Family Based Time-Restricted Eating

NCT05107726 | Completed

• 1 other identifier: PEDS-2021-30078
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (1)

• Change in body mass index (BMI)

  Change in body mass index from Screening to Week 12

  12 weeks

Study Arms (2)

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.

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

Interventions

TRE Group BEHAVIORAL

This group will practice time-restricted eating

TRE Group

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)
• + on Eating Disorder Survey

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota, Delaware Clinical Research Unit

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amy Gross, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 4, 2021
• Study Start: March 30, 2022
• Primary Completion: September 13, 2023
• Study Completion: September 13, 2023
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

US (1)