Health Program for Childhood Obesity

(HWB/SSB Trial)

Overseen By Natalia Sanchez, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Colorado State University

Must not be taking: Drugs, Alcohol

Disqualifiers: Severe emotional-behavioral disturbance, others

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

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Health Without Barriers/Salud Sin Barreras (HWB/SSB), designed to help families adopt healthier lifestyles. The goal is to determine if this program can reduce the risk of chronic diseases like type 2 diabetes in adolescents and their families. Adolescents aged 11-19 and their families living in Northern Colorado, particularly those facing obesity-related issues, may be well-suited for this trial. The program involves the entire family and is delivered in the community, focusing on healthy behaviors and stress management. As an unphased trial, this study offers families the chance to participate in innovative research that could enhance their health and well-being.

Do I need to stop my current medications to join the trial?

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 prior data suggests that this health program is safe for adolescents and their families?

Research has shown that the Health Without Barriers/Salud Sin Barreras (HWB/SSB) program is based on a family-focused lifestyle plan called the Healthy Living Program (HeLP). These programs aim to promote healthy habits and help manage stress. Since the trial focuses on lifestyle and behavior changes, it is generally safe because it doesn't involve new medications or medical procedures.

Previous studies have found that similar health programs are well-received. They improve health through education and lifestyle changes instead of medical treatments, resulting in a very low risk of unwanted side effects. The goal is to encourage healthier habits and lower the risk of chronic diseases like obesity and type 2 diabetes.

Overall, the program is designed to be safe and supportive for families, helping them make positive changes without the risk of harmful effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Health Without Barriers/Salud Sin Barreras (HWB/SSB) program because it takes a holistic, family-centered approach to tackling childhood obesity. Unlike many standard treatments that focus solely on the child, HWB/SSB involves the entire family, including siblings and other caregivers, which can foster a supportive environment for lasting lifestyle changes. Additionally, this program emphasizes cultural tailoring, making it particularly relevant for families in Southwest Colorado, which can lead to better engagement and outcomes. The focus on healthy stress management alongside promoting healthy behaviors also sets it apart, as it addresses both physical and mental aspects of health.

What evidence suggests that the Health Without Barriers/Salud Sin Barreras (HWB/SSB) program is effective for childhood obesity?

Research has shown that reducing sugary drink consumption can help prevent excessive weight gain and obesity in children. A clear link exists between consuming these beverages and becoming overweight. Participants in this trial will experience the Health Without Barriers/Salud Sin Barreras (HWB/SSB) program, which encourages families to make healthier choices, particularly by reducing sugary drink intake. Based on the Healthy Living Program, this initiative aims to involve the entire family in developing lasting healthy habits and managing stress. Although specific data on HWB/SSB is still being collected, its strategies are supported by strong evidence that lifestyle changes improve children's health. ^{1 2 6 7 8}

Who Is on the Research Team?

Lauren B Shomaker, PhD

Principal Investigator

Colorado State University

Are You a Good Fit for This Trial?

This trial is for adolescents aged 11-19 and their families in Northern Colorado who are affected by chronic diseases like obesity and type 2 diabetes. It aims to improve health behaviors and lifestyles, focusing on those with limited access to such interventions.

Inclusion Criteria

I am between 11-19 years old and live in or near Larimer or Weld County.

I am over 18, a parent of a teen (11-19), and live in or near Larimer/Weld County.

I am 18 or older, live in Larimer/Weld County or nearby, and plan to or have led HWB activities.

Exclusion Criteria

Parents/guardians with a medical and/or psychological/behavioral condition that could interfere with safety for themselves or others or interfere with the capability of their family or other participating families to potentially benefit from the program

I do not have a condition that could risk safety or hinder benefits from the program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-session community-delivered, whole-family intensive health behavior and lifestyle intervention over 6 weeks

6 weeks

12 sessions (in-person)

Follow-up

Participants are monitored for changes in psychological, health behavior, and health-related outcomes up to 1 year after HWB/SSB participation

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Health Without Barriers/Salud Sin Barreras (HWB/SSB)

Trial Overview

The Health Without Barriers/Salud Sin Barreras program being tested includes mindfulness-based activities, a preschool curriculum, nutrition/cooking education, parent education sessions, and physical activity programs designed for whole-family participation.

How Is the Trial Designed?

