Family Connections for Childhood Obesity

Overseen By Silva B Fabiana, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Disqualifiers: No telephone, Pregnancy, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 months

158 Participants Needed

Trial Summary

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

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

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 idea that Family Connections for Childhood Obesity is an effective treatment?

The available research shows that family-based approaches, like Family Connections for Childhood Obesity, are effective in improving overweight or obesity in children. One study highlights that these programs are particularly beneficial in underserved regions where access to such treatments is limited. Another study emphasizes the importance of family-centered care, which leads to better outcomes and greater satisfaction. Additionally, a study on clinical-community collaboration found that embedding family-based treatment in primary care clinics improved retention and child weight status over a year. These findings suggest that Family Connections is a promising treatment for childhood obesity. ^{1 2 3 4 5}

What data supports the effectiveness of the Family Connections treatment for childhood obesity?

Research shows that family-based approaches can effectively improve overweight or obesity in children, and incorporating family-centered care principles leads to better outcomes and satisfaction. Additionally, clinical-community collaboration in family-based programs has shown promise in improving child weight status. ^{1 2 3 4 5}

What safety data exists for the Family Connections childhood obesity treatment?

The available research does not provide specific safety data for the Family Connections childhood obesity treatment. However, related studies discuss logistical and cultural challenges, including safety concerns during home visitations, which could be addressed by conducting visits in pairs or combining them with group classes. These insights suggest that while safety concerns exist, they are being considered and addressed in the program's implementation. ^{1 3 6 7 8}

Is the Family Connections for Childhood Obesity program safe for participants?

The Family Connections for Childhood Obesity program, which includes home visitations, has been perceived as convenient and effective by participants, but some safety concerns were noted, such as scheduling difficulties and discomfort with visitors in the home. These concerns could be addressed by conducting visits in pairs or combining them with group classes. ^{1 3 6 7 8}

Is the Family Connections treatment a promising way to help with childhood obesity?

Yes, the Family Connections treatment is promising for childhood obesity. It focuses on involving families in healthy eating and exercise, which can help manage children's weight effectively. It also aims to improve access to care and satisfaction, especially in underserved areas, by using community resources and learning from families who have successfully improved their health. ^{1 3 8 9 10}

How is the Family Connections treatment for childhood obesity different from other treatments?

The Family Connections treatment is unique because it focuses on family-based interventions, leveraging both clinical and community resources to address socio-contextual factors, which are often overlooked in traditional treatments. This approach is informed by successful strategies from families who have improved their health behaviors despite challenging environments, making it particularly effective in underserved regions. ^{1 3 8 9 10}

What is the purpose of this trial?

There are marked ethnic and rural-urban disparities in the prevalence of childhood obesity (CO). Among Latino/Hispanic children, CO is almost 60% higher than that of non- Latino/Hispanic Whites, and among children in rural areas it is estimated to be 25% to almost 50% higher that of urban areas. By 2050 Latinos are expected to represent 51.2% of rural Nebraska's population, so addressing childhood obesity risk factors among Latinos/Hispanic families living in rural communities and Identifying effective interventions is an important priority. The first aim will be to collaboratively adapt all intervention materials to better fit the rural Latino/Hispanic community, including translation of materials to Spanish, inclusion of culturally relevant content and images, and use of health communication strategies to address different levels of health literacy. The second aim randomly assign enrolled participant dyads (parent and child) to either Family Connections (FC) or a waitlist standard-care (SC) group to determine preliminary effectiveness in reducing child body mass index (BMI) z-score (a standardized way to measure a child's weight in relation to their age and sex). This study will address three important questions as they apply to Latino/Hispanic in rural Nebraska: is a telephone delivered family-based childhood obesity (FBCO) program in rural Nebraska culturally relevant, usable and acceptable, is a telephone delivered FBCO program effective at reducing child BMI z-scores and what real-world factors influence the impact of the intervention to sustainably engage a meaningful population of Latino/Hispanic families who stand to benefit.

Research Team

Tzeyu Michaud, PhD

Principal Investigator

University of Nebraska

Eligibility Criteria

This trial is for Latino/Hispanic families in rural Nebraska with parents over 19 and children aged 6-12 who are overweight (BMI z-score ≥85th percentile). Families must have a phone, not plan to move or become pregnant soon, be willing to join the study randomly, and not be in another weight loss program.

