Piloting a Family-Based Intervention of Time-Restricted Eating to Treat Obesity
Phase: NA
Conditions: Childhood Obesity
Sponsor: University of Minnesota

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Piloting a Family-Based Intervention of Time-Restricted Eating to Treat 
Obesity 
 
VERSION DATE: 07Sep2022 
 
Page 1 of 26 
Template Revised On: 03/31/2021 
 
 
ANCILLARY REVIEWS 
DO NOT DELETE.  Submit the completed checklist below with your protocol. 
Which ancillary reviews do I need and when do I need them? 
Refer to HRP-309 for more information about these ancillary reviews. 
Select yes or 
no 
Does your study… 
If yes… 
Impact on 
IRB Review 
☐ Yes 
x No 
 
Include Gillette resources, staff 
or locations 
Gillette Scientific review and Gillette 
Research Administration approval is 
required.  Contact: 
research@gillettechildrens.com   
Required 
prior to IRB 
submission 
x Yes 
☐ No 
Involve Epic, or Fairview 
patients, staff, locations, or 
resources? 
The Fairview ancillary review will be 
assigned to your study by IRB staff 
Contact: ancillaryreview@Fairview.org 
Approval 
must be 
received 
prior to IRB 
committee/ 
designated 
review.   
 
Consider 
seeking 
approval 
prior to IRB 
submission. 
☐ Yes 
x No 
Include evaluation of drugs, 
devices, biologics, tobacco, or 
dietary supplements or data 
subject to FDA inspection? 
The regulatory ancillary review will be 
assigned to your study by IRB staff 
Contact: medreg@umn.edu  
 
See: 
https://policy.umn.edu/research/indide  
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Require Scientific Review? Not 
sure?  See guidance in the 
Investigator Manual (HRP-
103). 
 
Documentation of scientific merit must 
be provided.   
Contact: hrpp@umn.edu  
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Relate to cancer patients, 
cancer treatments, cancer 
screening/prevention, or 
tobacco? 
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radiopharmaceuticals, external 
beam or brachytherapy) 
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must be 
received 
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approval;  
 
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groups 
each have 
their own 
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Resonance Research (CMRR) 
as a study location? 
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review  
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Include the use of 
recombinant or synthetic 
nucleic acids, toxins, or 
infectious agents? 
Complete the IBC application via 
eprotocol.umn.edu 
 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Piloting a Family-Based Intervention of Time-Restricted Eating to Treat 
Obesity 
 
VERSION DATE: 07Sep2022 
 
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☐ Yes 
x No 
Include the use of human fetal 
tissue, human embryos, or 
embryonic stem cells? 
Contact OBAO for submission 
instructions and guidance 
application 
process.  
x Yes 
☐ No 
Include PHI or are you 
requesting a HIPAA waiver? 
If yes, HIPCO will conduct a review of 
this protocol. 
Contact: privacy@umn.edu  
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Use data from the Information 
Exchange (IE)? 
The Information Exchange ancillary 
review will be assigned to your study by 
IRB staff 
Contact: ics@umn.edu  
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must be 
received 
prior to IRB 
approval. 
 
These 
groups do 
not have a 
separate 
application 
process but 
additional 
information 
from the 
study team 
may be 
required. 
 
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Use the Biorepository and 
Laboratory Services to collect 
tissue for research? 
The BLS ancillary review will be 
assigned to your study by IRB staff. 
Contact: Jenny Pham 
Pham0435@umn.edu 
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x No 
Have a PI or study team 
member with a conflict of 
interest? 
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assigned to your study by IRB staff 
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x No 
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clinicaltrials.gov? 
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clinicaltrials.gov ancillary review will be 
assigned to your study by IRB staff 
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x Yes 
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OnCore? 
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ETHOS, the OnCore ancillary review will 
be assigned to your study by IRB staff 
Contact: oncore@umn.edu  
Does not 
affect IRB 
approval. 
 
 
 
 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Piloting a Family-Based Intervention of Time-Restricted Eating to Treat 
Obesity 
 
VERSION DATE: 07Sep2022 
 
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PROTOCOL COVER PAGE 
 
 
Protocol Title 
Piloting a Family-Based Intervention of Time-Restricted Eating to 
Treat Obesity 
Principal 
Investigator/Faculty 
Advisor 
Name: Amy Gross, PhD 
Department: Pediatrics 
Telephone Number: (612) 624-9865 
Email Address: acgross@umn.edu 
Student Investigator 
Name: N/A 
Current Academic Status (Student, Fellow, Resident): 
  
Department: 
Telephone Number: 
Institutional Email Address: 
Scientific Assessment 
I believe Scientific Assessment is not required. 
IND/IDE # (if 
applicable) 
N/A 
IND/IDE Holder 
N/A 
Investigational Drug 
Services # (if 
applicable) 
N/A 
Version 
Number/Date: 
Version 6.0, dated 07Sep2022 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Piloting a Family-Based Intervention of Time-Restricted Eating to Treat 
Obesity 
 
VERSION DATE: 07Sep2022 
 
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REVISION HISTORY 
 
Revision # 
Version Date 
Summary of Changes 
Consent Change? 
1 
14Dec2021 
Removes the term Bluetooth from the 
protocol and replaces it with the 
more accurate term of Bluetooth. 
 
Clarifies that a Registered Dietician 
from the University of Minnesota’s 
Nutrition Coordinating Center will be 
contacting the parent to perform an 
assessment of eating. 
 
Clarifies section 5.0 of the protocol for 
the standard care dyad who will be 
asked to limit calories and 
encouraged to follow appropriate 
portion sizes. 
 
Yes 
2 
12Jan2022 
Adds a prescreening/consent visit to 
be done via Zoom. 
 
