Childhood ObesityNCT05107726
Piloting a Family-Based Intervention of Time-Restricted Eating to Treat Obesity
A study testing TRE Group in people with Childhood Obesity, run by University of Minnesota at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- TRE Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2022to 13 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- BMI >/= 30 kg/m2 for the parent
- BMI > 95th percentile for the child
- Age 3-9 years for the child
- Age >/= 18 years old for the parent
Who cannot join
- Concurrent participation in another weight loss study
- Taking any medications for weight loss
- Pregnancy or anticipation of pregnancy in next 6 months (for the parent)
- 3+ on Eating Disorder Survey
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota, Delaware Clinical Research Unit
Minneapolis, Minnesota, 55414
About this study
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.
Read the detailed 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.
- Conditions
- Childhood Obesity
- Being tested
- TRE Group
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRE GroupBehavioural
This group will practice time-restricted eating
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: TRE Group |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI for Pediatric Participants
Change in baseline BMI (kg/m^2) among pediatric participants.
Measured: Change from baseline to 12 weeks. Table contains CHILDREN only.
Secondary outcomes (1)
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.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start30 Mar 2022
- Primary completion13 Sep 2023
- Study completion13 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Gross, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107726
- Sponsor's protocol ID
- PEDS-2021-30078
- Status last verified
- Apr 2026
- First submitted
- 25 Oct 2021
- Last updated
- 20 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41857344
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting a Family-Based Intervention of Time-Restricted Eating to Treat Obesity
- ClinicalTrials.gov ID
- NCT05107726
- Acronym / sponsor ID
- PEDS-2021-30078
- Conditions
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 4 Nov 2021 (actual)
- Results
- Posted 20 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| TRE Group | Experimental | Behavioral: TRE GroupIn 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 |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- BMI >/= 30 kg/m2 for the parent
- BMI > 95th percentile for the child
- Age 3-9 years for the child
- Age >/= 18 years old for the parent
Key exclusion criteria (4 listed)
- Concurrent participation in another weight loss study
- Taking any medications for weight loss
- Pregnancy or anticipation of pregnancy in next 6 months (for the parent)
- 3+ on Eating Disorder Survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRE GroupThis group will practice time-restricted eating | Behavioural | TRE Group |
Primary outcome
Change in BMI for Pediatric Participants
Time frame: Change from baseline to 12 weeks. Table contains CHILDREN only.
Change in baseline BMI (kg/m^2) among pediatric participants.
1 secondary outcome
Change in Body Mass Index (BMI) in Adult Participants
Time frame: Baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41857344Gross 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Gross, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRE Group in people with Childhood Obesity, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMI for Pediatric Participants (time frame: Change from baseline to 12 weeks. Table contains CHILDREN only.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05107726, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.