Clinical trial NCT05107726: Family Based Time-Restricted Eating
Official title: Piloting a Family-Based Intervention of Time-Restricted Eating to Treat Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 43
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in body mass index (BMI)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota, Delaware Clinical Research Unit
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Amy Gross, PhD
role: PRINCIPAL_INVESTIGATOR
References: