Wellness Coaching for Childhood Obesity

(WC4K Trial)

Overseen By Corinna M Koebnick, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Non-English/Spanish speakers

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

Compensation: Varies

Number of Visits: 6

Duration: 2 years

6600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a wellness coaching program designed to reduce childhood obesity by engaging with families and children. Known as Wellness Coaching for Families and Kids, the program trains pediatricians and lifestyle coaches to support families through motivational interviews and personalized coaching sessions. It aims to make this approach easy to implement in real-world clinics without requiring many extra resources. Children aged 2 to 8 with a body mass index (BMI) at or above the 85th percentile, who speak English or Spanish at home, may be suitable for this trial. As an unphased trial, it offers families the opportunity to contribute to innovative approaches in combating childhood obesity.

Will I have to stop taking my current medications?

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

What prior data suggests that this wellness coaching intervention is safe for children?

Research has shown that motivational wellness coaching safely helps reduce childhood obesity. Past studies have demonstrated that motivational interviewing (MI) successfully encourages children and families to adopt healthier lifestyles. Pediatricians trained in MI have observed that their patients are more likely to embrace healthy habits.

This coaching does not involve medicine or medical procedures, so the risk of physical side effects remains very low. It emphasizes conversations and guidance to promote healthier habits, making it a well-accepted option for families managing their child's weight.

Overall, evidence suggests that wellness coaching is a safe and promising method for addressing childhood obesity, aiding kids and families in making lasting changes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about wellness coaching for childhood obesity because it offers a personalized approach that involves the whole family. Unlike standard treatments that often focus solely on the child, this method trains pediatricians in Motivational Interviewing and behavioral intervention, allowing them to engage both parents and children. The innovative use of telephonic counseling by lifestyle coaches ensures continuous support over two years, integrating seamlessly with electronic medical records for a tailored experience. This comprehensive strategy not only addresses the child's health but also promotes lasting lifestyle changes for the entire family.

What evidence suggests that Wellness Coaching for Families and Kids might be an effective treatment for childhood obesity?

Research has shown that Motivational Interviewing (MI) can help reduce childhood obesity. In past studies, children who received wellness coaching from pediatricians trained in MI participated more than those with untrained pediatricians. This indicates that MI helps families become involved and motivated to make changes. In this trial, the Wellness Coaching for Families and Kids program will use MI techniques to engage families. Previous trials have proven that the program can lower children's body mass index (BMI), which measures body fat based on height and weight. By using conversation techniques, wellness coaching aims to build lasting healthy habits in kids. This method is designed to fit into everyday life, making it easier for families to participate and benefit. ^{1 2 3 4 6}

Who Is on the Research Team?

Corinna M Koebnick, PhD

Principal Investigator

Kaiser Permanente

Are You a Good Fit for This Trial?

This trial is for families with children aged 2-8 who are in the 85th percentile or higher for body mass index (BMI), indicating obesity. The study is open to those attending one of the 25 participating clinics offering motivational interview counseling. Families must speak English or Spanish as their primary language to join.

Inclusion Criteria

I am willing to receive motivational interviews and wellness coaching.

My child is between 2-8 years old with a BMI in the 85th percentile or higher.

Exclusion Criteria

My family primarily speaks a language other than English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Pediatricians conduct Motivational Interviewing sessions and refer patients to lifestyle coaches for telephonic counseling

2 years

6 telephonic sessions (45 min each) with lifestyle coaches, 3 in-person sessions (10 min each) with pediatricians

Follow-up

Participants are monitored for changes in BMI and other health metrics after the intervention

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Wellness Coaching for Families and Kids

Trial Overview The study tests a modified intervention designed to lower BMI in children, making it practical and sustainable in real-world clinical settings without needing many resources. It involves wellness coaching tailored for families and kids, aiming to provide effective strategies against childhood obesity.

How Is the Trial Designed?

