Healthy Lifestyle Program for Obesity Prevention in Hispanic Families

(HDHK Trial)

Overseen By Teresia M O'Connor, MD, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Must not be taking: Weight-affecting medications

Disqualifiers: Diabetes, Cardiovascular disease, Cognitive impairment, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a program called "Healthy Dads Healthy Kids" to help Hispanic families prevent obesity by focusing on both fathers and their children. The goal is to assess the effectiveness of this culturally adapted lifestyle program in promoting healthier habits. Participants will either join the program or follow standard national health guidelines for healthy eating and physical activity. Suitable candidates include Hispanic or Latino fathers (or male role models) living in the Greater Houston Area, with a body mass index (BMI) between 25 and 40, who have a child aged 5-11. As an unphased trial, this study offers a unique opportunity to contribute to research that could help Hispanic families adopt healthier lifestyles.

Will I have to stop taking my current medications?

The trial requires that participants are not currently taking medications that can affect weight or might be affected by weight loss. If you are on such medications, you may need to stop taking them to participate.

What prior data suggests that the 'Healthy Dads Healthy Kids' program is safe for Hispanic families?

Research shows that the "Healthy Dads Healthy Kids" program has been well-received by past participants. Studies have found that fathers in this program experienced significant health benefits. For instance, one study reported that fathers lost an average of 2.9 kg over six months. In another study, 85% of the fathers greatly improved their health.

These studies reported no major safety issues or serious side effects, suggesting the program is generally safe. By focusing on lifestyle changes like diet and exercise instead of medication, it poses minimal health risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Healthy Dads Healthy Kids" program because it focuses on involving the whole family, particularly Hispanic fathers and their children, in a lifestyle behavioral approach. Unlike standard options that typically emphasize individual dietary changes and exercise routines, this program fosters a supportive family environment to promote healthy habits. By encouraging fathers to be role models for their children, the program aims to create lasting changes in behavior that could prevent obesity more effectively than traditional methods. This family-centered approach is what sets it apart and holds promise for more sustainable health improvements.

What evidence suggests that the 'Healthy Dads Healthy Kids' program is effective for obesity prevention in Hispanic families?

Research shows that the "Healthy Dads, Healthy Kids" program, which participants in this trial may receive, helps fathers lose weight and encourages healthier habits in both dads and their children. Studies have found that this program supports weight loss in fathers and promotes better eating and exercise habits in kids. Specifically, it has been specially adapted for Hispanic families and demonstrated meaningful results in past trials. By involving the whole family, especially fathers, it aims to address obesity while respecting cultural differences. These findings suggest the program can effectively help Hispanic families prevent obesity. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for Hispanic fathers or male role models (18-65 years old) and their children (5-11 years old), living in the Greater Houston Area, with a BMI between 25 and 40. They must be able to read/write in Spanish or English and pass a health screener. Exclusions include those with certain medical conditions like uncontrolled diabetes, cardiovascular disease without clearance, plans to move away soon, extreme BMI values, or current participation in other weight management programs.

Inclusion Criteria

Pass the 2015 American College of Sports Medicine's exercise participation health screener

My mother (if available) plays a significant role in my children's lives.

Self-identify as Hispanic or Latino

Exclusion Criteria

My child is not between 5 and 11 years old.

I am unwilling to wear a movement tracking device for 7 days at three different times.

My child has a condition that affects their classroom participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline data collection for enrolled families before randomization

1-2 weeks

Treatment

Participants engage in the 10-week group-based culturally adapted PSNS program

10 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up assessments at 4 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Healthy Dads Healthy Kids

Trial Overview 'Healthy Dads Healthy Kids' program is being tested against standard care control for obesity prevention among Hispanic families. The program targets fathers as primary participants to improve both their own and their children's health outcomes by promoting physical activity and healthy dietary intake.

How Is the Trial Designed?

Group I: Standard of care control Experimental Treatment 1 Intervention

National guidelines and recommendations for healthy eating, physical activity and weight loss.

