Families Becoming Healthy Together (NCT04027426) | Clinical Trial Compass
CompletedNot Applicable
Families Becoming Healthy Together
United States83 participantsStarted 2019-10-29
Plain-language summary
The investigators plan to implement a novel limited RED (high-energy-dense) food variety prescription within a 18-month FBT to examine its effect on 18-month body mass index (BMI). This will be the first randomized control trial to examine how habituation rate, assessed via salivary habituation, mediates reduction in RED food intake, overall energy intake, and reductions in BMI over time, as well as if baseline habituation rate is a behavioral phenotype that moderates BMI outcomes. One hundred fifty-six children aged 8 to 12 years at \> 85th percentile BMI will be randomized to one of two, 18-month interventions compared in our 6-month pilot study: FBT (family-based behavioral obesity treatment) or FBT+Variety. Child and adult caregiver assessments will occur at 0, 6, 12, and 18 months on anthropometrics, dietary intake (RED food variety, energy, and diet quality), habituation, and physical activity.
Who can participate
Age range
8 Years – 12 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:
* age between 8 and 12 years
* \> 85th percentile BMI
* one adult caregiver (\> 18 years) living in the household with a BMI \> 25 kg/m2 willing to attend treatment meetings
Exclusion Criteria:
* child and adult caregiver report living in two separate households for \> 2 days per week
* child or adult caregiver report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q) (individuals reporting joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate)
* child or adult caregiver report being unable to walk for 2 blocks (1/4 mile) without stopping
* child or adult caregiver report major psychiatric diseases or organic brain syndromes
* child or adult caregiver report currently participating in a weight loss program and/or taking weight loss or appetite regulation medication or lost \> 5% of body weight during the past 6 months
* child report having bariatric surgery for weight loss/planning to have bariatric surgery in the next 18 months, adult caregiver having bariatric surgery in the previous two years or planning to have bariatric surgery in the next 18 months
* adult caregiver reports being pregnant, lactating, less than 6 months post-partum or plans to become pregnant in the next 18 months
* child or adult caregiver report planning to move outside o…
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.
1This trial looked at both child and adult BMI together — does that mean it's designed around the whole family making changes at once, and would that kind of family-based approach make sense for us given our household situation?
2The trial measured something called 'salivary habituation' in both kids and adults — can you explain what that is and why it matters for managing obesity, so I understand what this study was actually trying to learn?
3Since this trial is listed as 'Phase NA,' it sounds like it may be more of a behavioral or lifestyle research study rather than a drug trial — does that change the kinds of risks involved, and what would participation have actually required from families?
4This trial has already been completed — does that mean the results are available, and if so, do they show anything that might be relevant to the approach you'd recommend for managing my child's or my own weight?
5Are there currently open studies or evidence-based family programs similar to this one that we could actually participate in, or would standard care be a better starting point right now?
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.