ObesityEVONCT04708769
Elements Vital to Treat Obesity Study
A study testing Smartphone App Participants (APP) and Diabetes Prevention Program Participants (DPP) in people with Obesity, run by Northwestern University at 1 site in United States.
Trial summary
The overall objective of this study is to evaluate the first rigorously optimized, remotely delivered treatment for obesity against the current gold standard treatment in a head-to-head randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Smartphone App Participants (APP) and Diabetes Prevention Program Participants (DPP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 524 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2021to 10 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 30-45
- Weight stable
- Own a Smartphone and be willing to install our Smartphone app
- Willing to conduct video conference calls with study staff
Who cannot join
- Enrolled in any formal weight loss program
- Taking anti-obesity medications
- Not taking medications that may cause weight gain
- Unstable medical conditions
- Diabetes requiring insulin supplementation
- Crohn's Disease
Show all 14Show fewer
- Diagnosis of obstructive sleep apnea requiring intervention (i.e., CPAP)
- Assistive devices for mobility
- Hospitalizations for a psychiatric disorder within the past 5 years
- Cardiovascular disease symptoms while performing moderate intensity exercise
- Pregnancy, trying to get pregnant, or lactating.
- Bulimia or binge eating disorder
- Reports of active suicidal ideation
- Current substance abuse or dependence besides nicotine dependence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the EVO Treatment Optimized for Resource Constraints: Elements Vital to Treat Obesity.
The overall objective of this study is to evaluate the first rigorously optimized, remotely delivered treatment for obesity against the current gold standard treatment in a head-to-head randomized controlled trial. The investigators will be comparing the previously developed and optimized behavioral weight loss intervention (APP) to the Diabetes Prevention Program (DPP), to evaluate program weight-loss success and cost-effectiveness.
Read the detailed description
The proposed study seeks to determine if the APP program is an effective, resource-sensitive strategy to manage weight for obesity, as compared to the DPP program. During the 24-week active intervention phase, participants will be randomized to one of two treatments: 1) APP, wherein participants receive calorie, fat, and physical activity goals via a Smartphone application for self-monitoring, online educational readings, and biweekly sessions with a Health Promotionist; or 2) DPP, wherein participants are guided to self-monitor their physical activity, food intake, and weight via a participant log, and are guided through 16 sessions by a Health Promotionist. Assessments to track progress will occur remotely at the 3-month, 6-month, and 12-month time points of the program.
- Conditions
- Obesity
- Being tested
- Smartphone App Participants (APP), Diabetes Prevention Program Participants (DPP)
- Keywords
- Weight Loss, Diet, Physical Activity, Self Monitoring, Mobile Health
- Medical subject headings
- Obesity, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone App Participants (APP)Behavioural
Participants will receive calorie, fat, and physical activity goals, a Smartphone application for self-monitoring their diet, activity and weight, online educational readings, and brief bi-weekly remote health sessions with a Health Promotionist. They will also be provided with a wireless bluetooth scale and portable blood pressure machine.
Diabetes Prevention Program Participants (DPP)Behavioural
In accordance with the Center for Disease Control curriculum, participants will receive a participant log for tracking physical activity, food intake, and weight, a paper participant guide with worksheets, logs, and psycho-educational materials, and 16 hour long remote sessions with a Health Promotionist. They will also be provided with a wireless bluetooth scale and portable blood pressure machine.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone App Participants (APP) | Experimental | Smartphone application, diet and activity goals, online lessons, brief remote sessions with a Health Promotionist Receives: Behavioral: Smartphone App Participants (APP) |
| Diabetes Prevention Program Participants (DPP) | Experimental | Participant program manual, diet and activity logs, hour long remote sessions with a Health Promotionist Receives: Behavioral: Diabetes Prevention Program Participants (DPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Participant change in weight, in kilograms, from baseline to 6-months.