Changes the frequency of the REDCap 
surveys on time logs 
 
Adds follow-up questionnaires at 
months 3 and 6 after intervention. 
Yes 
3 
02Feb2022 
Removes the Visual Log of Appetite 
No 
4 
16Feb2022 
Removes the SF-36 questionnaire and 
replaces it with the Peds-QL Adult 
Quality of Life Inventory 
Questionnaire.   
 
We will administer the PedsQL, which 
is already listed in the protocol but 
will be adding the parent report 
versions.  The report the parent is 
asked to complete will be stratified 
based on the age of the child and 
could be: 
• PedsQL Parent Report for children 
8-12 
• Peds QL Parent Report for young 
children 5-7 
No 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Piloting a Family-Based Intervention of Time-Restricted Eating to Treat 
Obesity 
 
VERSION DATE: 07Sep2022 
 
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• Peds QL Parent Report for 
toddlers ages 2-4 
5 
07Sep2022 
Updates the protocol eligibility 
criteria 
No 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Piloting a Family-Based Intervention of Time-Restricted Eating to Treat 
Obesity 
 
VERSION DATE: 07Sep2022 
 
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Table of Contents 
 
1.0 
Objectives ........................................................................................................................... 8 
2.0 
Background ........................................................................................................................ 8 
3.0 
Study Endpoints/Events/Outcomes ................................................................................... 9 
4.0 
Study Intervention(s)/Investigational Agent(s) ............................................................... 10 
5.0 
Procedures Involved ........................................................................................................ 12 
6.0 
Data and Specimen Banking ............................................................................................ 14 
7.0 
Sharing of Results with Participants ................................................................................ 14 
8.0 
Study Population .............................................................................................................. 14 
9.0 
Vulnerable Populations .................................................................................................... 16 
10.0 
Local Number of Participants ........................................................................................... 17 
11.0 
Local Recruitment Methods ............................................................................................. 18 
12.0 
Withdrawal of Participants .............................................................................................. 18 
13.0 
Risks to Participants ......................................................................................................... 19 
14.0 
Potential Benefits to Participants .................................................................................... 19 
15.0 
Statistical Considerations ................................................................................................. 19 
16.0 
Health Information and Privacy Compliance ................................................................... 20 
17.0 
Confidentiality .................................................................................................................. 23 
18.0 
Provisions to Monitor the Data to Ensure the Safety of Participants ............................. 24 
19.0 
Provisions to Protect the Privacy Interests of Participants ............................................. 24 
20.0 
Compensation for Research-Related Injury ..................................................................... 24 
21.0 
Consent Process ............................................................................................................... 24 
22.0 
Setting .............................................................................................................................. 25 
23.0 
Multi-Site Research .......................................................................................................... 25 
24.0 
Coordinating Center Research ......................................................................................... 25 
25.0 
Resources Available ......................................................................................................... 25 
26.0 
References ........................................................................................................................ 25 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Piloting a Family-Based Intervention of Time-Restricted Eating to Treat 
Obesity 
 
VERSION DATE: 07Sep2022 
 
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ABBREVIATIONS/DEFINITIONS 
 
BMI 
Body mass index 
CPOM 
Center for Pediatric Obesity Medicine 
DCRU 
Delaware Clinical Research Unit 
GEE 
Generalized estimating equation 
NCC 
Nutrition Coordinating Center 
SD 
Standard deviation 
SOC  
Standard of care 
TRE 
Time-restricted eating 
 
 
 
 
 
 
 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Piloting a Family-Based Intervention of Time-Restricted Eating to Treat 
Obesity 
 
VERSION DATE: 07Sep2022 
 
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1.0 
Objectives 
1.1 Purpose:   
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. 
 
2.0 
Background 
2.1 Significance of Research Question/Purpose:    
Rigorous prior research in small-scale human studies show promising effects of 
TRE. In contrast to intentional caloric restriction, TRE presents a simplified 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Piloting a Family-Based Intervention of Time-Restricted Eating to Treat 
Obesity 
 
VERSION DATE: 07Sep2022 
 
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approach to obesity treatment. TRE establishes a consistent daily eating window 
(~8-12 hours) with ad libitum intake, while preserving a daily 12-16 hour fasting 
period. Our preliminary data in adults (PI: Chow), show that 12 weeks of TRE with 
ad libitum intake in adults who are overweight results in reduction of weight (-
3.7%), fat mass (-4%) and visceral fat (-11.1%).1 Moreover, our preliminary data 
show that TRE improves quality of life relative to baseline or unrestricted eating.2 
TRE’s agnostic approach to diet allows participants to eat ad libitum during their 
eating window according to food availability and cultural food preferences. 
Consequently, TRE presents a practical means of implementing prolonged fasting 
in adults, reducing eating occasions by 22%1 and daily caloric intake by ~8-20%.3,4 
TRE can be administered remotely, reducing frequently cited barriers to 
intentional caloric restriction such as transportation, scheduling or financial 
barriers.5,6  TRE requires less staff time, as our preliminary data show that the 
average visit duration for monitoring intentional caloric restriction in adults was 
46.1 (33.7) [mean (SD)] minutes, whereas the duration for TRE was significantly 
lower (p<0.01) at 24.4 (7.7) minutes.2 In summary, TRE’s simple approach of 
restricting the eating window results in weight reduction and increased quality of 
life while taking less staff and participant time than traditional obesity treatment 
approaches, likely increasing acceptability of TRE. 
 
It is well documented that obesity clusters in families. As such, obesity treatment 
should be made available to both children and adults, simultaneously. 
Traditionally, family-based therapy has been implemented by a few research 
groups and is time and resource intensive.7,8 Even on an individual level, multiple 
barriers likely impede the implementation and effectiveness of, as well as 
adherence to intentional caloric restriction. In contrast, TRE’s simple approach 
presents a potentially viable alternative to intentional caloric restriction. By 
allowing ad libitum intake during the eating window, TRE mitigates the 
understanding, literacy, dietary, and numeracy barriers often arising from 
intentional caloric restriction.5 Furthermore, the contact hours necessary to 
implement TRE will be significantly less than other interventions. This study will 
provide preliminary data to demonstrate feasibility and acceptability of TRE in the 
family unit, providing critical preliminary data to support NIH-level funding for a 
more detailed analysis of TRE in families.  
 