Group I: Wellness Coaching for Families and Kids Experimental Treatment 1 Intervention

For clinics assigned to mBMI2Kids intervention, Pediatricians will be trained in Motivational Interviewing (MI) and behavioral intervention. Pediatricians will conduct up to 3 sessions with each parent (3 x 10 min) and refer patients electronically to experienced MI-trained lifestyle coaches. With full access to the electronic medical record coaches will call referred families (child's BMI-for-age ≥85th percentile) and deliver a telephonic MI counseling over two years (6 x 45 min) simultaneous with pediatricians. 49 clinics will be selected with 24 participating in the intervention and 25 providing patients with usual care.

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A comprehensive educational approach that involves both the child and their family is essential for effectively managing obesity in children, emphasizing the importance of motivational interviewing and parental involvement.

Long-term success in obesity care requires a flexible, step-by-step follow-up plan that allows for ongoing negotiation of goals between caregivers, the child, and their family, ensuring that management strategies are tailored to the child's specific situation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[PRIMARY CARE INTERVENTIONS FOR PEDIATRIC OVERWEIGHT OR OBESITY]. Jouret, B., Haupp, A.[2018]

In a 12-week family-based program called Building Healthy Families, 22 obese children lost an average of 2.3 kg, while their parents lost an average of 6.4 kg, indicating the program's effectiveness in promoting weight loss for both children and parents.

The study found that reducing the intake of high-fat, high-calorie foods was a strong predictor of weight loss in children, highlighting the importance of dietary changes in successful obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a Family Based Pediatric Obesity Program - Preliminary Results. Ruebel, ML., Heelan, KA., Bartee, T., et al.[2019]

Nurses reported that the child-centred health dialogue (CCHD) intervention for addressing childhood overweight was emotionally challenging, but the training they received improved their ability to engage families in discussions about healthy lifestyles.

Despite the emotional difficulties, the structured training provided nurses with tools and support, enhancing their professionalism and effectiveness in conducting health dialogues with children and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A challenging balancing act to engage children and their families in a healthy lifestyle - Nurses' experiences of child-centred health dialogue in child health services in Sweden. Castor, C., Derwig, M., Borg, SJ., et al.[2021]

The review analyzed 31 family-based interventions for pediatric obesity, categorizing them into four types based on their focus on parent behaviors and assessment of child outcomes.

The authors suggest that current interventions could benefit from a broader focus on family dynamics and parenting skills, as this may enhance the effectiveness of obesity treatment in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based interventions for pediatric obesity: methodological and conceptual challenges from family psychology. Kitzmann, KM., Beech, BM.[2006]

The new model for diagnosing and treating childhood obesity emphasizes psycho-education for both children and parents, helping them become informed partners in managing weight, which enhances their autonomy and decision-making skills.

By involving the family's support network and providing resources like workbooks, the program fosters a sense of connectedness and motivation, which are crucial for maintaining a healthier lifestyle and adapting it as needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overweight and Obesity in Children: More Than Just the Kilos. van Mil, E., Struik, A.[2018]

A study involving 3,524 preschool children in China identified key risk factors for obesity, including high birth weight, parental BMI, and family structure, highlighting the importance of family dynamics in obesity prevention.

Breastfeeding in the first four months was initially protective against obesity, but this effect diminished when considering multiple factors, suggesting that a comprehensive approach is needed for effective family-based obesity interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-related risk factors of obesity among preschool children: results from a series of national epidemiological surveys in China. Zong, XN., Li, H., Zhang, YQ.[2018]

Childhood obesity is a major issue in the U.S., particularly in low-income communities, and having an obese parent significantly increases a child's risk of obesity.

This pilot study introduces a collaborative model of family group medical visits combined with healthy living workshops, targeting families with at least one obese child and parent, as a promising approach to combat pediatric obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fit and healthy family cAMP for engaging families in a child obesity intervention: a community health center pilot project. Weaver, SP., Kelley, L., Griggs, J., et al.[2018]

In a study of 75 participants in the Building Healthy Families program, those who achieved the largest reductions in BMI z-scores had high attendance and self-regulation skills, particularly among both children and mothers.

