Health Program for Childhood Obesity

(HWB/SSB Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Lauren B Shomaker, PhD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Colorado State University

No Placebo Group

Trial Summary

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.

Treatment Details

Interventions

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

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+

Dr. Mark Brown

Colorado State University

Chief Medical Officer

MD from Georgetown University School of Medicine

John Wyckoff

Colorado State University

Chief Executive Officer since 2017

Ph.D. in Veterinary Parasitology and Immunology from the University of Florida

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+

Aviva Abosch

University of Colorado, Denver

Chief Medical Officer since 2019

MD

Uday B. Kompella

University of Colorado, Denver

Chief Executive Officer since 2015

PhD in Pharmaceutical Sciences

United States Department of Agriculture (USDA)

Collaborator

Trials

103

Recruited

287,000+

Brooke Rollins

United States Department of Agriculture (USDA)

Chief Executive Officer

Bachelor's degree in Agricultural Economics from Texas A&M University

Dr. Martin Makary

United States Department of Agriculture (USDA)

Chief Medical Officer

MD from Harvard Medical School