Wise Social Psychological Interventions to Improve Outcomes of Behavioral Weight Control in Children With Obesity
Phase: NA
Conditions: Obesity, Childhood
Sponsor: Stanford University

 
Wise Social Psychological Interventions to Improve Outcomes 
of Behavioral Weight Control in Children with Obesity 
NCT04422951 
April 30, 2023 
1. 
PURPOSE OF THE STUDY 
a. 
Brief Summary 
Weight loss interventions for children and their families often have variable outcomes 
and are hindered by low attendance or relapse. We will test if brief social psychological 
interventions (termed “wise” interventions) designed to overcome psychological barriers 
may improve participants' efforts toward a weight management program, their attitudes 
about themselves and their weight, and their weight control. 
b. 
Objectives 
We seek to improve outcomes of pediatric weight control interventions by adding novel, 
yet brief (less than 20 minutes) activities to pediatric weight management for children 
with obesity. 
 
These wise interventions have proven very successful in improving school performance 
in children but are only recently have been applied to health behavior change. If found to 
be effective, these activities can easily be added to standard weight control interventions 
to increase their effectiveness and would be a major contribution to improving immediate 
and long-term health and well being of children seeking treatment for obesity. 
c. 
Rationale for Research in Humans 
The purpose of the study is to test the efficacy of new strategies for enhancing weight 
management in children with obesity and their families. 
2. 
STUDY PROCEDURES 
a. 
Procedures 
Recruitment and screening: 
We intend to recruit 200 households of children ages 10 through 16 years with obesity 
who are enrolled in usual care pediatric weight management and their parents. 
 
Pediatric weight management programs will be identified and asked to distribute a study 
recruitment flyer and/or email to their patients. All recruiting materials will direct 
potentially interested parents to our Stanford study website that describes the study and 
provides a REDCap screening survey to assess possible eligibility. 
 

April 30, 2023 
 
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A copy of the approved consent and assent forms will also be available via a link on our 
Stanford study website. 
 
To qualify, children must be enrolled in pediatric weight management and parents or 
legal guardians must complete an online eligibility screening questionnaire that is 
available on our study website in REDCap. At the start of the screening survey, they will 
read the waiver of documentation for recruitment and click continue to proceed to the 
screening questions. If a family meets preliminary eligibility criteria, they will be asked if 
they would like to schedule a baseline appointment (zoom video call). After they have 
scheduled an appointment, they will be emailed the consent and assent forms. 
 
Baseline screening and measurement: 
Parent(s) and child(ren) must attend an initial Zoom video call with a research 
coordinator. During this call and prior to collecting any data, we will explain all aspects 
of the study including data collection measures, intervention activities and randomization 
and obtain signed consent from the parent/guardian and signed assent from the child. All 
questions will be answered by study staff prior to families signing consent forms 
(parents/guardians) and assent forms(children). The consent/assent forms are on 
REDCap, which allows participants to use their mouse (desktop) or finger (mobile) to 
record signatures. 
 
Measures in baseline appointment – part 1 
After children and parents complete assent and consent forms, they will be asked to 
complete all survey measures including demographics, household composition, physical 
activity and eating habits, screen use, puberty stage, overconcern with weight or shape, 
school grades, and psychosocial measures. Children and parents will be encouraged to 
complete online REDCap surveys on separate devices. The research coordinator will 
review all surveys for completeness before ending the call. Parents will be asked to 
schedule a second zoom call within the upcoming 3 weeks. An electronic cellular-
connected scale (BodyTrace), a tape measure to measure height, and a food portion size 
booklet to use during the dietary recall will be mailed to participants. Parents will be 
emailed a lab requisition for their child to have fasting blood tests collected at their local 
Quest labs. 
 
Measures in baseline appointment – part 2 
During the second Zoom video appointment, child’s and parent's heights and weights will 
be measured using the mailed tape measure and electronic scale, and children will 
complete a 24-hour dietary recall. Child weight measurements will be used to determine 
child’s eligibility into the study (>=95th BMI percentile for age and sex). After finalizing 
eligibility and completing all baseline measures, participants will be randomized. 
 
