Behavior, Health, Child Obesity
Conditions
Brief summary
A randomized controlled trial enrolling 900 parent-infant dyads (English and Spanish speaking) comparing Greenlight (control), a behavioral intervention focusing on nutrition, physical activity, media use, and sleep as compared to Greenlight Plus (intervention) which includes the above materials plus a health information technology (HIT) intervention aimed at supporting family goal-setting and behavior change during well-child checks throughout the first 2 years of life.
Detailed description
The investigators propose a randomized trial to compare the effectiveness of two different approaches to early childhood obesity prevention in children 0-2 years of age. The investigators will randomize 900 parent-infant dyads, recruited from six newborn nurseries/primary care clinics. The participating organizations are part of both CORNET, a national practice-based research network of pediatric residency primary care practices supported by the Academic Pediatric Association (APA), and PCORnet, the national research network supported by PCORI. In the nursery or at the first newborn clinic visit, eligible families will be consented and randomized to one of two arms. In Arm 1 (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. In Arm 2 (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. Specific Aims & Hypotheses (H) include: Aim 1: Compare the effectiveness of the 2 arms on weight-for-length and other weight measures through age 2. H1: Arm 2 will be significantly better than Arm 1 in supporting healthy child weight-for-length trajectory over 2 years; Aim 2: Compare the effectiveness of the two approaches on parent-reported outcomes, including child feeding and physical activity behaviors, parent feeding beliefs and behaviors, media use, and quality of doctor-patient communication. H2: Arm 2 will be significantly better at improving parent-reported health behaviors. Aim 3: Examine differences in main outcomes by social determinants, including race/ethnicity, language, health literacy. H3: A literacy- and culturally-sensitive approach to obesity prevention will result in equal subgroup improvements. Aim 4: To compare weight-for-length trajectory over 2 years in both intervention arms with a non-enrolled comparison group, using data from the PCORnet Common Data Model at participating sites. H4: PCORnet analysis will reveal the benefit of both Greenlight approaches (Arms 1 and 2) compared to before Greenlight intervention implementation and the added benefit of Arm 2 (Greenlight Plus) over other approaches.
Interventions
BEHAVIORALGreenlight 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.
BEHAVIORALGreenlight
All residents and families seen in the participating clinics will receive the basic Greenlight materials.
Sponsors
Patient-Centered Outcomes Research Institute
Duke University
University of North Carolina, Chapel Hill
Stanford University
NYU Langone Health
University of Miami
Johns Hopkins University
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
All Greenlight Plus personnel that are in a position to change the study protocol or its implementation in study participants should be blinded to information that may allow them to do so, from when the study starts until the study ends, with specific exceptions. This means that all investigators and study staff should be blinded to study data aggregated by study arm that have the potential to impact the study's outcome. The study statistician and programmers s/he designates will be unblinded to post-randomization outcome, mediator, moderator and process data for the purposes of generating DSMB reports. The study statistician will remain objective when carrying out the activities of conducting the trials - preparing randomization schemes, processing of the data, cleaning and editing the data, preparation of analyses/reports of outcome, mediator, moderator and blinded process data, and transmitting those data to the DSMB.
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Days
Healthy volunteers
Yes
Inclusion criteria
For this study, eligible caregiver/infant dyads will be those with: 1. an English- or Spanish-speaking parent/legal guardian, 2. infant born in the newborn nursery with plans to have care in the local clinic OR presenting in that clinic for the first newborn visit (1-21 days of life), 3. attendance at first newborn clinic visit 4. no plans to leave the clinic within 2 years 5. Completion of baseline data collection (survey data, child weight and length measures prior to randomization). 6. Own a smartphone with access to data services
Exclusion criteria
Infant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Weight for Length Trajectory | Baseline to 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child BMI Z-score Trajectory | Baseline to 24 months | — |
| Child Weight-for-length Z-score Trajectory | Baseline to 24 months | — |
| Child Overweight and/or Obesity | at 24 months | Outcome defined by CDC or WHO standards |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Enrollment numbers and number of participants Started/Completed represent the number of dyads (child and parent).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 898 |
| 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. | 902 |
| Total | 1,800 |
Baseline characteristics
| Characteristic | Greenlight Plus | Greenlight | Total |
|---|---|---|---|
| Age, Customized Child gestational age | 39.3 weeks | 39.1 weeks | 39.1 weeks |
| Age, Customized Parent age | 30.2 years | 30.1 years | 30.1 years |
| Annual household income $100,000 or more | 64 Participants | 60 Participants | 124 Participants |
| Annual household income <$20,000 | 114 Participants | 103 Participants | 217 Participants |
| Annual household income $20,000 to $49,000 | 115 Participants | 108 Participants | 223 Participants |
| Annual household income $50,000 to $99,999 | 42 Participants | 58 Participants | 100 Participants |
