Healthy Family Foundations for Obesity

(HFF Trial)

Overseen By Mark Feinberg, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Penn State University

Disqualifiers: Cancer, AIDS, Multiple sclerosis, 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: 10

825 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the Healthy Family Foundations treatment for obesity?

Research shows that family-based programs, like the Healthy Family Foundations, can help reduce obesity in children when there is high attendance and self-regulation from both children and parents. Successful outcomes are linked to active participation and support within the family. ^{1 2 3 4 5}

How is the Healthy Family Foundations treatment different from other obesity treatments?

The Healthy Family Foundations treatment is unique because it focuses on improving family functioning, such as communication and behavior control, to address childhood obesity. This approach is different from other treatments that may not consider the family's role in managing obesity. ^{4 6 7 8 9}

What is the purpose of this trial?

The goal of this clinical trial is to test whether an adaptation of an evidence-based, couple-based preventive intervention at the transition to parenthood improves reduces obesity risk among infants and parents in military families via improved interparental support and coordination around health lifestyle behaviors and parenting. The main question it aims to answer is whether an adapted, innovative family-focused approach to obesity prevention can reduce rapid infant weight gain, new mothers' postpartum weight retention, and fathers' weight status. Participants randomized to the Healthy Family Foundations (HFF) intervention condition will participate in 10 online group classes (5 prenatal and 5 postnatal). Participants randomized to the control condition will receive standard of care and opportunities for education at their site. Researchers will compare the Healthy Family Foundations (HFF) intervention group with a Standard of Care control group to see if there are differences in weight, coparenting support, parent mental health and parent health behaviors.

Research Team

Mark Feinberg, PhD

Principal Investigator

Penn State University

Eligibility Criteria

This trial is for two-parent military families where at least one parent is active duty and they are expecting their first child, up to the seventh month of pregnancy. It's designed to see if a special program can help prevent obesity in infants and parents by improving support between partners.

Inclusion Criteria

Two-parent military families (one or more parents are active duty military)

Expecting a first child, through 7 months gestation

Exclusion Criteria

I do not have cancer, AIDS, severe cognitive issues, or other listed conditions.

Families will be excluded if both parents do not participate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prenatal Classes

Participants in the HFF intervention condition attend 5 weekly prenatal online group classes

5 weeks

5 visits (virtual)

Postnatal Classes

Participants in the HFF intervention condition attend 5 weekly postnatal online group classes

5 weeks

5 visits (virtual)

Follow-up

Participants are monitored for weight status and other health outcomes

12 months

Treatment Details

Interventions

• Healthy Family Foundations
• Standard of Care

Trial Overview The study tests 'Healthy Family Foundations', a family-focused obesity prevention approach with online classes before and after birth, against standard care. The goal is to see if it affects infant weight gain, postpartum weight retention in mothers, fathers' weight status, coparenting support, mental health and health behaviors.

Participant Groups

Group I: Healthy Family Foundations Intervention Experimental Treatment 1 Intervention

Participants randomized to the HFF intervention condition will participate in 10 weekly 2 hour classes (5 prenatal and 5 postnatal) in groups of 5-10 couples. Due to COVID, all classes will take place via Zoom. The classes will be led by male/female facilitator teams. The facilitators will be hired, trained and supervised by Penn State. Postnatal classes will occur 2-8 months after birth and will also be weekly and last 2 hours each.

Group II: Control Condition Active Control 1 Intervention

Participants randomized to the control condition will receive standard of care and opportunities for education at their site, including information about infant growth and development, infant care (including brief, standard information regarding breastfeeding/introduction to solid food), and quality childcare selection.

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

Approved in United States as Family Foundations for:

• Preventing obesity risk among infants and parents
• Improving interparental support and coordination around health lifestyle behaviors and parenting

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

State University of New York at Buffalo

Collaborator

Trials

279

Recruited

52,600+

Findings from Research

In a study of 75 participants in the Building Healthy Families program, those who achieved the largest reductions in BMI z-scores had high attendance and self-regulation skills, particularly among both children and mothers.