Group I: Health without Barriers/ Salud Sin Barreras (HWB/SSB) Experimental Treatment 6 Interventions

HWB/SSB is a community-delivered, whole-family intensive health behavior and lifestyle intervention intended to reduce adolescent risk of chronic diseases (i.e., T2D) through promoting health behaviors and healthy stress management. The program is based on a lifestyle intervention called the Healthy Living Program (HeLP), a family-centered obesity prevention and treatment program for children. Previous and ongoing work has focused on tailoring HWB/SSB implementation to ensure cultural suitability for adolescents and their families in Southwest Colorado. HWB/SSB emphasizes "whole family" involvement including the participation of siblings, elders, other caregivers, and relatives. HWB/SSB is delivered. The HWB/SSB intervention delivery is not considered human subjects research; only the evaluation, dissemination, and implementation elements are considered research. The intervention will be delivered regardless of any research activity.

Who Is Running the Clinical Trial?

Colorado State University

Lead Sponsor

Trials

138

Recruited

38,200+

Colorado State University Extension-Larimer County

Collaborator

Trials

1

Recruited

140+

Colorado State University Extension-La Plata County

Collaborator

Trials

2

Recruited

320+

National Institutes of Food and Agriculture

Collaborator

Trials

1

Recruited

140+

Colorado State University Extension-Weld County

Collaborator

Trials

1

Recruited

140+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

United States Department of Agriculture (USDA)

Collaborator

Trials

103

Recruited

287,000+

Published Research Related to This Trial

A 5-year collaborative program to combat childhood obesity successfully enrolled 832 out of 2746 referred children, with 392 completing the program, demonstrating effective community engagement and accessibility.

Participants who completed the program showed significant health improvements, including a reduction in BMI and increased cardiovascular endurance, indicating the program's efficacy in promoting healthier lifestyles among children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Implementation and Five-Year Evolution of a Childhood Healthy Weight Program: Making a Health Care-Community Partnership Work. Barlow, SE., Lorenzi, A., Reid, A., et al.[2021]

The Stanford GOALS trial is a three-year randomized controlled study involving overweight and obese children aged 7 to 11 from low-income Latino neighborhoods, testing a comprehensive intervention aimed at reducing body mass index (BMI) and improving health outcomes.

The intervention includes a combination of community sports programs, family-based strategies to improve diet and reduce screen time, and primary care counseling, making it a multi-faceted approach to tackle childhood obesity in a targeted population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family, community and clinic collaboration to treat overweight and obese children: Stanford GOALS-A randomized controlled trial of a three-year, multi-component, multi-level, multi-setting intervention. Robinson, TN., Matheson, D., Desai, M., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4529053/

Sugar-Sweetened Beverages and Obesity among Children ...

Conclusions: The majority of reviews concluded that there was a direct association between SSB consumption and weight gain, overweight, and obesity in children ...

2.

aging.networkofcare.org

aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials?keyword=%22Family%20Research%22

San Mateo Clinical Trials

Health Without Barriers/Salud Sin Barreras. Status: Recruiting Gender: Age: -. The goal of this study is to address a key health inequity - lack of community ...

3.

researchgate.net

researchgate.net/publication/264460961_Systematic_review_of_the_evidence_for_an_association_between_sugar-sweetened_beverage_consumption_and_risk_of_obesity

Systematic review of the evidence for an association ...

A systematic review of the evidence for an association between sugar-sweetened beverages and risk of obesity was conducted.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9221582/

Sugar-Sweetened Beverage Taxes and Population Health ...

The study by Gračner, Marquez-Padilla, and Hernandez-Cortes is the first to our knowledge to examine associations between an SSB tax and weight-related outcomes ...

5.

who.int

who.int/tools/elena/interventions/ssbs-childhood-obesity

Reducing consumption of sugar-sweetened beverages to ...

Current evidence suggests that increasing consumption of sugar-sweetened beverages is associated with overweight and obesity in children.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9918944/

Sugar-Sweetened Beverages and Metabolic Risk in Children ...

Data suggest that SSB intake has a negative effect on weight and obesity-related diseases. The leading mechanism linking SSB intake to the risk of gaining ...

7.

cdc.gov

cdc.gov/pcd/issues/2024/23_0354.htm

Factors Associated with Sugar-Sweetened Beverage ...

Increased consumption of SSBs is associated with adverse health outcomes in children and adults, including increased risk for obesity, type ...

8.

who.int

who.int/europe/publications/i/item/2024-10998-50770-76930

Policy brief on the association between sugar-sweetened ...

This policy brief emphasizes the multi-faceted health consequences of childhood obesity, including an increased risk of noncommunicable diseases ...