ObesityEHR-WWCNCT04514679

EHR Embedded Comparative Effectiveness Studies--WWC

A study testing Dietician / Health Coach and Health Coach / Dietician in people with Obesity, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Obesity
What is being tested?: Dietician / Health Coach and Health Coach / Dietician
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 23 Oct 2020to 27 Sep 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Inclusion Criteria: Adults (>18) able to consent, with sufficient fluency in English; Initial RD and HC visits are part of routine care as recommended by the provider; willing to be randomized

Exclusion Criteria: Pregnant women; Prisoners; Children (<18)

Trial locations and contacts

1 site in 1 country.

United States1 site

Dartmouth-Hitchcock
Lebanon, New Hampshire, 03756

Other trials in United States

About this study

Official title: Randomize Everyone: Creating Valid Instrumental Variables for Learning Health Care Systems

Randomize Everyone is a research project to develop new informatics systems and statistical methods for supporting randomization processes in EHR systems to do comparative effectiveness research. Two demonstration projects are being conducted in the Dartmouth Hitchcock Medical Center, designed to evaluate different weight loss interventions and common practices in the treatment of chronic low back pain.

Read the detailed description

EHR Embedded Comparative Effectiveness Studies-WWC will be held in the Weight and Wellness Clinics at Dartmouth-Hitchcock Medical Center. This study consists of randomizing enrollees to either the dietitian/health coach appointment sequence or the health coach/dietitian appointment sequence.

Conditions: Obesity
Being tested: Dietician / Health Coach, Health Coach / Dietician
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dietician / Health CoachBehavioural
The order of visit for the two types of providers is first Dietician then Health Coach.
Health Coach / DieticianBehavioural
The order of visit for the two types of providers is first Health Coach then Dietician.

Study groups in NCT04514679
Study group	Role	What they receive
Dietician / Health Coach	Active comparator	Patients having obesity treatment would first see a dietician, and then see a health coach. Receives: Behavioral: Dietician / Health Coach
Health Coach / Dietician	Active comparator	Patients having obesity treatment would first see a health coach, and then see a dietician. Receives: Behavioral: Health Coach / Dietician

What is being measured

The primary outcome is the main question the study is designed to answer.

Compliance Rate
Percentage of those in each arm who complete the two visits in the correct order assigned.
Measured: Baseline through approximately 2 months
Percentage of Eligible Patients Participating
Percentage of those identified as being eligible who were enrolled in the study.
Measured: One day, during the recruitment period of October 23, 2020 to February 3, 2021.

Secondary outcomes (1)

Change in Body Mass Index (BMI) at 30 Days
Linear trends (or "slopes") for per 30 days are calculated in each group. The slopes were calculated from repeated BMI measurements in each treatment group, and expressed in terms of the change in BMI predicted at 30 days post randomization.
Measured: 30 days since baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Oct 202027 Sep 2021

First posted17 Aug 2020
Study start23 Oct 2020
Primary completion27 Sep 2021
Study completion27 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ObesityStudies of the same condition, open and under way.
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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04514679
Sponsor's protocol ID: D19107a
Acronym: EHR-WWC
Status last verified: May 2025
First submitted: 10 Jan 2020
Last updated: 12 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomize Everyone: Creating Valid Instrumental Variables for Learning Health Care Systems
ClinicalTrials.gov ID: NCT04514679
Acronym / sponsor ID: EHR-WWC / D19107a
Conditions: Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
Collaborators: Trustees of Dartmouth College, Patient-Centered Outcomes Research Institute
Study start: 23 Oct 2020 (actual)
Primary completion: 27 Sep 2021 (actual)
Study completion: 27 Sep 2021 (actual)
First posted: 17 Aug 2020 (actual)
Results: Posted 12 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dietician / Health Coach	Active comparator	Behavioral: Dietician / Health CoachPatients having obesity treatment would first see a dietician, and then see a health coach.
Health Coach / Dietician	Active comparator	Behavioral: Health Coach / DieticianPatients having obesity treatment would first see a health coach, and then see a dietician.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

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
Dietician / Health CoachThe order of visit for the two types of providers is first Dietician then Health Coach.	Behavioural	Dietician / Health Coach
Health Coach / DieticianThe order of visit for the two types of providers is first Health Coach then Dietician.	Behavioural	Health Coach / Dietician

Primary outcome

Compliance Rate
Time frame: Baseline through approximately 2 months
Percentage of those in each arm who complete the two visits in the correct order assigned.
Percentage of Eligible Patients Participating
Time frame: One day, during the recruitment period of October 23, 2020 to February 3, 2021.
Percentage of those identified as being eligible who were enrolled in the study.

1 secondary outcome

Change in Body Mass Index (BMI) at 30 Days
Time frame: 30 days since baseline

Results and safety

Results posted to the registry on 12 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dietician / Health Coach	30	30
Health Coach / Dietician	30	30

Primary outcome: Compliance Rate

Time frame: Baseline through approximately 2 months. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Dietician / Health Coach n = 28	Health Coach / Dietician n = 29
Value	87 (66 to 97)	76 (54 to 90)

Population analysed: Those who had health record data, which eliminated 3 patients.

Primary outcome: Percentage of Eligible Patients Participating

Time frame: One day, during the recruitment period of October 23, 2020 to February 3, 2021.. Number (95% Confidence Interval). Unit: percentage of eligible patients

Measure	All Eligible Patients n = 459
Value	13.1 (10.2 to 16.6)

Population analysed: All patients who were identified as being eligible.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months post randomization. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dietician / Health Coach	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Health Coach / Dietician	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Limitations and caveats (from the sponsor): This study is part of a project that evaluates the utility of methods to use randomized methods for evaluating comparative effectiveness questions using the electronic health record of a health system. The primary focus is on the feasibility of the method, including the patient participation and compliance rates for an intervention in an obesity clinic involving timing of visits to a health coach and a dietician. The results regarding the efficacy of the intervention are secondary outcomes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Obesity

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Not yet recruitingObservational study
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dietician / Health Coach and Health Coach / Dietician in people with Obesity, run by Dartmouth-Hitchcock Medical Center 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?

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 12 Jun 2025. 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?

Yes. Results are posted in the registry (first posted 12 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Compliance Rate (time frame: Baseline through approximately 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04514679.

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 12 Jun 2025.