Trial Outcomes & Findings for Piloting a Family-Based Intervention of Time-Restricted Eating to Treat Obesity (NCT NCT05107726)

NCT ID: NCT05107726

Last Updated: 2026-05-20

Results Overview

Change in baseline BMI (kg/m\^2) among pediatric participants.

Recruitment status

COMPLETED

Study phase

Target enrollment

36 participants

Primary outcome timeframe

Change from baseline to 12 weeks. Table contains CHILDREN only.

Results posted on

2026-05-20

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	20	16
Overall Study COMPLETED	20	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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).

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Change from baseline to 12 weeks. Table contains CHILDREN only.

Population: Results table contains CHILDREN only

Change in baseline BMI (kg/m\^2) among pediatric participants.

Outcome measures

Outcome measures
Measure	TRE Group n=10 Participants 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	Standard of Care Group n=8 Participants 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
Change in BMI for Pediatric Participants	-0.7 BMI (weight in kg/height in m^2) Standard Deviation 4.6	-0.9 BMI (weight in kg/height in m^2) Standard Deviation 1.4

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Change from baseline in BMI (kg/m\^2) among Adult participants. Results table contains PARENTS only.

Outcome measures

Outcome measures
Measure	TRE Group n=10 Participants 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	Standard of Care Group n=8 Participants 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
Change in Body Mass Index (BMI) in Adult Participants	0.4 BMI (weight in kg/height in m^2) Standard Deviation 1.1	-1.3 BMI (weight in kg/height in m^2) Standard Deviation 0.7