Group II: Healthy Dads Healthy Kids Experimental Treatment 1 Intervention

A group-based lifestyle behavioral program for Hispanic fathers and children

Healthy Dads Healthy Kids is already approved in United Kingdom, United States for the following indications:

Approved in United Kingdom as Healthy Dads Healthy Kids UK for:

• Weight management in fathers and healthy eating and physical activity behaviors in children

Approved in United States as Healthy Dads Healthy Kids for:

• Obesity prevention in Hispanic fathers and children

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

YMCA of Greater Houston

Collaborator

Trials

1

Recruited

220+

TEXAS CHILDREN'S HEALTH PLAN

Collaborator

Trials

1

Recruited

220+

University of Newcastle, Australia

Collaborator

Trials

12

Recruited

6,100+

San Diego State University

Collaborator

Trials

182

Recruited

119,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The Healthy Dads Healthy Kids (HDHK) program, which targets fathers and their children for obesity intervention, received positive feedback from a Hispanic Family Panel, indicating strong agreement with its goals but suggesting a need for greater emphasis on parenting and reducing children's screen time.

Barriers to father engagement were identified, such as work schedules and concerns about child care, highlighting the need for cultural adaptations to the program that consider literacy levels and family dynamics in Hispanic communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cultural adaptation of 'Healthy Dads, Healthy Kids' for Hispanic families: applying the ecological validity model. O'Connor, TM., Perez, O., Beltran, A., et al.[2023]

The Healthy Families Study is a randomized controlled trial involving 272 Hispanic families with children aged 5-7, aimed at preventing excessive weight gain through a culturally-targeted behavioral intervention over 12 months.

The intervention focuses on promoting healthy eating, increasing physical activity, and reducing sedentary behavior, with the primary outcome being changes in children's body mass index, which could provide important insights into addressing childhood obesity in Hispanic communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy families study: design of a childhood obesity prevention trial for Hispanic families. Zoorob, R., Buchowski, MS., Beech, BM., et al.[2021]

The Papás Saludables, Niños Saludables (PSNS) program, a 10-week lifestyle intervention for Hispanic fathers and children, received positive feedback for its culturally relevant content on nutrition and physical activity, highlighting its effectiveness in improving father-child bonding.

Participants, including 26 fathers, 26 mothers, and 45 children, suggested extending the program duration, indicating a strong engagement and interest in continuing the lifestyle changes promoted by PSNS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Papás Saludables, Niños Saludables: Perspectives From Hispanic Parents and Children in a Culturally Adapted Father-Focused Obesity Program. Perez, O., Beltran, A., Isbell, T., et al.[2022]

The family-based intervention, Abriendo Caminos, led to a significant short-term reduction in BMI z-scores among Hispanic children, indicating its effectiveness in preventing unhealthy weight gain immediately after the program.

However, the benefits were not sustained at 6 months post-intervention, highlighting the need for ongoing support and strategies to maintain healthy behaviors over the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized control trial of a childhood obesity prevention family-based program: "Abriendo Caminos" and effects on BMI. Teran-Garcia, M., Hammons, AJ., Olvera, N., et al.[2023]

The 'Healthy Dads, Healthy Kids' program led to significant weight loss in fathers, with an average loss of 7.6 kg over 6 months, compared to no weight change in the control group, indicating its efficacy in promoting weight management.

The program also improved various health metrics in fathers, such as waist circumference, BMI, blood pressure, and physical activity, while positively influencing children's physical activity and dietary habits, highlighting the program's role in fostering healthier family dynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 'Healthy Dads, Healthy Kids' randomized controlled trial: efficacy of a healthy lifestyle program for overweight fathers and their children. Morgan, PJ., Lubans, DR., Callister, R., et al.[2022]

The Padres Preparados, Jóvenes Saludables program, designed to improve energy balance-related behaviors among low-income Latino fathers and adolescents, did not show significant improvements in dietary habits or weight status after 8 weeks of intervention with 147 father/adolescent dyads participating.