3.0 
Study Endpoints/Events/Outcomes 
3.1 Primary Endpoint/Event/Outcome: Evaluate feasibility and acceptability of 
implementing TRE in families by quantifying recruitment, adherence and 
intervention burden.  We anticipate that we will recruit ~3 families per month for 
a total of 10 families in each intervention group (N=20), with a retention rate of 
70-80% across both groups.   

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Piloting a Family-Based Intervention of Time-Restricted Eating to Treat 
Obesity 
 
VERSION DATE: 07Sep2022 
 
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• In the TRE group, there will be close agreement between tooth brushing 
times (recorded with Bluetooth-enabled toothbrush) and self-reported 
eating window. 
• Family-based TRE will result in less intervention burden than intentional 
caloric restriction, as documented by less staff time administering the 
intervention. 
3.2 Secondary Endpoint(s)/Event(s)/Outcome(s):  
• Compare weight/BMI change between the TRE group and the SOC group.  
We hypothesize that the weight/BMI outcomes between the two groups 
will be comparable. 
• Assess relationship between child and adult weight/BMI outcomes with 
TRE.  We hypothesize that parent and child weight/BMI change will be 
positively correlated. 
 
4.0 
Study Intervention(s)/Investigational Agent(s) 
4.1 Description:  
This pilot study will be designed as a 12-week randomized trial comparing the 
effects of family-based TRE to family-based intentional caloric restriction 
(standard of care) on weight (Figure 1).  Our study is innovative in using mobile 
technology to monitor participants and to engage the parent-child dyad in our 
interventions.  We propose the novel concept of providing Bluetooth-enabled 
electronic toothbrushes to all participants to facilitate monitoring of the eating 
window.  We will also use a Bluetooth-enabled sale for weekly weights by the 
parent-child dyad to facilitate calculation of the weight trajectory.  Finally, we will 
deliver most sessions virtually by Zoom or by phone. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Piloting a Family-Based Intervention of Time-Restricted Eating to Treat 
Obesity 
 
VERSION DATE: 07Sep2022 
 
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We will enroll 10 family units (i.e., parent/child dyad) per intervention, for an 
anticipated total of 40 participants and 20 families in the overall study.  
Participating families will include children who are 3-9 years old with obesity (BMI 
> 95th percentile) and a parent with obesity (BMI > 30 kg/m2).   
 
Consent will be discussed and obtained by a study investigator or the study 
coordinator via Zoom after explaining the entire study in detail, asking the 
parent(s)/guardian(s) to explain the purpose, risk and benefits, and other details 
of the study, and giving them an opportunity to ask questions.  A copy of the 
consent form and assent form will be mailed to the family so that they can review 
this before the video meeting. At least one parent signature will be required for 
parental permission. However, the study team will encourage both 
parents/guardians to be present at the initial visit to learn about the study and 
ask questions. We will ask that the parents return the signed/dated consent form 
and assent form for counter signature by the individual who conducted the video 
consent process.  As children under the age of 8 will be enrolled, we will take a 
verbal consent as an agreement to participate and will not enroll the child if the 
child gives verbal dissent. 
 
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 Bluetooth-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 Bluetooth-enabled toothbrush will be accessed by 
study staff to approximate the eating window. The adult from each family unit 
will receive a periodic REDCap-administered emails 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.  
 
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. 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 Bluetooth-enabled toothbrush and periodic REDCap surveys but 
will not be instructed on when to brush teeth or to shorten their eating window.   
 
In both intervention groups, the child and adult participant will weigh themselves 
on a consistently weekly basis, using a Bluetooth-enabled scale. This is a common 
aspect of behavioral weight loss interventions (i.e., self-monitoring) and will serve 
as ongoing data collection (see outcomes below). Additionally, treatment will be 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Piloting a Family-Based Intervention of Time-Restricted Eating to Treat 
Obesity 
 
VERSION DATE: 07Sep2022 
 
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primarily delivered to the adult participant, as prior research indicates adult-only 
sessions are as effective as joint sessions for younger children.7,9,10 That is, 
parents and children will attend two in-person sessions: baseline and 12 weeks. 
Only parents will attend virtual sessions. Sessions occur on a weekly basis for the 
first 4 weeks and every other week for the final 8 weeks (see Schedule of Events).  
 
4.2 
Drug/Device Handling:  Not applicable. 
4.3 
Biosafety:  Not applicable. 
4.4 
Stem Cells:  Not applicable. 
4.5 
Fetal Tissue:  Not applicable. 
 
5.0 
Procedures Involved 
5.1 Study Design:  This is a pilot study in which we will explore whether time-
restricted eating is acceptable and feasible for a family and whether utilizing TRE 
is as useful in weight loss as standard of care (calorie control) in families.  20 
dyads (a dyad will consist of a parent and a child) will be enrolled.  Half of the 
dyads will be randomized to receive standard of care and the other half of the 
dyads will be asked to follow a time limited eating program.  Here is what will 
happen for each group: 
Standard care:  This dyad will be asked to limit calories and will be encouraged to 
follow appropriate portion sizes, increase their vegetable, fruit and lean protein 
consumption.  Families in this group will also be advised to decrease their 
consumption of energy-dense but low-quality items such as sugar sweetened 
beverages.  Families in this group will: 
• receive Bluetooth-enabled toothbrushes but will not be instructed on when to 
brush their teeth 
• will be asked to fill out periodic REDCap surveys 
• will be asked to weigh themselves on a consistent weekly basis utilizing a 
Bluetooth-enabled scale.   
• Treatment will be delivered to the adult participant and the child at baseline 
and 12-week visits.  Parents will be asked to attend Zoom or telephone 
sessions weekly for the first 4 weeks and every other week for the final 8 
weeks of the study.  
 