Inclusion Criteria

I am a child aged 6-12, overweight, living in the target area, and agree to join the study.

Exclusion Criteria

No telephone

Contraindication to physical activity or weight loss

Planning to move in the next 12 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cultural Adaptation

Collaborative adaptation of intervention materials to fit the rural Latino/Hispanic community profile, including translation and inclusion of culturally relevant content

Not specified

Treatment

Participants receive the Family Connections intervention, including 2 in-person group sessions and 10 IVR calls over 6 months

6 months

2 in-person sessions, 10 IVR calls

Follow-up

Participants are monitored for changes in BMI z-scores and other health outcomes

6-12 months post baseline

Treatment Details

Interventions

• Family Connections

Trial Overview The 'Family Connections' program aims to reduce childhood obesity through culturally adapted materials delivered via automated calls. The study will compare this approach against standard care by looking at changes in child BMI z-scores and evaluating the program's potential for wider use.

Participant Groups

Group I: Family Connection Experimental Treatment 1 Intervention

Parent participants will receive an activity workbook that promotes increased physical activity, healthy diets and decreased screen time, two in-person support sessions spaced and 10 Interactive Voice Response (IVR) automated telephone system calls providing health education messages over 6 months.

Group II: Waitlist Standard-Care Active Control 1 Intervention

Parent participants will receive an activity workbook that promotes increased physical activity, healthy diets and decreased screen time and placement on 6-month delayed start (waitlist) in the FC program.

Family Connections is already approved in United States for the following indications:

Approved in United States as Family Connections for:

• Childhood Obesity Prevention

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

University of Nebraska Lincoln

Collaborator

Trials

40

Recruited

13,200+

Findings from Research

In a study involving 139 children aged 5-12 with obesity or overweight, neither the high-intensity iChoose program nor the low-intensity Family Connections program showed significant changes in BMI z-scores after 6 months, indicating that both interventions may need further refinement to be effective.

Family Connections demonstrated higher retention rates (84% vs. 63% for iChoose), better engagement, and lower implementation costs per child, suggesting that a lower intensity, parent-focused approach may be more suitable for underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing two different family-based childhood obesity treatment programmes in a medically underserved region: Effectiveness, engagement and implementation outcomes from a randomized controlled trial. Zoellner, JM., You, W., Hill, JL., et al.[2022]

In a multicenter randomized controlled trial involving families with at least one overweight parent and a healthy child, changes in the mother's body mass index (BMI) were positively associated with changes in the BMI-for-age Z-scores of both children, indicating that parental weight management can influence children's weight outcomes.

The study highlights the effectiveness of family-based dietary interventions for weight maintenance, suggesting that including parents in these programs can benefit children's weight management, regardless of the child's initial weight status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association of changes in body mass index and metabolic parameters between adults with overweight or obesity and their children in a family-based randomized trial (DiOGenes). Pang, MD., Yilmaz, H., Astrup, A., et al.[2022]

The Connect for Health study is a randomized controlled trial involving children aged 2-12 with overweight or obesity, aiming to improve BMI and health-related quality of life through a tailored intervention that connects families with community resources.

The intervention, delivered by trained health coaches over a year, utilizes geographic information systems to address socio-contextual factors, potentially leading to better obesity-related outcomes compared to standard pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Connect for Health: Design of a clinical-community childhood obesity intervention testing best practices of positive outliers. Taveras, EM., Marshall, R., Sharifi, M., et al.[2022]

The modified Family Centered-Care Assessment (mFCCA) tool showed excellent reliability and validity in evaluating family-centered care in childhood obesity interventions, with a high response rate of 87% from 629 parents.

Children receiving enhanced primary care plus health coaching experienced a significantly greater perception of family-centeredness compared to those receiving only enhanced primary care, suggesting that individualized health coaching is an effective approach in pediatric weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-centeredness of childhood obesity interventions: psychometrics & outcomes of the family-centered care assessment tool. Simione, M., Sharifi, M., Gerber, MW., et al.[2021]

The family-based treatment program, Healthy Hawks Primary Plus (HHP+), showed significantly better retention rates at 1 year (73.9%) compared to a standard treatment program (38.3%), indicating its effectiveness in keeping families engaged in obesity treatment.