Randomization: 
Families will be randomized to treatment conditions after completing baseline measures, 
using Efron’s biased coin randomization stratified by location, sex, and race/ethnicity, to 
promote balance on key characteristics that may influence weight changes, and allow 
examination of sex as a biological variable. Investigators and all data collection staff will 

April 30, 2023 
 
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remain blinded to treatment condition assignment until all participants have completed 
the final follow-up assessments. 
 
Interventions: 
The research activities will be delivered as online videos and activities sent 9 times 
throughout the program. Parents will be emailed REDCap surveys that link to Qualtrics 
activities; one with a parent video/activity and one with a child video/activity. The WISE 
interventions encourage values affirmations and a growth mindset. The control videos 
and activities reinforce diet and physical activity messages that are part of the weight 
control program. 
 
Follow-up Assessments 
Children and parents/guardians will complete data collection visits at 3 and 6 months post 
randomization. With the exception of demographic measures and a few baseline only 
measures, the 3- and 6-month visits will include measures previously collected at 
baseline. Fasting blood tests are included only at baseline and 6-month visits. 
b. 
Procedure Risks 
There are minimal risks in the research protocol. All research measures will be obtained 
by trained research assistants and phlebotomy by qualified phlebotomists at Quest 
Diagnostics, a nationwide commercial lab. 
c. 
Use of Deception in the Study 
There will be no deception used in the research. 
d. 
Use of Audio and Video Recordings 
No audio or video recording will occur by study staff. 
 
As part of one of the intervention activities, children will be asked to upload a photo or a 
drawing to their individually assigned REDCap surveys. This image is similar to a profile 
image and designed to increase engagement. Children are instructed to not include 
photographs with faces. 
 
Only qualified research staff will have access to images uploaded to REDCap. 
e. 
Alternative Procedures or Courses of Treatment 
No standard or alternative treatment will be withheld. 
f. 
Will it be possible to continue the more (most) appropriate therapy for the 
participant(s) after the conclusion of the study? 
No additional continuing treatment will be made available by the study after conclusion 
of the study. 

April 30, 2023 
 
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g. 
Study Endpoint(s) 
The main study endpoint is BMI change over 6 months, at the end of treatment. We do 
not plan to perform interim analyses of treatment 
outcomes or terminate the study early for efficacy or futility because: 
• 
Potential effects of the social psychological interventions are to 
• 
mitigate drop out and increase perseverance with the treatment program over 
time. 
• 
The interventions aim to affect weight gain trajectory and maintenance, 
intervention effects may not be observed over the short term. 
• 
Alternatively, statistically significant short-term benefits may not reflect 
clinically significant health benefits over 6 months (the full length of the study). 
• 
This study aims to calculate with some assurance the size of the 
difference between treatment outcomes (effect size) within reasonable confidence 
intervals, and to avoid bias in the estimates of effect sizes (because random high values in 
treatment effect may be used to justify early stopping, but rarely would random low 
values). 
• 
We should avoid interim analyses and unnecessary "alpha-spending," which 
reduces the power of the study. 
• 
Study participants in both treatment groups are being provided with beneficial 
interventions. 
 
The Safety Officer may request an interim analysis at any time during the study for 
purposes of assessing safety/harm. 
 
The study will be terminated if there is clear evidence of harm or harmful side-effects of 
the treatment or participation in the study that outweighs evidence of the benefits of 
participation. Each Safety Officer report (approximately every six months) will conclude 
with a recommendation to continue or to terminate the study. A copy of this letter will be 
forwarded to the IRB and the NIH Program Officer. A termination recommendation may 
be made by the Safety Officer at any time during the study if deemed necessary. 
3. 
BACKGROUND  
a. 
Past Experimental and/or Clinical Findings 
Childhood obesity is a medical and public health priority. Pediatric obesity in the U.S. 
has more than tripled over the past 3 decades. Childhood obesity is associated with 
substantial medical, psychological, and social morbidities. Most treatments for children 
with obesity have produced modest, unsustained effects, and there remains a great need 
for new approaches to increase and sustain weight loss among children with obesity. 
 