TRE:  This dyad will be asked to limit their eating window to 10-12 hours per day, 
during which they can eat ad libitum.  Families in this group will be asked to: 
• brush their teeth twice daily with the Bluetooth-enabled toothbrush: in the 
morning and then again in the evening  within ½ hour of completion of their 
evening meal.  This will serve as a cue to stop evening eating.   
• will be asked to fill out periodic REDCap surveys.  

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Piloting a Family-Based Intervention of Time-Restricted Eating to Treat 
Obesity 
 
VERSION DATE: 07Sep2022 
 
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• will be asked to weigh themselves on a consistent weekly basis utilizing a 
Bluetooth-enabled scale. 
• Treatment will be delivered to the adult participant and the child at baseline 
and 12-week visits.  Parents will be asked to attend Zoom or telephone 
sessions weekly for the first 4 weeks and every other week for the final 8 
weeks of the study. 
 
Schedule of Events 
 
Prescreening/Consent 
Baseline / Week 0 
Week 1 
Week 2 
Week 3 
Week 4 
Week 5 
Week 6 
Week 7 
Week 8 
Week 9 
Week 10 
Week 11 
Week 12 
Follow-Up Month 1 
Follow-Up Month 3 
Follow-Up Month 6 
Consent 
V 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dietary treatment 
session 
 
P 
V 
V 
V 
V 
 
V 
 
V 
 
V 
 
P 
 
 
 
Demographics 
 
P 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Height and weight 
 
P 
 
 
 
 
 
 
 
 
 
 
 
P 
 
 
 
Weight via Bluetooth-
scale 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
Questionnaires 
• Child Eating 
Behavior 
Questionnaire 
• Adult Eating 
Behavior 
Questionnaire 
• Child Feeding 
Questionnaire 
• Peds-QL  
• Peds-QL Parent 
Report Versions 
(aged 2-4, 5-7 or 
8-12) 
• Peds-QL Adult 
Quality of Life 
Inventory 
Questionnaire 
 
P/V 
 
 
 
 
 
 
 
 
 
 
 
P/V 
 
 
 
24-hour recall 
 
V 
 
 
 
 
 
 
 
 
 
 
 
V 
 
 
 
Satisfaction survey 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
Daily time log1 
 
ß to be done via REDCap for 5 consecutive days three times during 
treatment (e.g., weeks 1, 6 and 12)à 
 
 
 
Use of Bluetooth-
toothbrush 
 
ß to be done twice daily at home by participantsà 
 
 
 
Note: P= in person, V= via virtual visit, X=completion time 
1 
All families will receive automated, email-based REDCap survey for the parent to document the time that they 
and their child started eating in the morning and their last eating occasion of the day.  This will serve as a 
measure of the length of the eating window.  
 
 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Piloting a Family-Based Intervention of Time-Restricted Eating to Treat 
Obesity 
 
VERSION DATE: 07Sep2022 
 
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5.2 Study Duration:  
● 
It is anticipated that it will take six months to recruit the 20 parent/child 
dyads (40 individuals total) to participate in the study.   
● 
Each dyad will be enrolled in the study for 12-14 weeks for screening 
through treatment. Follow up surveys will be sent at 1, 3, and 6 months 
following the end of treatment.   
5.3 Use of radiation:  Not applicable.  
5.4 Use of Center for Magnetic Resonance Research: Not applicable. 
6.0 
Data and Specimen Banking: Not applicable. 
7.0 
Sharing of Results with Participants 
7.1 Participants will have access to their scale and toothbrush data results.  We will 
offer to send participants copies of the published data, if they would like to have 
results of the entire study.   
8.0 
Study Population 
8.1 Inclusion Criteria:  
• BMI > 30 kg/m2 for the parent 
• BMI > 95th percentile for the child 
• Age 3-9 years old for the child 
• Age > 18 years old for the parent 
 
8.2 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 (see attached)  
• Must be on a stable dose of any weight-altering medications 
 
8.3 Prescreening/Consent: Individuals who appear to meet the study criteria based 
on a pre-screening telephone call will be asked to participate in a virtual (video) 
visit. At that visit, consent will be discussed and obtained, height and weight will 
be self-reported by parent for both parent and child, so that estimated BMI can 
be calculated, and inclusion/exclusion criteria will be reviewed.  Individuals who 
meet the BMI requirement and the inclusion/exclusion criteria will enroll in the 
study.   
 
Following consent and prior to the Baseline/Week 0 session, parents will be 

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PROTOCOL TITLE: Piloting a Family-Based Intervention of Time-Restricted Eating to Treat 
Obesity 
 
VERSION DATE: 07Sep2022 
 
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contacted by the University of Minnesota Nutrition Coordinating Center (NCC) 
staff and will be asked to provide three 24-hour dietary recalls for themselves and 
for their child (for a total of six).  NCC staff will be blinded to participant 
intervention assignment.  Using this 24-hour dietary recall data, we will calculate 
the daily average caloric intake and healthy eating index, as well as the eating 
window. 
 