Participants in the HHP+ program experienced significant reductions in their child’s weight status, as measured by %BMIp95, suggesting that this community-based approach can effectively help manage pediatric obesity in underrepresented populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical-Community Collaboration: A Strategy to Improve Retention and Outcomes in Low-Income Minority Youth in Family-Based Obesity Treatment. Tripicchio, GL., Ammerman, AS., Ward, DS., et al.[2021]

Families invited to a childhood obesity program often disengaged because they perceived the program as unnecessary, believing their children were not overweight or were simply growing into their size.

Initial communication about children's BMI was crucial; many parents felt angered by generic letters detailing their child's weight, suggesting that a more personalized approach could improve engagement in such programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'She's not obese, she's a normal 5-year-old and she keeps up with the other kids': families' reasons for not attending a family-based obesity management programme. Povey, RC., Cowap, LJ., Scholtens, K., et al.[2022]

Home visitation as part of a childhood obesity program was seen as convenient and effective for engaging families and promoting behavior change, according to insights from 25 parents and 3 patient navigators.

However, challenges such as scheduling difficulties and discomfort with home visits were noted, suggesting that future strategies could include conducting visits in pairs or integrating group classes for additional support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home Visitations for Delivering an Early Childhood Obesity Intervention in Denver: Parent and Patient Navigator Perspectives. Knierim, SD., Moore, SL., Raghunath, SG., et al.[2021]

The study involves 108 children aged 6-17 with obesity and their caregivers, who will be randomized to receive either Family Navigation (FN) combined with Usual Care or just Usual Care over a 12-month period, aiming to improve access and reduce attrition in obesity management.

Family Navigation is designed to enhance care access through logistical and relational strategies, and the study will evaluate its acceptability and effectiveness in reducing barriers to treatment, with data collected at multiple time points to inform future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-center, randomized, 12-month, parallel-group, feasibility study to assess the acceptability and preliminary impact of family navigation plus usual care versus usual care on attrition in managing pediatric obesity: a study protocol. Ball, GDC., O'Neill, MG., Noor, R., et al.[2023]

A study involving 21 parents/guardians identified key barriers to participating in family-based obesity treatment programs, including lack of time, frustration from past failures, and perceived costs of healthy options.

Facilitators for participation included convenient locations, supportive program leaders, and rewards for children's progress, highlighting the importance of caregiver input in designing effective obesity interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-Based Behavioral Treatment for Childhood Obesity: Caretaker-Reported Barriers and Facilitators. Staiano, AE., Marker, AM., Comeaux, J., et al.[2023]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparing two different family-based childhood obesity treatment programmes in a medically underserved region: Effectiveness, engagement and implementation outcomes from a randomized controlled trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The association of changes in body mass index and metabolic parameters between adults with overweight or obesity and their children in a family-based randomized trial (DiOGenes). [2022]

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

Connect for Health: Design of a clinical-community childhood obesity intervention testing best practices of positive outliers. [2022]

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

Family-centeredness of childhood obesity interventions: psychometrics & outcomes of the family-centered care assessment tool. [2021]

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

Clinical-Community Collaboration: A Strategy to Improve Retention and Outcomes in Low-Income Minority Youth in Family-Based Obesity Treatment. [2021]

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

'She's not obese, she's a normal 5-year-old and she keeps up with the other kids': families' reasons for not attending a family-based obesity management programme. [2022]

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

Home Visitations for Delivering an Early Childhood Obesity Intervention in Denver: Parent and Patient Navigator Perspectives. [2021]

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

A multi-center, randomized, 12-month, parallel-group, feasibility study to assess the acceptability and preliminary impact of family navigation plus usual care versus usual care on attrition in managing pediatric obesity: a study protocol. [2023]

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

Family-Based Behavioral Treatment for Childhood Obesity: Caretaker-Reported Barriers and Facilitators. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Treatment of childhood obesity in obese families. [2020]