NCT05041855Active, not recruiting
Childhood Obesity Treatment Designed for Low Income and Hispanic Families
Family Inclusive Childhood Obesity Treatment Designed for Low Income and Hispanic Families
Source: ClinicalTrials.gov · Last updated 30 Mar 2025
Brief summary (registry, in English)
This study is a type-1 hybrid effectiveness-implementation RCT comparing a novel family-inclusive childhood obesity treatment program, the "Healthy Living Program" (HeLP), to a protocol that enhances usual primary care to deliver Recommended Treatment of Obesity in Primary Care (RTOP). Children with obesity and their families will be referred to the study by primary care providers and randomized to HeLP or RTOP. The clinical setting is a practice-based research network serving majority Hispanic and Medicaid-insured populations. The intensive phase and booster sessions of HeLP will take place at recreation centers located near the clinics and will be led by health educators employed by the clinics. Visits with primary care providers (PCPs) for HeLP maintenance or RTOP will occur at the clinics.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 554 (actual)
- First submitted
- 3 Sept 2021
- Start date
- 15 Nov 2021
- Primary completion date
- 31 May 2026
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Obesity
- NCT number
- NCT05041855
What you commit to
- Study type: Interventional
- Participants enrolled: 554
- From 15 Nov 2021 to the primary completion date, 31 May 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Child non-ambulatory, non-verbal, or diagnosed with a genetic syndrome associated with obesity.
- Children with severe depression on initial screening (CES-D \>/=40 or suicidal ideation) will be excluded and referred to psychiatric treatment and therapy.
- Children who have been diagnosed by PCP at time of initial screening with severe comorbidities of obesity, including:
- Type 2 diabetes
- Stage 2 hypertension
- Severe hyperlipidemia
- Severe obstructive sleep apnea will be excluded from the study and directed to the only Tertiary Care Childhood Obesity Treatment program in the state of Colorado: Lifestyle Medicine at Children's Hospital Colorado.
Other
- Parent without fluency in either Spanish or English
- Current participation in a clinically referred obesity treatment program
Who the study is looking for
- Child aged 2-16yrs
- With overweight or obesity (BMI \>85th percentile)
- Referred by PCP
- Primary Adult Caregiver
- Up to two siblings of any BMI status (if multiple siblings are available, enrollment goals stratified by age and BMI will be used to select siblings for enrollment.)
Age in the registry: 2 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Anschutz Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Colorado State University-College of Health and Human Sciences Coordinator of this site? Confirm its status | Fort Collins | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.