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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to address childhood obesity among Latino/Hispanic families in rural Nebraska. The researchers aim to determine if a program called Family Connections can reduce children's body mass index (BMI) by promoting healthy habits such as improved diet and increased physical activity. Participants are divided into two groups: one begins the program immediately, while the other joins later. Families with children aged 8-12 who have higher than average weight and live in rural areas are well-suited for this trial. As an unphased trial, it offers families the opportunity to contribute to important research that could enhance children's health and well-being.

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 prior data suggests that the Family Connections program is safe for children?

Research has shown that the Family Connections program improves health habits such as exercise and healthy eating. Although specific safety data for this program is unavailable, its "Not Applicable" trial phase indicates it does not involve testing a new drug or risky treatment. Instead, the program emphasizes education and lifestyle changes, which are generally safe.

The program employs tools like activity workbooks and phone calls to provide guidance. Similar programs have used these methods, and participants have received them well. The sources provided report no negative effects, so participants can expect a low-risk experience focused on education and support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Family Connections approach for childhood obesity because it emphasizes family involvement and education. Unlike traditional treatments that might focus solely on individual diet and exercise plans, this method integrates family dynamics by providing parents with tools like activity workbooks and interactive phone sessions to promote healthier lifestyles. This holistic approach aims to create a supportive environment at home, making it easier for children to adopt and maintain healthy habits. Additionally, by incorporating interactive voice response systems for continuous engagement, it offers a unique way to keep families motivated and informed over an extended period.

What evidence suggests that the Family Connections program might be an effective treatment for childhood obesity?

Research has shown that treatments involving the whole family, such as Family Connections, can help manage childhood obesity. In this trial, some participants will receive the Family Connections program, which includes an activity workbook, in-person support sessions, and Interactive Voice Response (IVR) calls. Studies have found that when family members participate in lifestyle changes, like eating healthier and being more active, children's weight improves. Although some studies did not find significant changes in BMI z-scores (a measure of weight for age and sex), many families continued with the program. Family-based methods have proven effective in regular healthcare settings, aiding children in better weight control. This suggests that Family Connections might help reduce obesity-related problems among Latino/Hispanic children in rural areas. ^{1 6 7 8 9}

Who Is on the Research Team?

Tzeyu Michaud, PhD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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]

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]

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 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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34396714/

Comparing two different family-based childhood obesity ... Neither intervention yielded significant improvements in child BMI z-score or parent BMI, yet both were delivered with high fidelity.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00433901

NCT00433901 | Family Connections Weight Management The prevalence of overweight children has increased significantly over the past 3 decades and 3 out of every 4 overweight children become obese adults.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39813376/

Comparing Two Programs to Help Families Living in ... The primary aim was to determine the relative effectiveness of 2 family-based childhood obesity interventions (Family Connections and iChoose)

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714419301296

A comparative effectiveness trial of two family-based ... This research addresses literature gaps related to the features within clinical and community settings that could improve both child weight status.

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2805906

Family-Based Behavioral Treatment for Childhood Obesity ... Family-based treatment can be successfully implemented in pediatric primary care settings and leads to improved weight loss outcomes.

6. withpower.com withpower.com/trial/phase-pediatric-obesity-1-2021-4721f

Family Connections for Childhood Obesity What safety data exists for the Family Connections childhood obesity treatment? The available research does not provide specific safety data for the Family ...

7. bmjopen.bmj.com bmjopen.bmj.com/content/14/10/e089186

the Hispanic Family Connections study protocol Introduction Addressing childhood obesity risk factors like home environment, parental roles, excess weight, physical activity and healthy eating among ...

8. link.springer.com link.springer.com/article/10.1007/s40615-025-02420-x

Two-Year Outcomes for the Active and Healthy Families ... The results suggest the need for ongoing support of families in the AHF program over time and combining the program with other pediatric obesity ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03245775

A Trial of Two Family-based Childhood Obesity Treatment ... The primary aim is to determine the relative effectiveness in child BMI z-scores at 3, 6, and 12-months post baseline of iChoose+ versus Family Connections.