| Annual household income Do not know/not sure | 91 Participants | 96 Participants | 187 Participants |
| Annual household income Prefer not to answer | 23 Participants | 26 Participants | 49 Participants |
| Child birth weight | 3.3 kg | 3.3 kg | 3.3 kg |
| Household food insecurity Food insecure | 67 Participants | 74 Participants | 141 Participants |
| Household food insecurity Food secure | 379 Participants | 374 Participants | 753 Participants |
| Parent education level College degree | 90 Participants | 100 Participants | 190 Participants |
| Parent education level Grade school (K-4) | 5 Participants | 4 Participants | 9 Participants |
| Parent education level High school graduate or GED | 127 Participants | 101 Participants | 228 Participants |
| Parent education level Middle school (5-8) | 26 Participants | 39 Participants | 65 Participants |
| Parent education level No school | 1 Participants | 2 Participants | 3 Participants |
| Parent education level Post graduate or professional degree | 66 Participants | 64 Participants | 130 Participants |
| Parent education level Some college or technical/vocational school | 76 Participants | 81 Participants | 157 Participants |
| Parent education level Some high school (9-12) | 58 Participants | 60 Participants | 118 Participants |
| Parent health literacy Adequate | 186 Participants | 185 Participants | 371 Participants |
| Parent health literacy Limited | 250 Participants | 250 Participants | 500 Participants |
| Parent preferred language English | 294 Participants | 293 Participants | 587 Participants |
| Parent preferred language Spanish | 155 Participants | 158 Participants | 313 Participants |
| Race/Ethnicity, Customized Child race/ethnicity Black, non-Hispanic | 62 Participants | 81 Participants | 143 Participants |
| Race/Ethnicity, Customized Child race/ethnicity Hispanic | 204 Participants | 201 Participants | 405 Participants |
| Race/Ethnicity, Customized Child race/ethnicity Other or multiple | 86 Participants | 79 Participants | 165 Participants |
| Race/Ethnicity, Customized Child race/ethnicity White, non-Hispanic | 95 Participants | 90 Participants | 185 Participants |
| Race/Ethnicity, Customized Parent race/ethnicity Black, non-Hispanic | 68 Participants | 85 Participants | 153 Participants |
| Race/Ethnicity, Customized Parent race/ethnicity Hispanic | 230 Participants | 215 Participants | 445 Participants |
| Race/Ethnicity, Customized Parent race/ethnicity Other or multiple | 47 Participants | 51 Participants | 98 Participants |
| Race/Ethnicity, Customized Parent race/ethnicity White, non-Hispanic | 104 Participants | 100 Participants | 204 Participants |
| Sex/Gender, Customized Sex of child-Female | 243 Participants | 233 Participants | 476 Participants |
| Sex/Gender, Customized Sex of child-Male | 206 Participants | 218 Participants | 424 Participants |
| Sex/Gender, Customized Sex of parent-Female | 433 Participants | 441 Participants | 874 Participants |
| Sex/Gender, Customized Sex of parent-Male | 15 Participants | 10 Participants | 25 Participants |
| Sex/Gender, Customized Sex of parent-Other | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 898 | 2 / 902 |
| other Total, other adverse events | 1 / 898 | 0 / 902 |
| serious Total, serious adverse events | 0 / 898 | 0 / 902 |
Outcome results
Primary
Child Weight for Length Trajectory
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Greenlight Plus | Child Weight for Length Trajectory | 6 Months | 11.9 kg/m | Standard Deviation 1.2 |
| Greenlight Plus | Child Weight for Length Trajectory | 12 Months | 13.1 kg/m | Standard Deviation 1.3 |
| Greenlight Plus | Child Weight for Length Trajectory | 2 Months | 9.3 kg/m | Standard Deviation 1 |
| Greenlight Plus | Child Weight for Length Trajectory | 15 Months | 13.5 kg/m | Standard Deviation 1.4 |
| Greenlight Plus | Child Weight for Length Trajectory | 1 Month | 8.0 kg/m | Standard Deviation 0.9 |
| Greenlight Plus | Child Weight for Length Trajectory | 18 Months | 13.9 kg/m | Standard Deviation 1.4 |
| Greenlight Plus | Child Weight for Length Trajectory | 4 Months | 10.8 kg/m | Standard Deviation 1.2 |
| Greenlight Plus | Child Weight for Length Trajectory | 24 Months | 14.8 kg/m | Standard Deviation 1.6 |
| Greenlight Plus | Child Weight for Length Trajectory | 9 Months | 12.7 kg/m | Standard Deviation 1.3 |
| Greenlight | Child Weight for Length Trajectory | 24 Months | 15.2 kg/m | Standard Deviation 2 |
| Greenlight | Child Weight for Length Trajectory | 9 Months | 12.9 kg/m | Standard Deviation 1.3 |
| Greenlight | Child Weight for Length Trajectory | 1 Month | 8.0 kg/m | Standard Deviation 0.8 |
| Greenlight | Child Weight for Length Trajectory | 2 Months | 9.4 kg/m | Standard Deviation 1 |
| Greenlight | Child Weight for Length Trajectory | 4 Months | 11.0 kg/m | Standard Deviation 1.2 |
| Greenlight | Child Weight for Length Trajectory | 12 Months | 13.4 kg/m | Standard Deviation 1.5 |
| Greenlight | Child Weight for Length Trajectory | 15 Months | 13.8 kg/m | Standard Deviation 1.6 |
| Greenlight | Child Weight for Length Trajectory | 18 Months | 14.2 kg/m | Standard Deviation 1.6 |
| Greenlight | Child Weight for Length Trajectory | 6 Months | 12.0 kg/m | Standard Deviation 1.3 |
Comparison: Linear mixed-effects model (random intercepts and slopes for clinics and participants within clinics). A priori adjustment for baseline variables: child birth weight and biological sex, race/ethnicity, health literacy, language, education, income, and food insecurity. Child age and birth weight were included using natural splines with 3 DoF.~Effect evaluated using Wald test with a 2-sided, 0.05 significance level. Null hypothesis: Equal weight-for-length growth trajectories in the two groups.p-value: <0.00195% CI: [-0.57, -0.09]Regression, Linear
Secondary
Child BMI Z-score Trajectory
Time frame: Baseline to 24 months
Secondary
Child Overweight and/or Obesity
Outcome defined by CDC or WHO standards
Time frame: at 24 months
Secondary
Child Weight-for-length Z-score Trajectory
Time frame: Baseline to 24 months