Existing weight control interventions may be limited in their success, in part, because of 
the many psychological barriers and threats that children and families face when 
attempting to manage their weights. Therefore, one potentially effective and efficient way 
to enhance the success of behavioral treatments and reduce variability in outcomes may 
be to focus on changing the attitudes and preparedness of the participants. One of the 
most formidable psychological barriers faced by people trying to control their weight is 

April 30, 2023 
 
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the belief that they cannot succeed. The associated lack of self-efficacy results from the 
countless setbacks that are often encountered. Self-efficacy may also be damaged by the 
child’s awareness of social-stereotypes about children with obesity, such as their lack of 
control and/or discipline, biologic/genetic propensity for obesity, lack of athleticism, etc., 
that may cause anxiety and stress. Thus, interventions designed to help children 
overcome the obstacle of low efficacy beliefs in the face of challenges and setbacks 
should be more successful in promoting long-term changes in health behaviors. We 
believe that certain brief and precisely targeted psychological interventions, termed 
“wise” interventions, can act as key levers in the behavior change process, aiding the 
success of more traditional behavioral interventions by increasing perceptions of efficacy. 
These wise interventions target beliefs about ability and performance and help buffer 
against psychological and social-environmental threats, making one more open to 
information regarding how to make changes, better able to cope with the psychological 
threats and setbacks they experience along the way and thus, better able to take advantage 
of the behavioral skills they are learning. When applied in a specifically timed way, wise 
interventions have proven effective at producing remarkably large and long-term 
improvements in children’s academic performance. Based on our understanding of the 
barriers faced by children with obesity and families, and the very promising results of our 
pilot studies, these interventions are particularly well-suited to combine with behavioral 
interventions for pediatric obesity. 
b. 
Findings from Past Animal Experiments 
N/A 
4. 
PARTICIPANT POPULATION 
a. 
Planned Enrollment 
(i) We expect to enroll approximately 200 families. Because multiple eligible children 
and parents may be enrolled from a single family, this is expected to include up to 240 
eligible children and 240 eligible parents. 
(ii) We are the only site involved in this research. Therefore, the total sample will be 
approximately 200 families. 
(iii) Children aged 10-16 years with obesity and their parents/guardians. Children and 
their parents are included because this is a study to test a family-based approach to reduce 
weight gain in children with obesity using online methods. 
b. 
Age, Gender, and Ethnic Background 
Based on past experience in the existing pediatric weight control treatments, we 
anticipate participants to be approximately: 55% girls, 45% boys, 50% white, 3% 
African-American, 25% Latino/Hispanic, 1% Native American, 8% Asian/Pacific 
Islander and 13% other (including multi-ethnic). 
c. 
Vulnerable Populations 
Up to approximately 240 10-16 year-old children with obesity (in 200 families). 
 
Rationale for Involvement of Potentially Vulnerable Subjects. 

April 30, 2023 
 
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Children with obesity are at increased risk of related morbidities, including hypertension, 
dyslipidemias, diabetes, non-alcoholic fatty liver disease, and atherosclerosis, among 
others, and future risk of heart disease, stroke and many cancers. However, most 
available pediatric obesity treatment programs produce only limited and non-sustained 
effects. There is a great need for new, innovative approaches to improve and sustain 
weight control among overweight and obese children. In the proposed trial, we will test 
the addition of several promising and potentially generalizable social psychological 
strategies. 
 
To minimize risks and chance of harm, assent will be obtained from all children and 
consent will be obtained from parents/guardians for their child's and their own 
participation, after full explanation of the study, via zoom video call. Parents/guardians 
will be required to accompany their child during participation in the study zoom calls. 
 
Serious Adverse Events (medical problems where the study participant was hospitalized, 
had any problem resulting in a persistent or significant disability, had any problems that 
were life-threatening, or resulted in a birth defect in a newborn child) will be assessed at 
3 and 6 months. Adverse events any medical illnesses or injuries requiring a visit to a 
medical care provider or institution) that the participant believes possibly related to their 
participation in the study will be assessed as part of the follow-up assessments at 3 and 6 
months. A report form has been designed for this purpose to at least include a brief 
description, severity, resolution, potential relationship to study participation, and actions 
taken with respect to study participation. The PI will evaluate each event to determine if 
it meets the criteria of an Unanticipated Problem (UP) – which is unexpected, possibly 
related to participation in the study, and harmful. We will inform the IRB immediately of 
all Unanticipated Problems, and all adverse events, regardless of seriousness, will be 
reported to the IRB during annual reports/reviews. 
 