Successful outcomes were linked to mothers achieving clinically meaningful weight loss and children maintaining high attendance rates, suggesting that both parental involvement and self-regulation are crucial for effective obesity treatment in families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative Comparative Analysis of Program and Participant Factors That Explain Success in a Micropolitan Pediatric Weight Management Intervention. Golden, CA., Heelan, KA., Hill, JL., 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]

The pilot program 'Shape Up and Eat Right' (SUPER) aimed at African-American families with obesity showed low attendance rates, averaging only 23.4%, indicating challenges in participant retention, likely due to socioeconomic barriers.

Despite low attendance, the program was rated positively by participants, and some positive changes were observed, such as reduced screen time for children and a significant decrease in salt intake post-intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shape-Up and Eat Right Families Pilot Program: Feasibility of a Weight Management Shared Medical Appointment Model in African-Americans With Obesity at an Urban Academic Medical Center. Srivastava, G., Palmer, KD., Ireland, KA., et al.[2022]

In a study involving 39 youths aged 8 to 18 with nonalcoholic fatty liver disease (NAFLD), family functioning was found to be significantly associated with higher body mass index (BMI) and elevated cholesterol, HbA1c, and glucose levels, indicating its impact on obesity-related health issues.

The findings suggest that screening for family functioning could be beneficial in treatment programs for NAFLD, as it may help identify families that would benefit from family-centered behavioral interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family Functioning Predicts Body Mass Index and Biochemical Levels of Youths with Nonalcoholic Fatty Liver Disease. Smith, JD., Montaño, Z., Maynard, A., et al.[2022]

Bariatric surgery patients who viewed their child as overweight or obese experienced more family dysfunction and less support for healthy eating and exercise habits compared to those who did not have this perception.

Single parents were more likely to perceive their children as overweight or obese and reported greater family dysfunction, indicating a need for targeted support to improve family dynamics and promote healthier behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived child weight status, family structure and functioning, and support for health behaviors in a sample of bariatric surgery patients. Pratt, KJ., Ferriby, M., Noria, S., et al.[2021]

A local scheme was implemented to support families at risk of childhood obesity by providing home visits from a specially trained health visitor, addressing a gap in training and confidence among health visitors.

The health visitor used a family partnership model, which empowers parents and caregivers to develop their own solutions for managing obesity, promoting a collaborative approach to health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health visitors tackle childhood obesity. Vassie, A.[2015]

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 conference highlighted that both childhood obesity and dental caries are influenced by excessive sugar consumption, emphasizing the need for awareness of sugar content in foods and beverages among health professionals and parents.

Oral health professionals play a crucial role in preventing childhood obesity by identifying at-risk children and providing education and referrals, linking oral health directly to overall childhood obesity prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introduction to proceedings of healthy futures: engaging the oral health community in childhood obesity prevention national conference. Tinanoff, N., Holt, K.[2018]

The systematic review of 21 studies found that poor family functioning is significantly associated with an increased risk of overweight and obesity in children and adolescents, highlighting the importance of family dynamics in addressing these health issues.

Intervention studies suggest that improving family functioning can lead to positive changes in child weight, indicating that family-based approaches may be effective in obesity prevention and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship between family functioning and child and adolescent overweight and obesity: a systematic review. Halliday, JA., Palma, CL., Mellor, D., et al.[2022]

References

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

Qualitative Comparative Analysis of Program and Participant Factors That Explain Success in a Micropolitan Pediatric Weight Management Intervention. [2022]

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. Switzerland pubmed.ncbi.nlm.nih.gov

Shape-Up and Eat Right Families Pilot Program: Feasibility of a Weight Management Shared Medical Appointment Model in African-Americans With Obesity at an Urban Academic Medical Center. [2022]

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

Family Functioning Predicts Body Mass Index and Biochemical Levels of Youths with Nonalcoholic Fatty Liver Disease. [2022]

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

Perceived child weight status, family structure and functioning, and support for health behaviors in a sample of bariatric surgery patients. [2021]

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

Health visitors tackle childhood obesity. [2015]

7. Germany pubmed.ncbi.nlm.nih.gov

Treatment of childhood obesity in obese families. [2020]

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

Introduction to proceedings of healthy futures: engaging the oral health community in childhood obesity prevention national conference. [2018]

9. England pubmed.ncbi.nlm.nih.gov

The relationship between family functioning and child and adolescent overweight and obesity: a systematic review. [2022]