THRIVE 2.0 Program for Preventing Childhood Obesity

(THRIVE Trial)

Overseen By Sarah Francis, PhD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Neonatal ICU, Congenital anomaly, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 6 months

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to test a responsive parenting obesity prevention program with infants and caregivers of color (e.g., non-White; Hispanic/Latinx) and/or who are economically marginalized (i.e., publicly insured), delivered via Integrated Behavioral Health (IBH) in pediatric primary care. The main questions it aims to answer are: * 1) Is the obesity prevention intervention delivered via IBH in pediatric primary care feasible and acceptable to families of color and/or families who are economically marginalized? * 2) Will it prevent rapid weight gain during infancy? Participants will complete baseline (newborn), post-treatment (9 months), and follow-up assessments (12 months). Participants assigned to treatment will receive 4 prevention sessions as part of their typical well-child visit in pediatric primary care. Researchers hypothesize that infants in the obesity prevention intervention will have stable weight gain compared to infants in the control group (treatment as usual) will experience more rapid weight gain.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether participants need to stop taking their current medications.

Is the THRIVE 2.0 program safe for preventing childhood obesity?

The THRIVE 2.0 program, which focuses on responsive parenting to prevent childhood obesity, has been evaluated in studies like the INSIGHT trial. These studies have not reported any safety concerns, suggesting that the program is generally safe for use in humans. ^{1 2 3 4 5}

How is the THRIVE 2.0 treatment different from other treatments for preventing childhood obesity?

THRIVE 2.0 is unique because it focuses on teaching parents responsive parenting techniques during infancy to promote healthy growth and self-regulation, which can help prevent obesity. Unlike other treatments that might focus on diet or exercise alone, this approach emphasizes the parent-child relationship and feeding practices to reduce the risk of overeating and overweight. ^{1 3 6 7 8}

What data supports the effectiveness of the THRIVE 2.0 treatment for preventing childhood obesity?

Research shows that responsive parenting interventions, like THRIVE 2.0, can help prevent childhood obesity by promoting healthy growth and self-regulation in infants. Studies have found that such interventions improve parent-child relationships and reduce the risk of overweight/obesity without focusing directly on diet or exercise. ^{1 2 3 9 10}

Who Is on the Research Team?

Tiffany Rybak, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for infants of color or from low-income families, born weighing at least 2500 grams and delivered between 37-42 weeks. They must be receiving care in the study's pediatric primary care setting and have English-speaking caregivers. Infants with certain health conditions, drug exposures, or whose families plan to move away within a year are excluded.

Inclusion Criteria

Infant receiving care provided at our pediatric primary care setting

I was born weighing 2500 grams or more.

From a racial/ethnic minority group (i.e., non-white, or Hispanic or Latinx) and/or economically marginalized background (i.e., household income at or below 138% of federal poverty level; qualifying for Medicaid)

Exclusion Criteria

My baby has a birth condition affecting feeding, like cleft palate.

My newborn was in the NICU for more than a week.

My family and I do not plan to move from the area within the next year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the THRIVE 2.0 responsive parenting intervention during well-child visits at 1, 2, 4, and 6 months

6 months

4 visits (in-person)

Post-treatment Assessment

Assessment of primary and secondary outcomes, including conditional weight gain and various questionnaires

3 months

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 12 months

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• THRIVE 2.0

Trial Overview The THRIVE 2.0 program aims to prevent obesity by teaching responsive parenting during regular well-child visits in pediatric primary care for high-risk infants. The study will compare weight gain between those who receive this intervention and those who get usual treatment over a period of up to one year.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

The Teaching Healthy Responsive Parenting during Infancy to promote Vital growth and rEgulation (THRIVE 2.0) group will consist of 4 sessions delivered by the trained IBH provider, in conjunction with the 1, 2, 4, and 6 month well-child visit in primary care. The THRIVE curriculum teaches responsive parenting principles targeted to establish healthy eating, sleeping, and regulation habits for infants.

Group II: Control Group Active Control 1 Intervention

Control arm: Usual Pediatric Care. The control condition is usual care delivered by pediatricians at 1, 2, 4, and 6 month well child visits.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

The INSIGHT study, involving 279 mother-infant pairs, demonstrated that a responsive parenting intervention improved infant sleep behaviors, leading to shorter bedtime routines and earlier bedtimes at 16 and 40 weeks.

Infants in the RP group experienced longer nocturnal sleep durations by an average of 35, 25, and 22 minutes at 8, 16, and 40 weeks, respectively, indicating the intervention's effectiveness in promoting better sleep habits during infancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

INSIGHT Responsive Parenting Intervention and Infant Sleep. Paul, IM., Savage, JS., Anzman-Frasca, S., et al.[2022]

Responsive parenting, which involves a structured and emotionally supportive interaction between caregivers and children, is crucial for developing healthy eating behaviors in children.

The paper suggests that incorporating responsive feeding practices into strategies aimed at promoting healthy growth can help prevent both underweight and overweight issues in young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responsive feeding is embedded in a theoretical framework of responsive parenting. Black, MM., Aboud, FE.[2023]

The INSIGHT study is a randomized controlled trial involving 316 first-time mothers and their newborns, testing a responsive parenting intervention aimed at preventing obesity by promoting self-regulation in feeding and reducing the risk of overeating.