Baseline/Week 0: Individuals will be asked to come to the Delaware Clinical 
Research Unit (DCRU).  At that visit, height and weight will be measured so that 
BMI can be calculated. Individuals who no longer meet inclusion/exclusion criteria 
will be excluded (e.g., outside BMI range based on in-person measurement 
compared to self-reported). Participants who meet the inclusion/exclusion 
criteria will be randomized to their intervention group. Participants will be 
provided with a Bluetooth-enabled scale and instructed to weigh themselves 
once per week.  Participants will also be provided with Bluetooth-enabled 
toothbrushes.  Participants randomized to the TRE treatment will be asked to 
brush their teeth twice daily and to brush their teeth within 30 minutes after the 
evening meal to note that they have ceased eating until the next day.  
Participants randomized to SOC will have a dietary session with a dietician to 
discuss food portions and food selections that encourage reduced caloric intake. 
They will be given portioned dishes as part of this treatment. Participants 
randomized to TRE will meet with the dietician to discuss the length and timing of 
the eating window. All parents will be asked to complete demographic 
information and questionnaires.  Parents will be told that they will receive 
periodic emails (see schedule of events) asking them to log into REDCap and 
complete a survey about what time the family started and stopped eating meals 
for the day.   
 
Weeks 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10:  Parents will have 
a dietary session with the dietician to discuss their respective intervention. That 
is, parents in TRE will discuss implementation of the eating window and parents 
in SOC will discuss food portions and food selections that encourage reduced 
caloric intake.  Parents will be reminded that they should utilize the Bluetooth-
enabled scale to weigh themselves as well as their child once per week.  Parents 
will be reminded to fill out the REDCap survey daily and will be reminded to utilize 
the Bluetooth-toothbrush. 
 
Week 12:  Participants will return to the Delaware Clinical Research Unit.  They 
will receive a session with the study dietician.  The height and weight of the 
parent and the child will be measured and BMI calculated.  The parent will be 
asked to fill out questionnaires about eating as well as a satisfaction survey.  

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Parents will be contacted by a Registered Dietician from the University of 
Minnesota Nutrition Coordinating Center (NCC) staff and will be asked to provide 
three 24-hour dietary recalls for themselves and for their child (for a total of six). 
 
Follow-up:  The parent will receive a satisfaction survey to be completed 
electronically at 1, 3, and 6 months following treatment . 
 
9.0 
Vulnerable Populations 
9.1 
Vulnerable Populations:  
 
Population / Group 
Identify whether any of the 
following populations will be 
targeted, included (not necessarily 
targeted) or excluded from 
participation in the study.  
Children 
Targeted Population 
Pregnant women/fetuses/neonates 
Excluded from Participation 
Prisoners 
Excluded from Participation 
Adults lacking capacity to consent 
and/or adults with diminished 
capacity to consent, including, but 
not limited to, those with acute 
medical conditions, psychiatric 
disorders, neurologic disorders, 
developmental disorders, and 
behavioral disorders 
Excluded from Participation 
Non-English speakers 
Excluded from Participation 
Those unable to read (illiterate) 
Included/Allowed to Participate 
Employees of the researcher 
Excluded from Participation 
Students of the researcher 
Excluded from Participation 
Undervalued or disenfranchised 
social group 
Included/Allowed to Participate 

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Active members of the military 
(service members), DoD personnel 
(including civilian employees) 
Excluded from Participation 
Individual or group that is 
approached for participation in 
research during a stressful situation 
such as emergency room setting, 
childbirth (labor), etc. 
Excluded from Participation 
Individual or group that is 
disadvantaged in the distribution of 
social goods and services such as 
income, housing, or healthcare. 
Included/Allowed to Participate 
Individual or group with a serious 
health condition for which there are 
no satisfactory standard treatments. 
Included/Allowed to Participate 
Individual or group with a fear of 
negative consequences for not 
participating in the research (e.g. 
institutionalization, deportation, 
disclosure of stigmatizing behavior). 
Included/Allowed to Participate 
Any other circumstance/dynamic 
that could increase vulnerability to 
coercion or exploitation that might 
influence consent to research or 
decision to continue in research. 
Included/Allowed to Participate 
 
9.2 Additional Safeguards:  
Children will be part of the targeted enrollment for this study.  As the children 
enrolled will be between the ages of 3 and 9, we will only ask for the child to 
assent if they are aged 8-9; children aged 3-7 will be exempt from the assent 
process.  The parent who also enrolls (to complete the dyad) will consent for 
study participation and will also sign the parental consent indicating that their 
child can participate in the study. 
10.0 Local Number of Participants 
10.1 Local Number of Participants to be Consented: A total of 20 parent/child dyads 
(40 total individuals) will be asked to participate in the study.  10 parent/child 

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dyads will be randomized to standard care and 10 parent/child dyads will be 
randomized to time-restricted eating. 
11.0 Local Recruitment Methods 
11.1 Identification of Potential Participants:  Recruitment will be achieved by a number 
of methods that have been effective in the Center for Pediatric Obesity Medicine 
(CPOM) as well as in the Department of Medicine in the past.  These include 
mailing letters to potentially eligible participants based on an initial screening of 
eligibility in the electronic health record, as well as clinical recruitment efforts by 
members of the investigation team and other physicians within CPOM and the 
Medical School.  Notably, within MHealth Fairview Clinics, there are over 14,000 
children aged 3-9 with obesity who are potentially eligible participants. 
Retention of patients with obesity can be particularly challenging; thus, we have 
established robust methods over the years that allow successful retention of 
youth and families.  Our history of successfully conducting clinical trials of obesity 
treatments provides evidence that we can realistically retain the required number 
of participants.17  We will maximize our ability to do this by expressing our 
gratitude for their time and effort, providing the highest level of customer service 
possible, establishing rapport and trust with the families, and facilitating regular 
communication among the investigators.  Additionally, we will monitor the 
recruitment and retention rates monthly and will adjust our retention and 
recruitment strategies if indicated. 
11.2 Recruitment Materials: Letters and flyers will be developed for this project and 
sent to the IRB for approval before implementation. 
11.3 Payment: Families will be appropriately compensated for their time.  Each family 
will receive $35 per in-person visit and $15 for each virtual session.  The total 
compensation will be $175/family.  They will also be allowed to keep the 
Bluetooth-enabled scale and the Bluetooth-enabled toothbrushes at the end of 
the study.  Payments to the parent/child dyad will be made via Greenphire 
ClinCard. 
12.0 Withdrawal of Participants 
12.1 Withdrawal Circumstances: Individuals are free to withdraw from study 
participation at any time, they should just inform the study team. 
12.2 Termination Procedures: Data that had been collected before the dyad elected to 
withdraw from the study will be kept in the participant file.  No additional 
information will be collected from the dyad after they have indicated that they no 
longer want to participate in the study. 
 
