Family Matters Intervention for Childhood Obesity

Recruiting at 3 trial locations

Overseen By Amanda Trofholz, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Dietary restrictions, Non-custodial parents

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

Compensation: Varies

Number of Visits: 8

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The proposed study is a 12-month, individual randomized controlled trial (RCT). The main aim of the study is to decrease cardiovascular disease risk (BMI percentile, neck circumference) and improve child diet quality in children ages 5-10 years old by increasing family meal quality (i.e., dietary intake, interpersonal atmosphere) and quantity (i.e., frequency of family meals) via innovative technology (i.e., ecological momentary intervention (EMI), video feedback) and partnerships with primary care and Community Health Workers (CHWs).

Will I have to stop taking my current medications?

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

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

The Family Matters Intervention is unique because it focuses on a family-based approach, involving both children and their parents in behavioral changes, which has been shown to improve weight loss outcomes compared to treatments that do not involve the family. ^{1 2 3 4 5}

What data supports the effectiveness of the Family Matters Intervention for Childhood Obesity treatment?

Research shows that family-based approaches can be effective in helping children with overweight or obesity, as they often lead to better weight-related outcomes by involving the whole family in lifestyle changes. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for children aged 5-10 with obesity (BMI ≥75th percentile) who have ≤3 family dinner meals per week. It includes their primary caregiver and at least one sibling, possibly other family members too. Participants must attend certain Minnesota clinics, not plan to move soon, speak English or Spanish, and come from diverse racial/ethnic backgrounds.

Inclusion Criteria

My child's BMI is in the top 25% for their age and sex.

I am a child aged 5-10, visit specific clinics, and my caregiver and a sibling will join the study.

One of the following race/ethnicities: African American, Hispanic/Latino, Native American, Asian American, or White. In order to examine racial/ethnic differences in study hypotheses, equal numbers of children per racial/ethnic group (total=525) will be recruited.

Exclusion Criteria

Children with medically necessary dietary restrictions (reviewed by MD from primary care clinics).

I am a non-custodial parent with less than 50% living time with my child.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive ecological momentary intervention (EMI) prompts, in-home or virtual education visits, and video feedback focusing on family meal quality and quantity

16 weeks

8 in-home or virtual visits

Maintenance

Participants receive reduced EMI tips on high stress days to build self-efficacy and increase sustainability of new behaviors

8 weeks

Follow-up

Participants are monitored for changes in BMI percentile, neck circumference, and dietary quality

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Ecological Momentary Intervention
• Family Matters Intervention
• Feedback on Video-recorded Family Meals
• In-home Visits and Food Preparation Activities
• Maintenance

Trial Overview The study tests a 12-month program aimed at reducing childhood obesity by improving the quality and frequency of family meals using video feedback and real-time interventions through technology. It involves in-home visits, food preparation activities, and partnerships with healthcare workers.

How Is the Trial Designed?

Group I: EMI + HV + Video feedback, Virtual Experimental Treatment 3 Interventions

EMI + HV + Video Feedback (Arm 2) education visits will all be delivered virtually, and the arm includes: (1) tailored ecological momentary intervention (EMI) prompts sent to parents targeting momentary behaviors (e.g., stress) around family meal quality and quantity for 16 weeks; (2) bi-weekly in-home educational visits (total of 8) with a community health worker (CHW) focusing on family meal quality (i.e., dietary quality, interpersonal quality) and quantity (i.e., frequency of family meals), and 8 weeks "Try it Yourself" activities that reinforce the messages and skills taught by a CHW (for a total of 16 weeks); (3) video feedback on a video-taped family meal delivered every other week during the in-home visit with the CHW; (4) a 8-week maintenance phase with EMI tips delivered on high stress days.

Group II: EMI + HV + Video feedback, Hybrid Experimental Treatment 4 Interventions

EMI + HV + Video Feedback (Arm 3) education visits will be delivered virtually and in-home, and the arm includes: (1) tailored ecological momentary intervention (EMI) prompts sent to parents targeting momentary behaviors (e.g., stress) around family meal quality and quantity for 16 weeks; (2) bi-weekly in-home educational visits (total of 8) with a community health worker (CHW) focusing on family meal quality (i.e., dietary quality, interpersonal quality) and quantity (i.e., frequency of family meals), and 8 weeks "Try it Yourself" activities that reinforce the messages and skills taught by a CHW (for a total of 16 weeks); (3) video feedback on a video-taped family meal delivered every other week during the in-home visit with the CHW; (4) a 8-week maintenance phase with EMI tips delivered on high stress days.

Group III: EMI Experimental Treatment 2 Interventions

EMI (Arm 1): (1) tailored ecological momentary intervention (EMI) prompts sent to parents targeting momentary behaviors (e.g., stress) around family meal quality and quantity for 16 weeks; and (2) a 8-week maintenance phase with EMI tips delivered on high stress days.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

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]

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]

Family-based behavioral interventions are effective in improving weight-related outcomes in children, with 93% of systematic reviews indicating success in managing child weight and behaviors.

Parent-targeted strategies, whether involving parents alone or with their children, showed similar or greater effectiveness, emphasizing the importance of parental involvement in promoting healthy eating and exercise habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of family-based weight management interventions for children with overweight and obesity: an umbrella review. Chai, LK., Collins, C., May, C., et al.[2020]

A family-oriented multidisciplinary intervention program aimed at reducing weight gain in young children with obesity did not result in any significant change in BMI standard deviation scores (SDS) after three years, with both intervention and control groups showing a median decrease of 0.19.

The study involved 31 families in the intervention group and 33 in the control group, with initial BMI SDS values indicating that the program did not effectively curtail weight increase, regardless of social or behavioral factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A family-oriented intervention programme to curtail obesity from five years of age had no effect over no intervention. Donkor, HM., Grundt, JH., Júlíusson, PB., et al.[2021]

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]

A family-based intervention for managing childhood obesity was effective, showing a greater improvement in weight among schoolchildren with overweight or obesity when both the child and at least one parent were involved in the program.

The study involved 60 schoolchildren aged 6 to 12 years, with significant weight differences observed between the intervention group and the control group, highlighting the importance of family engagement in obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Family intervention for the management of overweight and obesity in schoolchildren]. González-Heredia, R., Castañeda-Sánchez, O., López-Morales, CM., et al.[2019]

The study evaluates a 10-week family-based lifestyle intervention for children aged 8-12 with overweight and obesity, aiming to enroll 186 families in British Columbia, Canada, to assess its impact on child body mass index (BMI) and related health behaviors.

The intervention includes 26 hours of contact through group sessions and online resources, focusing on healthy eating, physical activity, and mental health, with outcomes measured at baseline, post-intervention, and follow-up to determine effectiveness and implementation success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based, healthy living intervention for children with overweight and obesity and their families: a 'real world' trial protocol using a randomised wait list control design. Liu, S., Marques, IG., Perdew, MA., et al.[2020]

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 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]

Citations

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

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

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. Australia pubmed.ncbi.nlm.nih.gov

Effectiveness of family-based weight management interventions for children with overweight and obesity: an umbrella review. [2020]

4. Norway pubmed.ncbi.nlm.nih.gov

A family-oriented intervention programme to curtail obesity from five years of age had no effect over no intervention. [2021]

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. Mexico pubmed.ncbi.nlm.nih.gov

[Family intervention for the management of overweight and obesity in schoolchildren]. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Family-based, healthy living intervention for children with overweight and obesity and their families: a 'real world' trial protocol using a randomised wait list control design. [2020]

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

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

9. Germany pubmed.ncbi.nlm.nih.gov

Treatment of childhood obesity in obese families. [2020]