Some also express concern that obesity treatment can increase the risk of unhealthful 
eating behaviors, although the bulk of available data do not support this, including a 
recent meta-analysis. Since the 1980’s, our research group has studied risk and 
prevention of disordered eating behaviors among children and teens. As a result, we 
carefully consider the risks of disordered eating behaviors in all our obesity prevention 
and treatment research. A diagnosis of anorexia nervosa, bulimia nervosa or binge eating 
disorder, past or present, and any self-induced vomiting, or use of diuretics or laxatives 
for weight loss are exclusions for the study for the adult participant and any child living 
in the household. 
 
The wise social psychological interventions proposed in this research have been found to 
be beneficial in multiple past studies in other domains (e.g., schools) and are designed to 
bolster self-integrity and focus on overall well-being, not specifically on weight. 
d. 
Stanford Populations 
We will not recruit from Stanford laboratory personnel, employees, or students. 

April 30, 2023 
 
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e. 
Healthy Volunteers 
Participants are children with obesity who are otherwise healthy and their 
parents/guardians who are also healthy. 
 
This is a weight control study for otherwise healthy children and their parents/guardians. 
Pediatric obesity is associated with substantial medical, psychological, and social 
morbidities. For example, population-based data from Bogalusa, LA indicated that more 
than 60% of obese 5-10 year old children already suffered from at least one physiological 
risk factor for cardiovascular disease, such as hypertension, dyslipidemias, and/or 
hyperinsulinemia, and 25% had 2 or more risk factors. Increased childhood obesity has 
also led to a new epidemic of Type 2 diabetes in children and adolescents, a problem that 
was previously limited to adults, and now accounting for up to 45% of all newly 
diagnosed diabetes in children. Conditions associated with overweight, such as sleep 
apnea and gallbladder disease, tripled in children and adolescents between 1979–1981 
and 1997–1999. Overweight children and adolescents also are much more likely to 
become overweight adults. Therefore, there is a compelling rationale to try to prevent and 
reduce obesity in children, for its immediate and future benefits. Targeting efforts at 
children may not only improve pediatric health, but potentially reduce and delay the 
incidence of chronic diseases in adults, such a heart disease, stroke, diabetes, and many 
cancers associated with obesity. 
 
The measures being taken to minimize the risks and the chance of harm to the volunteers 
and the additional safeguards that have been included to protect participants' rights and 
and welfare are described above in 8c. 
f. 
Recruitment Details 
We intend to recruit 200 households of children aged 10-16 years with obesity and their 
parents. Pediatric weight management programs will be identified and asked to distribute 
a study recruitment flyer and/or email to their patients. All recruiting materials will direct 
potentially interested parents to our Stanford study website that describes the study and 
provides a REDCap screening survey to assess possible eligibility. A copy of the 
approved consent and assent forms will also be available via a link on our Stanford study 
website. 
 
We will not be targeting children directly – only their interested parents/guardians. Other 
than distributing our study flyers/emails, weight management program staff will not 
participate in recruiting or providing information about the study. 
g. 
Eligibility Criteria 
i. 
Inclusion Criteria 
10-16 year old children with obesity (BMI ≥ 95th %ile for age and sex). 
Live in continental USA. 
Internet access and Zoom video capability. 
Interest in receiving Stanford online activities. 

April 30, 2023 
 
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Completion of baseline data collection activities, including willingness to use the 
Stanford provided electronic scale and tape measure to measure weight and height 
during the assessment sessions. 
 
As we are interested in testing generalizable strategies for weight control in diverse 
populations, the eligibility criteria are designed to be liberal, to maximize the 
generalizability of the results, but also maintain the internal validity of the test of the 
intervention. 
ii. 
Exclusion Criteria 
To enhance internal validity, children will not be eligible if they: 
 
1) Diagnosed with a medical condition affecting growth (a genetic or metabolic 
disease/syndrome associated obesity, Type 1 diabetes, Type 2 diabetes taking 
medication, chronic gastrointestinal diseases, Chronic renal diseases, uncorrected 
structural heart disease, heart failure, heart transplant, AIDS or HIV infection, 
pregnancy); are taking medications affecting growth (systemic corticosteroids more 
than 2 weeks in the past year, insulin, oral hypoglycemics, thyroid hormone, growth 
hormone); 
 
2) Child has had, or in next 6 months plans to have bariatric surgery; 
 
3) Parent/guardian, or any child in the household has ever been diagnosed with an 
eating disorder such as anorexia nervosa, bulimia nervosa or binge eating disorder, or 
self-induce vomits or uses diuretics or laxatives for weight loss. 
 
