Childhood Obesity
Conditions
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
This group will practice time-restricted eating
Sponsors
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Change in BMI for Pediatric Participants | Change from baseline to 12 weeks. Table contains CHILDREN only. | Change in baseline BMI (kg/m\^2) among pediatric participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (BMI) in Adult Participants | Baseline to 12 weeks | Change from baseline in BMI (kg/m\^2) among Adult participants. Results table contains PARENTS only. |
Countries
United States
Contacts
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 type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |