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Completed

NCT Number: NCT04073394

Individualized Lifestyle Intervention for Obesity Management Based on Obesity Phenotypes

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Standard Lifestyle Intervention

Behavioral

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 Intervention

Behavioral

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.

Primary outcomes

  1. 12-week total body weight loss

    Time frame: 12 weeks

    Change in body weight during the 12 week study

Secondary outcomes

  1. Responder Rate

    Time frame: 12 weeks

    Proportion of patients losing > 3% of total body weight

  2. Waist Circumference

    Time frame: 12 weeks

    Change in waist circumference (cm)

  3. Fat Loss

    Time frame: 12 weeks

    Change in fat mass during the 12 week study using DEXA

  4. Calorie Intake

    Time frame: 12 weeks

    Change in daily calorie intake

  5. Calories to Fullness

    Time frame: 12 weeks

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

  6. Gastric Emptying

    Time frame: 12 weeks

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

  7. Gastric Emptying 2 Hours

    Time frame: 12 weeks

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

  8. Anxiety Level

    Time frame: 12 weeks

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

  9. Emotional Eating

    Time frame: 12 weeks

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

  10. Resting Metabolic Rate

    Time frame: 12 weeks

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

  11. Adherence

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 29, 2019
Registry last updated
Feb 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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