StEP OUT Program for Childhood Obesity

Overseen By Michelle W Katzow, MD, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Diminished mental capacity, serious illness, others

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

Compensation: Varies

Number of Visits: 5

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this intervention development study is to optimize the Starting Early to Prevent Obesity Using Telehealth (StEP OUT) intervention for feasibility and acceptability, using human-centered design and community-engaged research methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the StEP OUT treatment for childhood obesity?

Research shows that telehealth interventions can help improve healthy eating and physical activity in children with obesity. For example, a study found that telehealth coaching led to reduced intake of sugary drinks and better nutrition habits, suggesting that similar approaches like StEP OUT could be effective. ^{1 2 3 4 5}

Is the StEP OUT Program for Childhood Obesity safe for children?

The StEP OUT Program, which uses telehealth coaching to improve nutrition and physical activity for children with obesity, has been evaluated for safety. The study found no significant adverse effects, suggesting it is generally safe for children. ^{1 3 6 7 8}

What makes the StEP OUT treatment for childhood obesity unique?

The StEP OUT treatment is unique because it uses telehealth to engage children and their families in obesity prevention, focusing on early intervention and education to modify behaviors at home, which is different from traditional in-person programs. ^{8 9 10 11 12}

Research Team

Michelle W Katzow, MD, MS

Principal Investigator

Northwell Health

Eligibility Criteria

This trial is for pregnant individuals at least 18 years old, who are Hispanic/Latinx, speak English or Spanish, and have a phone or device for video calls. They must be receiving or eligible for WIC benefits and be at least 14 weeks into their pregnancy.

Inclusion Criteria

Has a phone or device to participate in video calls

Receiving or eligible to receive WIC benefits

Self-identify as Hispanic/Latinx

Exclusion Criteria

I have trouble making decisions due to my mental condition.

Serious medical or psychiatric illness

Serious fetal illness

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the StEP OUT intervention, an online, group-based nutrition education and parenting support program, beginning in the third trimester of pregnancy and continuing through the first four to six months of infancy.

4-6 months

5 formal sessions (primarily via remote videoconference)

Follow-up

Participants are monitored for feasibility and acceptability of the intervention, with data collected after each session and at the end of the program.

4 months

Treatment Details

Interventions

• StEP OUT

Trial Overview The StEP OUT intervention aims to prevent childhood obesity through telehealth methods. It's in the development phase where its ease of use and acceptance are being evaluated using design thinking and community input.

Participant Groups

Group I: StEP OUT Intervention Experimental Treatment 1 Intervention

See intervention description

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Findings from Research

The study involved 58 children from rural Midwest families, revealing that their average BMI was in the 94th percentile, indicating a high prevalence of obesity among participants.

Despite engaging in sufficient physical activity (about 65 minutes of moderate activity daily), children consumed over 2,000 kcal daily, primarily from high-calorie, low-nutrient foods, suggesting a need for targeted dietary interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating rural pediatric obesity through telemedicine: baseline data from a randomized controlled trial. Gallagher, KS., Davis, AM., Malone, B., et al.[2021]

A 5-year collaborative program to combat childhood obesity successfully enrolled 832 out of 2746 referred children, with 392 completing the program, demonstrating effective community engagement and accessibility.

Participants who completed the program showed significant health improvements, including a reduction in BMI and increased cardiovascular endurance, indicating the program's efficacy in promoting healthier lifestyles among children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Implementation and Five-Year Evolution of a Childhood Healthy Weight Program: Making a Health Care-Community Partnership Work. Barlow, SE., Lorenzi, A., Reid, A., et al.[2021]

A telehealth coaching intervention for families of children with obesity led to significant reductions in unhealthy nutrition behaviors, such as a decrease in sugar-sweetened beverage intake by 2.14 servings per week, and improved family meal frequency and parental self-efficacy in meal management.

Despite these positive changes in nutrition behaviors, there were no significant differences in body mass index (BMI) z-scores between child participants and matched controls one year after the intervention, indicating that while the program improved dietary habits, it did not lead to immediate changes in weight status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-Based Telehealth Initiative to Improve Nutrition and Physical Activity for Children With Obesity and Its Utility During COVID-19: A Mixed Methods Evaluation. Poulsen, MN., Hosterman, JF., Wood, GC., et al.[2022]

The GOALS intervention led to a significant reduction in child BMI z-score by 0.07, which was maintained 12 months after the program, indicating its effectiveness in addressing childhood obesity.

Parents reported positive changes in family physical activity and dietary behaviors, suggesting that the program successfully promoted a whole-family approach to lifestyle changes, although there were no significant changes in parent BMI or child self-perceptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Service evaluation of the GOALS family-based childhood obesity treatment intervention during the first 3 years of implementation. Watson, PM., Dugdill, L., Pickering, K., et al.[2022]

In a study of 394 obese youth aged 5 to 19, participation in a family-centered outpatient weight management program led to significant reductions in weight, BMI, and BMI z score over an average of 5.6 months, without hindering growth.

