NCT04073394

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

July 6, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

February 3, 2023

Status Verified

February 1, 2023

Enrollment Period

1.6 years

First QC Date

August 28, 2019

Last Update Submit

February 2, 2023

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • 12-week total body weight loss

    Change in body weight during the 12 week study

    12 weeks

Secondary Outcomes (11)

  • Responder Rate

    12 weeks

  • Waist Circumference

    12 weeks

  • Fat Loss

    12 weeks

  • Calorie Intake

    12 weeks

  • Calories to Fullness

    12 weeks

  • +6 more secondary outcomes

Study Arms (2)

Standard Lifestyle Intervention

ACTIVE COMPARATOR

Participants 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.

Behavioral: Standard Lifestyle Intervention

Modified Lifestyle Intervention

EXPERIMENTAL

Participants in this group will have a tailored diet, exercise, and behavioral plan according to their obesity phenotype.

Behavioral: Modified Lifestyle Intervention

Interventions

Standard Lifestyle InterventionBEHAVIORAL

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.

Standard Lifestyle Intervention
Modified Lifestyle InterventionBEHAVIORAL

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.

Modified Lifestyle Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

    PMID: 37007741DERIVED

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Andres Acosta, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 28, 2019

First Posted

August 29, 2019

Study Start

July 6, 2020

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

February 3, 2023

Record last verified: 2023-02

Locations

US(1)