Pediatric ObesityCHOICENCT04770311
Childhood Obesity Microbiome Study
A study testing Microbiome friendly diet in people with Pediatric Obesity, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to measure the effectiveness of a microbiome diet using direct food provision on dietary quality and microbiome composition among children with obesity. This study proposes a pilot randomized, controlled clinical trial in children of a dietary intervention informed by microbiome science. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Microbiome friendly diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2021to 20 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child aged 6 - 11 years (not yet aged 12)
- Child with BMI ≥ 95th percentile
- Parents are willing to accept home deliveries and have the ability to be home at the time and day that is most convenient for them to receive the groceries; or, have transportation available to go and pick up groceries at a time and date that is most convenient for them at a Walmart location.
Who cannot join
- Does the child have a current diagnosis of obesity due to an underlying condition such as hypothyroidism, Cushing's disease, or known genetic condition?
- Is the child currently taking any weight-loss medication (steroids, anti-psychotics, anti-depressants)
- Has the child started a stimulant medication in the past 3 months? (stimulants include, among others, Ritalin, Adderall, concerta, focalin, vyvanse).
- Is the child currently taking, or has taken in the past 4 weeks, an antibiotic?
- Is the child currently taking, or plans to take in the next 4 weeks, a weight loss medication?
- Is the patient on a pharmacotherapy or weight loss surgery track in Healthy Lifestyless?
- Has the patient lost more than 5% of their body weight in the preceding 6 months?
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Healthy Lifestyles Roxboro Street
Durham, North Carolina, 27704
About this study
The purpose of this study is to measure the effectiveness of a microbiome diet using direct food provision on dietary quality and microbiome composition among children with obesity. This study proposes a pilot randomized, controlled clinical trial in children of a dietary intervention informed by microbiome science.
Read the detailed description
Childhood obesity is a global health crisis and contributes to shortened life expectancy in the US, with higher rates and more serious co-morbidities among minorities. Existing dietary interventions demonstrate significant heterogeneity of treatment response among diverse populations, and clear information to tailor diet to individual-level characteristics is not yet available. Recent science suggests that the gut microbiome may in part explain inter-individual variation in pediatric obesity and treatment response. Intestinal microbial communities play causal roles in models of obesity and are distinct between individuals. However, it is unknown how the microbiome mediates response to existing dietary guidelines for children with obesity.
Evidence-based nutritional standards for treatment of pediatric obesity are well-established, and aim to reduce body mass index and cardio-metabolic risk. However, these standards have not translated into reduced prevalence of obesity among children, particularly those in racially diverse and low-income groups. One explanation is the significant inter-individual variability in metabolic response to dietary interventions, suggesting that certain food components in a diet may benefit some individuals more than others. Another explanation is that dietary adherence is highly variable, and requires skills or resources not available to all people. For example, translating dietary recommendations into food procurement, preparation, and consumption requires baseline levels of educational attainment, child acceptability of foods, diet compatibility with cultural preferences, and may be seen as time-consuming. These obstacles are hard to overcome for children and families from low-income and minority groups, who are known to have low show rates and engagement in nutrition studies despite being at disproportionate risk of diseases like obesity and metabolic disease. The one-size-fits-all approach to dietary recommendations is failing the most vulnerable children in the nation.
