Family Obesity Intervention for Obesity

Overseen By Lorna McNeill, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Exercise contraindications, others

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best way to help families reduce obesity, with a focus on racial and ethnic minority families. It compares two approaches: one providing direct support to parents and another involving the entire family (Parent and Family Obesity Intervention). The goal is to identify which method more effectively lowers obesity risk and, consequently, reduces obesity-related cancer risks. The trial seeks parents or caregivers who self-identify as racial or ethnic minorities, live with children aged 10-16, are not currently in a weight management program, and have a BMI of 30 or higher (considered obese). As an unphased study, this trial offers a unique opportunity to contribute to important research that could benefit families and communities.

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 these intervention programs are safe for families?

Research has shown that parental involvement in programs to help children can greatly improve the children's weight. One study found that with parental involvement, children exercised more and spent less time in front of screens, which helped lower their body mass index (BMI) scores. Another study demonstrated that these family-based programs helped children manage their weight better over time compared to regular care.

These programs focus on changing lifestyle habits, like eating healthier and being more active, rather than using medication. As a result, families usually find them easy to follow. Reports of serious side effects from these programs have not emerged. Instead, they encourage healthier habits for the whole family, creating a positive experience for everyone involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring innovative ways to tackle family obesity by involving the whole family in health interventions. Unlike typical treatments that might focus solely on the individual, this approach includes health coaching and peer support sessions for both parents and families, leveraging community resources like church-based support. By involving lay health workers (LHWs) and offering navigation sessions, the trial aims to create a more comprehensive support network that could lead to better long-term outcomes. This holistic approach could potentially make a significant difference in managing obesity by addressing it within the family context, rather than isolating the individual.

What evidence suggests that this trial's treatments could be effective for reducing obesity risk?

Research shows that programs involving parents and families can help reduce obesity in children. This trial includes different treatment arms for participants. In Arm I, parents receive health coaching sessions, navigation sessions with a lay health worker (LHW), and church-based peer support. Arm II involves family members receiving similar interventions. Arm III serves as a delayed comparison, where participants receive a handbook with core content but without individual support. One study found that when parents participated in obesity programs, their children's body weight, adjusted for age, decreased significantly. Another study discovered that children in family-based treatments had better long-term weight control compared to those who received standard care. Additionally, programs focused on parents, with regular follow-up sessions, consistently helped lower children's body weight. While some studies suggest that broader public health efforts are also necessary, evidence supports the effectiveness of these family and parent-focused programs in managing childhood obesity. ^{1 2 3 4 6}

Who Is on the Research Team?

Lorna McNeill

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for racial ethnic minority parents/caregivers and their children aged 10-16 living together. Parents must be obese, not in a weight management program, and between ages 18-65. They should speak English and have internet access. Excluded are those with exercise contraindications, current pregnancy or plans to become pregnant during the study.

Inclusion Criteria

I am a parent or caregiver and my BMI is 30 or higher.

I am a parent or caregiver aged between 18 and 65.

PARENTS/CAREGIVERS: Self-identify as a racial ethnic minority (i.e., black or African American or Hispanic)

Exclusion Criteria

PARENTS/CAREGIVERS: They are currently pregnant or thinking about becoming pregnant during study period

PARENTS/CAREGIVERS: They present any contraindications for exercise based on responses to the PA Readiness Questionnaire

PARENTS/CAREGIVERS: Principal investigator (PI) determines that parent/caregiver is unsuitable for the study for reasons not otherwise stated in the protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive health coaching sessions, navigation sessions with a lay health worker, and church-based peer support monthly for 6 months

6 months

6 visits (in-person or virtual)

Follow-up

Participants are monitored for behavioral, social, and environmental outcomes after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Parent and Family Obesity Intervention

Trial Overview The trial compares parent-focused versus family-focused programs to reduce obesity risk among racial ethnic minorities. It aims to see if these interventions can lower the chances of obesity-related cancers by promoting healthier behaviors within families.

How Is the Trial Designed?

Group I: Arm II (family intervention) Experimental Treatment 6 Interventions

Family members receive health coaching sessions over 50-60 minutes monthly for 6 months. Family members also receive navigation sessions with a LHW monthly for 6 months and church-based peer support monthly for 6 months.

Group II: Arm I (parent intervention) Experimental Treatment 6 Interventions

Parents receive health coaching sessions over 50-60 minutes monthly for 6 months. Parents also receive navigation sessions with a lay LHW monthly for 6 months and church-based peer support monthly for 6 months.

