, trained in clear health communication skills and shared goal-setting, will use the Greenlight Toolkit of low literacy, age- specific, parent education booklets to promote healthy family behaviors and obesity prevention. Greenlight: All residents and families seen in the participating clinics will receive the basic Greenlight materials.	Total n=1800 Participants Total of all reporting groups
Age, Customized Child gestational age	39.3 weeks n=448 Participants • Data is for the gestational age of children only. Data missing for 1 Greenlight Plus participant.	39.1 weeks n=451 Participants • Data is for the gestational age of children only. Data missing for 1 Greenlight Plus participant.	39.1 weeks n=899 Participants • Data is for the gestational age of children only. Data missing for 1 Greenlight Plus participant.
Age, Customized Parent age	30.2 years n=449 Participants • Data is for the age of parents only.	30.1 years n=451 Participants • Data is for the age of parents only.	30.1 years n=900 Participants • Data is for the age of parents only.
Sex/Gender, Customized Sex of child-Female	243 Participants n=898 Participants	233 Participants n=902 Participants	476 Participants n=1800 Participants
Sex/Gender, Customized Sex of child-Male	206 Participants n=898 Participants	218 Participants n=902 Participants	424 Participants n=1800 Participants
Sex/Gender, Customized Sex of parent-Female	433 Participants n=898 Participants	441 Participants n=902 Participants	874 Participants n=1800 Participants
Sex/Gender, Customized Sex of parent-Male	15 Participants n=898 Participants	10 Participants n=902 Participants	25 Participants n=1800 Participants
Sex/Gender, Customized Sex of parent-Other	1 Participants n=898 Participants	0 Participants n=902 Participants	1 Participants n=1800 Participants
Race/Ethnicity, Customized Child race/ethnicity · Black, non-Hispanic	62 Participants n=447 Participants • Data missing for 2 Greenlight Plus participants.	81 Participants n=451 Participants • Data missing for 2 Greenlight Plus participants.	143 Participants n=898 Participants • Data missing for 2 Greenlight Plus participants.
Race/Ethnicity, Customized Child race/ethnicity · Hispanic	204 Participants n=447 Participants • Data missing for 2 Greenlight Plus participants.	201 Participants n=451 Participants • Data missing for 2 Greenlight Plus participants.	405 Participants n=898 Participants • Data missing for 2 Greenlight Plus participants.
Race/Ethnicity, Customized Child race/ethnicity · White, non-Hispanic	95 Participants n=447 Participants • Data missing for 2 Greenlight Plus participants.	90 Participants n=451 Participants • Data missing for 2 Greenlight Plus participants.	185 Participants n=898 Participants • Data missing for 2 Greenlight Plus participants.
Race/Ethnicity, Customized Child race/ethnicity · Other or multiple	86 Participants n=447 Participants • Data missing for 2 Greenlight Plus participants.	79 Participants n=451 Participants • Data missing for 2 Greenlight Plus participants.	165 Participants n=898 Participants • Data missing for 2 Greenlight Plus participants.
Race/Ethnicity, Customized Parent race/ethnicity · Black, non-Hispanic	68 Participants n=449 Participants • Data missing for 2 Greenlight Plus participants.	85 Participants n=451 Participants • Data missing for 2 Greenlight Plus participants.	153 Participants n=900 Participants • Data missing for 2 Greenlight Plus participants.
Race/Ethnicity, Customized Parent race/ethnicity · Hispanic	230 Participants n=449 Participants • Data missing for 2 Greenlight Plus participants.	215 Participants n=451 Participants • Data missing for 2 Greenlight Plus participants.	445 Participants n=900 Participants • Data missing for 2 Greenlight Plus participants.
Race/Ethnicity, Customized Parent race/ethnicity · White, non-Hispanic	104 Participants n=449 Participants • Data missing for 2 Greenlight Plus participants.	100 Participants n=451 Participants • Data missing for 2 Greenlight Plus participants.	204 Participants n=900 Participants • Data missing for 2 Greenlight Plus participants.
Race/Ethnicity, Customized Parent race/ethnicity · Other or multiple	47 Participants n=449 Participants • Data missing for 2 Greenlight Plus participants.	51 Participants n=451 Participants • Data missing for 2 Greenlight Plus participants.	98 Participants n=900 Participants • Data missing for 2 Greenlight Plus participants.
Child birth weight	3.3 kg n=448 Participants • Data missing for 1 Greenlight Plus participant.	3.3 kg n=451 Participants • Data missing for 1 Greenlight Plus participant.	3.3 kg n=899 Participants • Data missing for 1 Greenlight Plus participant.
Parent health literacy Adequate	186 Participants n=436 Participants • Data missing for 13 Greenlight Plus and 16 Greenlight participants.	185 Participants n=435 Participants • Data missing for 13 Greenlight Plus and 16 Greenlight participants.	371 Participants n=871 Participants • Data missing for 13 Greenlight Plus and 16 Greenlight participants.