Recent science suggests that the gut microbiome provides new opportunities to address these long-standing challenges. Microbiome transplant experiments in mice have demonstrated that increased adiposity can be conferred from bacterial communities originating from individuals with obesity. Furthermore, variation in microbiome composition between individuals can predict response to dietary intervention, suggesting a mechanism for why certain individuals lose weight on specific diets and other individuals do not. Another intriguing aspect of microbiome science is how its adoption could introduce new methodological techniques to obesity treatment. In particular, the plummeting costs and turnaround times of metagenomic DNA sequencing used in microbiome research opens new opportunities for rapidly providing biomarker information to a wide number of people. |
No evidence exists that describes microbiome signatures with objective measures of dietary quality among children with obesity. The work to be completed here will be a vital first step towards integrating the promise of microbiome science into the treatment of pediatric obesity. Our team is uniquely suited to take this step as leaders in microbiome science (David) and childhood obesity (Armstrong). By working together to predict how individual microbiome variation shapes responses to diet therapy, an important step towards personalizing dietary recommendations for children based on gut microbiome signatures that predict the best outcome will be taken. In addition, linking microbial signatures to measures of diet quality will provide researchers with much-needed molecular tools for assessing dietary compliance and intervention success. Finally, insights into the impact of receiving metagenomic data on children's' motivation towards healthy behaviors could provide behavioral and implementation scientists with new tools for improving adherence with obesity treatment
- Conditions
- Pediatric Obesity
- Being tested
- Microbiome friendly diet
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiome friendly dietBehavioural
Families in the intervention group will have a microbiome-friendly nutrition assessment and will also receive groceries one time per week for four weeks to help achieve a more microbiome-friendly diet.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | In a typical Healthy Lifestyless Nutrition visit, dietitians provide medical nutrition therapy to patients and their families. This includes addressing abnormal, nutrition-related lab values and providing targeted nutrition advice (foods to include, foods to limit) in order to resolve said labs. Motivational interviewing techniques will be used to help families identify barriers to Lifestyles change and provide strategies to help overcome these barriers. Families will receive compensation per each nutritional visit. |
| Intervention | Other | Besides the usual standard of care during the nutrition visits, participants will have guidance on a microbiome-friendly diet and will receive groceries 1 time per week for 4 weeks. Receives: Behavioral: Microbiome friendly diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in child dietary quality as measured by the DSQ
The investigators will use the DSQ, which is the 26-item Dietary Screener Questionnaire, that asks about the frequency of consumption in the past month of selected foods and drinks. The DSQ captures intakes of fruits and vegetables, dairy/calcium, added sugars, whole grains/fiber, red meat, and processed meat. The study team will be focusing on microbiome friendly food, such as whole grains a fiber rich foods.
Measured: Baseline, week 4 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start9 Apr 2021
- Primary completion20 Nov 2021
- Study completion20 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Armstrong, MD, Principal investigator, Duke department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770311
- Sponsor's protocol ID
- Pro00107438
- Acronym
- CHOICE
- Status last verified
- Apr 2022
- First submitted
- 23 Feb 2021
- Last updated
- 15 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Obesity Microbiome Study
- ClinicalTrials.gov ID
- NCT04770311
- Acronym / sponsor ID
- CHOICE / Pro00107438
- Conditions
- Pediatric Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 20 Nov 2021 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to measure the effectiveness of a microbiome diet using direct food provision on dietary quality and microbiome composition among children with obesity. This study proposes a pilot randomized, controlled clinical trial in children of a dietary intervention informed by microbiome science.
Detailed description
Childhood obesity is a global health crisis and contributes to shortened life expectancy in the US, with higher rates and more serious co-morbidities among minorities. Existing dietary interventions demonstrate significant heterogeneity of treatment response among diverse populations, and clear information to tailor diet to individual-level characteristics is not yet available. Recent science suggests that the gut microbiome may in part explain inter-individual variation in pediatric obesity and treatment response. Intestinal microbial communities play causal roles in models of obesity and are distinct between individuals. However, it is unknown how the microbiome mediates response to existing dietary guidelines for children with obesity.
Evidence-based nutritional standards for treatment of pediatric obesity are well-established, and aim to reduce body mass index and cardio-metabolic risk. However, these standards have not translated into reduced prevalence of obesity among children, particularly those in racially diverse and low-income groups. One explanation is the significant inter-individual variability in metabolic response to dietary interventions, suggesting that certain food components in a diet may benefit some individuals more than others. Another explanation is that dietary adherence is highly variable, and requires skills or resources not available to all people. For example, translating dietary recommendations into food procurement, preparation, and consumption requires baseline levels of educational attainment, child acceptability of foods, diet compatibility with cultural preferences, and may be seen as time-consuming. These obstacles are hard to overcome for children and families from low-income and minority groups, who are known to have low show rates and engagement in nutrition studies despite being at disproportionate risk of diseases like obesity and metabolic disease. The one-size-fits-all approach to dietary recommendations is failing the most vulnerable children in the nation.
