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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial compares the effects of parent/caregiver-focused programs to family-focused programs in reducing obesity risk in racial ethnic minority families. Obesity tends to run in families, thus family-based interventions have been strongly recommended. Parent and family obesity programs may reduce obesity risk and ultimately reduce the risk of obesity-related cancer.

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 effectiveness of the Parent and Family Obesity Intervention treatment for obesity?

Family-based approaches, where parents are actively involved in the treatment, have been shown to be more effective in reducing childhood obesity compared to programs targeting only children. These interventions also tend to have lower dropout rates, indicating better engagement and potential success. ^{1 2 3 4 5}

Is the Family Obesity Intervention safe for humans?

The research articles do not provide specific safety data for the Family Obesity Intervention, but they focus on family-based approaches to managing childhood obesity, which generally involve behavioral and lifestyle changes rather than medical treatments, suggesting a low risk of harm. ^{1 4 6 7 8}

How does the Parent and Family Obesity Intervention treatment differ from other obesity treatments?

The Parent and Family Obesity Intervention is unique because it involves the entire family, focusing on changing family dynamics and behaviors to support weight loss, rather than just targeting the individual. This approach recognizes the influence of the family environment and parental involvement in achieving long-term success in managing obesity. ^{1 2 6 9 10}

Research Team

Lorna McNeill

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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©) intervention for managing pediatric obesity. Ball, GD., Mushquash, AR., Keaschuk, RA., 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 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]

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 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Treatment of childhood obesity in obese families. [2020]

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

Family-based interventions for pediatric obesity: methodological and conceptual challenges from family psychology. [2006]

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

Impact of treatment for childhood obesity on parental risk factors for cardiovascular disease. [2016]

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

Using Intervention Mapping to develop the Parents as Agents of Change (PAC&#169;) intervention for managing pediatric obesity. [2022]

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

Intervention for childhood obesity based on parents only or parents and child compared with follow-up alone. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Prevention of childhood obesity: recruiting strategies via local paediatricians and study protocol for a telephone-based counselling programme. [2015]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Randomized controlled comparison of two cognitive behavioral therapies for obese children: mother versus mother-child cognitive behavioral therapy. [2018]

9. England 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. [2022]

10. England pubmed.ncbi.nlm.nih.gov

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