An interventional study of TRE Group in Childhood Obesity, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment
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.
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.
1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.
This study's enrollment of 36 is below the median of 103 across 862 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In the TRE group, study staff will instruct the family unit on limiting the eating window to 10-12 hours per day, during which they can eat ad libitum. Notably, in the TRE group, participants (children and adults) will be instructed to brush their teeth with a WIFI-enabled toothbrush in the morning and specifically within ½ hour after their evening meal. This will serve as a cue to stop evening eating, and information from the WIFI-enabled toothbrush will be accessed by study staff to approximate the eating window. The adult from each family unit will receive a daily REDCap-administered email to indicate the timing of the first meal of the day and the last meal of the day for the parent and child, which will also serve as an estimate of the eating window.
Behavioral: TRE Group
The standard of care control group will receive dietary instruction that is based on a 1200-1500 calorie diet, as is typical of family-based interventions. Calorie counting will not be encouraged. However, families will be encouraged to follow appropriate portion sizes; increase vegetable, fruit and lean protein consumption; as well as decrease consumption of energy-dense but low-quality items (e.g., sugar sweetened beverages). Families in this group will also receive a WIFI-enabled toothbrush and daily REDCap surveys but will not be instructed on when to brush teeth or to shorten their eating window
This group will practice time-restricted eating
Change in BMI for Pediatric Participants
Change in baseline BMI (kg/m\^2) among pediatric participants.
Time frame: Change from baseline to 12 weeks. Table contains CHILDREN only.
Change in Body Mass Index (BMI) in Adult Participants
Change from baseline in BMI (kg/m\^2) among Adult participants. Results table contains PARENTS only.
Time frame: Baseline to 12 weeks
Recruitment letters were mailed to child participants within our health system based on an initial screening of eligibility of their electronic health record. This study also utilized recruitment flyers and posters that were posted in the community. Both the child participant and their parent participated in the study as a dyad. Results are posted by randomization group for each participant with the exception of the age, where results are broken down by the adult and child within each dyad.
| Milestone | TRE Group | Standard of Care Group |
|---|---|---|
| Started | 20 | 16 |
| Completed | 20 | 16 |
| Not completed | 0 | 0 |
Change in baseline BMI (kg/m\^2) among pediatric participants.
| BMI (weight in kg/height in m^2) | TRE Group | Standard of Care Group |
|---|---|---|
| Change in BMI for Pediatric Participants | -0.7 ± 4.6 | -0.9 ± 1.4 |
Change from baseline in BMI (kg/m\^2) among Adult participants. Results table contains PARENTS only.
| BMI (weight in kg/height in m^2) | TRE Group | Standard of Care Group |
|---|---|---|
| Change in Body Mass Index (BMI) in Adult Participants | 0.4 ± 1.1 | -1.3 ± 0.7 |
Collected over As this study was related to timed eating and tooth brushing habits, which are not greater than minimal risk, no adverse events or serious adverse events were monitored or assessed. All Cause mortality also was not monitored or assessed.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TRE Group | — | — | — |
| Standard of Care Group | — | — | — |
This study enrolled dyads consisting of one parent and one child. A total of 20 individuals were randomized to the TRE group (10 dyads) and 16 individuals were randomized to the standard of care group (8 dyads). All 36 participants had BMI calculations completed for the study.
| Age, Continuous(years) | TRE Group | Standard of Care Group | Total |
|---|---|---|---|
| Age of Parent | 37.777 ± 6.924 | 40.125 ± 5.914 | 38.882 ± 6.382 |
| Age of Child | 7.4 ± 1.577 | 6.625 ± 1.407 | 7.055 ± 1.513 |
| Sex: Female, Male(Participants) | TRE Group | Standard of Care Group | Total |
|---|---|---|---|
| Gender of Parent — Female | 8 | 8 | 16 |
| Gender of Parent — Male | 2 | 0 | 2 |
| Gender of Child — Female | 6 | 4 | 10 |
| Gender of Child — Male | 4 | 4 | 8 |
| Ethnicity (NIH/OMB)(Participants) | TRE Group | Standard of Care Group | Total |
|---|---|---|---|
| Parent Ethnicity — Hispanic or Latino | 2 | 0 | 2 |
| Parent Ethnicity — Not Hispanic or Latino | 8 | 7 | 15 |
| Parent Ethnicity — Unknown or Not Reported | 0 | 1 | 1 |
| Child Ethnicity — Hispanic or Latino | 4 | 0 | 4 |
| Child Ethnicity — Not Hispanic or Latino | 6 | 7 | 13 |
| Child Ethnicity — Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | TRE Group | Standard of Care Group | Total |
|---|---|---|---|
| Race of Parent — American Indian or Alaska Native | 0 | 0 | 0 |
| Race of Parent — Asian | 1 | 2 | 3 |
| Race of Parent — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Race of Parent — Black or African American | 1 | 0 | 1 |
| Race of Parent — White | 8 | 5 | 13 |
| Race of Parent — More than one race | 0 | 0 | 0 |
| Race of Parent — Unknown or Not Reported | 0 | 1 | 1 |
| Race of Child — American Indian or Alaska Native | 0 | 0 | 0 |
| Race of Child — Asian | 1 | 2 | 3 |
| Race of Child — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Race of Child — Black or African American | 1 | 1 | 2 |
| Race of Child — White | 7 | 3 | 10 |
| Race of Child — More than one race | 1 | 0 | 1 |
| Race of Child — Unknown or Not Reported | 0 | 2 | 2 |
| Region of Enrollment(Participants) | TRE Group | Standard of Care Group | Total |
|---|---|---|---|
| United States | 20 | 16 | 36 |
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