 

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12.3  
13.0 Risks to Participants 
13.1 Foreseeable Risks:  Risks for this study are minimal and include discomfort with 
recalling and reviewing meals, tiring of filling out daily REDCap inquiries, and 
potential frustrations (for the TRE group) with trying to brush their teeth in the 
evening within 30 minutes of finishing their evening meal.  There could be 
discomfort or dissatisfaction with limiting food intake to the eating window hours 
and/or with limiting caloric intake per standard of care recommendations. There 
is also a risk of breach of confidentiality. 
13.2 Reproduction Risks: Not applicable. 
13.3 Risks to Others: Not applicable. 
14.0 Potential Benefits to Participants 
14.1 Potential Benefits: Due to the interventions and self-monitoring, it is possible that 
participating in this study will lead to weight loss, which is desirable since we are 
enrolling participants with obesity. Families may also have increased awareness 
about the food that is being consumed and how portion control or limiting the 
times during the day that food is ingested can be helpful in weight loss.  It is 
hoped that the dietician intervention might help parents find strategies to 
encourage healthy eating within the home.  
15.0 Statistical Considerations 
Analysis Plan: We will summarize feasibility and adherence measures (recruitment and 
retention rate, proportion of days with documented eating window, eating window 
length) using sample proportions, means (standard deviations), and medians 
(interquartile ranges). Proportion of families completing the study (retention rate) will 
be compared between intervention groups using Fisher’s exact tests.  Agreement 
between toothbrush reported eating window and survey reported eating window will 
be evaluated using mixed effects models16 (to account for repeated measures for each 
family) and Bland-Altman Plots.17  
 
The primary outcome analysis will use a linear GEE model, with independence working 
correlation for family units, to compare change in BMI during the 12-week period (pre-
post) between participants assigned to the TRE intervention compared to the standard 
of care. This model will allow for estimating the TRE effect for children and adults while 
accounting for the correlation between parent and child measures. If we do not detect 
a difference in TRE effect for children and adults (p-value≥0.1) the treatment 
assignment by child indicator interaction will be removed from the model.  A similar 
approach will be used to compare changes in measures of diet quality (average caloric 
intake and HEI), eating and feeding behaviors, appetite, and quality of life measures 
between groups. Generalized linear mixed effects models will be used to evaluate 

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differences in weight trajectory between intervention groups. We will evaluate the 
correlation between parent and child change in BMI during the study using Pearson’s 
correlation coefficient, or Spearman’s correlation coefficient (if data visualizations 
indicate a non-linear trend). Total intervention time (sum of session time across the 
study) will be compared between groups using t-tests (or Wilcoxon rank sum tests if 
measures are highly skewed).    
 
We will check data distributions before conducting statistical tests and will transform 
the data if the normality assumption is not met. Logistic regression models will be used 
in place of linear regression models for binary data, as appropriate.  Analyses will be 
performed in R or SAS (Version 9.4, SAS Institute Inc., Cary, NC) 
 
Sample Size: Since the primary purpose of this pilot study is to collect preliminary data 
(specifically feasibility and variability measures) to inform study design for a fully 
powered clinical trial, this pilot study is powered to detect large differences in BMI 
change between groups. With n=20 per group (10 child-parent pairs), correlation 
between child-parent pairs ranging from 0.1 to 0.8,  and an alpha= 0.05 significance 
level, we will have 80% power to detect a difference in BMI change (pre-post) between 
treatment groups of 0.96 to 1.25 standard deviations (Cohen’s d of 0.96 to 1.25, a large 
effect size). 
 
16.0 Health Information and Privacy Compliance 
16.1 
Select which of the following is applicable to your research: 
☐ My research does not require access to individual health information and 
therefore assert HIPAA does not apply.   
 
X I am requesting that all research participants sign a HIPCO approved HIPAA 
Disclosure Authorization to participate in the research (either the standalone 
form or the combined consent and HIPAA Authorization). 
☐ I am requesting the IRB to approve a Waiver or an alteration of research 
participant authorization to participate in the research. 
Appropriate Use for Research:  
☐ An external IRB (e.g. Advarra) is reviewing and we are requesting use of the 
authorization language embedded in the template consent form in lieu of the 
U of M stand-alone HIPAA Authorization.  Note: External IRB must be serving 
as the privacy board for this option. 
 
16.2 
Identify the source of Private Health Information you will be using for your 
research (Check all that apply)   

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X I will use the Informatics Consulting Services (ICS) available through CTSI 
(also referred to as the University's Information Exchange (IE) or data 
shelter) to pull records for me 
X I will collect information directly from research participants. 
☐ I will use University services to access and retrieve records from the Bone 
Marrow Transplant (BMPT) database, also known as the HSCT 
(Hematopoietic Stem Cell Transplant) database. 
☐ I will pull records directly from EPIC. 
☐ I will retrieve record directly from axiUm / MiPACS 
☐ I will receive data from the Center for Medicare/Medicaid Services  
☐ I will receive a limited data set from another institution  
☐ Other.  Describe:  
 
16.3 
Explain how you will ensure that only records of patients who have agreed to 
have their information used for research will be reviewed. 
 