Recent science suggests that the gut microbiome provides new opportunities to address these long-standing challenges. Microbiome transplant experiments in mice have demonstrated that increased adiposity can be conferred from bacterial communities originating from individuals with obesity. Furthermore, variation in microbiome composition between individuals can predict response to dietary intervention, suggesting a mechanism for why certain individuals lose weight on specific diets and other individuals do not. Another intriguing aspect of microbiome science is how its adoption could introduce new methodological techniques to obesity treatment. In particular, the plummeting costs and turnaround times of metagenomic DNA sequencing used in microbiome research opens new opportunities for rapidly providing biomarker information to a wide number of people. |
No evidence exists that describes microbiome signatures with objective measures of dietary quality among children with obesity. The work to be completed here will be a vital first step towards integrating the promise of microbiome science into the treatment of pediatric obesity. Our team is uniquely suited to take this step as leaders in microbiome science (David) and childhood obesity (Armstrong). By working together to predict how individual microbiome variation shapes responses to diet therapy, an important step towards personalizing dietary recommendations for children based on gut microbiome signatures that predict the best outcome will be taken. In addition, linking microbial signatures to measures of diet quality will provide researchers with much-needed molecular tools for assessing dietary compliance and intervention success. Finally, insights into the impact of receiving metagenomic data on children's' motivation towards healthy behaviors could provide behavioral and implementation scientists with new tools for improving adherence with obesity treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –In a typical Healthy Lifestyless Nutrition visit, dietitians provide medical nutrition therapy to patients and their families. This includes addressing abnormal, nutrition-related lab values and providing targeted nutrition advice (foods to include, foods to limit) in order to resolve said labs. Motivational interviewing techniques will be used to help families identify barriers to Lifestyles change and provide strategies to help overcome these barriers. Families will receive compensation per each nutritional visit. |
| Intervention | Other | Behavioral: Microbiome friendly dietBesides the usual standard of care during the nutrition visits, participants will have guidance on a microbiome-friendly diet and will receive groceries 1 time per week for 4 weeks. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child aged 6 - 11 years (not yet aged 12)
- Child with BMI ≥ 95th percentile
- Parents are willing to accept home deliveries and have the ability to be home at the time and day that is most convenient for them to receive the groceries; or, have transportation available to go and pick up groceries at a time and date that is most convenient for them at a Walmart location.
Key exclusion criteria (7 listed)
- Does the child have a current diagnosis of obesity due to an underlying condition such as hypothyroidism, Cushing's disease, or known genetic condition?
- Is the child currently taking any weight-loss medication (steroids, anti-psychotics, anti-depressants)
- Has the child started a stimulant medication in the past 3 months? (stimulants include, among others, Ritalin, Adderall, concerta, focalin, vyvanse).
- Is the child currently taking, or has taken in the past 4 weeks, an antibiotic?
- Is the child currently taking, or plans to take in the next 4 weeks, a weight loss medication?
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiome friendly dietFamilies in the intervention group will have a microbiome-friendly nutrition assessment and will also receive groceries one time per week for four weeks to help achieve a more microbiome-friendly diet. | Behavioural | Intervention |
Primary outcome
Change in child dietary quality as measured by the DSQ
Time frame: Baseline, week 4 and week 8
The investigators will use the DSQ, which is the 26-item Dietary Screener Questionnaire, that asks about the frequency of consumption in the past month of selected foods and drinks. The DSQ captures intakes of fruits and vegetables, dairy/calcium, added sugars, whole grains/fiber, red meat, and processed meat. The study team will be focusing on microbiome friendly food, such as whole grains a fiber rich foods.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Armstrong, MD principal investigator
Duke department of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microbiome friendly diet in people with Pediatric Obesity, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in child dietary quality as measured by the DSQ (time frame: Baseline, week 4 and week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.