Successful outcomes were linked to mothers achieving clinically meaningful weight loss and children maintaining high attendance rates, suggesting that both parental involvement and self-regulation are crucial for effective obesity treatment in families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative Comparative Analysis of Program and Participant Factors That Explain Success in a Micropolitan Pediatric Weight Management Intervention. Golden, CA., Heelan, KA., Hill, JL., et al.[2022]

A family-centered obesity intervention using telehealth showed high engagement, with 87% of parents completing at least one health coaching contact and 93% responding to text messages.

The study involved 360 children aged 2 to 12 years, and 72% of parents reported high satisfaction with the telehealth content, indicating that this approach is both feasible and acceptable for supporting behavior change in childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Telehealth to Enhance Care in a Family-Centered Childhood Obesity Intervention. Bala, N., Price, SN., Horan, CM., et al.[2020]

Family Coaching is an innovative approach to delivering evidence-based prevention programs (EBPPs) that focuses on integrating multiple risk factors and behavior changes, making it a versatile option for families.

This method leverages trained community members to provide goal-oriented support, helping families set personalized goals and develop problem-solving skills, which can enhance the effectiveness and acceptance of health promotion interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family Coaching as a delivery modality for evidence-based prevention programs. Rotheram-Borus, MJ., Swendeman, D., Rotheram-Fuller, E., et al.[2019]

A 3-month family-based intervention for obese children from obese families resulted in significant weight loss and improved BMI percentiles compared to a control group, highlighting the efficacy of targeted interventions in this population.

The intervention also successfully reduced screen time and improved fitness levels, indicating that a combined approach addressing dietary, behavioral, and physical activity factors can lead to positive health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of childhood obesity in obese families. Nemet, D., Barzilay-Teeni, N., Eliakim, A.[2020]

A randomized control trial involving 60 obese students showed that a self-empowerment-based coaching program significantly reduced total body fat and improved healthy behavior habits compared to a control group.

The intervention group also reported greater improvements in satisfaction related to hobbies, exercise, sleep, and spiritual well-being, indicating a holistic benefit of the coaching approach in managing obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of self-empowerment-based patient-centered care for obese students in primary services: A randomized controlled trial. Dewi, DK., Sekartini, R., Sunardi, D., et al.[2023]

The 'Families for Health' program, a 12-week community-based intervention for childhood obesity, led to a significant reduction in BMI z scores among participants, with a decrease of -0.18 at 3 months and -0.21 at 9 months, indicating its potential efficacy.

Participants also reported improvements in children's quality of life, lifestyle habits, and parent-child relationships, suggesting that the program positively impacted both physical health and family dynamics, although some areas like self-esteem and fruit/vegetable consumption did not show significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot of "Families for Health": community-based family intervention for obesity. Robertson, W., Friede, T., Blissett, J., et al.[2008]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05143697

Motivational Wellness Coaching to Reduce Childhood ... An evidence-based method for treatment of childhood obesity to help engage and motivate patients is Motivational Interviewing (MI).

2. sciencedirect.com sciencedirect.com/science/article/pii/S0738399125005403

Training in motivational interviewing for pediatricians was ... Out of 19,888 eligible children, 10.3 % (n = 2045) were referred to wellness coaching (reached). The reach was higher in MI-trained compared to untrained ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40412364/

Training in motivational interviewing for pediatricians was ... Out of 19,888 eligible children, 10.3 % (n = 2045) were referred to wellness coaching (reached). The reach was higher in MI-trained compared to untrained ...

4. withpower.com withpower.com/trial/phase-obesity-2022-10553

Wellness Coaching for Childhood Obesity (WC4K Trial) This trial aims to reduce childhood obesity by using conversation techniques in healthcare settings. The focus is on children aged 2-8 who are overweight or ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05143697/motivational-wellness-coaching-to-reduce-childhood-obesity-in-families-and-kids

Motivational Wellness Coaching to Reduce Childhood ... The investigators propose to modify and test an intervention shown to lower children's body mass index(BMI) so that it is feasible, sustainable, ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK590582/

Do Weight Management Programs Involving Health Coaches ... Two interventions that included high-quality clinical care for obesity and linkages to community resources resulted in improved family-centered outcomes.