Group III: Arm III (delayed comparison) Active Control 3 Interventions

Participants receive a handbook that includes core content from the parent and family interventions, but without individual support from coaches, LHWs or the church.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

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]

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]

A study involving 60 obese children aged 6-11 years showed that a family-based approach, where parents were the sole agents of change, was more effective in reducing parental overweight compared to a program focused only on children.

This parent-targeted intervention also led to improved cardiovascular risk factors for both parents and children, highlighting the benefits of involving parents in obesity treatment programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of treatment for childhood obesity on parental risk factors for cardiovascular disease. Golan, M., Weizman, A., Fainaru, M.[2016]

Involving at least one parent actively in the weight loss process significantly improves both short- and long-term weight regulation in obese children aged 8-12 years, based on findings from four 10-year follow-up studies.

Increasing physical activity is crucial for maintaining long-term weight control, and support from family and friends is linked to better outcomes in childhood obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based behavioural intervention for obese children. Epstein, LH.[2022]

A pilot home-based intervention aimed at preventing childhood obesity showed that parents with a higher baseline BMI (≥25 kg/m²) experienced significant reductions in body mass and waist circumference after 6 and 18 months, compared to a control group.

Parents with a lower baseline BMI (<25 kg/m²) also benefited from the intervention, with the 4 home visits group showing reduced fat mass and the 2 home visits group showing lower body mass and BMI at the 6-month mark, although these effects were not sustained at 18 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized home-based childhood obesity prevention pilot intervention has favourable effects on parental body composition: preliminary evidence from the Guelph Family Health Study. Krystia, O., Ambrose, T., Darlington, G., 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]

A study involving 56 obese children and their families found that both parent-only and parent-child cognitive behavioral therapy (CBT) treatments equally reduced children's percent overweight after 6 months.

Both treatment approaches also similarly improved behavioral and psychological issues in children and mothers, indicating that either method can be effective for addressing childhood obesity and its associated challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled comparison of two cognitive behavioral therapies for obese children: mother versus mother-child cognitive behavioral therapy. Munsch, S., Roth, B., Michael, T., et al.[2018]

A family-based intervention program targeting both parents and children resulted in significant long-term reductions in BMI-standard deviation score (BMI-SDS) after 2 years, indicating its effectiveness in addressing childhood obesity.

While both intervention groups (parents-only and parents-and-child) showed short-term improvements in BMI-SDS after 3 months, only the parents-and-child group maintained significant reductions at the 2-year follow-up, suggesting that involving children in the intervention may enhance its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention for childhood obesity based on parents only or parents and child compared with follow-up alone. Yackobovitch-Gavan, M., Wolf Linhard, D., Nagelberg, N., et al.[2019]

The 'Parents as Agents of Change' (PAC) intervention was developed using Intervention Mapping principles, focusing on a 16-session program for parents of children aged 8-12 with obesity, addressing individual, family, and environmental factors.

The intervention was successfully implemented in a multidisciplinary weight management center, demonstrating a structured approach to developing evidence-based strategies for managing pediatric obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Intervention Mapping to develop the Parents as Agents of Change (PAC&#169;) intervention for managing pediatric obesity. Ball, GD., Mushquash, AR., Keaschuk, RA., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11201836/

The Impact of Parental Involvement in the Prevention and ... Conclusion: Parental involvement in childhood obesity interventions significantly impacts BMI z-score, exercise levels, screen time, and dietary ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2667368125000622

Systematic Review of Parental Influence on Pediatric Obesity Parent-focused interventions with booster sessions consistently demonstrated significant reductions in children's body mass index z-scores ...

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

Family-Based Behavioral Treatment for Childhood Obesity ... At 24 months, children receiving family-based treatment had better weight outcomes than those receiving usual care based on the difference in ...

4. sciencemediacentre.es sciencemediacentre.es/en/programs-focused-parents-are-insufficient-prevent-childhood-obesity-according-meta-analysis

Childhood obesity: family intervention is not enough Childhood obesity prevention programmes focused on parents show no impact; broader public health actions are needed, according to a study.

5. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-21120-5

The effectiveness of a 10-week family-focused e-Health ... Mixed ANOVA analysis confirmed that the web-based program decreased BMI z-score over 10 weeks compared with a lack of change in BMI z-score with ...

6. cdc.gov cdc.gov/obesity/family-action/index.html

Preventing Childhood Obesity: 6 Things Families Can Do Compared to children with healthy weight, children with obesity are at a higher risk for asthma, sleep apnea, bone and joint problems, type 2 ...