Measured: Baseline to 6-Months
Secondary outcomes (1)
Costs of treatment
Costs of EVO versus DPP implementation
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start16 Mar 2021
- Primary completion15 Dec 2025
- Study completion10 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 524 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine
- Responsible party
- Principal investigator, Angela Fidler Pfammatter, PhD, Northwestern University
- Investigators
- Angela Pfammatter, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708769
- Sponsor's protocol ID
- STU00212742
- Acronym
- EVO
- Status last verified
- Apr 2026
- First submitted
- 12 Jan 2021
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.
PubMed 38375882
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the EVO Treatment Optimized for Resource Constraints: Elements Vital to Treat Obesity.
- ClinicalTrials.gov ID
- NCT04708769
- Acronym / sponsor ID
- EVO / STU00212742
- Conditions
- Obesity
- Keywords
- Weight Loss, Diet, Physical Activity, Self Monitoring, Mobile Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 524 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Washington University School of Medicine
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 10 Jul 2026 (estimated)
- First posted
- 14 Jan 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 overall objective of this study is to evaluate the first rigorously optimized, remotely delivered treatment for obesity against the current gold standard treatment in a head-to-head randomized controlled trial. The investigators will be comparing the previously developed and optimized behavioral weight loss intervention (APP) to the Diabetes Prevention Program (DPP), to evaluate program weight-loss success and cost-effectiveness.
Detailed description
The proposed study seeks to determine if the APP program is an effective, resource-sensitive strategy to manage weight for obesity, as compared to the DPP program. During the 24-week active intervention phase, participants will be randomized to one of two treatments: 1) APP, wherein participants receive calorie, fat, and physical activity goals via a Smartphone application for self-monitoring, online educational readings, and biweekly sessions with a Health Promotionist; or 2) DPP, wherein participants are guided to self-monitor their physical activity, food intake, and weight via a participant log, and are guided through 16 sessions by a Health Promotionist. Assessments to track progress will occur remotely at the 3-month, 6-month, and 12-month time points of the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone App Participants (APP) | Experimental | Behavioral: Smartphone App Participants (APP)Smartphone application, diet and activity goals, online lessons, brief remote sessions with a Health Promotionist |
| Diabetes Prevention Program Participants (DPP) | Experimental | Behavioral: Diabetes Prevention Program Participants (DPP)Participant program manual, diet and activity logs, hour long remote sessions with a Health Promotionist |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI 30-45
- Weight stable
- Own a Smartphone and be willing to install our Smartphone app
- Willing to conduct video conference calls with study staff
Key exclusion criteria (14 listed)
- Enrolled in any formal weight loss program
- Taking anti-obesity medications
- Not taking medications that may cause weight gain
- Unstable medical conditions
- Diabetes requiring insulin supplementation
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 |
|---|---|---|
| Smartphone App Participants (APP)Participants will receive calorie, fat, and physical activity goals, a Smartphone application for self-monitoring their diet, activity and weight, online educational readings, and brief bi-weekly remote health sessions with a Health Promotionist. They will also be provided with a wireless bluetooth scale and portable blood pressure machine. | Behavioural | Smartphone App Participants (APP) |
| Diabetes Prevention Program Participants (DPP)In accordance with the Center for Disease Control curriculum, participants will receive a participant log for tracking physical activity, food intake, and weight, a paper participant guide with worksheets, logs, and psycho-educational materials, and 16 hour long remote sessions with a Health Promotionist. They will also be provided with a wireless bluetooth scale and portable blood pressure machine. | Behavioural | Diabetes Prevention Program Participants (DPP) |
Primary outcome
Weight
Time frame: Baseline to 6-Months
Participant change in weight, in kilograms, from baseline to 6-months.
1 secondary outcome
Costs of treatment
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 38375882Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.
- 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.
Angela Pfammatter, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone App Participants (APP) and Diabetes Prevention Program Participants (DPP) in people with Obesity, run by Northwestern 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 4 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Weight (time frame: Baseline to 6-Months). 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 NCT04708769, which also lists 1 linked publication.
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 6 May 2026.