Skip to content

Piloting a Family-Based Intervention of Time-Restricted Eating to Treat Obesity

Piloting a Family-Based Intervention of Time-Restricted Eating to Treat Obesity

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05107726
Enrollment
36
Registered
2021-11-04
Start date
2022-03-30
Completion date
2023-09-13
Last updated
2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity

Brief 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.

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.

Interventions

BEHAVIORALTRE Group

This group will practice time-restricted eating

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in BMI for Pediatric ParticipantsChange from baseline to 12 weeks. Table contains CHILDREN only.Change in baseline BMI (kg/m\^2) among pediatric participants.

Secondary

MeasureTime frameDescription
Change in Body Mass Index (BMI) in Adult ParticipantsBaseline to 12 weeksChange from baseline in BMI (kg/m\^2) among Adult participants. Results table contains PARENTS only.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAmy Gross, PhD

University of Minnesota

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Baseline characteristics

Characteristic
Age, Continuous
Age of Child
7.055 years
STANDARD_DEVIATION 1.513
Age, Continuous
Age of Parent
38.882 years
STANDARD_DEVIATION 6.382
Ethnicity (NIH/OMB)
Child Ethnicity
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Child Ethnicity
Not Hispanic or Latino
6 Participants
Ethnicity (NIH/OMB)
Child Ethnicity
Unknown or Not Reported
0 Participants
Ethnicity (NIH/OMB)
Parent Ethnicity
Hispanic or Latino
2 Participants
Ethnicity (NIH/OMB)
Parent Ethnicity
Not Hispanic or Latino
7 Participants
Ethnicity (NIH/OMB)
Parent Ethnicity
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
Race of Child
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Race of Child
Asian
3 Participants
Race (NIH/OMB)
Race of Child
Black or African American
1 Participants
Race (NIH/OMB)
Race of Child
More than one race
1 Participants
Race (NIH/OMB)
Race of Child
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Race of Child
Unknown or Not Reported
2 Participants
Race (NIH/OMB)
Race of Child
White
10 Participants
Race (NIH/OMB)
Race of Parent
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Race of Parent
Asian
3 Participants
Race (NIH/OMB)
Race of Parent
Black or African American
1 Participants
Race (NIH/OMB)
Race of Parent
More than one race
0 Participants
Race (NIH/OMB)
Race of Parent
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Race of Parent
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
Race of Parent
White
13 Participants
Region of Enrollment
United States
36 Participants
Sex: Female, Male
Gender of Child
Female
6 Participants
Sex: Female, Male
Gender of Child
Male
4 Participants
Sex: Female, Male
Gender of Parent
Female
8 Participants
Sex: Female, Male
Gender of Parent
Male
2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026