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

Trial Summary

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 data supports the effectiveness of the treatment Health Without Barriers/Salud Sin Barreras (HWB/SSB) for childhood obesity?

Research shows that community-based, multi-component programs, like the Stanford GOALS trial, can help reduce weight gain in children with obesity. These programs often involve family and community support, which are key elements in the HWB/SSB treatment. ^{1 2 3 4 5}

What makes the Health Without Barriers/Salud Sin Barreras (HWB/SSB) treatment unique for childhood obesity?

The Health Without Barriers/Salud Sin Barreras (HWB/SSB) treatment is unique because it likely involves community health workers (CHWs) to deliver culturally and linguistically appropriate interventions, focusing on family behaviors to promote a healthy lifestyle, which is particularly beneficial for vulnerable populations who may not have access to traditional healthcare services. ^{2 6 7 8 9}

What is the purpose of this trial?

The overarching goal of this work is to address the limited access to evidence-based health behavior and lifestyle interventions for youth and families most impacted by preventable chronic diseases, including obesity and type 2 diabetes. In the current project, we implement a small single-arm pilot and feasibility trial of Health Without Barriers/Salud Sin Barreras (HWB/SSB), a culturally-adapted, whole-family intensive health behavior and lifestyle intervention to 11-19-year-old adolescents and their families living in Northern Colorado. Objectives are refining the HWB/SSB community facilitator training, evaluating the feasibility and acceptability of HWB/SSB implementation, and characterizing changes in health outcomes among adolescent participants.

Research Team

Lauren B Shomaker, PhD

Principal Investigator

Colorado State University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States 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. [2022]

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

Results From La Vida Buena (The Good Life): A Quasi-Experimental Intervention of a Community Health Worker-Led Family-Based Childhood Obesity Program for Latino Children 5-8 Years of Age on the U.S.-Mexico Border. [2023]

3. England pubmed.ncbi.nlm.nih.gov

A community-based, multi-level, multi-setting, multi-component intervention to reduce weight gain among low socioeconomic status Latinx children with overweight or obesity: The Stanford GOALS randomised controlled trial. [2022]

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

The Implementation and Five-Year Evolution of a Childhood Healthy Weight Program: Making a Health Care-Community Partnership Work. [2021]

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

Treating Children and Adolescents With Obesity: Characteristics of Success. [2023]

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

Social and Health Risk Factor Levels of Preschool Children Living Along the Texas-Mexico Border. [2020]

7. England pubmed.ncbi.nlm.nih.gov

La Vida Buena (The Good Life) evaluation: a quasi experimental intervention of a community health worker-led family-based childhood obesity program for Latino children 5-8 years of age on the US-Mexico border. [2021]

8. Mexico pubmed.ncbi.nlm.nih.gov

Interventions for the treatment of obesity among children and adolescents in Latin America: a systematic review. [2021]

9. Spain pubmed.ncbi.nlm.nih.gov

THAO-CHILD HEALTH PROGRAMME: COMMUNITY BASED INTERVENTION FOR HEALTHY LIFESTYLES PROMOTION TO CHILDREN AND FAMILIES: RESULTS OF A COHORT STUDY. [2021]