THRIVE 2.0: A randomized-controlled trial of an obesity prevention intervention designed for infants in pediatric primary care.
Tiffany M Rybak, Sarah E Francis, Constance A Mara...
https://pubmed.ncbi.nlm.nih.gov/40336701/Actively Recruiting
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-03-05
144
Participants Needed
1
Research Sites
8 weeks
Total Duration
Researchers are evaluating a responsive parenting program aimed at preventing obesity in infants from communities of color andor economically marginalized backgrounds. This study focuses on delivering the program through Integrated Behavioral Health in pediatric primary care to see if it is feasible, acceptable, and effective in preventing rapid weight gain during infancy. The trial involves infants who are publicly insured or belong to non-White or HispanicLatinx racial or ethnic groups, populations at higher risk for early childhood obesity and related health problems. The trial compares the THRIVE 2.0 responsive parenting intervention with usual pediatric care. The intervention includes four sessions delivered by a trained integrated behavioral health specialist during routine well-child visits at 1, 2, 4, and 6 months of age. THRIVE 2.0 focuses on teaching healthy feeding, sleeping, and regulation habits tailored to infant developmental stages. The control group receives standard pediatric care at the same visits without the additional intervention. Participants will complete assessments at baseline newborn, after treatment 9 months, and at follow-up 12 months. Researchers will measure infant weight gain patterns as the primary outcome and evaluate various feeding, sleeping, behavior, and caregiver-related questionnaires. The study monitors infant growth and development through well-child visits, questionnaires, and diaries, aiming to understand the impact of the parenting program on infant health and obesity risk over the first year of life.
CONDITIONS
A Novel Obesity Prevention Program for High-Risk Infants in Primary Care
T
Tiffany Rybak, PhD
S
Sarah Francis, PhD
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Children's Hospital Medical Center, Cincinnati
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | THRIVE 2.0 Behavioral Program | Standard Primary Care |
|---|---|---|
| What it is | A structured, primary care–based program for families promoting healthy infant feeding, sleep, and activity to prevent obesity risk. | Routine pediatric care visits without additional focused behavioral intervention on feeding, sleep, or activity. |
| Role in the trial | Investigational intervention being tested for preventing excess weight gain in high-risk infants. | Comparator group for evaluating whether the intervention leads to better outcomes than usual care. |
| Primary use | Family-centered coaching and education sessions aimed at developing healthy feeding routines, sleep habits, and parent–infant interaction from infancy onward. | Standard medical supervision and advice during routine pediatric visits, without extra behavioral coaching. |
| How it is given or performed | Families receive structured behavioral sessions integrated into routine well-child visits, including education, modeling, and parent coaching on infant feeding, sleep, soothing, and routines. | Families attend routine pediatric visits without additional behavioral sessions or targeted education beyond usual care. |
| Evidence status | Efficacy is under active investigation; results from this trial are not yet established. | Reflects the outcomes of routine care in primary care settings for high-risk infants; no additional behavioral intervention provided. |
| Important limitations | The intervention's effectiveness is not yet established and generalizability may be limited to families in pediatric primary care, primarily from minority and/or economically marginalized backgrounds. | Outcomes under usual care may be influenced by local care practices and may not represent those in significantly different healthcare settings. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - First 6 months of infant's life
Participants attend routine pediatric primary care well-child visits where they receive four prevention sessions focused on responsive parenting to promote healthy eating, sleeping, and regulation habits for infants.
4 visits (in-person) at 1, 2, 4, and 6 months
Duration - Up to infant age 12 months
Participants' infants are monitored for growth and health outcomes following the intervention period to assess long-term effects on weight gain and related behaviors.
2 visits (in-person) at 9 and 12 months
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Tiffany M Rybak, Sarah E Francis, Constance A Mara...
https://pubmed.ncbi.nlm.nih.gov/40336701/Children's Hospital Medical Center, Cincinnati
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor