Family Connections for Childhood Obesity

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AF
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Overseen BySilva B Fabiana, PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: University of Nebraska
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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.12345

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.16789

Who Is on the Research Team?

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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
See 4 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Family ConnectionExperimental Treatment1 Intervention
Group II: Waitlist Standard-CareActive Control1 Intervention

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

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Approved in United States as Family Connections for:

Find a Clinic Near You

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.
'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.
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.
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]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.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.
NCT00433901 | Family Connections Weight ManagementThe 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.govpubmed.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)
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.
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.
Family Connections for Childhood ObesityWhat safety data exists for the Family Connections childhood obesity treatment? The available research does not provide specific safety data for the Family ...
the Hispanic Family Connections study protocolIntroduction Addressing childhood obesity risk factors like home environment, parental roles, excess weight, physical activity and healthy eating among ...
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 ...
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.
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