16.4 
Approximate number of records required for review: 
We will ask that individuals who might meet study criteria, and who have not 
opted out of being contacted about research opportunities, be pulled into the 
data shelter.  We will work with FV and the IE to have recruitment letters sent 
to potential participants.  The MHealth system currently has ~ 14,000 children 
who are diagnosed with obesity who may be eligible for study participation. 
16.5 
Please describe how you will communicate with research participants during 
the course of this research.  Check all applicable boxes 
☐ This research involves record review only. There will be no communication 
with research participants. 
☐ Communication with research participants will take place in the course of 
treatment, through MyChart, or other similar forms of communication used 
with patients receiving treatment.  
x Communication with research participants will take place outside of 
treatment settings. If this box is selected, please describe the type of 
communication and how it will be received by participants.  

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16.6 
Explain how the research team has legitimate access to patients/potential 
participants: 
Individuals who would be pulled for a recruitment letter would be patients 
within the MHealth FV system who have not opted out of being informed 
about research studies. 
16.7 Location(s) of storage, sharing and analysis of research data, including any links to 
research data (check all that apply).   
x In the data shelter of the Information Exchange (IE)  
 x Store ☐ Analyze 
☐ Share 
☐ In the Bone Marrow Transplant (BMT) database, also known as the HSCT 
(Hematopoietic Stem Cell Transplant) Database  
 ☐ Store 
☐ Analyze 
☐ Share 
x In REDCap (recap.ahc.umn.edu)  
 x Store  
x Analyze 
x Share 
☐ In Qualtrics (qualtrics.umn.edu) 
 ☐ Store 
☐ Analyze 
☐ Share 
x In OnCore (oncore.umn.edu)  
 x Store ☐ Analyze 
☐ Share 
x In the University’s Box Secure Storage (box.umn.edu) 
 x Store ☐ Analyze 
☐ Share 
☐ In an AHC-IS supported server. Provide folder path, location of server and IT 
Support Contact: 
 ☐ Store 
☐ Analyze 
☐ Share 
x In an AHC-IS supported desktop or laptop.  
Provide UMN device numbers of all devices:  
 x Store ☐ Analyze 
☐ Share 
☐ Other. Describe:  

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Indicate if  data will be collected, downloaded, accessed, shared or stored using a 
server, desktop, laptop, external drive or mobile device (including a tablet 
computer such as an iPad or a smartform (iPhone or Android devices) that you 
have not already identified in the preceding questions 
☐I will use a server not previously listed to collect/download research data 
☐I will use a desktop or laptop not previously listed 
☐I will use an external hard drive or USB drive (“flash” or “thumb” drives) not 
previously listed  
☐I will use a mobile device such as a tablet or smartphone not previously listed 
 
16.8 Consultants. Vendors. Third Parties. Individuals participating in the study will 
download apps for the Bluetooth scale and the Bluetooth toothbrushes that will 
track their weights and toothbrushing times.  The app for the scale will allow the 
user to share their data and participants will be asked to email the study team 
with their results (this can be sent in a csv format to the study team).  The app for 
the toothbrush does not allow for sharing so individuals can screenshot their data 
and send to the study team or simply show the study team their phone to review 
the data at their visits.  Data that is transmitted to the study team from the 
participant (such as the csv file for the scale data) will be stored in Box.  It is our 
understanding from meeting with the HIPCO office that participants are free to 
send data to us and only after it is received by us, does it need to be protected. 
16.9 Links to identifiable data: Csv files that the participants send to us that contain 
their Bluetooth scale information will be stored in Box as it is HIPAA compliant. 
 
16.10 Sharing of Data with Research Team Members. Data will be kept in REDCap and 
Box and only those individuals who are working on the study will have access to 
these items. 
16.11 Storage of Documents: Paper documents will be kept in individual participant 
binders and will be kept in an office that is locked when not in use.  Electronic 
records may be kept in Box and REDCap, which utilize two level authentication. 
16.12 Disposal of Documents:  We anticipate keeping data for at least six years.  When 
data is ready to be destroyed, a company that specializes in the shredding of 
confidential documents will be utilized to destroy any paper files. 
17.0 Confidentiality 
17.1 Data Security: Absolute confidentiality will be maintained.  All data will be stored 
in locked offices and will not be released without consent of the participant.  Data 
that is collected will be entered into REDCap which is only accessible by the study 

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team.  Data to be used in scientific presentations or publications will not contain 
participant identifiers. 
18.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
18.1 Data Integrity Monitoring. The biostatisticians will issue queries on data that is 
analyzed where data is missing or does not seem to be correct and the study 
team will review the study file and make corrections. 
18.2 Data Safety Monitoring. Case report forms will be reviewed for accurate 
completion by individuals within the Center for Pediatric Obesity Medicine. 
19.0 Provisions to Protect the Privacy Interests of Participants 
19.1 Protecting Privacy:  see HIPCO ancillary review. 
19.2 Access to Participants: Please refer to the recruitment section. 
20.0 Compensation for Research-Related Injury 
20.1 Compensation for Research-Related Injury:  
Treatment for injuries that result from participating in the research activity will be 
available.  Those treatments include first aid, emergency treatment and follow-up 
care as needed.  Care for injuries will be billed in the ordinary manner, to the 
subject or their insurance company.  Subjects will be encouraged to contact the 
study team if they think that they have suffered a research related injury. 
 
21.0 Consent Process 
21.1 Consent Process (when consent will be obtained):  
Consent will be obtained by the study team after explaining the entire study in 
detail, asking the participants to explain the purpose, risk and benefits, and other 
details of the study, and giving the participants an opportunity to ask questions.  
A copy of the signed consent form will be given to the participants. 
21.2 Waiver or Alteration of Consent Process (when consent will not be obtained):Not 
applicable.   
21.3 Waiver of Written/Signed Documentation of Consent (when written/signed 
consent will not be obtained):  Not applicable  
21.4 Non-English Speaking Participants: Not applicable.  
21.5 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 years 
of age):  Children aged 3-9 will be allowed to enroll in this study.  For children 
aged 3-7, the parent will sign a parental consent form to indicate that the child 
may enroll in the study and no assent will be collected.  Participants who are aged 
8-9 will be asked to sign an assent form and their parent will be asked to sign a 
parental consent form.  We are planning on having only one parent signature in 
the parental consent form. 

