Wellness Coaching for Childhood Obesity

(WC4K Trial)

Overseen by Corinna M Koebnick, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Kaiser Permanente

Disqualifiers: Non-English/Spanish speakers

No Placebo Group

Trial Summary

What is the purpose of this 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 obese, especially from diverse and low-income backgrounds. Healthcare providers will discuss weight management with parents and connect them with lifestyle coaches for additional support through phone calls. These conversation techniques have shown promise in promoting weight loss and positive health behavior changes in both adults and children.

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 data supports the effectiveness of the treatment Wellness Coaching for Families and Kids?

Research shows that family-based wellness coaching, which includes self-empowerment and motivational strategies, can help children and their families manage obesity by improving self-regulation and attendance in programs. Studies highlight the importance of involving parents and using motivational interviewing to achieve better outcomes in weight management. ^{1 2 3 4 5}

Is wellness coaching for childhood obesity safe for humans?

Family-based wellness coaching programs, which include elements like nutrition education and physical activity, have been used in treating childhood obesity and generally focus on promoting healthier lifestyles. These programs are typically considered safe as they involve non-invasive strategies like goal-setting and skill development, and they are designed to align with family values and priorities. ^{6 7 8 9 10}

How is the Wellness Coaching for Families and Kids treatment different from other treatments for childhood obesity?

This treatment is unique because it involves family-based wellness coaching, which actively engages both children and their parents in lifestyle changes, using methods like telehealth for personalized support. Unlike other treatments, it focuses on improving family dynamics and parenting skills to address obesity, making it a comprehensive approach. ^{5 9 11 12 13}

Research Team

Corinna M Koebnick, PhD

Principal Investigator

Kaiser Permanente

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Wellness Coaching for Families and Kids (Behavioral Intervention)

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.

Participant Groups

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+

Greg A. Adams

Kaiser Permanente

Chief Executive Officer since 2019

MBA from University of Southern California

Dr. Edward M. Ellison

Kaiser Permanente

Chief Medical Officer since 2015

MD from Harvard Medical School

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

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

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

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

Chief Medical Officer since 2007

MD, M.A.C.P.

Findings from Research

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]

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 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]

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]

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]

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]

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]

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 '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]

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]

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]

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]

References

1. India pubmed.ncbi.nlm.nih.gov

The effectiveness of self-empowerment-based patient-centered care for obese students in primary services: A randomized controlled trial. [2023]

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

Qualitative Comparative Analysis of Program and Participant Factors That Explain Success in a Micropolitan Pediatric Weight Management Intervention. [2022]

3. France pubmed.ncbi.nlm.nih.gov

[PRIMARY CARE INTERVENTIONS FOR PEDIATRIC OVERWEIGHT OR OBESITY]. [2018]

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

Overweight and Obesity in Children: More Than Just the Kilos. [2018]

5. England 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. [2021]

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

Family Coaching as a delivery modality for evidence-based prevention programs. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Treatment of childhood obesity in obese families. [2020]

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

Outcomes of a Family Based Pediatric Obesity Program - Preliminary Results. [2019]

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

Family-based interventions for pediatric obesity: methodological and conceptual challenges from family psychology. [2006]

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

Pilot of "Families for Health": community-based family intervention for obesity. [2008]

11. England pubmed.ncbi.nlm.nih.gov

Family-related risk factors of obesity among preschool children: results from a series of national epidemiological surveys in China. [2018]

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

Use of Telehealth to Enhance Care in a Family-Centered Childhood Obesity Intervention. [2020]

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

Fit and healthy family cAMP for engaging families in a child obesity intervention: a community health center pilot project. [2018]