The main outcome measured is the BMI z-score at age 3 years, with additional assessments on infant weight gain patterns, maternal feeding styles, and maternal health, which could provide valuable insights for future obesity prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study. Paul, IM., Williams, JS., Anzman-Frasca, S., et al.[2022]

A systematic review of six studies involving low-income families found that general parenting interventions can significantly improve child weight outcomes, even without direct focus on diet or physical activity.

The interventions, which targeted parents of children from infancy to adolescence, showed medium to large effect sizes in reducing the risk of overweight/obesity by promoting positive parenting practices like fostering attachments and improving communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of General Parenting Intervention Impacts on Child Weight as a Secondary Outcome. Kong, KL., Anzman-Frasca, S., Burgess, B., et al.[2023]

The HAPPY intervention, aimed at reducing obesity risk in infants of overweight/obese women, was found to be feasible and acceptable, with positive feedback from participants and high fidelity in delivery, despite low attendance rates.

While the study was not large enough to confirm a definitive effect, there was a promising trend suggesting a potential reduction in infant weight at 12 months, indicating that the intervention may help lower the risk of obesity in infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The HAPPY (Healthy and Active Parenting Programmme for early Years) feasibility randomised control trial: acceptability and feasibility of an intervention to reduce infant obesity. McEachan, RRC., Santorelli, G., Bryant, M., et al.[2022]

A systematic review identified 29 randomized controlled trials aimed at preventing childhood obesity, primarily conducted in high-income countries, with interventions focusing on diet, activity, sleep, and parenting education.

While 11 trials reported on child weight-related outcomes, most lacked the power to show significant effects; however, many did report improvements in healthy practices like breastfeeding and physical activity among intervention groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Registered Randomized Controlled Trials for the Prevention of Obesity in Infancy. Mihrshahi, S., Jawad, D., Richards, L., et al.[2021]

The GROW trial is a 3-year randomized controlled study involving 600 parent-child pairs aimed at preventing childhood obesity through a family-centered, community-based intervention focusing on healthy lifestyle changes.

The intervention includes skill-building in nutrition and physical activity, and aims to create sustainable behavior changes by utilizing community resources, with the primary outcome being the trajectory of childhood BMI over the study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Growing Right Onto Wellness (GROW): a family-centered, community-based obesity prevention randomized controlled trial for preschool child-parent pairs. Po'e, EK., Heerman, WJ., Mistry, RS., et al.[2021]

The responsive parenting (RP) intervention significantly improved feeding practices among mothers, promoting structured feeding routines and reducing non-responsive practices like using food to soothe infants, which could help lower obesity risk.

Mothers in the RP group were more likely to set limits and maintain consistent feeding schedules, indicating that early guidance on responsive feeding can positively influence infant feeding behaviors in the first year of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

INSIGHT responsive parenting intervention and infant feeding practices: randomized clinical trial. Savage, JS., Hohman, EE., Marini, ME., et al.[2019]

The 3 Pillars Study (3PS) pilot program, designed for parents of preschool-aged children, did not show significant changes in screen time or feeding behaviors after 6 weeks, but it did lead to improvements in household chaos and sleep outcomes, suggesting a positive impact on family routines.

Parents found the 3PS program highly acceptable, indicating that a relational approach to promoting healthy lifestyle behaviors could be a promising strategy for preventing obesity in young children, warranting further research with a larger sample size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of the 3 Pillars Study (3PS), a relationship-based programme targeting parent-child interactions, healthy lifestyle behaviours, and the home environment in parents of preschool-aged children: A pilot randomised controlled trial. Marsh, S., Taylor, R., Galland, B., et al.[2023]

A systematic review of 12 studies found that interventions aimed at preventing or reducing obesity in children under 2 years old had limited success, with no interventions showing improvement in child weight status.

While some educational interventions improved dietary intake and parental knowledge about nutrition, the overall quality of the studies was poor to fair, indicating a need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions aimed at decreasing obesity in children younger than 2 years: a systematic review. Ciampa, PJ., Kumar, D., Barkin, SL., et al.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

INSIGHT Responsive Parenting Intervention and Infant Sleep. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Responsive feeding is embedded in a theoretical framework of responsive parenting. [2023]

3. England pubmed.ncbi.nlm.nih.gov

The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Systematic Review of General Parenting Intervention Impacts on Child Weight as a Secondary Outcome. [2023]

5. England pubmed.ncbi.nlm.nih.gov

The HAPPY (Healthy and Active Parenting Programmme for early Years) feasibility randomised control trial: acceptability and feasibility of an intervention to reduce infant obesity. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Review of Registered Randomized Controlled Trials for the Prevention of Obesity in Infancy. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Growing Right Onto Wellness (GROW): a family-centered, community-based obesity prevention randomized controlled trial for preschool child-parent pairs. [2021]

8. England pubmed.ncbi.nlm.nih.gov

INSIGHT responsive parenting intervention and infant feeding practices: randomized clinical trial. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Results of the 3 Pillars Study (3PS), a relationship-based programme targeting parent-child interactions, healthy lifestyle behaviours, and the home environment in parents of preschool-aged children: A pilot randomised controlled trial. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Interventions aimed at decreasing obesity in children younger than 2 years: a systematic review. [2021]