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21.6 Cognitively Impaired Adults, or adults with fluctuating or diminished capacity to 
consent:  Not applicable. 
21.7 Adults Unable to Consent:  Not applicable. 
21.8 Assent:  Assent will be utilized for participants who are aged 8-9.  No assent will 
be utilized for participants aged 3-7. 
22.0 Setting 
22.1 Research Sites:  
● 
Delaware Clinical Research Unit 
● 
University of Minnesota Nutrition Coordinating Center (NCC) 
22.2 International Research: Not applicable.  
23.0 Multi-Site Research: Not applicable. 
24.0 Coordinating Center Research:  Not applicable. 
25.0 Resources Available:  Not applicable. 
26.0 References 
1. 
Chow LS, Manoogian ENC, Alvear A, et al. Time-Restricted Eating Effects on Body 
Composition and Metabolic Measures in Humans who are Overweight: A Feasibility 
Study. Obesity (Silver Spring, Md). May 2020;28(5):860-869. doi:10.1002/oby.22756 
2. 
Crose A, Alvear A, Singroy S, et al. Time-Restricted Eating Improves Quality of Life 
Measures in Overweight Humans. Nutrients. 2021;13(5):1430.  
3. 
Gabel K, Hoddy KK, Haggerty N, et al. Effects of 8-hour time restricted feeding on body 
weight and metabolic disease risk factors in obese adults: A pilot study. Nutrition and 
healthy aging. 2018;4(4):345-353. doi:10.3233/NHA-170036 
4. 
Wilkinson MJ, Manoogian ENC, Zadourian A, et al. Ten-Hour Time-Restricted Eating 
Reduces Weight, Blood Pressure, and Atherogenic Lipids in Patients with Metabolic 
Syndrome. Cell Metabolism. 2020/01/07/ 2020;31(1):92-104.e5. 
doi:https://doi.org/10.1016/j.cmet.2019.11.004 
5. 
Vijan S, Stuart NS, Fitzgerald JT, et al. Barriers to following dietary recommendations in 
Type 2 diabetes. Diabetic medicine : a journal of the British Diabetic Association. Jan 
2005;22(1):32-8. doi:10.1111/j.1464-5491.2004.01342.x 
6. 
Staiano AE, Marker AM, Comeaux J, Frelier JM, Hsia DS, Broyles ST. Family-Based 
Behavioral Treatment for Childhood Obesity: Caretaker-Reported Barriers and 
Facilitators. The Ochsner journal. 2017;17(1):83-92.  
7. 
Janicke DM, Sallinen BJ, Perri MG, et al. Comparison of Parent-Only vs Family-Based 
Interventions for Overweight Children in Underserved Rural Settings: Outcomes From 
Project STORY. Archives of pediatrics & adolescent medicine. 2008;162(12):1119-1125. 
doi:10.1001/archpedi.162.12.1119 
8. 
Boutelle KN, Strong D, Liang J, et al. Comparative Costs of a Parent-Only and Parent and 
Child Treatment for Children with Overweight or Obesity. Obesity (Silver Spring, Md). 
2021;29(2):388-392. doi:10.1002/oby.23069 

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9. 
Ek A, Chamberlain KL, Sorjonen K, et al. A Parent Treatment Program for Preschoolers 
With Obesity: A Randomized Controlled Trial.(Report). Pediatrics. 
2019;144(2)doi:10.1542/peds.2018-3457 
10. 
Boutelle KN, Cafri G, Crow SJ. Parent-Only Treatment for Childhood Obesity: A 
Randomized Controlled Trial. Obesity (Silver Spring, Md). 2011;19(3):574-580. 
doi:10.1038/oby.2010.238 
11. 
Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual 
analogue scales in assessment of appetite sensations in single test meal studies. 
International Journal of Obesity. 2000;24(1):38-48. doi:10.1038/sj.ijo.0801083 
12. 
Hunot C, Fildes A, Croker H, Llewellyn CH, Wardle J, Beeken RJ. Appetitive traits and 
relationships with BMI in adults: Development of the Adult Eating Behaviour 
Questionnaire. Appetite. 2016;105:356-363. doi:10.1016/j.appet.2016.05.024 
13. 
Wardle J, Guthrie CA, Sanderson S, Rapoport L. Development of the Childrens' Eating 
Behaviour Questionnaire. Journal of Child Psychology and Psychiatry. 2001;42(7):963-
970.  
14. 
Varni JW, Seid M, Kurtin PS. PedsQL™ 4.0: Reliability and Validity of the Pediatric 
Quality of Life Inventory™ Version 4.0 Generic Core Scales in Healthy and Patient 
Populations. Medical care. 2001;39(8):800-812. doi:10.1097/00005650-200108000-
00006 
15. 
Ware JE. SF-36 health survey update. Spine (Philadelphia, Pa 1976). 2000;25(24):3130-
3139. doi:10.1097/00007632-200012150-00008 
16. 
Hamlett A, Ryan L, Wolfinger R. On the use of PROC MIXED to estimate correlation in 
the presence of repeated measures. Proc Statistics and Data Analysis. 2004:129-198.  
17. 
Bland JM, Altman DG. Agreement Between Methods of Measurement with Multiple 
Observations Per Individual. Journal of biopharmaceutical statistics. 2007;17(4):571-
582. doi:10.1080/10543400701329422