4) Child cannot fully participate in the interventions (e.g. be able to participate in 
routine physical activity) 
 
5) Cannot fully participate in the assessments: child or primary caregiver not able to 
read surveys in English or Spanish, child not in mainstream classes at least70% 
h. 
Screening Procedures 
On our study website, a link to an online screener in REDCap will be available. We will 
obtain a limited waiver of authorization for recruitment prior to asking potential 
participants to complete the online screener. (Section 15). After completing the waiver of 
documentation, the screening survey will assess inclusion and exclusion criteria listed 
above. 
 
If the family is potentially eligible, based on their screening survey responses, and if they 
are potentially interested in volunteering and learning more about the study, they will 
schedule an initial Zoom video call (zoom #1) and will provide their name, email address 
and phone number to confirm the meeting and to receive links to the consent and assent 
forms. 
 
During Zoom #1, the parent/guardian and child(ren) will meet with a research 
coordinator who will explain the study including data collection measures, intervention 

April 30, 2023 
 
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activities and randomization and obtain signed consent from the parent/guardian and 
signed assent from the child. If the parent/guardian and child sign consent and assent and 
complete the survey measures they will schedule a second Zoom call (Zoom #2) and will 
be mailed an electronic cellular-connected scale, a tape measure, and a food portion size 
booklet to use during the dietary recall in Zoom #2. Parents will be emailed a lab 
requisition for their child to have fasting blood tests collected at their local Quest labs. 
 
During Zoom call #2 the child’s height and weight will be collected to determine if the 
child’s BMI percentile meets study eligibility requirements. 
 
After finalizing eligibility and completing baseline measures, participants will be 
randomized. 
i. 
Participation in Multiple Protocols 
Parents/guardians are asked if they or the participating child are participating in any other 
research studies during their first online Zoom meeting. We will allow participation in 
another study if it is not another weight control study or focused on changing diet, 
physical activity and/or screen time behaviors, and/or it does not increase risks to 
participants. 
j. 
Payments to Participants 
Parent/child family units will be compensated with a $30 gift card for their time and in 
appreciation at completion of the 3-month post-randomization assessments and a $50 gift 
card at the completion of the 6-month post-randomization assessment. 
 
We will not include information about financial compensation for assessments in our 
recruitment materials because we do not want to entice families motivated by the 
financial compensation, but rather want to recruit families interested in the Stanford 
online activities. 
 
In our previous research we have offered similar levels of compensation. Families have 
told us that financial compensation is not necessary or an important reason for joining the 
study but they do appreciate this expression that we value their time and participation in 
the measures. In our experience, these payments do not constitute undue pressure to 
participate in the study. 
k. 
Costs to Participants 
Participants are not charged for participation in the research study. 
l. 
Planned Duration of the Study 
Each child and parent/guardian will participate for a total of 6 months. 
 
(i) Screening 
Pre-screening online is estimated to take less than 15 minutes. 
 
(ii) Active Participation in the Study 

April 30, 2023 
 
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Baseline: Explanation of the study, confirmation of eligibility, completion of the 
consent/assent, and baseline measures will occur face-to-face via two Zoom calls. 
Estimated time = 90-120 minutes. 
 
Intervention activities are sent to families by Qualtrics links via REDCap 9 times 
(throughout the 6 months study). Activities include short videos which range in length 
from 45 seconds to 5 minutes and/or a Qualtrics reading and writing activity that should 
take less than 15 minutes. 
 
Follow-up Assessment Appointments: Face-to-face via Zoom follow-up assessments will 
occur approximately three months and six months after randomization. At the 3 and 6-
month assessments, surveys will be administered, diet recalls collected, and height and 
weight will be measured. After six months, blood test requisitions will also be emailed. 
Estimated time for the 3- and 6-month Zoom appointments is 60 minutes. 
 
