Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05107726 |
| Other study ID # |
PEDS-2021-30078 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 30, 2022 |
| Est. completion date |
September 13, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
University of Minnesota |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will test whether managing the hours during which people eat, called time
restricted eating, might help them to lose weight. For this study, one parent and a child
will enroll as a group (called a dyad).
The dyads will be assigned at random to practice time restricted eating (within 10-12 hours
per day) but will be able to eat whatever they would like or to limit portion size and
increase fruit, vegetable and lean protein intake and limit sugar sweetened beverages and
undergo . Both groups will receive dietary counseling, Bluetooth toothbrushes and scales to
help monitor their progress.
The study will last for 12 weeks and will have one survey four weeks after the last in person
visit. There will be 2 in person visits, 7 virtual visits, 2 phone visits and daily time
logs.
Description:
This study will provide preliminary data to demonstrate feasibility and acceptability of
time-restricted eating (TRE) in the family unit, providing critical preliminary data to
support NIH-level funding for a more detailed analysis of TRE in families.
Obesity affects over 40% of adults and over 25% of children in the United States. Obesity -
defined in adults as a body mass index (BMI) > 30 kg/m2 and in children as BMI > 95th
percentile - is associated with several physical and psychological comorbidities, such as
hypertension, heart disease, type 2 diabetes mellitus, and reduced quality of life.
Heritability of obesity is 40-75%. Thus, if a parent is obese, children in the family have a
high likelihood of also becoming obese due to both genetic and environmental factors. As
such, treatments that apply to the family unit can address the public health concern of
obesity at the child and adult level.
Typically, obesity treatment primarily focuses on intentional caloric restriction. In adults
with obesity, behavior-based weight loss programs result in weight reduction of 1-4 kg over
one year. In children with obesity, lifestyle modification therapy typically results in
weight stabilization, while children without treatment gain weight. Weight stabilization
results in reductions in body mass index parameters (e.g., percent BMI or BMI z-score) due to
increased height in children. Family-based obesity treatment also focuses on intentional
caloric restriction through reduced consumption of energy dense foods, as well as increased
consumption of low energy density foods, increased physical activity, and implementation of
strategic parenting practices. Parent BMI change is a significant predictor of child outcomes
in family-based treatment. Unfortunately, family-based interventions are typically time and
resource intensive, thus limiting their receptiveness by many families.
In contrast to intentionally restricting calories, time-restricted eating (TRE) intentionally
restricts the eating window while allowing ad libitum intake during the window. TRE's
agnostic approach to eating allows individuals to select foods that align with their needs
and preferences. Multiple studies in adults, including our own, demonstrate TRE reduces
weight. The postulated mechanism is that a reduced eating window reduces the number of eating
occasions to reduce daily caloric intake.
