Childhood Obesity Treatment Designed for Low Income and Hispanic Families (NCT05041855) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Childhood Obesity Treatment Designed for Low Income and Hispanic Families
United States554 participantsStarted 2021-11-15
Plain-language summary
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.
Who can participate
Age range
2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.)
Exclusion Criteria:
* Parent without fluency in either Spanish or English
* Current participation in a clinically referred obesity treatment program
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Body Mass Index (BMI) %95 in children with obesity (treatment)
Timeframe: From Baseline to Month 18
2
Change in Body Mass Index (BMI) %95 in healthy and overweight children (prevention)