(iii) Analysis of Participant Data 
We anticipate keeping this protocol active for at least 10 years (5 years beyond the end of 
participant involvement) to complete data analysis and paper writing. 
5. 
RISKS 
a. 
Potential Risks 
i. 
Investigational devices 
N/A 
ii. 
Investigational drugs 
N/A 
iii. 
Commercially available drugs, biologics, reagents or chemicals 
N/A 
iv. 
Procedures 
Blood tests (venipuncture) are associated with transient local discomfort and possible 
bruising. Blood draws will occur at baseline and 6-month follow-up assessments. None of 
our measures have been associated with complications in our recent studies with 
hundreds of children in this same age group, using the similar measurement protocols. 
v. 
Radioisotopes/radiation-producing machines 
N/A 
vi. 
Physical well-being 
No evidence of risk to physical well-being. 
vii. 
Psychological well-being 

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No evidence of risk to psychological well-being. Previous research using similar 
interventions have enhanced psychological well-being in both children and adults. 
viii. 
Economic well-being 
No evidence of risk to economic well-being. 
ix. 
Social well-being 
No evidence of risk to social well-being. 
 
A breach of confidentiality might be considered a risk to social well-being, however this 
has not occurred in our studies to date. 
x. 
Overall evaluation of risk 
Low 
b. 
International Research Risk Procedures 
N/A 
c. 
Procedures to Minimize Risk 
A data collection/tracking system will provide confidentiality to all participants. All 
collected data are identified by study identification numbers but not names. No one 
except the research staff will have access to data. Electronic data will be kept in password 
protected files on password protected computers and all data forms and computers are 
kept in locked offices, to comply with Stanford Medical Center HIPAA policies. 
Consistent with Stanford University policy, all project staff will be required to complete 
the Human Subjects and HIPAA training modules for certification. These methods have 
proven successful at protecting confidentiality in our prior research. 
 
Adverse events (any medical illnesses or injuries requiring a visit to a medical care 
provider or institution) will be assessed as part of the follow-up assessments. An adverse 
events recording form has been designed for this purpose, to systematically document all 
adverse events occurring during the course of the study (to at least include a brief 
description, severity, resolution, potential relationship to study participation, and action 
taken with respect to study participation). Intervention staff will also be trained to 
investigate and record adverse events continuously, between assessments, as they become 
aware of them. 
 
Although the evidence suggests treatment does not cause disordered eating, overweight 
children and families seeking treatment are at increased risk irrespective of participating 
in treatment. Therefore, as noted above, diagnosis of anorexia nervosa, bulimia nervosa 
or binge eating disorder, past or present, as well as self-induced vomiting and use of 
diuretics or laxatives for weight loss are exclusions for the study for both children and 
parents. 
 
A Safety Officer and the Stanford University Administrative Panel on Human Subjects in 
Medical Research (IRB) will be informed within 7 days of learning of all unanticipated 

April 30, 2023 
 
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problems. With the exception of SAEs for otherwise healthy childbirth, all adverse 
events, regardless of seriousness, will be reported to the IRB during annual 
reports/reviews. 
 
The Safety Officer is an independent physician who is designated to provide ongoing 
oversight to protect participant safety and make ongoing assessments of the balance 
between risks and benefits. The Safety Officer is a Stanford University faculty member 
who is not involved in this study or in the Principal Investigator's chain of command. 
They have relevant clinical and clinical trials experience and expertise. Confidentiality of 
participant data will be maintained throughout all Safety Officer reviews. The Safety 
Officer will act in an advisory capacity to NIH, the Principal Investigator, and Stanford 
University to monitor patient safety and the performance of the study. 
 