Despite the program's focus on experiential learning in nutrition and physical activity, the results indicate that further interventions targeting Latino fathers are necessary to effectively influence energy balance-related behaviors in their adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Padres Preparados, Jóvenes Saludables: intervention impact of a randomized controlled trial on Latino father and adolescent energy balance-related behaviors. Baltaci, A., Hurtado Choque, GA., Davey, C., et al.[2023]

The adaptation of the Familias Unidas intervention for obesity prevention in Hispanic adolescents involved input from experts and families, leading to a program that emphasizes improved family health, nutrition education, and physical activity engagement.

Pilot testing showed that parents were enthusiastic about hands-on nutrition training, and adolescents expressed a desire for more joint physical activities with their parents, highlighting the importance of family involvement in obesity prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Familias Unidas for Health and Wellness: Adapting an Evidence-Based Substance Use and Sexual Risk Behavior Intervention for Obesity Prevention in Hispanic Adolescents. St George, SM., Messiah, SE., Sardinas, KM., et al.[2023]

The family-level intervention aimed at reducing obesity in Hispanic adolescents did not show significant improvements in the adolescents' dietary intake or physical activity, indicating that the intervention may not be effective for this age group.

However, the intervention did lead to positive changes in parents' dietary habits and a reduction in their BMI, suggesting that while the adolescents did not benefit directly, the parents experienced some short-term health improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a Family-Based Intervention Promoting Healthy Weight Strategies in Overweight Hispanic Adolescents and Parents: An RCT. Prado, G., Fernandez, A., St George, SM., et al.[2021]

The Healthy Dads Healthy Kids (HDHK) program successfully reduced fathers' weight by an average of 3.6 kg, with this weight loss maintained over 12 months, demonstrating its efficacy in promoting healthier lifestyles among overweight fathers.

Improvements were also observed in children's BMI z-scores and lifestyle behaviors, indicating that the program positively impacted both fathers and their children, especially in low socioeconomic communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twelve-month outcomes of a father-child lifestyle intervention delivered by trained local facilitators in underserved communities: The Healthy Dads Healthy Kids dissemination trial. Morgan, PJ., Collins, CE., Lubans, DR., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7475092/

Feasibility of Targeting Hispanic Fathers and Children in ... Healthy Dads Healthy Kids was the first obesity prevention intervention targeting fathers and demonstrated weight loss among fathers and behavior change among ...

2. trialx.com trialx.com/clinical-trials/listings/252998/efficacy-trial-healthy-dads-healthy-kids-for-hispanic-fathers-and-children/

Efficacy Trial Healthy Dads, Healthy Kids for Hispanic ... This is an efficacy trial to assess a culturally adapted 'Healthy Dads Healthy Kids' for Hispanic families.

3. ijbnpa.biomedcentral.com ijbnpa.biomedcentral.com/articles/10.1186/s12966-020-00949-0

Cultural adaptation of 'Healthy Dads, Healthy Kids' for ... All trials demonstrated significant and clinically meaningful effects on fathers' weight loss, and fathers' and children's lifestyle behaviors [ ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3260407/

The 'Healthy Dads, Healthy Kids' community effectiveness trial The 'Healthy Dads, Healthy Kids' program was designed to help overweight fathers lose weight and positively influence the health behaviors of their children.

5. withpower.com withpower.com/trial/phase-dietary-intakes-3-2022-15f6a

Healthy Lifestyle Program for Obesity Prevention in Hispanic ... The Healthy Dads Healthy Kids program has been tested in various communities and has shown positive outcomes in weight and lifestyle improvements for fathers ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31826896/

Healthy Dads, Healthy Kids UK, a weight management ... Participants: Fathers with overweight or obesity and their children aged 4-11 years. Intervention: Participants were randomised in a 1:2 ratio ...

7. bmjopen.bmj.com bmjopen.bmj.com/content/9/12/e033534

Healthy Dads, Healthy Kids UK, a weight management ... Table 2 summarises fathers' weight change from baseline. The intervention group had a 2.9 kg (95% CI 0.6 to 5.1) reduction in weight at 6 months' follow-up.

8. hmri.org.au hmri.org.au/healthy-dads-healthy-kids-case-study/

Healthy Dads, Healthy Kids (Case Study) In the trial program of Healthy Dads Healthy Kids, fathers significantly improved their health profiles, and 85 per cent of fathers achieved a ...