Adverse Events

TRE Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amy Gross

University of Minnesota

Phone: (612) 624-9865

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	TRE Group n=20 Participants 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	Standard of Care Group n=16 Participants 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	Total n=36 Participants Total of all reporting groups
Age, Continuous Age of Parent	37.777 years STANDARD_DEVIATION 6.924 • n=10 Participants • 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).	40.125 years STANDARD_DEVIATION 5.914 • n=8 Participants • 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).	38.882 years STANDARD_DEVIATION 6.382 • n=18 Participants • 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).
Age, Continuous Age of Child	7.4 years STANDARD_DEVIATION 1.577 • n=10 Participants • 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).	6.625 years STANDARD_DEVIATION 1.407 • n=8 Participants • 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).	7.055 years STANDARD_DEVIATION 1.513 • n=18 Participants • 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).
Sex: Female, Male Gender of Parent · Female	8 Participants n=10 Participants • This study enrolled parent/child dyads. The gender of the dyads were broken out by parent and child for each treatment group.	8 Participants n=8 Participants • This study enrolled parent/child dyads. The gender of the dyads were broken out by parent and child for each treatment group.	16 Participants n=18 Participants • This study enrolled parent/child dyads. The gender of the dyads were broken out by parent and child for each treatment group.
Sex: Female, Male Gender of Parent · Male	2 Participants n=10 Participants • This study enrolled parent/child dyads. The gender of the dyads were broken out by parent and child for each treatment group.	0 Participants n=8 Participants • This study enrolled parent/child dyads. The gender of the dyads were broken out by parent and child for each treatment group.	2 Participants n=18 Participants • This study enrolled parent/child dyads. The gender of the dyads were broken out by parent and child for each treatment group.
Sex: Female, Male Gender of Child · Female	6 Participants n=10 Participants • This study enrolled parent/child dyads. The gender of the dyads were broken out by parent and child for each treatment group.	4 Participants n=8 Participants • This study enrolled parent/child dyads. The gender of the dyads were broken out by parent and child for each treatment group.	10 Participants n=18 Participants • This study enrolled parent/child dyads. The gender of the dyads were broken out by parent and child for each treatment group.
Sex: Female, Male Gender of Child · Male	4 Participants n=10 Participants • This study enrolled parent/child dyads. The gender of the dyads were broken out by parent and child for each treatment group.	4 Participants n=8 Participants • This study enrolled parent/child dyads. The gender of the dyads were broken out by parent and child for each treatment group.	8 Participants n=18 Participants • This study enrolled parent/child dyads. The gender of the dyads were broken out by parent and child for each treatment group.
Ethnicity (NIH/OMB) Parent Ethnicity · Hispanic or Latino	2 Participants n=10 Participants • The population was broken out by parent and by child in the dyad and by treatment group	0 Participants n=8 Participants • The population was broken out by parent and by child in the dyad and by treatment group	2 Participants n=18 Participants • The population was broken out by parent and by child in the dyad and by treatment group
Ethnicity (NIH/OMB) Parent Ethnicity · Not Hispanic or Latino	8 Participants n=10 Participants • The population was broken out by parent and by child in the dyad and by treatment group	7 Participants n=8 Participants • The population was broken out by parent and by child in the dyad and by treatment group	15 Participants n=18 Participants • The population was broken out by parent and by child in the dyad and by treatment group
Ethnicity (NIH/OMB) Parent Ethnicity · Unknown or Not Reported	0 Participants n=10 Participants • The population was broken out by parent and by child in the dyad and by treatment group	1 Participants n=8 Participants • The population was broken out by parent and by child in the dyad and by treatment group	1 Participants n=18 Participants • The population was broken out by parent and by child in the dyad and by treatment group
Ethnicity (NIH/OMB) Child Ethnicity · Hispanic or Latino	4 Participants n=10 Participants • The population was broken out by parent and by child in the dyad and by treatment group	0 Participants n=8 Participants • The population was broken out by parent and by child in the dyad and by treatment group	4 Participants n=18 Participants • The population was broken out by parent and by child in the dyad and by treatment group
Ethnicity (NIH/OMB) Child Ethnicity · Not Hispanic or Latino	6 Participants n=10 Participants • The population was broken out by parent and by child in the dyad and by treatment group	7 Participants n=8 Participants • The population was broken out by parent and by child in the dyad and by treatment group	13 Participants n=18 Participants • The population was broken out by parent and by child in the dyad and by treatment group
Ethnicity (NIH/OMB) Child Ethnicity · Unknown or Not Reported	0 Participants n=10 Participants • The population was broken out by parent and by child in the dyad and by treatment group	1 Participants n=8 Participants • The population was broken out by parent and by child in the dyad and by treatment group	1 Participants n=18 Participants • The population was broken out by parent and by child in the dyad and by treatment group
Race (NIH/OMB) Race of Parent · American Indian or Alaska Native	0 Participants n=10 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	0 Participants n=8 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	0 Participants n=18 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.
Race (NIH/OMB) Race of Parent · Asian	1 Participants n=10 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	2 Participants n=8 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	3 Participants n=18 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.
Race (NIH/OMB) Race of Parent · Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	0 Participants n=8 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	0 Participants n=18 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.
Race (NIH/OMB) Race of Parent · Black or African American	1 Participants n=10 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	0 Participants n=8 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	1 Participants n=18 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.
Race (NIH/OMB) Race of Parent · White	8 Participants n=10 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	5 Participants n=8 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	13 Participants n=18 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.
Race (NIH/OMB) Race of Parent · More than one race	0 Participants n=10 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	0 Participants n=8 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	0 Participants n=18 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.
Race (NIH/OMB) Race of Parent · Unknown or Not Reported	0 Participants n=10 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	1 Participants n=8 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	1 Participants n=18 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.
Race (NIH/OMB) Race of Child · American Indian or Alaska Native	0 Participants n=10 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	0 Participants n=8 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	0 Participants n=18 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.
Race (NIH/OMB) Race of Child · Asian	1 Participants n=10 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	2 Participants n=8 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	3 Participants n=18 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.
Race (NIH/OMB) Race of Child · Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	0 Participants n=8 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	0 Participants n=18 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.
Race (NIH/OMB) Race of Child · Black or African American	1 Participants n=10 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	1 Participants n=8 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	2 Participants n=18 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.
Race (NIH/OMB) Race of Child · White	7 Participants n=10 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	3 Participants n=8 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	10 Participants n=18 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.
Race (NIH/OMB) Race of Child · More than one race	1 Participants n=10 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	0 Participants n=8 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	1 Participants n=18 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.
Race (NIH/OMB) Race of Child · Unknown or Not Reported	0 Participants n=10 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	2 Participants n=8 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.	2 Participants n=18 Participants • This study enrolled parent/child dyads. Ethnicity results are reported by parent group and child group.
Region of Enrollment United States	20 Participants n=20 Participants	16 Participants n=16 Participants	36 Participants n=36 Participants