Throughout the course of the study, while participants are enrolled, the Safety Officer 
will meet with the Principal Investigator to review study progress and safety, including 
all adverse events. An emergency meeting may be called at any time by the Principal 
Investigator, the Safety Officer or the study Statistician, should questions of participant 
safety arise. At meetings during the course of the trial, the Safety Officer's 
responsibilities are to: 
• review plans for data safety and monitoring; 
• evaluate the progress of the trial, including periodic assessments of data quality and 
timeliness, participant recruitment, accrual and retention, participant risk versus benefit, 
and other factors that can affect study outcome; 
• consider factors external to the study when relevant information becomes available, 
such as scientific or therapeutic developments that may have an impact on the safety of 
the participants or the ethics of the trial; 
• protect the safety of the study participants; 
• report on the safety and progress of the trial; 
• make recommendations to the NIH, the PI, and the Stanford University Administrative 
Panel on Human Subjects in Medical Research (Institutional Review Board, IRB) 
concerning continuation, termination or other modifications of the trial based on the 
observed beneficial or adverse effects of the treatment under study; 
• ensure the confidentiality of the trial data and the results of monitoring; and, 
• assist NIH by commenting on any problems with study conduct, enrollment, and sample 
size and/or data collection. 
 
As an additional safety measure and potential benefit to participants, we will also screen 
participants for pre-existing or incident conditions that may pose a risk to their health, but 
are not expected to result from participation in the study. This represents an additional 
safety mechanism for study participants. Parents/guardians will be notified and referred 
to their primary medical care provider for further evaluation and care as needed, 
according to the appropriate current recommended cut-offs for abnormal measures of 
dyslipidemias, impaired fasting glucose/prediabetes, and diabetes. Notifications and 
referrals are made in writing, with a full explanation, and followed-up with subsequent 
phone calls. 

April 30, 2023 
 
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d. 
Study Conclusion 
The study will be terminated if there is clear evidence of harm or harmful side-effects of 
the treatment or participation in the study that outweighs evidence of the benefits of 
participation, if study progress (study accrual, participant retention, ability to implement 
the study) is judged to be insufficient to result in a valid study, or new information 
becomes available from other studies suggesting the risks of participation in this study 
outweigh the potential benefits. 
 
Each Safety Officer report will conclude with a recommendation to continue or to 
terminate the study. A copy of this letter will be forwarded to the IRB and the NIH 
Program Officer. A termination recommendation may be made by the Safety Officer at 
any time during the study if deemed necessary. 
 
We will not perform interim analyses of treatment outcomes or 
terminate the study early for efficacy or futility, for reasons 
related to the nature of the research question (see full explanation above). The Safety 
Officer may make a request for interim analyses at any time during the study for purposes 
of assessing safety/harm. 
e. 
Data Safety Monitoring Plan (DSMC) 
i. 
Data and/or events subject to review 
The database manager and statistician will compile and report: recruitment and 
retention, quality control of measurements, fidelity of the of intervention 
implementation, participant progress in the study, and all AE, SAEs, and UPs. 
ii. 
Person(s) responsible for Data and Safety Monitoring 
The Principal Investigator and the Co-Investigators have primary responsibility. In 
addition, we have appointed an independent and qualified Stanford Investigator, Dr. 
Anisha Patel, as a Safety Officer, who has been approved by the sponsor (NIDDK, 
NIH). 
iii. 
DSMB Reporting 
We will report unexpected deaths or life-threatening experiences related to the 
research to the IRB within 5 working days from the PD learning of the event. An 
unanticipated problem (UP) will be reported to the IRB within 10 working days from 
receiving assessment from the Safety Officer. All other adverse events will be 
documented monthly and reported to the Safety Officer semi-annually and to the IRB 
annually. 
iv. 
Will the Protocol Director be the only monitoring entity? (Y/N) 
No 
v. 
Will a board, committee, or safety monitor be responsible for study monitoring? 
(Y/N) 
Yes 

April 30, 2023 
 
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6. 
BENEFITS 
Potential Benefits of the Proposed Research to the Subjects and Others: Participants may benefit 
from reduced weight gain and reduced physical, psychological and social morbidities and 
mortality associated with excess weight, the potential psychological and social benefits of 
participating in a treatment program, and the potential health benefits of improved diet and 
activity behaviors. Other children and the public may benefit from the potential scientific and 
public health impact of the knowledge that may result from this study. The potential benefits to 
the subject and to others outweigh the potential risks. 
7. 
PRIVACY AND CONFIDENTIALITY 
All participant information and specimens are handled in compliance with the Health Insurance 
Portability and Accountability Act (HIPAA) and privacy policies of Stanford University, Stanford 
Health Care, and Stanford Children’s Health.