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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRE Group | Experimental | 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. |
|
| Standard of Care Group | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRE Group | Behavioral | This group will practice time-restricted eating |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in BMI for Pediatric Participants | Change in baseline BMI (kg/m^2) among pediatric participants. | Change from baseline to 12 weeks. Table contains CHILDREN only. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Gross, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota, Delaware Clinical Research Unit | Minneapolis | Minnesota | 55414 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41857344 | Derived | Gross AC, Helgeson ES, Wang Q, Chow LS. Pilot Randomised Controlled Trial of the Feasibility and Acceptability of Family-Based Time Limited Eating to Treat Obesity. Pediatr Obes. 2026 Mar;21(3):e70103. doi: 10.1111/ijpo.70103. |
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Participants were screened and consent was discussed and obtained electronically. Participants were then contacted by the University of Minnesota Nutrition Coordinating Center (NCC) for the first of three 24-hour dietary recalls before the randomization to the time restricted eating (TRE) group or standard of care group.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | TRE Group | 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. TRE Group: This group will practice time-restricted eating |
| FG001 | Standard of Care 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | TRE Group | 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. TRE Group: This group will practice time-restricted eating |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The age at screening was collected for each parent and child in the dyad. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in BMI for Pediatric Participants | Change in baseline BMI (kg/m^2) among pediatric participants. | Results table contains CHILDREN only | Posted | Mean | Standard Deviation | BMI (weight in kg/height in m^2) | Change from baseline to 12 weeks. Table contains CHILDREN only. |
|
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.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TRE Group | 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. TRE Group: This group will practice time-restricted eating |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Gross | University of Minnesota | (612) 624-9865 | acgross@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 7, 2022 | Nov 21, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 12, 2022 | Nov 21, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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A total of 20 dyads will be enrolled in this study. A dyad will consist of a parent and a child. Dyads will be randomized to one of two treatment groups: the time restricted eating (TRE) group or standard of care control group.
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| BG001 | Standard of Care 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 |
| BG002 | Total | Total of all reporting groups |
This study enrolled parent/child dyads. For this reason, the TRE Group had 20 total participants (10 parents and 10 children) and the Standard of Care Group had 16 total participants (8 parents and 8 children).
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | This study enrolled parent/child dyads. The gender of the dyads were broken out by parent and child for each treatment group. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity was collected for each parent and child via survey at the screening visit. | The population was broken out by parent and by child in the dyad and by treatment group | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race was collected at the screening visit from each parent and child in the dyad based on the NIH definitions. | This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group. | Count of Participants | Participants |
|
| Region of Enrollment | All participants (the parent/child dyads) were recruited from the United States. | Count of Participants | Participants |
|
| OG001 | Standard of Care 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 |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | BMI (weight in kg/height in m^2) | Baseline to 12 weeks |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Standard of Care 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 | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|