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ObesityNCT04073394

Individualized Lifestyle Intervention for Obesity Management Based on Obesity Phenotypes

A study testing Standard Lifestyle Intervention and Modified Lifestyle Intervention in people with Obesity, run by Mayo Clinic 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

The purpose of this protocol is to define an "individualized diet" approach based on obesity related phenotypes (pathophysiology obesity classification), which would increase weight loss, adherence, and weight loss maintenance. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Standard Lifestyle Intervention and Modified Lifestyle Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
215 participants
Where
1 siteUnited States
Study dates
6 Jul 2020to 31 Jan 2022
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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults with obesity (BMI >30Kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and uncontrolled life-threatening comorbidities (i.e. unstable angina).
  • Age: 18-65 years.
  • Gender: Men or women.

Who cannot join

  • Weight change greater than 3% in the previous 3 months (weight stable).
  • History of bariatric surgery including lap band and bariatric endoscopy.
  • Significant untreated psychiatric dysfunction including binge eating disorders and bulimia.
  • Current use of anti-obesity pharmacotherapy, medications known to affect weight (e.g., corticosteroids) or GLP-1 agonist/analog for T2DM
  • A positive score on the AUDIT-C questionnaire as judged by an investigator.
  • Patient has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherence

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: "Mayo Clinic Diet" Individualized Lifestyle Intervention for Obesity Management Based on Obesity Phenotypes (PHENO-Diet Trial)

The purpose of this protocol is to define an "individualized diet" approach based on obesity related phenotypes (pathophysiology obesity classification), which would increase weight loss, adherence, and weight loss maintenance.

Conditions
Obesity
Being tested
Standard Lifestyle Intervention, Modified Lifestyle Intervention
Medical subject headings
Obesity

What participants receive

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

  • Standard Lifestyle InterventionBehavioural

    Research team will prescribe diet, exercise, behavioral plan for the participant to follow for the 12 week study. The lifestyle plan will be based on the Mayo Clinic Diet program.

  • Modified Lifestyle InterventionBehavioural

    Research team will prescribe diet, exercise, behavioral plan for the participant to follow for the 12 week study. The lifestyle plan will be based on the participants obesity phenotype.

Study groups in NCT04073394
Study groupRoleWhat they receive
Standard Lifestyle InterventionActive comparatorParticipants in this group will be instructed to follow a standard low calorie diet, recommended to have 30 minutes of physical activity 3-5 days per week, and will be followed by a wellness couch weekly.
Receives: Behavioral: Standard Lifestyle Intervention
Modified Lifestyle InterventionExperimentalParticipants in this group will have a tailored diet, exercise, and behavioral plan according to their obesity phenotype.
Receives: Behavioral: Modified Lifestyle Intervention

What is being measured

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

  1. 12-week total body weight loss

    Change in body weight during the 12 week study

    Measured: 12 weeks

Secondary outcomes (11)

  1. Responder Rate

    Proportion of patients losing > 3% of total body weight

    Measured: 12 weeks

  2. Waist Circumference

    Change in waist circumference (cm)

    Measured: 12 weeks

  3. Fat Loss

    Change in fat mass during the 12 week study using DEXA

    Measured: 12 weeks

  4. Calorie Intake

    Change in daily calorie intake

    Measured: 12 weeks

  5. Calories to Fullness

    Change in calories consumed to fullness during the 12 week study using satiation test

    Measured: 12 weeks

  6. Gastric Emptying

    Change in half gastric emptying time during the 12 week study using scintigraphy

    Measured: 12 weeks

  7. Gastric Emptying 2 Hours

    Change in gastric emptying percentage at 2 hours during the 12 week study using scintigraphy

    Measured: 12 weeks

  8. Anxiety Level

    Change is anxiety level during the 12 week study using the HADS-A scale

    Measured: 12 weeks

  9. Emotional Eating

    Change is emotional eating level during the 12 week study using the TFEQ score

    Measured: 12 weeks

  10. Resting Metabolic Rate

    Change in resting energy expenditure during the 12 week study using an indirect calorimetry

    Measured: 12 weeks

  11. Adherence

    Adherence and compliance with program defined by the number of contacts with the team

    Measured: 12 weeks

Timeline

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

  1. First posted29 Aug 2019
  2. Study start6 Jul 2020
  3. Primary completion31 Jan 2022
  4. Study completion31 Jan 2022

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04073394
Sponsor's protocol ID
19-007485
Status last verified
Feb 2023
First submitted
28 Aug 2019
Last updated
3 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Anazco D, Koball A, Cifuentes L, Villamarin J, Friend J, Fansa S, Espinosa MA, Rieck TM, Grothe K, Camilleri M, Hurtado MD, Acosta A, Clark MM, Hensrud DD. Phenotype tailored lifestyle intervention for weight management in individuals with emotional eating: A secondary analysis of the PHENO-Diet trial. Obes Pillars. 2026 Jun 17;19:100284. doi: 10.1016/j.obpill.2026.100284. eCollection 2026 Sep.

    PubMed 42382664

  • Cifuentes L, Ghusn W, Feris F, Campos A, Sacoto D, De la Rosa A, McRae A, Rieck T, Mansfield S, Ewoldt J, Friend J, Grothe K, Lennon RJ, Hurtado MD, Clark MM, Camilleri M, Hensrud DD, Acosta A. Phenotype tailored lifestyle intervention on weight loss and cardiometabolic risk factors in adults with obesity: a single-centre, non-randomised, proof-of-concept study. EClinicalMedicine. 2023 Mar 24;58:101923. doi: 10.1016/j.eclinm.2023.101923. eCollection 2023 Apr.

    PubMed 37007741

Questions about this trial

What is this clinical trial studying?

A study testing Standard Lifestyle Intervention and Modified Lifestyle Intervention in people with Obesity, run by Mayo Clinic 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 6 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 3 Feb 2023. 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?

12-week total body weight loss (time frame: 12 weeks). 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 NCT04073394, which also lists 2 linked publications.

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 3 Feb 2023.

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