Parent health literacy Limited	250 Participants n=436 Participants • Data missing for 13 Greenlight Plus and 16 Greenlight participants.	250 Participants n=435 Participants • Data missing for 13 Greenlight Plus and 16 Greenlight participants.	500 Participants n=871 Participants • Data missing for 13 Greenlight Plus and 16 Greenlight participants.
Parent preferred language Spanish	155 Participants n=449 Participants • Data is for the preferred language of parents only	158 Participants n=451 Participants • Data is for the preferred language of parents only	313 Participants n=900 Participants • Data is for the preferred language of parents only
Parent preferred language English	294 Participants n=449 Participants • Data is for the preferred language of parents only	293 Participants n=451 Participants • Data is for the preferred language of parents only	587 Participants n=900 Participants • Data is for the preferred language of parents only
Parent education level No school	1 Participants n=449 Participants • Data is for the education level of parents only	2 Participants n=451 Participants • Data is for the education level of parents only	3 Participants n=900 Participants • Data is for the education level of parents only
Parent education level Grade school (K-4)	5 Participants n=449 Participants • Data is for the education level of parents only	4 Participants n=451 Participants • Data is for the education level of parents only	9 Participants n=900 Participants • Data is for the education level of parents only
Parent education level Middle school (5-8)	26 Participants n=449 Participants • Data is for the education level of parents only	39 Participants n=451 Participants • Data is for the education level of parents only	65 Participants n=900 Participants • Data is for the education level of parents only
Parent education level Some high school (9-12)	58 Participants n=449 Participants • Data is for the education level of parents only	60 Participants n=451 Participants • Data is for the education level of parents only	118 Participants n=900 Participants • Data is for the education level of parents only
Parent education level High school graduate or GED	127 Participants n=449 Participants • Data is for the education level of parents only	101 Participants n=451 Participants • Data is for the education level of parents only	228 Participants n=900 Participants • Data is for the education level of parents only
Parent education level Some college or technical/vocational school	76 Participants n=449 Participants • Data is for the education level of parents only	81 Participants n=451 Participants • Data is for the education level of parents only	157 Participants n=900 Participants • Data is for the education level of parents only
Parent education level College degree	90 Participants n=449 Participants • Data is for the education level of parents only	100 Participants n=451 Participants • Data is for the education level of parents only	190 Participants n=900 Participants • Data is for the education level of parents only
Parent education level Post graduate or professional degree	66 Participants n=449 Participants • Data is for the education level of parents only	64 Participants n=451 Participants • Data is for the education level of parents only	130 Participants n=900 Participants • Data is for the education level of parents only
Annual household income <$20,000	114 Participants n=449 Participants • Data is for the income of the household	103 Participants n=451 Participants • Data is for the income of the household	217 Participants n=900 Participants • Data is for the income of the household
Annual household income $20,000 to $49,000	115 Participants n=449 Participants • Data is for the income of the household	108 Participants n=451 Participants • Data is for the income of the household	223 Participants n=900 Participants • Data is for the income of the household
Annual household income $50,000 to $99,999	42 Participants n=449 Participants • Data is for the income of the household	58 Participants n=451 Participants • Data is for the income of the household	100 Participants n=900 Participants • Data is for the income of the household
Annual household income $100,000 or more	64 Participants n=449 Participants • Data is for the income of the household	60 Participants n=451 Participants • Data is for the income of the household	124 Participants n=900 Participants • Data is for the income of the household
Annual household income Do not know/not sure	91 Participants n=449 Participants • Data is for the income of the household	96 Participants n=451 Participants • Data is for the income of the household	187 Participants n=900 Participants • Data is for the income of the household
Annual household income Prefer not to answer	23 Participants n=449 Participants • Data is for the income of the household	26 Participants n=451 Participants • Data is for the income of the household	49 Participants n=900 Participants • Data is for the income of the household
Household food insecurity Food insecure	67 Participants n=446 Participants • Data is for the household. Data missing from 3 Greenlight Plus and 3 Greenlight households.	74 Participants n=448 Participants • Data is for the household. Data missing from 3 Greenlight Plus and 3 Greenlight households.	141 Participants n=894 Participants • Data is for the household. Data missing from 3 Greenlight Plus and 3 Greenlight households.
Household food insecurity Food secure	379 Participants n=446 Participants • Data is for the household. Data missing from 3 Greenlight Plus and 3 Greenlight households.	374 Participants n=448 Participants • Data is for the household. Data missing from 3 Greenlight Plus and 3 Greenlight households.	753 Participants n=894 Participants • Data is for the household. Data missing from 3 Greenlight Plus and 3 Greenlight households.