Improvements in metabolic health were also observed, with many participants achieving normal blood pressure, cholesterol, and insulin levels by the end of treatment, indicating that even modest weight loss can lead to substantial health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship of health outcomes to improvement in BMI in children and adolescents. Kirk, S., Zeller, M., Claytor, R., et al.[2013]

A five-week telephone dietary counseling intervention for parents of overweight/obese children led to significant reductions in dietary glycemic load (GL) for those following a Low GL diet, demonstrating the efficacy of telehealth in promoting healthier eating habits.

The intervention achieved high attendance (86%) and completion rates (91%), indicating strong engagement and satisfaction among participants, which is crucial for the success of dietary interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A telephone intervention to achieve differentiation in dietary intake: a randomized trial in paediatric primary care. Rhodes, ET., Vernacchio, L., Mitchell, AA., et al.[2018]

A new app evaluation tool called Ped-WHAT was developed to assess smartphone applications for childhood obesity management based on evidence-based behavior modification strategies and American Academy of Pediatrics guidelines.

After training healthcare providers on how to use the Ped-WHAT tool, there were significant improvements in their knowledge and confidence in using these apps, highlighting the importance of provider education in effectively managing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity Applications in Smartphones: Development and Use of an Evaluation Tool. Al-Lami, N., Sear, K., Dai, W., et al.[2021]

The TennCare Weight Watchers Partnership Program effectively helped over half of the participating children and adolescents (53%) meet or exceed expert recommendations for managing obesity, demonstrating its efficacy as an intervention.

Participants who engaged in the program for more than 12 weeks or attended at least 10 meetings experienced a significant reduction in their body mass index z score by 5%, highlighting the importance of sustained participation for achieving weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight change in pediatric TennCare recipients referred to a commercial weight loss program. Mitchell, NS., Suh, CA., Stroebele, N., et al.[2021]

A survey of 1,583 Head Start programs revealed that 60% provided training workshops for staff on children's feeding and 63% on gross motor activities, indicating a strong focus on educating staff about healthy practices.

The majority of programs (84%) offered parent workshops on healthy food preparation, and 97% had community partnerships to promote healthy eating, showcasing a comprehensive approach to preventing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reaching staff, parents, and community partners to prevent childhood obesity in Head Start, 2008. Gooze, RA., Hughes, CC., Finkelstein, DM., et al.[2021]

The Early Childhood Obesity Prevention Program (ECHO) aims to improve obesity prevention in socio-economically disadvantaged Latino and Black children by enhancing maternal skills in nutrition and physical activity through home visitation, with a focus on behavior change over 12 months.

The intervention is designed to promote longer breastfeeding, delayed introduction of solids and juice, better sleep routines, reduced screen time, and improved maternal diet and activity levels, potentially leading to lower obesity rates in infants and mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Early Childhood Obesity Prevention Program (ECHO): an ecologically-based intervention delivered by home visitors for newborns and their mothers. Cloutier, MM., Wiley, J., Wang, Z., et al.[2023]

The 'Energy Up' program effectively helped inner-city girls lose weight, with obese participants losing an average of 12.9 pounds and overweight participants losing 2.9 pounds over a 9-month period.

The program's focus on avoiding addictive foods, promoting exercise, and building self-esteem contributed to its success, leading to plans for expansion to other schools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Energy Up": a novel approach to the weight management of inner-city teens. Chehab, LG., Pfeffer, B., Vargas, I., et al.[2009]

The HOP'N Home project successfully engaged parents in obesity prevention practices by teaching children to ask for healthful changes at home, with 100% of parents adopting the program and over 90% implementing changes.

The percentage of overweight or obese children decreased from 50% at the start of the program to 29% post-intervention, indicating a positive trend in obesity prevention, although the results were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent adoption and implementation of obesity prevention practices through building children's asking skills at family child care homes. Walch, TJ., Rosenkranz, RR., Schenkelberg, MA., et al.[2020]

References

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

Treating rural pediatric obesity through telemedicine: baseline data from a randomized controlled trial. [2021]

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

The Implementation and Five-Year Evolution of a Childhood Healthy Weight Program: Making a Health Care-Community Partnership Work. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Family-Based Telehealth Initiative to Improve Nutrition and Physical Activity for Children With Obesity and Its Utility During COVID-19: A Mixed Methods Evaluation. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Service evaluation of the GOALS family-based childhood obesity treatment intervention during the first 3 years of implementation. [2022]

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

The relationship of health outcomes to improvement in BMI in children and adolescents. [2013]

6. England pubmed.ncbi.nlm.nih.gov

A telephone intervention to achieve differentiation in dietary intake: a randomized trial in paediatric primary care. [2018]

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

Obesity Applications in Smartphones: Development and Use of an Evaluation Tool. [2021]

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

Weight change in pediatric TennCare recipients referred to a commercial weight loss program. [2021]

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

Reaching staff, parents, and community partners to prevent childhood obesity in Head Start, 2008. [2021]

10. England pubmed.ncbi.nlm.nih.gov

The Early Childhood Obesity Prevention Program (ECHO): an ecologically-based intervention delivered by home visitors for newborns and their mothers. [2023]

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

"Energy Up": a novel approach to the weight management of inner-city teens. [2009]

12. England pubmed.ncbi.nlm.nih.gov

Parent adoption and implementation of obesity prevention practices through building children's asking skills at family child care homes. [2020]