Greenlight Plus Study: Approaches to Early Childhood Obesity Prevention

Behavior, Health Clinical Trial

Official title:

Greenlight Plus Study: A Randomized Study of Approaches to Early Childhood Obesity Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04042467
• Other study ID #: 190311
• Status: Completed
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: January 17, 2024

Study information

• Verified date: February 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: January 17, 2024
• Est. primary completion date: January 17, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 21 Days

Eligibility

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 exclusion criteria:

1. born prior to 34 weeks gestation or birth weight <1500 grams; weight <3rd %tile at enrollment (World Health Organization growth curves); or

2. any chronic medical problem that may affect weight gain (e.g., metabolic disease, uncorrected congenital heart disease, renal disease, high-calorie formula; cleft palate; Down syndrome).

Caregiver exclusion criteria include:

1. <18 years old;

2. serious mental or neurologic illness that impairs ability to consent/participate;

3. poor visual acuity (corrected vision worse than 20/50 with Rosenbaum Screener).

4. biological mother is HIV-positive

Related Conditions & MeSH terms

• Behavior, Health
• Child Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Miami	Coral Gables	Florida
United States	Duke University	Durham	North Carolina
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	New York University	New York	New York
United States	Stanford University	Stanford	California

Sponsors (8)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Duke University, Johns Hopkins University, NYU Langone Health, Patient-Centered Outcomes Research Institute, Stanford University, University of Miami, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (1)

Heerman WJ, Perrin EM, Yin HS, Schildcrout JS, Delamater AM, Flower KB, Sanders L, Wood C, Kay MC, Adams LE, Rothman RL. The Greenlight Plus Trial: Comparative effectiveness of a health information technology intervention vs. health communication intervention in primary care offices to prevent childhood obesity. Contemp Clin Trials. 2022 Dec;123:106987. doi: 10.1016/j.cct.2022.106987. Epub 2022 Oct 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child weight for length trajectory		Baseline to 24 months
Secondary	Child BMI Z-score trajectory		Baseline to 24 months
Secondary	Child weight-for-length z-score trajectory		Baseline to 24 months
Secondary	Child overweight and/or obesity	Outcome defined by CDC or WHO standards	at 24 months