Healthy Lifestyle Program for Obesity Prevention in Hispanic Families

(HDHK Trial)

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Baylor College of Medicine

Must not be taking: Weight-affecting medications

Disqualifiers: Diabetes, Cardiovascular disease, Cognitive impairment, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests a program where Hispanic fathers and their children learn about healthy eating and exercise together. It targets overweight or obese Hispanic men who are father figures to children aged 5-11. The program aims to help families support each other in making healthier lifestyle choices.

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 data supports the effectiveness of the treatment Healthy Dads Healthy Kids for obesity prevention in Hispanic families?

The Healthy Dads Healthy Kids program, adapted for Hispanic families as Papás Saludables, Niños Saludables, has shown positive feedback from participants, with parents expressing enthusiasm for nutrition training and reporting improvements in family health habits. Additionally, similar family-based interventions have been effective in promoting healthy weight strategies and improving family engagement in physical activities, which are key components of obesity prevention. ^{1 2 3 4 5}

Is the Healthy Dads Healthy Kids program safe for participants?

The Healthy Dads Healthy Kids program has been tested in various communities and has shown positive outcomes in weight and lifestyle improvements for fathers and children, with high satisfaction and attendance levels, suggesting it is generally safe for participants. ^{1 6 7 8 9}

How is the Healthy Dads Healthy Kids treatment different from other obesity prevention treatments for Hispanic families?

The Healthy Dads Healthy Kids treatment is unique because it is a culturally adapted program specifically designed for Hispanic fathers and their children, focusing on improving family health through lifestyle changes. It emphasizes the role of fathers in promoting healthy habits and involves the whole family in activities and education, which is different from many other treatments that may not specifically target family dynamics or cultural aspects. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

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.

Father not passing the 2015 American College of Sports Medicine's exercise participation health screener and not providing medical clearance

Trial Timeline

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

Treatment Details

Interventions

• Healthy Dads Healthy Kids (Behavioral Intervention)

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.

Participant Groups

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

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Paul Klotman

Baylor College of Medicine

Chief Executive Officer since 2010

MD, PhD

James Versalovic

Baylor College of Medicine

Chief Medical Officer since 2020

MD from Baylor College of Medicine

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+

William Tong

San Diego State University

Chief Executive Officer since 2023

PhD in Chemistry from Iowa State University

Ramin Farzaneh-Far

San Diego State University

Chief Medical Officer since 2024

MD

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

Findings from Research

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-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 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 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-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 (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 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 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]

References

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

Papás Saludables, Niños Saludables: Perspectives From Hispanic Parents and Children in a Culturally Adapted Father-Focused Obesity Program. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Results of a Family-Based Intervention Promoting Healthy Weight Strategies in Overweight Hispanic Adolescents and Parents: An RCT. [2021]

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

Healthy families study: design of a childhood obesity prevention trial for Hispanic families. [2021]

4. Netherlands 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. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Randomized control trial of a childhood obesity prevention family-based program: "Abriendo Caminos" and effects on BMI. [2023]

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

Cultural adaptation of 'Healthy Dads, Healthy Kids' for Hispanic families: applying the ecological validity model. [2023]

7. England 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. [2022]

8. England 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. [2020]

9. England 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. [2023]